Complementary Feeding Interventions for Infants and Young Children Under Age 2: Scoping of Promising Interventions to Implement at the Community or State Level (2023)
Chapter: Appendix F: Scalability Assessments for Informative Studies
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Appendix E: Data Extraction Tables
Appendix F
Suggested Citation:
"Appendix F: Scalability Assessments for Informative Studies." National Academies of Sciences, Engineering, and Medicine. 2023. Complementary Feeding Interventions for Infants and Young Children Under Age 2: Scoping of Promising Interventions to Implement at the Community or State Level. Washington, DC: The National Academies Press.
doi: 10.17226/27239.
Appendix F
Scalability Assessments for Informative Studies
This appendix contains the following:
Table F-2: INFANT ExpandNet Checklist
Table F-4: INSIGHT ExpandNet Checklist
Table F-5: Family Spirit Nurture TIDieR
Table F-6: Family Spirit Nurture ExpandNet Checklist
INFANT
| Delivery Feature | RCT | Scale-Up |
|---|---|---|
| Brief Name: | INFANT: Melbourne Infant Feeding, Activity, and Nutrition Trial (INFANT)—a community-based cluster RCT of an early intervention promoting healthy eating and active play and, in turn, healthy growth from the start of life | INFANT: Infant Feeding, Activity and Nutrition (INFANT)—an early intervention promoting healthy eating and active play and, in turn, healthy growth from the start of life |
Suggested Citation:
"Appendix F: Scalability Assessments for Informative Studies." National Academies of Sciences, Engineering, and Medicine. 2023. Complementary Feeding Interventions for Infants and Young Children Under Age 2: Scoping of Promising Interventions to Implement at the Community or State Level. Washington, DC: The National Academies Press.
doi: 10.17226/27239.
| Delivery Feature | RCT | Scale-Up |
|---|---|---|
| Why: Describe any rationale, theory, or goal | Anticipatory guidance framework Social cognitive theory Parenting support theory | Anticipatory guidance framework Social cognitive theory Parenting support theory COM-B model of behavior |
| What: Materials (describe any physical or information materials used in the intervention, including given to participants or used in intervention delivery or in the training of providers) |
Session delivery
|
Session delivery
|
Suggested Citation:
"Appendix F: Scalability Assessments for Informative Studies." National Academies of Sciences, Engineering, and Medicine. 2023. Complementary Feeding Interventions for Infants and Young Children Under Age 2: Scoping of Promising Interventions to Implement at the Community or State Level. Washington, DC: The National Academies Press.
doi: 10.17226/27239.
| Delivery Feature | RCT | Scale-Up |
|---|---|---|
| What: Procedures (describe each of the procedures, activities, or processes used in the intervention) |
Facilitated group discussions, including watching videos
Peer support Exploration of barriers Interactive activities (e.g., tummy time with babies together) Reference to and promotion of DVDs and other take-home materials during the sessions Repeated text messages of educational materials sent after sessions are completed |
Facilitated group discussions, including watching the videos
Peer support Exploration of barriers Interactive activities (e.g., tummy time with babies together) App push notifications, activities (self-completed quizzes for personalized feedback), and parent forum Promotion of the app to parents from their infant’s birth. Reference to and promotion of the app during sessions. |
| Who: Intervention provider (describe their expertise, background, and any specific training given) | Intervention provider: Research dietitian employed by the research team Training of provider: 2-hr face-to-face training meetings prior to each round of INFANT sessions (six in total), facilitated by lead researchers/interventionists | Intervention provider: Delivered as part of routine practice by practitioners such as dietitians, maternal and child health nurses, health promotion officers, midwives, other parenting support or allied health workers. Training of intervention provider: 8- to 10-hr online training course offered over a 4- to 6-wk period (2–4 times per year) facilitated by lead interventionists and implementation experts. Annual 1- to 2-hr online refresher training. |
| Who: Target population | Parents (including first-time parents) of children ages 3–18 months | Parents |
| How: Mode of delivery (e.g., face to face; and whether it was individually or in a group) |
Face-to-face group sessions DVD and printed materials provided in sessions
Printed newsletters sent via text messaging and mail between sessions |
Face-to-face group sessions
Mobile phone app including notifications |
Suggested Citation:
"Appendix F: Scalability Assessments for Informative Studies." National Academies of Sciences, Engineering, and Medicine. 2023. Complementary Feeding Interventions for Infants and Young Children Under Age 2: Scoping of Promising Interventions to Implement at the Community or State Level. Washington, DC: The National Academies Press.
doi: 10.17226/27239.
| Delivery Feature | RCT | Scale-Up |
|---|---|---|
| Where: Location of intervention (including necessary infrastructure or relevant features) |
Community facilities close to where first-time parent group sessions were held (e.g., maternal and child health centers, libraries, community halls)
Sessions were delivered within existing first-time parent groups led by community maternal and child health nurses as part of free universal health care system in Victoria Australia INFANT sessions started with the group directly after the nurses concluded/when parents took over their own management of the groups |
Community facilities (e.g., maternal and child health centers, community health organization group rooms, libraries)
Sessions not limited to existing first-time parent groups Organizations have the option to adopt this approach, but it is not essential. Groups may be constructed for the purpose of delivery or embedded into existing groups. |
| When: Describe the number of times the intervention was delivered over what period of time (including the number of sessions, their schedule and duration, intensity or dose) |
Total intervention period: 15 months
6× 2-hr sessions at 3, 6, 9, 12, 15, 18 mo of age 5× newsletters sent between sessions |
Total intervention period: 18 months 4× 1.5-hr group sessions at 3, 6, 9, 12 mo of age
Additional support via app, including push notifications and discussion forum between birth and 18 mo |
| Tailoring: Adapted for individuals? (why, what, when, and how) | Group discussions were tailored to participants preferences, concerns, or situations |
Group discussions were tailored to participants’ preferences, concerns, or situations
The app push notifications are tailored according to the participant’s feeding mode (breast, formula, or mixed feeding) and child’s age and stage of development |
Suggested Citation:
"Appendix F: Scalability Assessments for Informative Studies." National Academies of Sciences, Engineering, and Medicine. 2023. Complementary Feeding Interventions for Infants and Young Children Under Age 2: Scoping of Promising Interventions to Implement at the Community or State Level. Washington, DC: The National Academies Press.
doi: 10.17226/27239.
| Delivery Feature | RCT | Scale-Up |
|---|---|---|
| How well: Planned (describe how and by whom and if any strategies were used to maintain or improve fidelity) |
Standardized session outline for facilitators to improve fidelity
Between-session newsletters sent via email and texting to participants to remind of key messages and promote adherence |
Standardized session outline for facilitators to improve fidelity
Data collection planned for monitoring fidelity includes (1) undertaking fidelity checklists from a subset of implementing sites, (2) facilitator reporting of delivery of intervention in 12-mo post-training survey |
| How well: Actual (describe the extent to which the intervention was delivered as planned) |
Program fidelity was audited via checklists by researchers attending but not delivering the intervention
68% of participants attended four or more of the six sessions |
Program implementation and data collection in progress; therefore, fidelity is currently uncertain. |
| Context: Funding and the broader environment |
Lead organization: Deakin University
Environment: occurred prior to policy/programs emphasis on pregnancy or early life period Funding: National Health and Medical Research Council Grant |
Lead organization: Overseen by Deakin University research interventionists, led by local government areas and services
Environment: Occurring in the context of COVID-19 pandemic and Victoria’s extensive lockdown periods Funding: Funding to enhance implementation provided by Victorian Department of Health (supports training at no cost to practitioners, seed funding for establishing the program, and implementation support). No additional funding for delivery for local organizations is currently provided. An evaluation of the scale-up is being funded by a 5-yr National Health and Medical Research Council Partnership Grant GNT1161223. |
SOURCES: Cameron et al. (2014); Campbell et al. (2013); Hesketh et al. (2020); Marshall et al. (2023); Spence et al. (2013, 2014); Zheng et al. (2022).
Suggested Citation:
"Appendix F: Scalability Assessments for Informative Studies." National Academies of Sciences, Engineering, and Medicine. 2023. Complementary Feeding Interventions for Infants and Young Children Under Age 2: Scoping of Promising Interventions to Implement at the Community or State Level. Washington, DC: The National Academies Press.
doi: 10.17226/27239.
TABLE F-2 INFANT ExpandNet Checklist
| Questions Related to Potential Scalability | Yes (+) | No (–) | More Information/Action Needed |
|---|---|---|---|
| Is input about the project being sought from a range of stakeholders (e.g., policy makers, program managers, providers, NGOs, beneficiaries)? | + | Scale-up based on inputs from efficacy trial, translational trial, and stakeholders’ input | |
| Are individuals from the future implementing agency involved in the design and implementation of the pilot? | + | Scale-up based on inputs from efficacy trial, translational trial, and stakeholders’ input | |
| Does the project have mechanisms for building ownership in the future implementing organization? | ? | To some extent, ongoing scale-up study likely to provide answers | |
| Does the innovation address a persistent health or service delivery problem? | + | Addressing unhealthy eating habits since early infancy and corresponding obesity risk is a top priority in Victoria | |
| Is the innovation based on sound evidence and preferable to alternative approaches? | + | Based on efficacy trial and sound conceptual frameworks | |
| Given the financial and human-resource requirements, is the innovation feasible in the local settings where it is to be implemented? | ? | Ongoing scale-up study may answer this question | |
| Is the innovation consistent with existing national health policies, plans, and priorities? | + | Addressing unhealthy eating habits since early infancy and corresponding obesity risk is a top priority in Victoria | |
| Is the project being designed in light of agreed-upon stakeholder expectations for where and to what extent interventions are to be scaled up? | + | Program already being scaled up with input from stakeholders |
Suggested Citation:
"Appendix F: Scalability Assessments for Informative Studies." National Academies of Sciences, Engineering, and Medicine. 2023. Complementary Feeding Interventions for Infants and Young Children Under Age 2: Scoping of Promising Interventions to Implement at the Community or State Level. Washington, DC: The National Academies Press.
doi: 10.17226/27239.
| Questions Related to Potential Scalability | Yes (+) | No (–) | More Information/Action Needed |
|---|---|---|---|
| Has the project identified and taken into consideration community, cultural, and gender factors that might constrain or support implementation of the innovation? | – | Unclear if and how potential inequities in benefit will be addressed. Disparities/inequities not addressed in scale-up study, although prior effect modification analysis conducted based on maternal education and age | |
| Have the norms, values, and operational culture of the implementing agency been taken into account in the design of the project? | ? | To some extent, as DOH is engaged and funding training | |
| Have the opportunities and constraints of the political, policy, health sector, and other institutional factors been considered in designing the project? | ? | To some extent; ongoing scale-up study may provide answers | |
| Has the package of interventions been kept as simple as possible without jeopardizing outcomes? | + | Scale-up based on inputs from efficacy trial, translational trial, and stakeholders’ input | |
| Is the innovation being tested in the variety of sociocultural and geographic settings where it will be scaled up? | + | Program currently being scaled up and evaluated using sound implementation science methods | |
| Is the innovation being tested in the type of service-delivery points and institutional settings in which it will be scaled up? | + | Program already being scaled up with input from stakeholders, including providers | |
| Does the innovation being tested require human and financial resources that can reasonably be expected to be available during scale-up? | + | Scale-up project currently being funded by DOH and NHMRC | |
| Will the financing of the innovation be sustainable? | ? | To some extent, ongoing scale-up study may provide a more concrete answer(s) | |
| Does the health system currently have the capacity to implement the innovation? If not, are there plans to test ways to increase health system’s capacity? | + | Program already being scaled up with input from stakeholders, including providers |
Suggested Citation:
"Appendix F: Scalability Assessments for Informative Studies." National Academies of Sciences, Engineering, and Medicine. 2023. Complementary Feeding Interventions for Infants and Young Children Under Age 2: Scoping of Promising Interventions to Implement at the Community or State Level. Washington, DC: The National Academies Press.
doi: 10.17226/27239.
| Questions Related to Potential Scalability | Yes (+) | No (–) | More Information/Action Needed |
|---|---|---|---|
| Are appropriate steps being taken to assess and document health outcomes as well as the process of implementation? | + | Scale-up being carefully assessed with robust implementation study | |
| Is there provision for early and continuous engagement with donors and technical partners to build a broad base of financial support for scale-up? | ? | Scale-up being carefully assessed with robust implementation study. However, unclear to what extent long-term funders have been engaged | |
| Are there plans to advocate for changes in policies, regulations, and other health systems components needed to institutionalize the innovation? | ? | To some extent, ongoing scale-up study may provide a more concrete answer(s) | |
| Does the project design include mechanisms to review progress and incorporate new learning into the implementation process? | + | Scale-up being carefully assessed with robust implementation study | |
| Is there a plan to share findings and insights from the pilot project during implementation? | + | Has already happened before adaptations made for ongoing scale-up. | |
| Is there a shared understanding among key stakeholders about the importance of having adequate evidence related to the feasibility and outcomes of the innovation prior to scaling up? | + | Scale-up based on inputs from efficacy trial, translational trial, and stakeholders’ input |
SOURCES: Cameron et al. (2014); Campbell et al. (2013); Hesketh et al. (2020); Marshall et al. (2023); Spence et al. (2013, 2014); Zheng et al. (2022).
INSIGHT
| Delivery Feature | RCT Intervention |
|---|---|
| Brief Name: | Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT)—RCT of an early life responsive parenting intervention to prevent rapid infant weight gain and childhood obesity |
Suggested Citation:
"Appendix F: Scalability Assessments for Informative Studies." National Academies of Sciences, Engineering, and Medicine. 2023. Complementary Feeding Interventions for Infants and Young Children Under Age 2: Scoping of Promising Interventions to Implement at the Community or State Level. Washington, DC: The National Academies Press.
doi: 10.17226/27239.
| Delivery Feature | RCT Intervention |
|---|---|
| Why: Describe any rationale, theory, or goal |
Goal: Prevent childhood obesity Theories: Responsive parenting framework |
| What: Materials (describe any physical or information materials used in the intervention, including given to participants or used in intervention delivery or in the training of providers) |
Session delivery
|
| What: Procedures (describe each of the procedures, activities, or processes used in the intervention) |
Research nurses delivered the intervention at four home visits
Education/guidance and discussions on responsive parenting/obesity prevention messages corresponding to four infant behavior states Specific messages on feeding taught to parents to recognize hunger and satiety cues, offer age-appropriate foods, portion size, repeated exposure, not to use food as a reward, etc. In-person and video demonstrations |
| Who: Intervention provider (describe their expertise, background, and any specific training given) |
Intervention provider: Research nurses Training of provider: Who performed the trainings was not described |
| Who: Target population | First-time parents (maternal age >20) that delivered full-term singleton newborns at Penn State Milton S. Hershey Medical Center |
| How: Mode of delivery (e.g., face to face; and whether it was individually or in a group) |
Face to face Videos Preliminary materials (not described other than mailed before the start of the intervention) |
| Where: Location of intervention (including necessary infrastructure or relevant features) | Home visits |
Suggested Citation:
"Appendix F: Scalability Assessments for Informative Studies." National Academies of Sciences, Engineering, and Medicine. 2023. Complementary Feeding Interventions for Infants and Young Children Under Age 2: Scoping of Promising Interventions to Implement at the Community or State Level. Washington, DC: The National Academies Press.
doi: 10.17226/27239.
| Delivery Feature | RCT Intervention |
|---|---|
| When: Describe the number of times the intervention was delivered over what period of time (including the number of sessions, their schedule and duration, intensity or dose) |
Four visits (child age 3‒4, 16, 28, and 40 wks) Length of the home visits was not described Two videos provided |
| Tailoring: Adapted for individuals? (why, what, when, and how) | Not described |
| How well: Planned (describe how and by whom and if any strategies were used to maintain or improve fidelity) | Research nurses followed a strict curriculum with routine fidelity assessment |
| How well: Actual (describe the extent to which the intervention was delivered as planned) | At the end of each home visit fidelity was assessed by the participating mothers (nurses delivered 96%, 88%, 91%, and 97% of outlined content at each of the four visits, respectively) |
| Context: Funding and the broader environment |
Timeframe: 2012–2017 Funding: NIH RO1 |
SOURCES: Harris et al. (2020); Hohman et al. (2017, 2020); Savage et al. (2016, 2018).
TABLE F-4 INSIGHT ExpandNeT Checklist
| Questions Related to Potential Scalability | Yes (+) | No (–) | More Information/Action Needed |
|---|---|---|---|
| Is input about the project being sought from a range of stakeholders (e.g., policy makers, program managers, providers, NGOs, beneficiaries)? | – | Not reported | |
| Are individuals from the future implementing agency involved in the design and implementation of the pilot? | – | Not reported | |
| Does the project have mechanisms for building ownership in the future implementing organization? | – | Not reported; specific future implementing organization(s) not identified | |
| Does the innovation address a persistent health or service delivery problem? | + | Prevention of childhood obesity |
Suggested Citation:
"Appendix F: Scalability Assessments for Informative Studies." National Academies of Sciences, Engineering, and Medicine. 2023. Complementary Feeding Interventions for Infants and Young Children Under Age 2: Scoping of Promising Interventions to Implement at the Community or State Level. Washington, DC: The National Academies Press.
doi: 10.17226/27239.
| Questions Related to Potential Scalability | Yes (+) | No (–) | More Information/Action Needed |
|---|---|---|---|
| Is the innovation based on sound evidence and preferable to alternative approaches? | ? | Unclear. Efficacy trial demonstrated impact on some targeted “how to feed” behaviors but had less impact on what children consumed. | |
| Given the financial and human-resource requirements, is the innovation feasible in the local settings where it is to be implemented? | ? | Unclear/unknown | |
| Is the innovation consistent with existing national health policies, plans, and priorities? | + | Consistent with Healthy People 2030 goal NWS-04: Reduce the proportion of children and adolescents with obesity | |
| Is the project being designed in light of agreed-upon stakeholder expectations for where and to what extent interventions are to be scaled up? | ? | Unclear/unknown | |
| Has the project identified and taken into consideration community, cultural, and gender factors that might constrain or support implementation of the innovation? | – | Not reported; study conducted in one community with a homogenous, privileged population | |
| Have the norms, values, and operational culture of the implementing agency been taken into account in the design of the project? | – | Not reported; no implementing agency identified | |
| Have the opportunities and constraints of the political, policy, health sector, and other institutional factors been considered in designing the project? | – | Not reported | |
| Has the package of interventions been kept as simple as possible without jeopardizing outcomes? | + | Four home visits, with some evidence of impact on how to feed and child weight-related outcomes | |
| Is the innovation being tested in the variety of sociocultural and geographic settings where it will be scaled up? | – | Study conducted in one community with a homogenous, privileged population |
Suggested Citation:
"Appendix F: Scalability Assessments for Informative Studies." National Academies of Sciences, Engineering, and Medicine. 2023. Complementary Feeding Interventions for Infants and Young Children Under Age 2: Scoping of Promising Interventions to Implement at the Community or State Level. Washington, DC: The National Academies Press.
doi: 10.17226/27239.
| Questions Related to Potential Scalability | Yes (+) | No (–) | More Information/Action Needed |
|---|---|---|---|
| Is the innovation being tested in the type of service-delivery points and institutional settings in which it will be scaled up? | + | Being tested in the home visiting setting and will be delivered in home visiting setting | |
| Does the innovation being tested require human and financial resources that can reasonably be expected to be available during scale-up? | + | There are many home visiting models operating in the United States; some use nurses to deliver curriculum | |
| Will the financing of the innovation be sustainable? | ? | Unclear, but likely, as there are many funding streams for home visiting in the United States | |
| Does the health system currently have the capacity to implement the innovation? If not, are there plans to test ways to increase health system’s capacity? | ? | NA | |
| Are appropriate steps being taken to assess and document health outcomes as well as the process of implementation? | – | Health outcomes well documented (Savage et al., 2016, 2018: Hohman et al., 2017; Harris et al., 2020), but no strong evidence of process evaluation/rigorous study of implementation process | |
| Is there provision for early and continuous engagement with donors and technical partners to build a broad base of financial support for scale-up? | ? | Unclear to what extent funders have been engaged | |
| Are there plans to advocate for changes in policies, regulations, and other health-systems components needed to institutionalize the innovation? | ? | Not reported | |
| Does the project design include mechanisms to review progress and incorporate new learning into the implementation process? | – | No strong evidence of process evaluation/rigorous study of implementation process | |
| Is there a plan to share findings and insights from the pilot project during implementation? | ? | Unclear |
Suggested Citation:
"Appendix F: Scalability Assessments for Informative Studies." National Academies of Sciences, Engineering, and Medicine. 2023. Complementary Feeding Interventions for Infants and Young Children Under Age 2: Scoping of Promising Interventions to Implement at the Community or State Level. Washington, DC: The National Academies Press.
doi: 10.17226/27239.
| Questions Related to Potential Scalability | Yes (+) | No (–) | More Information/Action Needed |
|---|---|---|---|
| Is there a shared understanding among key stakeholders about the importance of having adequate evidence related to the feasibility and outcomes of the innovation prior to scaling up? | ? | Unclear/not reported |
SOURCES: Harris et al. (2020); Hohman et al. (2017, 2020); Savage et al. (2016, 2018).
FAMILY SPIRIT NURTURE
TABLE F-5 Family Spirit Nurture TIDieR
| Delivery Feature | Part 1 RCT Information | Part 2 RCT Information |
|---|---|---|
| Brief Name: | Family Spirit Nurture (FSN)—Brief home visiting approach to reduce childhood obesity in Native American children | Preventing Early Childhood Obesity, Part 2: Family Spirit Nurture, prenatal through 18 mo; home visiting approach |
| Why: Describe any rationale, theory, or goal |
Goal: reduce childhood obesity Theory: G.R. Paterson’s family systems ecological developmental theory Social cognitive theory |
Goal: reduce childhood obesity Theory: G.R. Paterson’s family systems ecological developmental theory Social cognitive theory |
| What: Materials (describe any physical or information materials used in the intervention, including given to participants or used in intervention delivery or in the training of providers) |
Session delivery: Home visiting program delivered by Navajo paraprofessional family health coaches Resources provided to participants: FSN content included optimal infant feeding practices, responsive feeding, avoiding SSBs, optimal complementary feeding practices, and whole-family healthy eating practices Materials for training: not described |
Session delivery: Home visiting program delivered by Navajo paraprofessional family health coaches Resources provided to participants: FSN content included optimal infant feeding practices, responsive feeding, avoiding SSBs, optimal complementary feeding practices, and whole-family healthy eating practices Materials for training: not described |
Suggested Citation:
"Appendix F: Scalability Assessments for Informative Studies." National Academies of Sciences, Engineering, and Medicine. 2023. Complementary Feeding Interventions for Infants and Young Children Under Age 2: Scoping of Promising Interventions to Implement at the Community or State Level. Washington, DC: The National Academies Press.
doi: 10.17226/27239.
| Delivery Feature | Part 1 RCT Information | Part 2 RCT Information |
|---|---|---|
| What: Procedures (describe each of the procedures, activities, or processes used in the intervention) |
Lessons were highly visual, interactive, and incorporated cultural teachings related to infant feeding and nutrition. Each lesson included a hands-on activity (e.g., examination of the actual amount of sugar in specific SSBs) and exercises focused on goal setting and self-esteem. Each session had a warm-up, lesson content, and activities, a Q&A period, referral as needed, and summary handouts. Motivational interviewing |
Lessons were highly visual, interactive, and incorporated cultural teachings related to infant feeding and nutrition. Each lesson included a hands-on activity (e.g., examination of the actual amount of sugar in specific SSBs) and exercises focused on goal setting and self-esteem. Each session had a warm-up, lesson content and activities, a Q&A period, referral as needed, and summary handouts Motivational interviewing |
| Who: Intervention provider (describe their expertise, background, and any specific training given) | Navajo paraprofessionals family health coaches | Navajo paraprofessionals family health coaches |
| Who: Target population | Navajo mothers ages 13 or older that lived within 50 miles of Northern Navajo Medical Center and had an infant <14 weeks of age | Expectant Navajo and White Mountain Apache mothers ages 14–24 having first or second baby |
| How: Mode of delivery (e.g., face to face; and whether it was individually or in a group) |
Face to face Tablet use Tabletop flip charts (visuals) Verbal question-and-answer period Summary handouts after lessons |
Face to face Tablet use Tabletop flip charts (visuals) Verbal question-and-answer period Summary handouts after lessons |
| Where: Location of intervention (including necessary infrastructure or relevant features) | At home or other private locations | At home or other private locations |
Suggested Citation:
"Appendix F: Scalability Assessments for Informative Studies." National Academies of Sciences, Engineering, and Medicine. 2023. Complementary Feeding Interventions for Infants and Young Children Under Age 2: Scoping of Promising Interventions to Implement at the Community or State Level. Washington, DC: The National Academies Press.
doi: 10.17226/27239.
| Delivery Feature | Part 1 RCT Information | Part 2 RCT Information |
|---|---|---|
| When: Describe the number of times the intervention was delivered over what period of time (including the number of sessions, their schedule and duration, intensity or dose) |
Six lessons delivered every 2 weeks for 3–6 mo postpartum, 45 minutes each lesson |
36 one-on-one, up to 60-minute home visits that occur bi-weekly from 28 weeks gestation until birth, weekly from birth to infant age 3 mo, bi-weekly from infant age 3 to 6 mo, and monthly from child age 6 to 18 mo |
| Tailoring: Adapted for individuals? (why, what, when, and how) | Referrals are given on an as-needed basis during lessons | — |
| How well: Planned (describe how and by whom and if any strategies were used to maintain or improve fidelity) | Not described | To ensure the fidelity to the intervention and quality of the curriculum delivery for both the intervention and control groups, the FHCs (who only deliver lessons to intervention group) and FHLs (who deliver lessons to control group and administer self-report assessments for both intervention and control) complete a knowledge test for each lesson and complete two role plays. For each lesson before delivering the lesson to a participant. In addition, they are observed in person on a quarterly basis, and all lessons are audio recorded so that a random 10% of recordings can be reviewed and rated for fidelity. |
| How well: Actual (describe the extent to which the intervention was delivered as planned) | Of the 68 mothers randomized to the Family Spirit Nurture group, 60 received at least one home visit (88%). | — |
Suggested Citation:
"Appendix F: Scalability Assessments for Informative Studies." National Academies of Sciences, Engineering, and Medicine. 2023. Complementary Feeding Interventions for Infants and Young Children Under Age 2: Scoping of Promising Interventions to Implement at the Community or State Level. Washington, DC: The National Academies Press.
doi: 10.17226/27239.
| Delivery Feature | Part 1 RCT Information | Part 2 RCT Information |
|---|---|---|
| Context: Funding and the broader environment | Funding: Healthy Eating Research (HER); Navajo Area Indian Health Service (grants HHSI245201501072P and HHSI245201801201P), the Osprey Foundation (grant 132271), the McCune Charitable Foundation, and another private donor | Funding: Eunice Kennedy Shriver National Institute of Child Health and Human Development (5R01HD087407 Secondary funders include Share Our Strength (90074137); Indian Health Service–Navajo Nation (HHSI245201501072P; HHSI245201801201P); and Johns Hopkins Discovery Award (1605050088) |
SOURCES: Ingalls et al. (2019); Rosenstock et al. (2021).
TABLE F-6 Family Spirit Nurture ExpandNET Checklist
| Questions Related to Potential Scalability | Yes (+) | (No) (‒) | More Information/Action Needed |
|---|---|---|---|
| Is input about the project being sought from a range of stakeholders (e.g., policy makers, program managers, providers, NGOs, beneficiaries)? | + | Family Spirit Nurture parts 1 and 2 were co-designed with community leaders, home visitors, and other stakeholders from Tribal communities | |
| Are individuals from the future implementing agency involved in the design and implementation of the pilot? | + | Home visitors were involved in co-designing curriculum and testing the intervention | |
| Does the project have mechanisms for building ownership in the future implementing organization? | ? | Unclear, but the Family Spirit home visiting model is currently being implemented in >130 tribal communities in 21 U.S. states, providing a ready-made network that could rapidly scale up Family Spirit Nurture | |
| Does the innovation address a persistent health or service delivery problem? | + | Indigenous children and adults are disproportionately affected by obesity and its cardiometabolic consequences as a result of food and water insecurity and stress resulting from colonization and land loss |
Suggested Citation:
"Appendix F: Scalability Assessments for Informative Studies." National Academies of Sciences, Engineering, and Medicine. 2023. Complementary Feeding Interventions for Infants and Young Children Under Age 2: Scoping of Promising Interventions to Implement at the Community or State Level. Washington, DC: The National Academies Press.
doi: 10.17226/27239.
| Questions Related to Potential Scalability | Yes (+) | (No) (‒) | More Information/Action Needed |
|---|---|---|---|
| Is the innovation based on sound evidence and preferable to alternative approaches? | + | Family Spirit Nurture uses the same format and delivery system as Family Spirit, a national home visiting model designed by and for Tribal communities that meets HHS criteria to be designated as evidence based | |
| Given the financial and human resource requirements, is the innovation feasible in the local settings where it is to be implemented? | ? | Unclear, but likely, as the Family Spirit home visiting model is currently being implemented in >130 tribal communities in 21 U.S. states, providing a ready-made network that could rapidly scale up Family Spirit Nurture | |
| Is the innovation consistent with existing national health policies, plans, and priorities? | + | Consistent with Healthy People 2030 goal NWS-04: Reduce the proportion of children and adolescents with obesity | |
| Is the project being designed in light of agreed-upon stakeholder expectations for where and to what extent interventions are to be scaled up? | ? | Unclear, but likely, as the Family Spirit home visiting model is currently being implemented in >130 tribal communities in 21 U.S. states (Ingalls at al., 2019; Rosenstock et al., 2021), providing a ready-made network that could rapidly scale up Family Spirit Nurture | |
| Has the project identified and taken into consideration community, cultural, and gender factors that might constrain or support implementation of the innovation? | + | Family Spirit Nurture parts 1 and 2 were co-designed with community leaders, home visitors, and other stakeholders from Tribal communities (Ingalls et al., 2019; Rosenstock et al., 2021) | |
| Have the norms, values, and operational culture of the implementing agency been taken into account in the design of the project? | + | Family Spirit Nurture parts 1 and 2 were co-designed with community leaders, home visitors, and other stakeholders from Tribal communities (Ingalls 2019, Rosenstock 2021) | |
| Have the opportunities and constraints of the political, policy, health sector, and other institutional factors been considered in designing the project? | ? | Unclear |
Suggested Citation:
"Appendix F: Scalability Assessments for Informative Studies." National Academies of Sciences, Engineering, and Medicine. 2023. Complementary Feeding Interventions for Infants and Young Children Under Age 2: Scoping of Promising Interventions to Implement at the Community or State Level. Washington, DC: The National Academies Press.
doi: 10.17226/27239.
| Questions Related to Potential Scalability | Yes (+) | (No) (‒) | More Information/Action Needed |
|---|---|---|---|
| Has the package of interventions been kept as simple as possible without jeopardizing outcomes? | ‒ | Number of home visits increased from 6 (Family Spirit Nurture part 1) to 36 (Family Spirit Nurture part 2) | |
| Is the innovation being tested in the variety of sociocultural and geographic settings where it will be scaled up? | + | Family Spirit Nurture part 2 was conducted with two Navajo communities and one White Mountain Apache community (Fort Apache Indian Reservation) | |
| Is the innovation being tested in the type of service delivery points and institutional settings in which it will be scaled up? | + | Being tested in the home visiting setting and will be delivered in home visiting setting | |
| Does the innovation being tested require human and financial resources that can reasonably be expected to be available during scale-up? | + | The Family Spirit home visiting model is currently being implemented in >130 tribal communities in 21 U.S. states, providing a ready-made network that could rapidly scale up Family Spirit Nurture | |
| Will the financing of the innovation be sustainable? | ? | Unclear, but likely, as there are many funding streams for home visiting in the United States | |
| Does the health system currently have the capacity to implement the innovation? If not, are there plans to test ways to increase health system’s capacity? | ? | NA | |
| Are appropriate steps being taken to assess and document health outcomes as well as the process of implementation? | ‒ | Health outcomes well documented in two RCTs (Ingalls et al., 2019: Rosenstock et al., 2021) but no strong evidence of process evaluation/rigorous study of implementation process | |
| Is there provision for early and continuous engagement with donors and technical partners to build a broad base of financial support for scale-up? | ? | Unclear to what extent funders have been engaged |
Suggested Citation:
"Appendix F: Scalability Assessments for Informative Studies." National Academies of Sciences, Engineering, and Medicine. 2023. Complementary Feeding Interventions for Infants and Young Children Under Age 2: Scoping of Promising Interventions to Implement at the Community or State Level. Washington, DC: The National Academies Press.
doi: 10.17226/27239.
| Questions Related to Potential Scalability | Yes (+) | (No) (‒) | More Information/Action Needed |
|---|---|---|---|
| Are there plans to advocate for changes in policies, regulations, and other health system components needed to institutionalize the innovation? | ? | Unclear to what extent existing Family Spirit model programs would need to change to implement Family Spirit Nurture | |
| Does the project design include mechanisms to review progress and incorporate new learning into the implementation process? | ‒ | No strong evidence of process evaluation/rigorous study of implementation process | |
| Is there a plan to share findings and insights from the pilot project during implementation? | ? | Unclear | |
| Is there a shared understanding among key stakeholders about the importance of having adequate evidence related to the feasibility and outcomes of the innovation prior to scaling up? | ? | Unclear/not reported |
SOURCES: Bleiweiss-Sande et al. (2022); Ingalls et al. (2019); Rosenstock et al. (2021).
REFERENCES
Bleiweiss-Sande, R., E. Sama-Miller, C. Chavez, R. Coughlin, and A. Mraz Esposito. 2022. Assessing effectiveness of early childhood home visiting models implemented with tribal populations. Washington, DC: Office of Planning, Research, and Evaluation, Administration for Children and Familities, Department of Health and Human Services.
Cameron, A. J., K. Ball, K. D. Hesketh, S. A. McNaughton, J. Salmon, D. A. Crawford, S. Lioret, and K. J. Campbell. 2014. Variation in outcomes of the Melbourne Infant, Feeding, Activity and Nutrition Trial (InFANT) program according to maternal education and age. Preventive Medicine 58:58–63.
Campbell, K. J., S. Lioret, S. A. McNaughton, D. A. Crawford, J. Salmon, K. Ball, Z. McCallum, B. E. Gerner, A. C. Spence, A. J. Cameron, J. A. Hnatiuk, O. C. Ukoumunne, L. Gold, G. Abbott, and K. D. Hesketh. 2013. A parent-focused intervention to reduce infant obesity risk behaviors: A randomized trial. Pediatrics 131(4):652–660.
Harris, H. A., S. Anzman-Frasca, M. E. Marini, I. M. Paul, L. L. Birch, and J. S. Savage. 2020. Effect of a responsive parenting intervention on child emotional overeating is mediated by reduced maternal use of food to soothe: The INSIGHT RCT. Pediatric Obesity 15(1):e12645.
Suggested Citation:
"Appendix F: Scalability Assessments for Informative Studies." National Academies of Sciences, Engineering, and Medicine. 2023. Complementary Feeding Interventions for Infants and Young Children Under Age 2: Scoping of Promising Interventions to Implement at the Community or State Level. Washington, DC: The National Academies Press.
doi: 10.17226/27239.
Hohman, E. E., J. S. Savage, L. L. Birch, and I. M. Paul. 2020. The Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) responsive parenting intervention for firstborns affects dietary intake of secondborn infants. Journal of Nutrition 150(8):2139–2146.
Ingalls, A., S. Rosenstock, R. Foy Cuddy, N. Neault, S. Yessilth, N. Goklish, L. Nelson, R. Reid, and A. Barlow. 2019. Family Spirit Nurture (FSN)—A randomized controlled trial to prevent early childhood obesity in American Indian populations: Trial rationale and study protocol. BMC Obesity 6:18.
Marshall, N. E., B. Abrams, L. A. Barbour, P. Catalano, P. Christian, J. E. Friedman, W. W. Hay, T. L. Hernandez, N. F. Krebs, E. Oken, J. Q. Purnell, J. M. Roberts, H. Soltani, J. Wallace, and K. L. Thornburg. 2022. The importance of nutrition in pregnancy and lactation: Lifelong consequences. American Journal of Obstetrics and Gynecology 226(5):607–632.
Rosenstock, S., A. Ingalls, R. Foy Cuddy, N. Neault, S. Littlepage, L. Cohoe, L. Nelson, K. Shephard-Yazzie, S. Yazzie, A. Alikhani, R. Reid, A. Kenney, and A. Barlow. 2021. Effect of a home-visiting intervention to reduce early childhood obesity among Native American children: A randomized clinical trial. JAMA Pediatrics 175(2):133–142.
Savage, J. S., L. L. Birch, M. Marini, S. Anzman-Frasca, and I. M. Paul. 2016. Effect of the INSIGHT responsive parenting intervention on rapid infant weight gain and overweight status at age 1 year: A randomized clinical trial. JAMA Pediatrics 170(8):742–749.
Savage, J. S., E. E. Hohman, M. E. Marini, A. Shelly, I. M. Paul, and L. L. Birch. 2018. INSIGHT responsive parenting intervention and infant feeding practices: Randomized clinical trial. International Journal of Behavioral Nutrition and Physical Activity 15(1):64.
Spence, A. C., S. A. McNaughton, S. Lioret, K. D. Hesketh, D. A. Crawford, and K. J. Campbell. 2013. A health promotion intervention can affect diet quality in early childhood. Journal of Nutrition 143(1):1672–1678.
Spence, A. C., K. J. Campbell, D. A. Crawford, S. A. McNaughton, and K. D. Hesketh. 2014. Mediators of improved child diet quality following a health promotion intervention: The Melbourne InFANT program. The International Journal of Behavioral Nutrition and Physical Activity 11:137.
Zheng, M., K. D. Hesketh, S. A. McNaughton, J. Salmon, D. Crawford, A. J. Cameron, S. Lioret, and K. J. Campbell. 2022. Quantifying the overall impact of an early childhood multi-behavioural lifestyle intervention. Pediatric Obesity 17(3):e12861.
Suggested Citation:
"Appendix F: Scalability Assessments for Informative Studies." National Academies of Sciences, Engineering, and Medicine. 2023. Complementary Feeding Interventions for Infants and Young Children Under Age 2: Scoping of Promising Interventions to Implement at the Community or State Level. Washington, DC: The National Academies Press.
doi: 10.17226/27239.
Suggested Citation:
"Appendix F: Scalability Assessments for Informative Studies." National Academies of Sciences, Engineering, and Medicine. 2023. Complementary Feeding Interventions for Infants and Young Children Under Age 2: Scoping of Promising Interventions to Implement at the Community or State Level. Washington, DC: The National Academies Press.
doi: 10.17226/27239.
Suggested Citation:
"Appendix F: Scalability Assessments for Informative Studies." National Academies of Sciences, Engineering, and Medicine. 2023. Complementary Feeding Interventions for Infants and Young Children Under Age 2: Scoping of Promising Interventions to Implement at the Community or State Level. Washington, DC: The National Academies Press.
doi: 10.17226/27239.
Suggested Citation:
"Appendix F: Scalability Assessments for Informative Studies." National Academies of Sciences, Engineering, and Medicine. 2023. Complementary Feeding Interventions for Infants and Young Children Under Age 2: Scoping of Promising Interventions to Implement at the Community or State Level. Washington, DC: The National Academies Press.
doi: 10.17226/27239.
Suggested Citation:
"Appendix F: Scalability Assessments for Informative Studies." National Academies of Sciences, Engineering, and Medicine. 2023. Complementary Feeding Interventions for Infants and Young Children Under Age 2: Scoping of Promising Interventions to Implement at the Community or State Level. Washington, DC: The National Academies Press.
doi: 10.17226/27239.
Suggested Citation:
"Appendix F: Scalability Assessments for Informative Studies." National Academies of Sciences, Engineering, and Medicine. 2023. Complementary Feeding Interventions for Infants and Young Children Under Age 2: Scoping of Promising Interventions to Implement at the Community or State Level. Washington, DC: The National Academies Press.
doi: 10.17226/27239.
Suggested Citation:
"Appendix F: Scalability Assessments for Informative Studies." National Academies of Sciences, Engineering, and Medicine. 2023. Complementary Feeding Interventions for Infants and Young Children Under Age 2: Scoping of Promising Interventions to Implement at the Community or State Level. Washington, DC: The National Academies Press.
doi: 10.17226/27239.
Suggested Citation:
"Appendix F: Scalability Assessments for Informative Studies." National Academies of Sciences, Engineering, and Medicine. 2023. Complementary Feeding Interventions for Infants and Young Children Under Age 2: Scoping of Promising Interventions to Implement at the Community or State Level. Washington, DC: The National Academies Press.
doi: 10.17226/27239.
Suggested Citation:
"Appendix F: Scalability Assessments for Informative Studies." National Academies of Sciences, Engineering, and Medicine. 2023. Complementary Feeding Interventions for Infants and Young Children Under Age 2: Scoping of Promising Interventions to Implement at the Community or State Level. Washington, DC: The National Academies Press.
doi: 10.17226/27239.
Suggested Citation:
"Appendix F: Scalability Assessments for Informative Studies." National Academies of Sciences, Engineering, and Medicine. 2023. Complementary Feeding Interventions for Infants and Young Children Under Age 2: Scoping of Promising Interventions to Implement at the Community or State Level. Washington, DC: The National Academies Press.
doi: 10.17226/27239.
Suggested Citation:
"Appendix F: Scalability Assessments for Informative Studies." National Academies of Sciences, Engineering, and Medicine. 2023. Complementary Feeding Interventions for Infants and Young Children Under Age 2: Scoping of Promising Interventions to Implement at the Community or State Level. Washington, DC: The National Academies Press.
doi: 10.17226/27239.
Suggested Citation:
"Appendix F: Scalability Assessments for Informative Studies." National Academies of Sciences, Engineering, and Medicine. 2023. Complementary Feeding Interventions for Infants and Young Children Under Age 2: Scoping of Promising Interventions to Implement at the Community or State Level. Washington, DC: The National Academies Press.
doi: 10.17226/27239.
Suggested Citation:
"Appendix F: Scalability Assessments for Informative Studies." National Academies of Sciences, Engineering, and Medicine. 2023. Complementary Feeding Interventions for Infants and Young Children Under Age 2: Scoping of Promising Interventions to Implement at the Community or State Level. Washington, DC: The National Academies Press.
doi: 10.17226/27239.
Suggested Citation:
"Appendix F: Scalability Assessments for Informative Studies." National Academies of Sciences, Engineering, and Medicine. 2023. Complementary Feeding Interventions for Infants and Young Children Under Age 2: Scoping of Promising Interventions to Implement at the Community or State Level. Washington, DC: The National Academies Press.
doi: 10.17226/27239.
Suggested Citation:
"Appendix F: Scalability Assessments for Informative Studies." National Academies of Sciences, Engineering, and Medicine. 2023. Complementary Feeding Interventions for Infants and Young Children Under Age 2: Scoping of Promising Interventions to Implement at the Community or State Level. Washington, DC: The National Academies Press.
doi: 10.17226/27239.
Suggested Citation:
"Appendix F: Scalability Assessments for Informative Studies." National Academies of Sciences, Engineering, and Medicine. 2023. Complementary Feeding Interventions for Infants and Young Children Under Age 2: Scoping of Promising Interventions to Implement at the Community or State Level. Washington, DC: The National Academies Press.
doi: 10.17226/27239.
Suggested Citation:
"Appendix F: Scalability Assessments for Informative Studies." National Academies of Sciences, Engineering, and Medicine. 2023. Complementary Feeding Interventions for Infants and Young Children Under Age 2: Scoping of Promising Interventions to Implement at the Community or State Level. Washington, DC: The National Academies Press.
doi: 10.17226/27239.
Suggested Citation:
"Appendix F: Scalability Assessments for Informative Studies." National Academies of Sciences, Engineering, and Medicine. 2023. Complementary Feeding Interventions for Infants and Young Children Under Age 2: Scoping of Promising Interventions to Implement at the Community or State Level. Washington, DC: The National Academies Press.
doi: 10.17226/27239.
Suggested Citation:
"Appendix F: Scalability Assessments for Informative Studies." National Academies of Sciences, Engineering, and Medicine. 2023. Complementary Feeding Interventions for Infants and Young Children Under Age 2: Scoping of Promising Interventions to Implement at the Community or State Level. Washington, DC: The National Academies Press.
doi: 10.17226/27239.
Suggested Citation:
"Appendix F: Scalability Assessments for Informative Studies." National Academies of Sciences, Engineering, and Medicine. 2023. Complementary Feeding Interventions for Infants and Young Children Under Age 2: Scoping of Promising Interventions to Implement at the Community or State Level. Washington, DC: The National Academies Press.
doi: 10.17226/27239.
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