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This study evaluates the effect of a nutrition technical assistance training program for family child care home providers on the food they serve young children in their care and the food environment in their home. Half the providers will be assigned to the nutrition program and the other half will receive a comparison on environmental health.
Early care and education (ECE) providers play a vital role in ensuring that young children have access to nutritious foods. Over 25% of children in ECE (1.2 million children) attend Family Child Care Homes (FCCH). Improvements in the Child and Adult Care Food Program (CACFP) may introduce new barriers for FCCH, which have limited meal preparation capacity. Limited research has examined foods served by FCCH providers, and no group randomized trials have been conducted using a Community-Based Participatory approach in FCCH and including an evaluation of intervention costs.
Goals: 1. Determine compliance of menus and meals provided in FCCH with CACFP guidelines. 2. Determine the effectiveness of a community-based Nutrition Technical Assistance intervention to enhance meeting CACFP best-practices.
Methods: Conduct a cross-sectional assessment of a random sample of FCCH providers' (n=52) menus and meals served. Foods will be evaluated against the CACFP requirements and best-practices. After the cross-sectional examination, providers will be randomly assigned to a Nutrition Technical Assistance (n=26) or attention comparison intervention (n=26). The intervention is based on theoretical foundations and formative interviews, and will consist of two 60-90-minute visits to the FCCH and one group class lasting approximately 3 hours.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Behavioral: Nutrition assistance | Experimental | three encounters with Intervention team over three months: two home-based visits for 90 minutes each scheduled at the convenience of the provider and a 3- hour group class session with other providers. |
|
| Behavioral: Children's environmental health | Experimental | three encounters with Intervention team over three months: two home-based visits for 90 minutes each scheduled at the convenience of the provider and a 3- hour group class session with other providers. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutrition assistance | Behavioral | Participating family child care home providers in and around the Oklahoma City (OKC) area will be randomized to either the Nutrition, or an environmental health comparison group. Briefly, the Nutrition Technical Assistance Intervention and comparison group will consist of three encounters with the intervention team: two home-based, 90-minute visits scheduled at the convenience of the family child care home provider and a 3-hour group class session that will be conducted on a weekend. Total contact time with intervention staff will be 6 hours. All participants will receive a toolkit. Providers will complete either intervention over a period of three months. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Self-reported Nutrition Practices | Providers report the nutrition environment using the Nutrition and Physical Activity Self Assessment for Child Care (NAPSACC). Scores averaged across items range 0-4. Higher score indicates more desired/healthier outcome. | baseline, post 3-months, post 12-months |
| Measure | Description | Time Frame |
|---|---|---|
| Provider Nutrition Knowledge | Self-reported nutrition knowledge using a modified Revised General Nutrition Knowledge Questionnaire. It was reduced in length to 38 items from 88 items. Scores ranged from 0-38 with a higher score indicating greater nutrition knowledge. | baseline, post 3-months, post 12-months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan B Sisson, PhD | University of Oklahoma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73117 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40059639 | Derived | Sisson SB, Leidner J, Hall S, Williams BD, Vesely SK, Poe T, Ward DS, Crosscut C, Hildebrand D, Salvatore AL. Three- and Twelve-Month Changes in Child and Adult Care Food Program Best Practices and Preschool Children's Dietary Intake in Family Child Care Homes after the Happy Healthy Homes Randomized Controlled Trial. Child Obes. 2025 Jul;21(5):476-488. doi: 10.1089/chi.2024.0361. Epub 2025 Mar 10. | |
| 35125128 |
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Participants who were unresponsive after multiple follow-ups prior to group assignment OR those not interested anymore were excluded from the study.
Family Child Care Home Providers who participated in the Child and Adult Care Food Program within 60 miles of the university campus were invited to participate. Recruitment efforts were made at local training events and through food program sponsor emails and newsletters.
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| ID | Title | Description |
|---|---|---|
| FG000 | Behavioral: Environmental Health/Comparison | Three encounters with Intervention team over three months: two home-based visits for 90 minutes each scheduled at the convenience of the provider and a 3- hour group class session with other providers. Environmental health: Participating family child care home providers in and around the Oklahoma City (OKC) area will be randomized to either the Nutrition, or an environmental health comparison group. Briefly, the Nutrition Technical Assistance Intervention and comparison group will consist of three encounters with the intervention team: two home-based, 90-minute visits scheduled at the convenience of the family child care home provider and a 3-hour group class session that will be conducted on a weekend. Total contact time with intervention staff will be 6 hours. All participants will receive a toolkit. Providers will complete either intervention over a period of three months. |
| FG001 | Behavioral: Nutrition Assistance | three encounters with Intervention team over three months: two home-based visits for 90 minutes each scheduled at the convenience of the provider and a 3- hour group class session with other providers. Nutrition assistance: Participating family child care home providers in and around the Oklahoma City (OKC) area will be randomized to either the Nutrition, or an environmental health comparison group. Briefly, the Nutrition Technical Assistance Intervention and comparison group will consist of three encounters with the intervention team: two home-based, 90-minute visits scheduled at the convenience of the family child care home provider and a 3-hour group class session that will be conducted on a weekend. Total contact time with intervention staff will be 6 hours. All participants will receive a toolkit. Providers will complete either intervention over a period of three months. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Behavioral: Nutrition Assistance | three encounters with Intervention team over three months: two home-based visits for 90 minutes each scheduled at the convenience of the provider and a 3- hour group class session with other providers. Participating family child care home providers in and around the Oklahoma City (OKC) area will be randomized to either the Nutrition, or an environmental health comparison group. Briefly, the Nutrition Technical Assistance Intervention and comparison group will consist of three encounters with the intervention team: two home-based, 90-minute visits scheduled at the convenience of the family child care home provider and a 3-hour group class session that will be conducted on a weekend. Total contact time with intervention staff will be 6 hours. All participants will receive a toolkit. Providers will complete either intervention over a period of three months. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Self-reported Nutrition Practices | Providers report the nutrition environment using the Nutrition and Physical Activity Self Assessment for Child Care (NAPSACC). Scores averaged across items range 0-4. Higher score indicates more desired/healthier outcome. | Posted | Mean | Standard Deviation | units on a scale | baseline, post 3-months, post 12-months |
|
1 year
Adverse events were defined as described by clinicaltrials.gov. Participants reporting any events were reported to study personnel. Study personnel reported to the institution
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Behavioral: Nutrition Assistance | three encounters with Intervention team over three months: two home-based visits for 90 minutes each scheduled at the convenience of the provider and a 3- hour group class session with other providers. Nutrition assistance: Participating family child care home providers in and around the Oklahoma City (OKC) area will be randomized to either the Nutrition, or an environmental health comparison group. Briefly, the Nutrition Technical Assistance Intervention and comparison group will consist of three encounters with the intervention team: two home-based, 90-minute visits scheduled at the convenience of the family child care home provider and a 3-hour group class session that will be conducted on a weekend. Total contact time with intervention staff will be 6 hours. All participants will receive a toolkit. Providers will complete either intervention over a period of three months. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Susan B. Sisson, Principal Investigator | University of Oklahoma Health Sciences | (405) 271-2113 | 41176 | susan-sisson@ouhsc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 13, 2018 | Mar 19, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D044342 | Malnutrition |
| D015438 | Health Behavior |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D063105 | Food Assistance |
| ID | Term |
|---|---|
| D011632 | Public Assistance |
| D005380 | Financing, Government |
| D005381 | Financing, Organized |
| D004467 | Economics |
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Randomized trial where family child care home providers (the participant) are randomized to either nutrition or environmental health technical assistance intervention. Interventions are matched for time and contact
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|
| Children's environmental health/comparison | Behavioral | Participating family child care home providers in and around the OKC area will be randomized to either the Nutrition, or an environmental health intervention that will receive an Integrated Pest Management and Green Cleaning intervention with the same format and visit frequency. Briefly, the Intervention will consist of three encounters with the intervention team: two home-based, 90-minute visits scheduled at the convenience of the family child care home provider and a 3-hour group class session that will be conducted on a weekend. Total contact time with intervention staff will be 6 hours. All participants will receive a toolkit. Providers will complete either intervention over a period of three months. |
|
| Change in Compliance of Menu With Child and Adult Care Food Program Best Practices |
menus are compared to the best practices of the Child and Adult Care Food Program (CACFP). The scale measures the number of elements of the menu which are compliance with the CACFP best practices. The CACFP best Practice compliance tool has a range of 0-25. A higher score is associated with a more desirable outcome and thus higher CACFP best practice compliance. |
| baseline, post 3-months, post 12-months |
| Change in Children's Dietary Intake of Vegetables at Lunch | Observation of children's dietary intake on 2 unannounced days using the Dietary Observation in Child Care methods and Food Processor for nutrient analysis. Outcome is cups of vegetables consumed. | baseline, post 3-months, post 12-months |
| Derived |
| Sisson SB, Eckart E, Williams BD, Patel SM, Kracht CL, Davis HA, Ward DS, Hildebrand D, Stoner JA, Stinner E, Kerr KE, Salvatore A. Family child care home providers' self-reported nutrition and physical activity practices, self-efficacy, barriers and knowledge: baseline findings from happy healthy homes. Public Health Nutr. 2022 Aug;25(8):2111-2124. doi: 10.1017/S1368980022000337. Epub 2022 Feb 7. |
| 31470886 | Derived | Sisson SB, Salvatore AL, Hildebrand D, Poe T, Merchant C, Slawinski M, Kracht CL, Stoner JA, Alcala Lazarte N, Schneider LAF, Weber J, Jones F, Ward D. Interventions to promote healthy environments in family child care homes in Oklahoma-Happy Healthy Homes: study protocol for a randomized controlled trial. Trials. 2019 Aug 30;20(1):541. doi: 10.1186/s13063-019-3616-9. |
| BG001 | Behavioral: Children's Environmental Health/Comparison | three encounters with Intervention team over three months: two home-based visits for 90 minutes each scheduled at the convenience of the provider and a 3- hour group class session with other providers. Participating family child care home providers in and around the Oklahoma City (OKC) area will be randomized to either the Nutrition, or an environmental health comparison group. Briefly, the Nutrition Technical Assistance Intervention and comparison group will consist of three encounters with the intervention team: two home-based, 90-minute visits scheduled at the convenience of the family child care home provider and a 3-hour group class session that will be conducted on a weekend. Total contact time with intervention staff will be 6 hours. All participants will receive a toolkit. Providers will complete either intervention over a period of three months. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Annual household income | Number | participants |
|
| Highest level of education | Number | participants |
|
| OG001 | Behavioral: Nutrition Assistance | three encounters with Intervention team over three months: two home-based visits for 90 minutes each scheduled at the convenience of the provider and a 3- hour group class session with other providers. Nutrition assistance: Participating family child care home providers in and around the Oklahoma City (OKC) area will be randomized to either the Nutrition, or an environmental health comparison group. Briefly, the Nutrition Technical Assistance Intervention and comparison group will consist of three encounters with the intervention team: two home-based, 90-minute visits scheduled at the convenience of the family child care home provider and a 3-hour group class session that will be conducted on a weekend. Total contact time with intervention staff will be 6 hours. All participants will receive a toolkit. Providers will complete either intervention over a period of three months. |
|
|
|
| Secondary | Provider Nutrition Knowledge | Self-reported nutrition knowledge using a modified Revised General Nutrition Knowledge Questionnaire. It was reduced in length to 38 items from 88 items. Scores ranged from 0-38 with a higher score indicating greater nutrition knowledge. | Posted | Mean | Standard Deviation | units on a scale | baseline, post 3-months, post 12-months |
|
|
|
|
| Secondary | Change in Compliance of Menu With Child and Adult Care Food Program Best Practices | menus are compared to the best practices of the Child and Adult Care Food Program (CACFP). The scale measures the number of elements of the menu which are compliance with the CACFP best practices. The CACFP best Practice compliance tool has a range of 0-25. A higher score is associated with a more desirable outcome and thus higher CACFP best practice compliance. | Posted | Mean | Standard Deviation | units on a scale | baseline, post 3-months, post 12-months |
|
|
|
|
| Secondary | Change in Children's Dietary Intake of Vegetables at Lunch | Observation of children's dietary intake on 2 unannounced days using the Dietary Observation in Child Care methods and Food Processor for nutrient analysis. Outcome is cups of vegetables consumed. | Posted | Mean | Standard Deviation | cups | baseline, post 3-months, post 12-months |
|
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | Behavioral: Children's Environmental Health | three encounters with Intervention team over three months: two home-based visits for 90 minutes each scheduled at the convenience of the provider and a 3- hour group class session with other providers. Children's environmental health: Participating family child care home providers in and around the OKC area will be randomized to either the Nutrition, or an environmental health intervention that will receive an Integrated Pest Management and Green Cleaning intervention with the same format and visit frequency. Briefly, the Intervention will consist of three encounters with the intervention team: two home-based, 90-minute visits scheduled at the convenience of the family child care home provider and a 3-hour group class session that will be conducted on a weekend. Total contact time with intervention staff will be 6 hours. All participants will receive a toolkit. Providers will complete either intervention over a period of three months. | 0 | 21 | 0 | 21 | 0 | 21 |
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| D004472 |
| Health Care Economics and Organizations |
| 12-month |
|
| 12-month |
|
| 12-month |
|