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This project evaluates the effectiveness of an evidence-based intervention (HEALTH) to prevent weight gain and promote weight loss when disseminated and implemented in real-world settings, through Parents as Teachers. To enhance the impact of HEALTH, the study also evaluates implementation outcomes from the training curriculum (implementation strategy) and external validity when HEALTH is implemented within this national home visiting organization. This partnership has potential for significant impact on obesity and chronic diseases such as cardiovascular disease and diabetes.
Excessive weight gain among young adult women age 18-35 years is an alarming and overlooked trend that must be addressed to reverse the epidemics of obesity and chronic disease. During this vulnerable period women tend to gain disproportionally large amounts of weight compared to men and other life periods. A lifestyle modification intervention (HEALTH) that prevented weight gain, promoted sustained weight loss, and reduced waist circumference was developed in partnership with Parents as Teachers (PAT), a national home visiting, community based organization with significant reach in this population. PAT provides parent-child education and services free-of-charge to nearly 170,000 families through up to 25 free home visits per year until the child enters kindergarten. This study will extend these findings with a pragmatic cluster randomized controlled trial to evaluate dissemination and implementation of HEALTH across three levels (mother, parent educator, PAT site) to achieve widespread impact. The pragmatic cluster randomized controlled trial will evaluate HEALTH and the HEALTH training curriculum (implementation strategy) on weight among mothers with overweight and obesity across the US (N= 200 HEALTH; N= 200 usual care). Parent educators from 40 existing PAT sites (20 HEALTH, 20 usual care) will receive the HEALTH training curriculum through the PAT National Center, using PAT's existing training infrastructure, as a continuing education opportunity. An extensive evaluation, guided by RE-AIM (Reach, Efficacy, Adoption, Implementation, and Maintenance) will determine implementation outcomes (acceptability, adoption, appropriateness, feasibility, fidelity, and adaptation) at the parent educator level. The Conceptual Framework for Implementation research will characterize determinants that influence HEALTH dissemination and implementation at three levels: mother, parent educator, PAT site to enhance external validity (reach and maintenance) and population level impact. The findings from this innovative study will have significant potential to help reverse the trend of excessive weight gain among young adult women, a critical priority target in battling the epidemics of obesity and chronic disease, by reaching women with an evidence-based intervention nation-wide.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Eating & Active Living Taught at Home | Experimental | PAT National Center will train educators affiliated with PAT sites in HEALTH; among these, using the HEALTH training curriculum (implementation strategy). Participants at HEALTH sites receive usual care PAT+evidence-based life-style change strategies to prevent weight gain and promote weight loss embedded within and delivered as part of home visits. |
|
| Usual Care | Active Comparator | Participants at usual care PAT sites will receive PAT as usual |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Healthy Eating & Active Living Taught at Home | Behavioral | PAT National Center will train educators affiliated with PAT sites in HEALTH; among these, using the HEALTH training curriculum, which includes training materials, an ~8 hour training delivered through a synchronous web-based experience, and ongoing consultation. Participants at HEALTH sites receive usual care PAT+evidence-based life-style change strategies to prevent weight gain and promote weight loss embedded within and delivered as part of home visits. In addition to the usual care PAT curriculum content, goal setting related to healthy weight, and the importance of parental modeling of healthy eating and physical activity are incorporated throughout the discussion and visit. HEALTH will be delivered over 24 months via a (1) core and (2) maintenance phase. The visits begin with greater frequency, and taper. Consistent with PAT practice, the frequency and number of visits are determined by the family's needs and preferences. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Weight | Mother's body weight assessed by data collector | 24-months |
| Measure | Description | Time Frame |
|---|---|---|
| Fidelity of Delivery to the Intervention | Parent educators' fidelity to the intervention will all be assessed using a coding document (developed for the current study), which will be applied to audio-recordings of study visits, and will document the following components: adherence, quality of delivery, exposure to the intervention, and participant responsiveness or involvement, all of which share a common unit of measure |
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For Parent educators:
Inclusion Criteria:
Exclusion Criteria:
For Participants:
Inclusion Criteria:
Exclusion Criteria:
For the participants (i.e., not the parent educators), only women will be included: Including only female participants is scientifically justified, as the study focus is addressing the dramatic weight gain women experience in early adulthood, which is not experienced to the same extent among men. Further, HEALTH was tested and demonstrated effectiveness only in mothers, and the very small number of fathers who participate in PAT will not provide an adequate sample to evaluate HEALTH in this population.
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| Name | Affiliation | Role |
|---|---|---|
| Rachel G Tabak, PhD, RD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University in St. Louis | St Louis | Missouri | 63130 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41731558 | Derived | Gilbert A, Haire-Joshu D, Morshed AB, Schwarz CD, Kemner A, Tabak RG. Accessibility, acceptability, and usage during COVID-19 of the evidence-based intervention Healthy Eating and Active Living Taught at Home (HEALTH): implications for implementation strategies. Int J Behav Nutr Phys Act. 2026 Feb 24;23(1):31. doi: 10.1186/s12966-026-01896-y. | |
| 41498407 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Eating & Active Living Taught at Home | PAT National Center will train educators affiliated with PAT sites in HEALTH; among these, using the HEALTH training curriculum (implementation strategy). Participants at HEALTH sites receive usual care PAT+evidence-based life-style change strategies to prevent weight gain and promote weight loss embedded within and delivered as part of home visits. Healthy Eating & Active Living Taught at Home: PAT National Center will train educators affiliated with PAT sites in HEALTH; among these, using the HEALTH training curriculum, which includes training materials, an ~8 hour training delivered through a synchronous web-based experience, and ongoing consultation. Participants at HEALTH sites receive usual care PAT+evidence-based life-style change strategies to prevent weight gain and promote weight loss embedded within and delivered as part of home visits. In addition to the usual care PAT curriculum content, goal setting related to healthy weight, and the importance of parental modeling of healthy eating and physical activity are incorporated throughout the discussion and visit. HEALTH will be delivered over 24 months via a (1) core and (2) maintenance phase. The visits begin with greater frequency, and taper. Consistent with PAT practice, the frequency and number of visits are determined by the family's needs and preferences. |
| FG001 | Usual Care | Participants at usual care PAT sites will receive PAT as usual Usual Care: The Foundational (usual care) curriculum uses a strength-based, solution-focused model to provide parents with child development knowledge and parenting support, empowering parents as their child's first and most influential teacher. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents.
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Eating & Active Living Taught at Home | PAT National Center will train educators affiliated with PAT sites in HEALTH; among these, using the HEALTH training curriculum (implementation strategy). Participants at HEALTH sites receive usual care PAT+evidence-based life-style change strategies to prevent weight gain and promote weight loss embedded within and delivered as part of home visits. Healthy Eating & Active Living Taught at Home: PAT National Center will train educators affiliated with PAT sites in HEALTH; among these, using the HEALTH training curriculum, which includes training materials, an ~8 hour training delivered through a synchronous web-based experience, and ongoing consultation. Participants at HEALTH sites receive usual care PAT+evidence-based life-style change strategies to prevent weight gain and promote weight loss embedded within and delivered as part of home visits. In addition to the usual care PAT curriculum content, goal setting related to healthy weight, and the importance of parental modeling of healthy eating and physical activity are incorporated throughout the discussion and visit. HEALTH will be delivered over 24 months via a (1) core and (2) maintenance phase. The visits begin with greater frequency, and taper. Consistent with PAT practice, the frequency and number of visits are determined by the family's needs and preferences. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents. |
| 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 Weight | Mother's body weight assessed by data collector | Posted | Mean | Standard Deviation | Kg | 24-months |
|
2 years
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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 | Healthy Eating & Active Living Taught at Home | PAT National Center will train educators affiliated with PAT sites in HEALTH; among these, using the HEALTH training curriculum (implementation strategy). Participants at HEALTH sites receive usual care PAT+evidence-based life-style change strategies to prevent weight gain and promote weight loss embedded within and delivered as part of home visits. Healthy Eating & Active Living Taught at Home: PAT National Center will train educators affiliated with PAT sites in HEALTH; among these, using the HEALTH training curriculum, which includes training materials, an ~8 hour training delivered through a synchronous web-based experience, and ongoing consultation. Participants at HEALTH sites receive usual care PAT+evidence-based life-style change strategies to prevent weight gain and promote weight loss embedded within and delivered as part of home visits. In addition to the usual care PAT curriculum content, goal setting related to healthy weight, and the importance of parental modeling of healthy eating and physical activity are incorporated throughout the discussion and visit. HEALTH will be delivered over 24 months via a (1) core and (2) maintenance phase. The visits begin with greater frequency, and taper. Consistent with PAT practice, the frequency and number of visits are determined by the family's needs and preferences. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rachel Tabak | Washington University in St. Louis | 3149350153 | rtabak@wustl.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 | Jul 17, 2025 | Jul 22, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 5, 2020 | Jul 22, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000072001 | Diet, Healthy |
| ID | Term |
|---|---|
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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Healthy Eating & Active Living Taught at Home (HEALTH) embeds content related to healthy eating and activity within Parents as Teachers (PAT)'s existing home visits.
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|
| Usual Care | Behavioral | The Foundational (usual care) curriculum uses a strength-based, solution-focused model to provide parents with child development knowledge and parenting support, empowering parents as their child's first and most influential teacher. |
|
|
| throughout intervention delivery, which can range from 2-4 years for parent educators depending on when their site is randomized |
| Gilbert A, Martinez A, Farabi S, Cortez A, Baumann AA, Haire-Joshu D, Brownson RC, Morshed AB, Tabak RG. Social determinants of health influence maternal health behaviors and engagement in an obesity prevention intervention. Transl Behav Med. 2026 Jan 7;16(1):ibaf088. doi: 10.1093/tbm/ibaf088. |
| 40211363 | Derived | Tabak RG, Schwarz CD, Kemner A, Haire-Joshu D. Cross-Sectional associations between inner setting determinants of self-efficacy and intent to deliver a healthy eating and activity curriculum embedded in a community setting. Int J Behav Nutr Phys Act. 2025 Apr 10;22(1):42. doi: 10.1186/s12966-025-01736-5. |
| 38414886 | Derived | Farabi SS, Schwarz C, Persaud A, Gilbert A, Haire-Joshu D, Tabak RG. Sleep, Stress, and Cardiometabolic Health in Women of Childbearing Age with Overweight and Obesity. Womens Health Rep (New Rochelle). 2024 Feb 21;5(1):143-151. doi: 10.1089/whr.2023.0138. eCollection 2024. |
| 34909520 | Derived | Tabak RG, Schwarz CD, Kemner A, Johnston S, Aramburu A, Haire-Joshu D. Social Determinants of Health Discussed with Mothers During Personal Visits Before and During the COVID-19 Pandemic. Health Equity. 2021 Sep 3;5(1):536-544. doi: 10.1089/heq.2020.0140. eCollection 2021. |
| 31238955 | Derived | Tabak RG, Schwarz CD, Kemner A, Schechtman KB, Steger-May K, Byrth V, Haire-Joshu D. Disseminating and implementing a lifestyle-based healthy weight program for mothers in a national organization: a study protocol for a cluster randomized trial. Implement Sci. 2019 Jun 25;14(1):68. doi: 10.1186/s13012-019-0916-0. |
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Providers not included in the primary outcome. |
|
| BG001 | Usual Care | Participants at usual care PAT sites will receive PAT as usual Usual Care: The Foundational (usual care) curriculum uses a strength-based, solution-focused model to provide parents with child development knowledge and parenting support, empowering parents as their child's first and most influential teacher. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents. | Count of Participants | Participants |
|
| Race (NIH/OMB) | As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents. | Count of Participants | Participants |
|
| Baseline Weight | As a dissemination and implementation trial, the current study includes outcomes at the parent level (n=309) as well as the perspectives of the providers (n=311) delivering the intervention. Since these providers completed data collection (e.g., their perspectives of the intervention) these 311 individuals were considered human subjects and enrolled in the study. However, the focus of the primary outcome is on the weight outcomes among the 309 parents. | Median | Inter-Quartile Range | Kg |
|
| OG001 | Usual Care | Participants at usual care PAT sites will receive PAT as usual Usual Care: The Foundational (usual care) curriculum uses a strength-based, solution-focused model to provide parents with child development knowledge and parenting support, empowering parents as their child's first and most influential teacher. |
|
|
| Secondary | Fidelity of Delivery to the Intervention | Parent educators' fidelity to the intervention will all be assessed using a coding document (developed for the current study), which will be applied to audio-recordings of study visits, and will document the following components: adherence, quality of delivery, exposure to the intervention, and participant responsiveness or involvement, all of which share a common unit of measure | Posted | Count of Units | Visit recordings | throughout intervention delivery, which can range from 2-4 years for parent educators depending on when their site is randomized | Visit recordings | Visit recordings |
|
|
|
| 0 |
| 349 |
| 0 |
| 349 |
| 0 |
| 349 |
| EG001 | Usual Care | Participants at usual care PAT sites will receive PAT as usual Usual Care: The Foundational (usual care) curriculum uses a strength-based, solution-focused model to provide parents with child development knowledge and parenting support, empowering parents as their child's first and most influential teacher. | 0 | 271 | 0 | 271 | 0 | 271 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Male |
|
| Unknown or Not Reported |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|