ObesityPhase 3HEALTH D&INCT03758638
Healthy Eating and Active Living Taught at Home (HEALTH) Dissemination & Implementation (D&I)
A Phase 3 study testing Healthy Eating & Active Living Taught at Home in people with Obesity, run by Washington University School of Medicine at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Healthy Eating & Active Living Taught at Home
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 620 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2019to 30 Jun 2025
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Deliver PAT at a site participating in the study
- Provide informed consent
- 18-45 years of age
- overweight or obese (BMI 25-45 kg/m2)
- English or Spanish speaking
- participating or willing to participate in PAT at a participating PAT site for 2 years
- able to give informed consent for participation
Who cannot join
- At least 18 years of age
- For Participants:
- currently pregnant or planning to become pregnant in the next 24 months
- unable to speak English or Spanish
- unable to engage in a walking program
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University in St. Louis
St Louis, Missouri, 63130
About this study
Official title: Disseminating and Implementing A Lifestyle Based Healthy Weight Program in a National Organization
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.
Read the detailed description
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.
- Conditions
- Obesity
- Being tested
- Healthy Eating & Active Living Taught at Home, Usual Care
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Eating & Active Living Taught at HomeBehavioural
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.
Usual CareBehavioural
Also called Parents as Teachers
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Healthy Eating & Active Living Taught at Home |
| Usual Care | Active comparator | Participants at usual care PAT sites will receive PAT as usual Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Weight
Mother's body weight assessed by data collector
Measured: 24-months
Secondary outcomes (1)
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
Measured: throughout intervention delivery, which can range from 2-4 years for parent educators depending on when their site is randomized
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start25 Jan 2019
- Primary completion31 Jul 2024
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 620 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachel G Tabak, PhD, RD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03758638
- Sponsor's protocol ID
- 201810157-1R01HL143360
- Acronym
- HEALTH D&I
- Status last verified
- Oct 2025
- First submitted
- 26 Nov 2018
- Last updated
- 12 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: * Only data with identifiers removed will be shared publicly. * Any identified data to be shared will only be done so in coordination with the Human Research Protection Office at Washington University in St. Louis and the Institutional Review Board (IRB) at the requesting investigator's institution. * Datasets with identifiers will only be accessible to study team members with appropriate Human Subjects training.
Publications
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.
PubMed 41731558Gilbert 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.
PubMed 41498407Tabak 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.
PubMed 40211363Farabi 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.
PubMed 38414886Tabak 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.
PubMed 34909520Tabak 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.
PubMed 31238955
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disseminating and Implementing A Lifestyle Based Healthy Weight Program in a National Organization
- ClinicalTrials.gov ID
- NCT03758638
- Acronym / sponsor ID
- HEALTH D&I / 201810157-1R01HL143360
- Conditions
- Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 620 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 25 Jan 2019 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 29 Nov 2018 (actual)
- Results
- Posted 12 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Healthy Eating & Active Living Taught at Home | Experimental | Behavioral: Healthy Eating & Active Living Taught at HomePAT 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 | Behavioral: Usual CareParticipants at usual care PAT sites will receive PAT as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Deliver PAT at a site participating in the study
- Provide informed consent
- 18-45 years of age
- overweight or obese (BMI 25-45 kg/m2)
- English or Spanish speaking
Key exclusion criteria (5 listed)
- At least 18 years of age
- currently pregnant or planning to become pregnant in the next 24 months
- unable to speak English or Spanish
- unable to engage in a walking program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy Eating & Active Living Taught at HomePAT 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. | Behavioural | Healthy Eating & Active Living Taught at Home |
| Usual CareAlso: Parents as TeachersThe 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. | Behavioural | Usual Care |
Primary outcome
Change in Weight
Time frame: 24-months
Mother's body weight assessed by data collector
1 secondary outcome
Fidelity of Delivery to the Intervention
Time frame: throughout intervention delivery, which can range from 2-4 years for parent educators depending on when their site is randomized
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41731558Gilbert 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.
- Derived from this study: PubMed 41498407Gilbert 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.
- Derived from this study: PubMed 40211363Tabak 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.
- Derived from this study: PubMed 38414886Farabi 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.
- Derived from this study: PubMed 34909520Tabak 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.
- Derived from this study: PubMed 31238955Tabak 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.
- Individual participant dataSharing planned: Undecided. * Only data with identifiers removed will be shared publicly. * Any identified data to be shared will only be done so in coordination with the Human Research Protection Office at Washington University in St. Louis and the Institutional Review Board (IRB) at the requesting investigator's institution. * Datasets with identifiers will only be accessible to study team members with appropriate Human Subjects training.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel G Tabak, PhD, RD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Healthy Eating & Active Living Taught at Home in people with Obesity, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Weight (time frame: 24-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03758638, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2025.