ObesityPhase 2HEALTH-P2NCT04253977
Promoting Healthy Weight Across the Pregnancy and Postpartum Period
A Phase 2 study testing HEALTH-P2 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-P2) to prevent excessive weight gain from pregnancy through 12 months postpartum 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?
- HEALTH-P2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 784 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2020to 31 Mar 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- pregnant
- overweight or obese (BMI over 25 kg/m2) before becoming pregnant
- English or Spanish speaking
- participating or willing to participate in PAT at a participating PAT site until baby turns 1
- able to give informed consent for participation
Who cannot join
- At least 18 years of age
- For the participants:
- planning to become pregnant again before their baby turns 1
- unable to engage in a walking program
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Washington University in St. Louis
St Louis, Missouri, 63130
Rachel Tabak, PhD, RD, 314-935-0153, rtabak@wustl.edu
Cindy Schwarz, MPH,MS,RD, 3149353063, cschwarz@wustl.edu
About this study
Official title: Promoting Healthy Weight Across the Pregnancy and Postpartum Period Through Dissemination of an Evidence Based Intervention
This project evaluates the effectiveness of an evidence-based intervention (HEALTH-P2) to prevent excessive weight gain from pregnancy through 12 months postpartum when disseminated and implemented in real-world settings, through Parents as Teachers. To enhance the impact of HEALTH-P2, the study also evaluates implementation outcomes from the training curriculum (implementation strategy) and external validity when HEALTH-P2 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
Women are exceptionally vulnerable during childbearing years to gain disproportionally large amounts of weight when compared to men or other life periods. Weight gained during pregnancy and retained after the postpartum period contributes to obesity development and progression. Evidence based lifestyle interventions addressing the trajectory of weight gain across the childbearing continuum can reverse these alarming trends of excessive weight among young women, but have had limited uptake due to time, expense, and parenting priorities. To address this gap, our research team developed the lifestyle intervention Healthy Eating, Activity Living, Taught at Home during Pregnancy and Postpartum (HEALTH-P2) in partnership with Parents as Teachers (PAT). This study will provide evidence for the dissemination and implementation (D\&I) of HEALTH-P2 across PAT's network of sites, promoting healthy weight on a national scale. The study builds on our previous work with a pragmatic cluster randomized controlled trial to evaluate D\&I of HEALTH-P2 across multiple levels to achieve widespread impact. First, we will determine weight outcomes (12-month postpartum weight; gestational weigh gain) among 336 overweight/obese women (N=168 HEALTH-P2; N=168 usual care) when parent educators (~8/site) from PAT sites nationwide receive the HEALTH-P2 training through PAT National Center's existing training infrastructure and conduct HEALTH-P2 as part of routine practice. From a D\&I perspective, an evaluation guided by RE-AIM will measure implementation outcomes (acceptability, appropriateness, feasibility, fidelity, adaptation). Further, the Conceptual Framework for Implementation Research will guide an assessment of contextual factors that influence external validity at multiple levels (mother, parent educator, PAT site).
- Conditions
- Obesity
- Being tested
- HEALTH-P2, 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.
HEALTH-P2Behavioural
The HEALTH-P2 curriculum includes evidence based lifestyle change strategies to prevent excess gestational weight gain and postpartum weight retention embedded within and delivered as part of home visits.
Usual CareBehavioural
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 |
|---|---|---|
| HEALTH-P2 | Experimental | Along with PAT National Center, parent educators affiliated with PAT sites in HEALTH-P2; with be trained to use the HEALTH-P2 training curriculum (implementation strategy). Receives: Behavioral: HEALTH-P2 |
| 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
Measured: 12 months postpartum
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 posted5 Feb 2020
- Study start3 Feb 2020
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Healthy Eating \& Active Living Taught at Home during Pregnancy and Postpartum (HEALTH-P2) embeds content related to healthy eating and activity within Parents as Teachers (PAT)'s existing home visits.
- Masking
- None (open label)
- Enrolment
- 784 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Debra Haire-Joshu, PhD, Principal investigator, Washington University School of MedicineRachel G Tabak, PhD, RD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04253977
- Sponsor's protocol ID
- 201909155
- Acronym
- HEALTH-P2
- Status last verified
- Oct 2023
- First submitted
- 31 Jan 2020
- Last updated
- 12 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Healthy Weight Across the Pregnancy and Postpartum Period Through Dissemination of an Evidence Based Intervention
- ClinicalTrials.gov ID
- NCT04253977
- Acronym / sponsor ID
- HEALTH-P2 / 201909155
- Conditions
- Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 784 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
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-P2) to prevent excessive weight gain from pregnancy through 12 months postpartum when disseminated and implemented in real-world settings, through Parents as Teachers. To enhance the impact of HEALTH-P2, the study also evaluates implementation outcomes from the training curriculum (implementation strategy) and external validity when HEALTH-P2 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
Women are exceptionally vulnerable during childbearing years to gain disproportionally large amounts of weight when compared to men or other life periods. Weight gained during pregnancy and retained after the postpartum period contributes to obesity development and progression. Evidence based lifestyle interventions addressing the trajectory of weight gain across the childbearing continuum can reverse these alarming trends of excessive weight among young women, but have had limited uptake due to time, expense, and parenting priorities. To address this gap, our research team developed the lifestyle intervention Healthy Eating, Activity Living, Taught at Home during Pregnancy and Postpartum (HEALTH-P2) in partnership with Parents as Teachers (PAT). This study will provide evidence for the dissemination and implementation (D\&I) of HEALTH-P2 across PAT's network of sites, promoting healthy weight on a national scale. The study builds on our previous work with a pragmatic cluster randomized controlled trial to evaluate D\&I of HEALTH-P2 across multiple levels to achieve widespread impact. First, we will determine weight outcomes (12-month postpartum weight; gestational weigh gain) among 336 overweight/obese women (N=168 HEALTH-P2; N=168 usual care) when parent educators (~8/site) from PAT sites nationwide receive the HEALTH-P2 training through PAT National Center's existing training infrastructure and conduct HEALTH-P2 as part of routine practice. From a D\&I perspective, an evaluation guided by RE-AIM will measure implementation outcomes (acceptability, appropriateness, feasibility, fidelity, adaptation). Further, the Conceptual Framework for Implementation Research will guide an assessment of contextual factors that influence external validity at multiple levels (mother, parent educator, PAT site).
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 during Pregnancy and Postpartum (HEALTH-P2) embeds content related to healthy eating and activity within Parents as Teachers (PAT)'s existing home visits.
| Arm | Type | Receives |
|---|---|---|
| HEALTH-P2 | Experimental | Behavioral: HEALTH-P2Along with PAT National Center, parent educators affiliated with PAT sites in HEALTH-P2; with be trained to use the HEALTH-P2 training curriculum (implementation strategy). |
| 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 (8 listed)
- Deliver PAT at a site participating in the study
- Provide informed consent
- 18-45 years of age
- pregnant
- overweight or obese (BMI over 25 kg/m2) before becoming pregnant
Key exclusion criteria (4 listed)
- At least 18 years of age
- planning to become pregnant again before their baby turns 1
- 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 |
|---|---|---|
| HEALTH-P2The HEALTH-P2 curriculum includes evidence based lifestyle change strategies to prevent excess gestational weight gain and postpartum weight retention embedded within and delivered as part of home visits. | Behavioural | HEALTH-P2 |
| Usual CareThe 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: 12 months postpartum
Mother's body weight
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
- 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.
Debra Haire-Joshu, PhD principal investigator
Washington University School of Medicine
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 2 study testing HEALTH-P2 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 8 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 12 Oct 2023. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rachel Tabak, PhD, RD (314-935-0153, rtabak@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in weight (time frame: 12 months postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Oct 2023.