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Promoting Healthy Weight Across the Pregnancy and Postpartum Period (HEALTH-P2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04253977
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : February 21, 2020
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: HEALTH-P2 Behavioral: Usual Care Phase 2

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 468 overweight/obese women (N=234 HEALTH-P2; N=234 usual care) when parent educators (~8/site) from 36 PAT sites nationwide (18 HEALTH-P2, 18 usual care) 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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 784 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Prevention
Official Title: Promoting Healthy Weight Across the Pregnancy and Postpartum Period Through Dissemination of an Evidence Based Intervention
Actual Study Start Date : February 3, 2020
Estimated Primary Completion Date : March 31, 2024
Estimated Study Completion Date : March 31, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HEALTH-P2
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).
Behavioral: HEALTH-P2
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.

Active Comparator: Usual Care
Participants at usual care PAT sites will receive PAT as usual.
Behavioral: 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.




Primary Outcome Measures :
  1. Change in weight [ Time Frame: 12 months postpartum ]
    Mother's body weight


Secondary Outcome Measures :
  1. 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 ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   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 gestational weight gain.
Accepts Healthy Volunteers:   Yes
Criteria

For Parent educators:

Inclusion Criteria:

  • Deliver PAT at a site participating in the study
  • Provide informed consent

Exclusion Criteria:

• At least 18 years of age

For the participants:

Inclusion Criteria:

  • 18-45 years of age
  • pregnant but before 20 weeks gestation
  • overweight or obese (BMI 25-45 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

Exclusion Criteria:

  • planning to become pregnant again before their baby turns 1
  • unable to engage in a walking program

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04253977


Contacts
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Contact: Rachel Tabak, PhD, RD 314-935-0153 rtabak@wustl.edu
Contact: Cindy Schwarz, MPH,MS,RD 3149353063 cschwarz@wustl.edu

Locations
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United States, Missouri
Washington University in St. Louis Recruiting
Saint Louis, Missouri, United States, 63130
Contact: Rachel Tabak, PhD, RD    314-935-0153    rtabak@wustl.edu   
Contact: Cindy Schwarz, MPH,MS,RD    3149353063    cschwarz@wustl.edu   
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Debra Haire-Joshu, PhD Washington University School of Medicine
Principal Investigator: Rachel G Tabak, PhD, RD Washington University School of Medicine
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04253977    
Other Study ID Numbers: 201909155
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 21, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No