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
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Behavioral: HEALTH-P2 Behavioral: Usual Care||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||784 participants|
|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)|
|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|
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).
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.
- Change in weight [ Time Frame: 12 months postpartum ]Mother's body weight
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04253977
|Contact: Rachel Tabak, PhD, RDfirstname.lastname@example.org|
|Contact: Cindy Schwarz, MPH,MS,RDemail@example.com|
|Principal Investigator:||Debra Haire-Joshu, PhD||Washington University School of Medicine|
|Principal Investigator:||Rachel G Tabak, PhD, RD||Washington University School of Medicine|