Healthy Eating and Active Living Taught at Home (HEALTH) Dissemination & Implementation (D&I) (HEALTH D&I)
|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: NCT03758638|
Recruitment Status : Recruiting
First Posted : November 29, 2018
Last Update Posted : March 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Behavioral: Healthy Eating & Active Living Taught at Home Behavioral: Usual Care||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||728 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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)|
|Official Title:||Disseminating and Implementing A Lifestyle Based Healthy Weight Program in a National Organization|
|Actual Study Start Date :||January 25, 2019|
|Estimated Primary Completion Date :||September 2023|
|Estimated Study Completion Date :||September 2023|
Experimental: 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.
Behavioral: 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.
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.
Other Name: Parents as Teachers
- Change in Weight [ Time Frame: 24-months ]Mother's body weight assessed by data collector
- 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
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): NCT03758638
|Contact: Rachel G Tabak, PhD, RDfirstname.lastname@example.org|
|Contact: Cindy D Schwarz, MPH, MS, RDemail@example.com|
|United States, Missouri|
|Washington University in St. Louis||Recruiting|
|Saint Louis, Missouri, United States, 63130|
|Contact: Rachel G Tabak, PhD 314-935-0153 firstname.lastname@example.org|
|Contact: Cindy Schwarz, MPH, MS, RD 314-935-3063 email@example.com|
|Principal Investigator:||Rachel G Tabak, PhD, RD||Washington University School of Medicine|