Obesity Clinical Trial
— HEALTH D&IOfficial 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.
Status | Recruiting |
Enrollment | 624 |
Est. completion date | September 2024 |
Est. primary completion date | September 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 Participants: Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Washington University in St. Louis | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Weight | Mother's body weight assessed by data collector | 24-months | |
Secondary | 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 | throughout intervention delivery, which can range from 2-4 years for parent educators depending on when their site is randomized |
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