New Media Obesity Treatment in Community Health Centers
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obesity
- Sponsor
- Duke University
- Enrollment
- 351
- Locations
- 1
- Primary Endpoint
- Weight change
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This purpose of this trial is to determine whether a 12-month eHealth behavioral intervention that includes interactive self-monitoring and feedback, tailored skills training materials, telephone counseling calls, and primary care physician (PCP) counseling will produce greater weight change at 12 months than a standard primary care control.
Detailed Description
This is a patient randomized trial in which patients will be randomized into one of two treatment arms: 1) standard primary care; or 2) primary care plus a 12-month eHealth behavioral intervention (iOTA), which includes interactive self-monitoring and feedback, tailored skills training materials, 18 telephone counseling calls, and primary care provider counseling. The primary outcome is weight change at 12 months. Participants will be 351 adult male and female patients from local community health centers with obesity and a related comorbidity.
Investigators
Eligibility Criteria
Inclusion Criteria
- •At least 1 visit in the previous 12 months to an adult medicine, internal medicine, or family practice provider at a participating community health center
- •BMI between 30.0-45.0 kg/m2 and weight ≤ 320 pounds
- •Diagnosis of hypertension or diabetes
Exclusion Criteria
- •Current pregnancy
- •Pregnancy in previous 12 months
- •Heart attack/stroke in previous 2 years
- •Active cancer diagnosis
- •Current participation in another weight loss study
Outcomes
Primary Outcomes
Weight change
Time Frame: Baseline - 12 months
Weight will be measured at baseline and 12 months using a SECA 876 scale.
Secondary Outcomes
- Global Framingham risk score(Baseline - 12 months)
- Physical activity(Baseline -12 months)
- The achievement and maintenance of > 5% weight loss(Baseline - 12 months)
- An evaluation of the intervention's impact and dissemination potential using the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework(12 and 24 months)
- Diet(Baseline - 12 months)
- Cardiometabolic risk markers(Baseline - 12 months)