New Media Obesity Treatment in Community Health Centers

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Behavioral: eHealth weight loss intervention

• Registration Number: NCT01827800
• Lead Sponsor: Duke University

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.

Study Timeline

• Study First Submitted: 2013-04-03
• Study First Submitted QC: 2013-04-05
• Study First Posted: 2013-04-10
• Study Start: 2013-06
• Primary Completion: 2015-09
• Study Completion: 2018-07-31
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-10
• Last Update Posted: 2018-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 351

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
eHealth weight loss intervention	eHealth weight loss intervention	The 12-month eHealth behavioral intervention includes interactive self-monitoring and feedback, tailored skills training materials, telephone counseling calls from a study coach, and primary care provider counseling.

Primary Outcome Measures

Name	Time	Method
Weight change	Baseline - 12 months	Weight will be measured at baseline and 12 months using a SECA 876 scale.

Secondary Outcome Measures

Name	Time	Method
Global Framingham risk score	Baseline - 12 months	The Framingham Risk Score is a validated scoring system used to determine an individual's chances of developing cardiovascular disease. We will calculate this score at baseline and 12 months.
Physical activity	Baseline -12 months	Physical activity will be measured at baseline and 12 months using the GPAQ (the Global Physical Activity Questionnaire developed by the World Health Organization).
The achievement and maintenance of > 5% weight loss	Baseline - 12 months	Weight will be measured at baseline and 12 months using a SECA 876 scale.
An evaluation of the intervention's impact and dissemination potential using the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework	12 and 24 months	RE-AIM was originally developed as a framework for consistent reporting of research results and later used to organize reviews of the existing literature on health promotion and disease management in different settings. The acronym stands for Reach, Effectiveness, Adoption, Implementation, and Maintenance which together determine public health impact. More recently, RE-AIM has been used to translate research into practice and to help plan programs and improve their chances of working in "real-world" settings. The framework has also been used to understand the relative strengths and weaknesses of different approaches to health promotion and chronic disease self-management-such as in-person counseling, group education classes, telephone counseling, and internet resources.
Diet	Baseline - 12 months	Dietary assessments will be performed at baseline and 12 months using the ASA24, a self-administered dietary recall measure developed by the National Cancer Institute.
Cardiometabolic risk markers	Baseline - 12 months	Risk markers include waist circumference, systolic and diastolic blood pressure, lipid panel and A1c levels

Trial Locations

Locations (1)

Duke University; 🇺🇸 Durham, North Carolina, United States