Overview

This trial is active, not recruiting.

Condition obesity
Treatment ehealth weight loss intervention
Sponsor Duke University
Start date June 2013
End date September 2015
Trial size 351 participants
Trial identifier NCT01827800, B0033

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
ehealth weight loss intervention
This trial involves a multi-level, systems-change weight loss intervention. At the provider level, we make it easier for PCPs to deliver weight loss counseling by embedding patient progress data and counseling recommendations in the electronic health record. At the patient level, we provide engaging self-monitoring interfaces, immediate tailored feedback, skills training, and evidence-based lifestyle counseling from trusted care providers.
(No Intervention)
Participants in the usual care arm will receive the usual primary care services offered by their community health center primary care providers.

Primary Outcomes

Measure
Weight change
time frame: Baseline - 12 months

Secondary Outcomes

Measure
The achievement and maintenance of > 5% weight loss
time frame: Baseline - 12 months
Diet
time frame: Baseline - 12 months
Cardiometabolic risk markers
time frame: Baseline - 12 months
Global Framingham risk score
time frame: Baseline - 12 months
An evaluation of the intervention's impact and dissemination potential using the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework
time frame: 12 and 24 months
Physical activity
time frame: Baseline -12 months

Eligibility Criteria

Male or female participants at least 21 years old.

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

Additional Information

Official title New Media Obesity Treatment in Community Health Centers
Principal investigator Gary Bennett, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Duke University.