CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 840 enrolled
Drug / intervention
Online weight management program +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02656693
NCT02656693N/ACompleted

Integrating Online Weight Management With Primary Care Support: Patient-Centered Strategies for Addressing Overweight and Obesity in Primary Care

Brigham and Women's Hospital·interventional·Posted Jan 15, 2016·Updated Nov 5, 2020

In Brief

A clinical study evaluating Online weight management program and Population health management support for Obesity. Completed, enrolled 840 participants across 1 site.

Detailed Summary

The goal of this project is to adapt an evidence-based online weight management program and integrate it with population management support from primary care practices. Investigators then will conduct a three-arm, cluster-randomized trial to compare the effectiveness of 1) the combined intervention (online weight management program plus population management support) with 2) the stand-alone online weight management program and with 3) usual care, among overweight and obese primary care patients with type 2 diabetes or hypertension. The specific aims are: 1. a. To adapt an online weight management program and integrate it with population management support, incorporating input from patients, primary care clinicians, and other stakeholders; afterward, investigators will acquire feedback on the positive and negative aspects of the intervention. b. To compare the effectiveness of the combined intervention (online weight management program plus population management support) with the stand-alone online program and with usual care. Hypothesis 1: The combined intervention will lead to greater weight loss at 12 months compared with the stand-alone online program and with usual care. 2. To identify mediators of the combined intervention and the stand-alone online program. Hypothesis 2: The effects of the combined intervention and the stand-alone online program on weight loss will be mediated by patients' level of engagement, changes in self-efficacy, and changes in diet and physical activity. 3. To explore whether the effectiveness of the combined intervention and the stand-alone weight management program varies by patient characteristics. Hypothesis 3: The interventions will be more effective among patients who are younger, white, and higher socioeconomic status, although the population management strategy may help to reduce these differences.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity
CountriesUnited States

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 15, 2016
Enrollment StartJul 19, 2016
Primary CompletionNov 8, 2018
Study CompletionMay 8, 2019
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 10.5 years ago

Interventions

Online weight management programbehavioral

Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program.

Population health management supportbehavioral

Patients will receive weight-related population health management support from their primary care practice; their online weight management program data will be monitored by the population health manager, who will conduct outreach with patients at designated points according to the protocol.