Weight Loss Maintenance (WLM)

Not Applicable

Completed

• Conditions: Cardiovascular Diseases; Heart Diseases; Obesity; Diabetes Mellitus, Non-insulin Dependent; Hypertension
• Interventions: Behavioral: Personal contact (PC); Behavioral: Interactive technology (IT)

• Registration Number: NCT00054925
• Lead Sponsor: Duke University

Brief Summary

To determine the effectiveness of continuous patient contact on weight loss maintenance.

Detailed Description

BACKGROUND:

Overweight/obesity is the second leading cause of death in the US, and is growing in prevalence at an alarming rate. Control of overweight/obesity is increasingly recognized as a high national priority because of its contribution to cardiovascular (CVD) risk factors and ultimately to CVD itself. The short-term success of behavioral interventions for weight loss has been repeatedly documented. Unfortunately, because weight re-gain is extremely common, a disappointingly, small proportion of individuals achieve long-term weight control. Of the factors that are associated with sustained weight loss, one of the most important is continued intervention with frequent contacts.

DESIGN NARRATIVE:

The study is a multi-center, randomized, controlled trial \[Weight Loss Maintenance Trial (MAINTENANCE)\] to determine the effects of two innovative behavioral interventions, each designed to maintain frequent contacts, compared to a usual care control group. Overweight and obese individuals (60% women, 40% African Americans) who are taking medication for hypertension, dyslipidemia and/or type 2 diabetes will enter a 6-month, weight loss program. Those 800 individuals who lose at least 4 kg (approximately 9 pounds) will then be randomized into one of three groups: a Personal Contact (PC) Intervention that provides monthly personal contacts with a trained interventionist, primarily via telephone; an Interactive Technology (IT) Intervention that provides frequent contacts through a state-of-the-art interactive web-based program supplemented by other communication technologies; or Usual Care (UC). The primary outcome will be weight change from the end of the initial weight loss program to the end of the 30-month weight maintenance intervention period. Other outcomes will include weight change in subgroups, prevalence of CVD risk factors, measures of behavior change, and cost of implementation. For each outcome, the Personal Contact and Interactive Technology interventions will be compared to Usual Care and, if different from Usual Care, to each other. To successfully combat the obesity epidemic, clinicians and health care systems must have options that are effective and feasible and that can be provided to large numbers of individuals.

Phase II intervention completed: July 2007

Phase III intervention completed: October 2009

Study Timeline

• Study Start: 2003-01
• Study First Submitted: 2003-02-13
• Study First Submitted QC: 2003-02-13
• Study First Posted: 2003-02-14
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-06
• Last Update Posted: 2012-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1685

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Personal contact (PC)	Personal contact (PC)	The Personal Contact (PC) intervention offers one-on-one guidance and support in maintaining weight loss.
Interactive technology (IT)	Interactive technology (IT)	Utilizes internet and automated phone technology to enhance the frequency and timeliness of feedback.

Primary Outcome Measures

Name	Time	Method
Change in Weight	Baseline to 30 months