Weight Loss Maintenance (WLM) — WLM  

Obesity Clinical Trial

Official title: Weight Loss Maintenance (WLM)

Status Completed

Clinical Trial Summary

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

Clinical Trial 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes Mellitus, Non-insulin Dependent
• Diabetes Mellitus, Type 2
• Heart Diseases
• Hypertension
• Obesity

• NCT number: NCT00054925
• Study type: Interventional
• Source: Duke University
• Status: Completed
• Phase: N/A
• Start date: January 2003
• Completion date: October 2009