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Weight Loss Maintenance (WLM)
This study has been completed.
Study NCT00054925.   Last updated on October 7, 2008.
Information provided by National Heart, Lung, and Blood Institute (NHLBI)
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Weight Loss Maintenance (WLM)
Weight Loss Maintenance (WLM)

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

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
Interventional
Prevention, Randomized
 
 
Cardiovascular Diseases
Heart Diseases
Obesity
Diabetes Mellitus, Non-Insulin Dependent
Hypertension
Behavioral: Personal Contact
Device: Interactive Web-based technology
 
Completed
 
January 2003
June 2007

Overweight men and women who took medication for hypertension, type 2 diabetes and/or hyperlipidemia in the six month weight loss phase. and who were able to lose approximately 9 pounds. There will be approximately 60% women and 40% African Americans.

Both
25 Years and older
No
 
 
NCT00054925
156
National Heart, Lung, and Blood Institute (NHLBI)
Investigator: Lawrence Appel Johns Hopkins University
Investigator: Phillip Brantley LSU Pennington Biomedical Research Center
Investigator: Jack Hollis Kaiser Foundation Research Institute
Investigator: Victor Stevens Kaiser Foundation Research Institute
Investigator: Laura Svetkey Duke University
National Heart, Lung, and Blood Institute (NHLBI)
October 2008
February 13, 2003
October 7, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.