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Weight Loss Maintenance (WLM)

This study is ongoing, but not recruiting participants.
Information provided by National Heart, Lung, and Blood Institute (NHLBI)

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Descriptive Information Fields
Brief Title  Weight Loss Maintenance (WLM)
Official Title 
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

Study Phase Phase III
Study Type  Interventional
Study Design  Prevention, Randomized
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Cardiovascular Diseases
Heart Diseases
Obesity
Diabetes Mellitus, Non-Insulin Dependent
Hypertension
Intervention  Behavioral: Personal Contact
Device: Interactive Web-based technology
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment 
Start Date  January 2003
Completion Date December 2007
Eligibility Criteria 

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.

Gender Both
Ages 25 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries 
Administrative Information Fields
NCT ID  NCT00054925
Organization ID 156
Secondary IDs ††
Study Sponsor  National Heart, Lung, and Blood Institute (NHLBI)
Collaborators ††
Investigators 
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    
Information Provided By National Heart, Lung, and Blood Institute (NHLBI)
Verification Date December 2005
First Received Date  February 13, 2003
Last Updated Date July 24, 2007

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




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