Analysis of five year follow-up data from the Weight Loss Maintenance Trial

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DESCRIPTION (provided by investigator): This application addresses broad Challenge Area (04) Clinical Research, and specific Challenge Topic 04-HL-104: Perform secondary analyses of existing data to answer important clinical and preventive medicine research questions. While only a minor public health issue 50 years ago, overweight/obesity has now become a major contributor to CVD risk through effects on blood pressure, insulin resistance, and lipids. Fortunately, even modest weight loss improves these risk factors, and well-designed, contemporary behavioral interventions typically yield a clinically significant 6-month weight loss for 1/2 to 2/3 of the participants. To reduce CVD morbidity and mortality, however, weight loss must be sustained long-term (defined by NHLBI as at least 5 years), and only a few controlled clinical trials have systematically compared weight loss maintenance strategies for more than one year. Developing more effective long-term maintenance strategies has become one of the most important concerns in the field of obesity treatment. The Weight Loss Maintenance Trial (WLM) was a multi-center, randomized, controlled trial that compared strategies for maintaining weight loss in high risk adults. WLM participants were 1032 overweight/obese adults (38 percent African American, 37 percent male) taking medication for hypertension and/or dyslipidemia, who achieved a clinically significant weight loss during an initial 6-month weight loss program (Phase I). These participants were randomly assigned to one of two behavioral interventions or to a no-treatment control condition. Phase II intervention continued for 21/2 years after randomization (3 years from the start of initial weight loss). At the end of phase II, with a greater than 90 percent follow-up data collection rate, 40-46 percent of the participants in each treatment group were maintaining clinically significant weight loss. Funding for WLM ended after phase II. However, 3 of the 4 clinical centers continued intervention activities and have collected follow-up data for another 2 1/2 years, extending follow-up to a total of 5 years after the start of phase II. These follow-up data were collected with the hope that funding for their analysis could be obtained in the future. To that end, this application requests funding to analyze and disseminate the five year follow-up data. These analyses will provide a rare opportunity to identify and compare short-term (6 month), intermediate-term (2 1/2 years post randomization) and long-term (5 years post randomization) predictors of relapse and maintenance in a large and racially diverse participant group. Of particular interest is whether continued intervention is necessary to sustain weight loss after 2 1/2 years of successful maintenance. Since the data have already been collected, this work can be accomplished in a 2- year time frame while simultaneously addressing the employment goals of the ARRA. The biggest challenge in fighting the obesity epidemic is developing better ways to help individuals that have lost weight maintain their weight loss over many years. This challenge grant application requests funding to analyze follow-up data collected 2 1/2 years following the end of a major study that tested several different weight loss maintenance strategies. These analyses will provide a rare opportunity to identify and compare short-term (6 month), intermediate-term (2 1/2 years post randomization) and long-term (5 years post randomization) predictors of maintenance in a large and racially diverse participant group.