University of Minnesota, School of Public Health
Minneapolis, Minnesota, 55454, United States
NCT Number: NCT00670462
This study is a randomized clinical trial comparing state-of-the-art, standard behavior therapy for weight loss (SBT) with a maintenance tailored treatment (MTT) with varied behavioral prescriptions, goals, and formats over time. The overall hypothesis in the study is that the two treatment approaches will show different patterns of weight loss over time, and in particular that the MTT approach would be associated with better long-term maintenance of weight loss.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Minneapolis, Minnesota, 55454, United States
Recent dramatic increases in prevalence have made obesity the number one nutritional problem in the US. Of particular concern is the fact that, although available treatments are effective in producing clinically significant weight loss, their ability to sustain weight loss long term is poor. This study is based on a conceptual analysis of this problem that argues for greater attention to two issues related to the temporal dynamics of the challenge of long-term weight control. These are: 1) the environment is continually changing and is not supportive of weight control and 2) the intervention methods that are effective in inducing short-term changes in behaviors and weight often lose their potency over time because of habituation.
This study is a randomized trial in which obese men and women are assigned to one of two study conditions, Standard Behavior Treatment (SBT) or Maintenance-Tailored Treatment (MTT). The MTT has adaptation to change as its central theme. A primary technique that is used to convey this theme that is different than traditional behavior treatment is that participants are asked to deliberately change weight-loss strategies systematically over time rather than to use the same approach consistently across time. Frequent change serves as a platform for teaching a larger variety of weight-control skills and thus strengthening study participants ability to adapt their weight-control strategies to changing circumstances. Changing weight-control strategies regularly also helps to reduce the extent to which habituation to strategies implemented invariantly over time diminish the salience of behavioral cues and the potency of behavioral reinforcers for sustaining weight-control efforts over time. Individuals in both treatment groups receive active intervention for a period of 18 months, followed by 12 months of no-treatment follow-up.
The primary hypothesis tested is that MTT will produce larger mean weight losses at 30-month follow-up than SBT. Moreover, it is predicted that the better long-term success of the MTT group will be due primarily to better weight-loss success beyond 6 months, the point at which most people begin to regain weight with standard therapy.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
SBT is state-of-the-art behavioral weight loss treatment, comprised of 6 months of weekly treatment meetings followed by 6 months of biweekly meetings and 6 months of monthly meetings. Topical coverage and behavioral assignments include typical combination of energy balance information and self-control skills training. MTT has the same number of treatment contacts, but the contacts are distributed in distinct 8-week segments, each of which have a unique topic and unique behavioral assignments. Between each segment, participants are left on their own for 4 weeks with instructions to continue regular weighing but otherwise to make their own choices about what to do for weight control.
Other names: lifestyle intervention
Time frame: Baseline to18 months
Time frame: Baseline and 6 months
change from baseline in energy expenditure at 6 months
Time frame: Baseline and 6 months
Time frame: baseline, 6, 12, 18, and 30 months
Time frame: baseline
Time frame: baseline, 6, 12, 18, and 30 months
Time frame: baseline, 6, 12, 18, and 30 months
Time frame: baseline, 6, 12, 18, and 30 months
Time frame: baseline, 6, 12, 18, and 30 months
Time frame: baseline, 6, 12, 18, and 30 months
Time frame: 12 months
change from baseline in energy expenditure at 12 months
Time frame: 18 months
change from baseline in energy expenditure at 18 months
Time frame: 12 months
Time frame: 18 months
Time frame: 6 months
Time frame: 12 months
Time frame: 18 months
Time frame: 30 months
University of Minnesota
Other
Acronym: LIFE
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