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Sponsors and Collaborators: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) University of Washington |
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Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | 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.
Condition | Intervention | Phase |
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Obesity |
Behavioral: weight loss intervention |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | Maintenance-Tailored Obesity Treatment |
Enrollment: | 213 |
Study Start Date: | October 2004 |
Estimated Study Completion Date: | July 2008 |
Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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SBT: Active Comparator
Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then "embellishes" these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).
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Behavioral: weight loss intervention
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.
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MTT: Experimental
Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy "embellishments" as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors.
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Behavioral: weight loss intervention
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.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Minnesota | |
University of Minnesota, School of Public Health | |
Minneapolis, Minnesota, United States, 55454 |
Principal Investigator: | Robert W Jeffery, PhD | University of Minnesota, School of Public Health |
Responsible Party: | University of Minnesota ( Robert W. Jeffery, Principal Investigator ) |
Study ID Numbers: | DK064596 |
Study First Received: | April 30, 2008 |
Last Updated: | April 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00670462 History of Changes |
Health Authority: | United States: Federal Government |
obesity, weight loss, treatment |
Body Weight Signs and Symptoms Obesity Weight Loss |
Nutrition Disorders Overweight Overnutrition |
Body Weight Signs and Symptoms Obesity |
Nutrition Disorders Overweight Overnutrition |