Maintenance-Tailored Obesity Treatment

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Maintenance-Tailored Obesity Treatment

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Standard Behavioral Treatment (SBT)
* Behavioral: Maintenance-Tailored Treatment (MTT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must be 18 years of age or older Body mass index between 30.0 and 37.0 Exclusion Criteria: serious current physical disease (e.g., heart disease, cancer, and diabetes) for which physician supervision of diet and exercise would be needed. initial fasting glucose values above 120 mg/dl resting blood pressure at or above 90 DBP or 150 SBP will be strongly encouraged to see their primary care physician for further evaluation and will not be accepted into the study unless they do so and have physician consent for participation. physical problems that preclude their participation in the diet and exercise components of the program currently taking weight-loss medications currently participating in another formal weight loss-program currently pregnant or plan to become pregnant during the next 30 months currently receiving treatment for a major psychological disorder or have scores on the Beck Depression Inventory above 27.0, indicative of likely clinical depression. only one individual per household accepted into the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Behavioral Treatment (SBT)<br>Standard Behavioral Treatment (SBT) for weight loss intervention 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). | Behavioral: Standard Behavioral Treatment (SBT)<br>* 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.<br>* Other names: lifestyle intervention;|
| Experimental: Maintenance-Tailored Treatment (MTT)<br>Maintenance-Tailored Treatment (MTT) for weight loss intervention 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. | Behavioral: Maintenance-Tailored Treatment (MTT)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Body Weight |  | Baseline to18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Activity, Energy Expenditure | change from baseline in energy expenditure at 6 months | Baseline and 6 months | 
| Change From Baseline in Energy Intake at 6 Months |  | Baseline and 6 months | 
| Blood Pressure |  | baseline, 6, 12, 18, and 30 months | 
| Waist-to-hip Ratio at Baseline |  | baseline | 
| Blood Glucose |  | baseline, 6, 12, 18, and 30 months | 
| Insulin |  | baseline, 6, 12, 18, and 30 months | 
| HDL |  | baseline, 6, 12, 18, and 30 months | 
| Triglycerides |  | baseline, 6, 12, 18, and 30 months | 
| Mood State |  | baseline, 6, 12, 18, and 30 months | 
| Physical Activity, Energy Expenditure | change from baseline in energy expenditure at 12 months | 12 months | 
| Physical Activity, Energy Expenditure | change from baseline in energy expenditure at 18 months | 18 months | 
| Change From Baseline in Energy Intake at 12months |  | 12 months | 
| Change From Baseline in Energy Intake at 18 Months |  | 18 months | 
| Waist-to-hip Ratio at 6 Months |  | 6 months | 
| Waist-to-hip Ratio at 12 Months |  | 12 months | 
| Waist-to-hip Ratio at 18 Months |  | 18 months | 
| Waist-to-hip Ratio at 30 Months |  | 30 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, weight loss, treatment