- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00670462
Maintenance-Tailored Obesity Treatment (LIFE)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Minnesota
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Minneapolis, Minnesota, United States, 55454
- University of Minnesota, School of Public Health
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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ACTIVE_COMPARATOR: Standard Behavioral Treatment (SBT)
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).
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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:
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EXPERIMENTAL: Maintenance-Tailored Treatment (MTT)
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Change in Body Weight
Time Frame: Baseline to18 months
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Baseline to18 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical Activity, Energy Expenditure
Time Frame: Baseline and 6 months
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change from baseline in energy expenditure at 6 months
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Baseline and 6 months
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Change From Baseline in Energy Intake at 6 Months
Time Frame: Baseline and 6 months
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Baseline and 6 months
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Blood Pressure
Time Frame: baseline, 6, 12, 18, and 30 months
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baseline, 6, 12, 18, and 30 months
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Waist-to-hip Ratio at Baseline
Time Frame: baseline
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baseline
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Blood Glucose
Time Frame: baseline, 6, 12, 18, and 30 months
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baseline, 6, 12, 18, and 30 months
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Insulin
Time Frame: baseline, 6, 12, 18, and 30 months
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baseline, 6, 12, 18, and 30 months
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HDL
Time Frame: baseline, 6, 12, 18, and 30 months
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baseline, 6, 12, 18, and 30 months
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Triglycerides
Time Frame: baseline, 6, 12, 18, and 30 months
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baseline, 6, 12, 18, and 30 months
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Mood State
Time Frame: baseline, 6, 12, 18, and 30 months
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baseline, 6, 12, 18, and 30 months
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Physical Activity, Energy Expenditure
Time Frame: 12 months
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change from baseline in energy expenditure at 12 months
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12 months
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Physical Activity, Energy Expenditure
Time Frame: 18 months
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change from baseline in energy expenditure at 18 months
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18 months
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Change From Baseline in Energy Intake at 12months
Time Frame: 12 months
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12 months
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Change From Baseline in Energy Intake at 18 Months
Time Frame: 18 months
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18 months
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Waist-to-hip Ratio at 6 Months
Time Frame: 6 months
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6 months
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Waist-to-hip Ratio at 12 Months
Time Frame: 12 months
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12 months
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Waist-to-hip Ratio at 18 Months
Time Frame: 18 months
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18 months
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Waist-to-hip Ratio at 30 Months
Time Frame: 30 months
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30 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Robert W Jeffery, PhD, University of Minnesota
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0402S56276
- R01DK067362 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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