Maintenance-Tailored Obesity Treatment (LIFE)
|Obesity||Behavioral: Standard Behavioral Treatment (SBT) Behavioral: Maintenance-Tailored Treatment (MTT)|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Maintenance-Tailored Obesity Treatment|
- Change in Body Weight [ Time Frame: Baseline to18 months ]
- Physical Activity, Energy Expenditure [ Time Frame: Baseline and 6 months ]change from baseline in energy expenditure at 6 months
- Change From Baseline in Energy Intake at 6 Months [ Time Frame: Baseline and 6 months ]
- Blood Pressure [ Time Frame: baseline, 6, 12, 18, and 30 months ]
- Waist-to-hip Ratio at Baseline [ Time Frame: baseline ]
- Blood Glucose [ Time Frame: baseline, 6, 12, 18, and 30 months ]
- Insulin [ Time Frame: baseline, 6, 12, 18, and 30 months ]
- HDL [ Time Frame: baseline, 6, 12, 18, and 30 months ]
- Triglycerides [ Time Frame: baseline, 6, 12, 18, and 30 months ]
- Mood State [ Time Frame: baseline, 6, 12, 18, and 30 months ]
- Physical Activity, Energy Expenditure [ Time Frame: 12 months ]change from baseline in energy expenditure at 12 months
- Physical Activity, Energy Expenditure [ Time Frame: 18 months ]change from baseline in energy expenditure at 18 months
- Change From Baseline in Energy Intake at 12months [ Time Frame: 12 months ]
- Change From Baseline in Energy Intake at 18 Months [ Time Frame: 18 months ]
- Waist-to-hip Ratio at 6 Months [ Time Frame: 6 months ]
- Waist-to-hip Ratio at 12 Months [ Time Frame: 12 months ]
- Waist-to-hip Ratio at 18 Months [ Time Frame: 18 months ]
- Waist-to-hip Ratio at 30 Months [ Time Frame: 30 months ]
|Study Start Date:||October 2004|
|Study Completion Date:||July 2010|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
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).
Behavioral: Standard Behavioral Treatment (SBT)
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 Name: lifestyle intervention
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.
|Behavioral: Maintenance-Tailored Treatment (MTT)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00670462
|United States, Minnesota|
|University of Minnesota, School of Public Health|
|Minneapolis, Minnesota, United States, 55454|
|Principal Investigator:||Robert W Jeffery, PhD||University of Minnesota, MN|