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Completed

NCT Number: NCT00670462

Maintenance-Tailored Obesity Treatment

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota, School of Public Health

Minneapolis, Minnesota, 55454, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard Behavioral Treatment (SBT)

Behavioral

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

Maintenance-Tailored Treatment (MTT)

Behavioral

Primary outcomes

  1. Change in Body Weight

    Time frame: Baseline to18 months

Secondary outcomes

  1. Physical Activity, Energy Expenditure

    Time frame: Baseline and 6 months

    change from baseline in energy expenditure at 6 months

  2. Change From Baseline in Energy Intake at 6 Months

    Time frame: Baseline and 6 months

  3. Blood Pressure

    Time frame: baseline, 6, 12, 18, and 30 months

  4. Waist-to-hip Ratio at Baseline

    Time frame: baseline

  5. Blood Glucose

    Time frame: baseline, 6, 12, 18, and 30 months

  6. Insulin

    Time frame: baseline, 6, 12, 18, and 30 months

  7. HDL

    Time frame: baseline, 6, 12, 18, and 30 months

  8. Triglycerides

    Time frame: baseline, 6, 12, 18, and 30 months

  9. Mood State

    Time frame: baseline, 6, 12, 18, and 30 months

  10. Physical Activity, Energy Expenditure

    Time frame: 12 months

    change from baseline in energy expenditure at 12 months

  11. Physical Activity, Energy Expenditure

    Time frame: 18 months

    change from baseline in energy expenditure at 18 months

  12. Change From Baseline in Energy Intake at 12months

    Time frame: 12 months

  13. Change From Baseline in Energy Intake at 18 Months

    Time frame: 18 months

  14. Waist-to-hip Ratio at 6 Months

    Time frame: 6 months

  15. Waist-to-hip Ratio at 12 Months

    Time frame: 12 months

  16. Waist-to-hip Ratio at 18 Months

    Time frame: 18 months

  17. Waist-to-hip Ratio at 30 Months

    Time frame: 30 months

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • University of Washington

Registry information

Acronym: LIFE

Important dates

Study start
2004
Primary completion
2010
Study completion
2010
First posted
May 1, 2008
Registry last updated
Mar 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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