Clinical trial NCT00670462: Maintenance-Tailored Obesity Treatment
Official title: Maintenance-Tailored Obesity Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: obesity, weight loss, treatment
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: University of Washington
First posted: 2008-05-01
Enrollment: 213
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Body Weight
timeFrame: Baseline to18 months
Secondary outcomes:
measure: Physical Activity, Energy Expenditure
timeFrame: Baseline and 6 months
measure: Change From Baseline in Energy Intake at 6 Months
timeFrame: Baseline and 6 months
measure: Blood Pressure
timeFrame: baseline, 6, 12, 18, and 30 months
measure: Waist-to-hip Ratio at Baseline
timeFrame: baseline
measure: Blood Glucose
timeFrame: baseline, 6, 12, 18, and 30 months
measure: Insulin
timeFrame: baseline, 6, 12, 18, and 30 months
measure: HDL
timeFrame: baseline, 6, 12, 18, and 30 months
measure: Triglycerides
timeFrame: baseline, 6, 12, 18, and 30 months
measure: Mood State
timeFrame: baseline, 6, 12, 18, and 30 months
measure: Physical Activity, Energy Expenditure
timeFrame: 12 months
measure: Physical Activity, Energy Expenditure
timeFrame: 18 months
measure: Change From Baseline in Energy Intake at 12months
timeFrame: 12 months
measure: Change From Baseline in Energy Intake at 18 Months
timeFrame: 18 months
measure: Waist-to-hip Ratio at 6 Months
timeFrame: 6 months
measure: Waist-to-hip Ratio at 12 Months
timeFrame: 12 months
measure: Waist-to-hip Ratio at 18 Months
timeFrame: 18 months
measure: Waist-to-hip Ratio at 30 Months
timeFrame: 30 months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota, School of Public Health
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Robert W Jeffery, PhD
role: PRINCIPAL_INVESTIGATOR
References: