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Maintenance-Tailored Obesity Treatment (LIFE)

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard Behavioral Treatment (SBT)
Maintenance-Tailored Treatment (MTT)
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring obesity, weight loss, treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Minnesota, School of Public Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Behavioral Treatment (SBT)

Maintenance-Tailored Treatment (MTT)

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Change in Body Weight

Secondary Outcome Measures

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

Full Information

First Posted
April 30, 2008
Last Updated
February 17, 2017
Sponsor
University of Minnesota
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT00670462
Brief Title
Maintenance-Tailored Obesity Treatment
Acronym
LIFE
Official Title
Maintenance-Tailored Obesity Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Washington

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
obesity, weight loss, treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
213 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Behavioral Treatment (SBT)
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Maintenance-Tailored Treatment (MTT)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard Behavioral Treatment (SBT)
Other Intervention Name(s)
lifestyle intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Maintenance-Tailored Treatment (MTT)
Primary Outcome Measure Information:
Title
Change in Body Weight
Time Frame
Baseline to18 months
Secondary Outcome Measure Information:
Title
Physical Activity, Energy Expenditure
Description
change from baseline in energy expenditure at 6 months
Time Frame
Baseline and 6 months
Title
Change From Baseline in Energy Intake at 6 Months
Time Frame
Baseline and 6 months
Title
Blood Pressure
Time Frame
baseline, 6, 12, 18, and 30 months
Title
Waist-to-hip Ratio at Baseline
Time Frame
baseline
Title
Blood Glucose
Time Frame
baseline, 6, 12, 18, and 30 months
Title
Insulin
Time Frame
baseline, 6, 12, 18, and 30 months
Title
HDL
Time Frame
baseline, 6, 12, 18, and 30 months
Title
Triglycerides
Time Frame
baseline, 6, 12, 18, and 30 months
Title
Mood State
Time Frame
baseline, 6, 12, 18, and 30 months
Title
Physical Activity, Energy Expenditure
Description
change from baseline in energy expenditure at 12 months
Time Frame
12 months
Title
Physical Activity, Energy Expenditure
Description
change from baseline in energy expenditure at 18 months
Time Frame
18 months
Title
Change From Baseline in Energy Intake at 12months
Time Frame
12 months
Title
Change From Baseline in Energy Intake at 18 Months
Time Frame
18 months
Title
Waist-to-hip Ratio at 6 Months
Time Frame
6 months
Title
Waist-to-hip Ratio at 12 Months
Time Frame
12 months
Title
Waist-to-hip Ratio at 18 Months
Time Frame
18 months
Title
Waist-to-hip Ratio at 30 Months
Time Frame
30 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert W Jeffery, PhD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota, School of Public Health
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States

12. IPD Sharing Statement

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Maintenance-Tailored Obesity Treatment

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