Maintenance-Tailored Obesity Treatment

NCT00670462 | Completed Results DMC

• 2 other identifiers: 0402S56276R01DK067362
• Study Type: interventional
• Target: 213
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

obesity, weight loss, treatment

Outcome Measures

Primary Outcomes (1)

• Change in Body Weight

  Baseline to18 months

Secondary Outcomes (17)

• Physical Activity, Energy Expenditure

  Baseline and 6 months

• Change From Baseline in Energy Intake at 6 Months

  Baseline and 6 months

• Blood Pressure

  baseline, 6, 12, 18, and 30 months

• Waist-to-hip Ratio at Baseline

  baseline

• Blood Glucose

  baseline, 6, 12, 18, and 30 months

Study Arms (2)

Standard Behavioral Treatment (SBT)

ACTIVE COMPARATOR

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)

Maintenance-Tailored Treatment (MTT)

EXPERIMENTAL

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)

Interventions

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.

Also known as: lifestyle intervention

Standard Behavioral Treatment (SBT)

Maintenance-Tailored Treatment (MTT) BEHAVIORAL

Maintenance-Tailored Treatment (MTT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be 18 years of age or older
• Body mass index between 30.0 and 37.0

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• University of Washington: collaborator

Study Sites (1)

University of Minnesota, School of Public Health

Minneapolis, Minnesota, 55454, United States

Location

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Results Point of Contact

• Title: Robert W. Jeffery PhD
• Organization: University of Minnesota

jeffe001@umn.edu

612-626-8580

Study Officials

• Robert W Jeffery, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2008
• First Posted: May 1, 2008
• Study Start: October 1, 2004
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: March 22, 2017
• Results First Posted: November 20, 2014

Record last verified: 2017-02

Locations

US (1)