N/A
N=213
Maintenance-Tailored Obesity Treatment
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT00670462 ↗Enrolled (actual)
213
Serious AEs
0.5%
Results posted
Nov 2014
Primary outcome: Primary: Change in Body Weight — 9.3; 8.3 kg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Standard Behavioral Treatment (SBT) (Behavioral); Maintenance-Tailored Treatment (MTT) (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Body Weight |
9.3; 8.3 | — |
| SECONDARY Physical Activity, Energy Expenditure |
856.3; 356.0 | — |
| SECONDARY Change From Baseline in Energy Intake at 6 Months |
-491.2; -576.4 | — |
| SECONDARY Blood Pressure |
— | — |
| SECONDARY Waist-to-hip Ratio at Baseline |
.85; .99 | — |
| SECONDARY Blood Glucose |
— | — |
| SECONDARY Insulin |
— | — |
| SECONDARY HDL |
— | — |
| SECONDARY Triglycerides |
— | — |
| SECONDARY Mood State |
— | — |
| SECONDARY Physical Activity, Energy Expenditure |
856.3; 356.0 | — |
| SECONDARY Physical Activity, Energy Expenditure |
856.3; 356.0 | — |
| SECONDARY Change From Baseline in Energy Intake at 12months |
-544.1; -538.2 | — |
| SECONDARY Change From Baseline in Energy Intake at 18 Months |
-326.3; -490.1 | — |
| SECONDARY Waist-to-hip Ratio at 6 Months |
.84; .96 | — |
| SECONDARY Waist-to-hip Ratio at 12 Months |
.83; .95 | — |
| SECONDARY Waist-to-hip Ratio at 18 Months |
.83; .96 | — |
| SECONDARY Waist-to-hip Ratio at 30 Months |
.85; .97 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00670462). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.