N/A
N=320
Project Impact: An Innovative Approach to Weight Loss Maintenance
Obesity · Weight Loss · Overweight
Bottom Line
View on ClinicalTrials.gov: NCT02363010 ↗Enrolled (actual)
320
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcome: Primary: Change in Body Weight — 10.5; 10.2; 9.9; 12.3 percent weight loss — p=.68
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Gold Standard Behavior Therapy for Weight Loss (Behavioral); Behavior Therapy for Weight Loss with Physical Activity Emphasis (Behavioral); Acceptance-based Behavior Therapy for Weight Loss with PA emphasis (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Drexel University
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Body Weight |
10.5; 10.2; 9.9; 12.3; 12.8; 11.6 | .68 |
| PRIMARY Change in Physical Activity |
64.2; 64.2; 48.6; 133.9; 143.0; 128.8 | .41 |
| SECONDARY Cardiorespiratory Fitness |
537.1; 576.6; 562.2; 503.9; 528.2; 514.1 | .06 |
| SECONDARY Waist Circumference |
42.6; 42.6; 41.8; 39.0; 39.7; 38.9 | .59 |
Summary
The major goal of this project is to evaluate an innovative approach to obesity. This study will determine if behavioral treatment can be improved by 1) implementing a primary focus on PA following initial weight loss treatment, and 2) using a novel, acceptance-based approach to the promotion of PA.
Eligibility Criteria
Inclusion Criteria
- Have a BMI between 27 and 45 kg/m2
- Have the ability to engage in at least 15 minutes of moderate physical activity (e.g. brisk walking)
- Successfully complete all steps in the enrollment process, including attendance at all pre-randomization clinic visits and providing physician clearance
Exclusion Criteria
- Have a medical condition that prevents safe engagement in moderate-to-vigorous physical activity
- Are lactating, pregnant, or planning to become pregnant in the next three years
- Report recently beginning a course of or changing the dosage of prescription medications that can cause significant weight loss or weight gain
- Are participating in or plan to participate in another weight loss program in the next three years
- Have a primary family member or member of their household participating in the study
Data sourced from ClinicalTrials.gov (NCT02363010). 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.