Clinical Trials Directory

Trials / Completed

CompletedNCT02363010

Project Impact: An Innovative Approach to Weight Loss Maintenance

1R01DK100345-01A1: An Innovative, Physical Activity-focused Approach to Weight Loss Maintenance

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
320 (actual)
Sponsor
Drexel University · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

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.

Detailed description

Most adults who engage in lifestyle modification find it difficult to maintain a high level of PA over the long-term, and most also find that weight regain is inevitable. The current portfolio of available interventions does not adequately address these challenges. This project is designed to test the effectiveness of an intervention that is specifically designed to enhance the ability to maintain, in the long-term, a level of PA high enough to achieve long-term weight loss maintenance. In the study, 300 obese adults will be recruited from the community and provided with 6 months of group-based, standard behavioral treatment for induction of weight loss (Phase I). A 6-month Phase I was chosen so that all participants will have sufficient time to accomplish initial weight loss before Phase II begins, allowing Phase II to truly be a test of weight loss maintenance. In Phase II, participants will receive one of three interventions, to be delivered for an additional 12 months: 1) behavioral treatment, with the standard emphasis on maintaining changes in diet and PA (BT), 2) behavioral treatment, with a primary emphasis on using these skills to maintain PA (BT-PA), or 3) acceptance-based behavioral treatment, with a primary emphasis on using these skills to maintain PA (ABT-PA). Assessments will be conducted at baseline, 6 months, 18 months (end of treatment), 24 months (6-month follow-up), and 36 months (18-month follow-up).

Conditions

Interventions

TypeNameDescription
BEHAVIORALGold Standard Behavior Therapy for Weight LossGroup- based behavioral treatment for weight loss and weight loss maintenance, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session).
BEHAVIORALBehavior Therapy for Weight Loss with Physical Activity EmphasisGroup-based behavioral treatment for weight loss and weight loss maintenance, with a larger emphasis on physical activity goals (65% of session) than eating-related goals (25% of session).Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session).
BEHAVIORALAcceptance-based Behavior Therapy for Weight Loss with PA emphasisGroup-based, acceptance-based behavioral treatment for weight loss and weight loss maintenance, with a larger emphasis on physical activity goals (65% of session) than eating-related goals (25% of session).Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session).

Timeline

Start date
2014-08-01
Primary completion
2019-08-01
Completion
2021-12-31
First posted
2015-02-13
Last updated
2023-03-03
Results posted
2021-11-17

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02363010. Inclusion in this directory is not an endorsement.