Clinical trial NCT02363010: Project Impact: An Innovative Approach to Weight Loss Maintenance
Official title: 1R01DK100345-01A1: An Innovative, Physical Activity-focused Approach to Weight Loss Maintenance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Weight Loss
Overweight
Keywords: Obesity
Weight loss
Overweight
Lead sponsor: Drexel University
Sponsor class: OTHER
First posted: 2015-02-13
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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

Primary outcomes:
measure: Change in Body Weight
timeFrame: Baseline, 6 months, 12 months, 18 months, 24 months, 36 months
measure: Change in Physical Activity
timeFrame: Baseline, 6 months, 12 months, 18 months, 24 months, 36 months
Secondary outcomes:
measure: Cardiorespiratory Fitness
timeFrame: Baseline, 6 months, 12 months, 18 months, 24 months, 36 months
measure: Waist Circumference
timeFrame: Baseline, 6 months, 12 months, 18 months, 24 months, 36 months
Other outcomes:
measure: Exploratory Moderator: Emotional Overeating
timeFrame: 0 months, 6 months
measure: Exploratory Moderator: Disinhibited Eating.
timeFrame: 0 months, 6 months
measure: Exploratory Moderator: Hedonic Hunger
timeFrame: 0 months, 6 months
measure: Exploratory Moderator: Appetitive Response to Exercise
timeFrame: 0 months, 6 months
Locations:
city: Philadelphia
country: United States
facility: Drexel University
state: Pennsylvania
Study officials:
affiliation: Drexel University
name: Meghan Butryn, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Butryn ML, Crane NT, Lufburrow E, Hagerman CJ, Forman EM, Zhang F. The Role of Physical Activity in Long-term Weight Loss: 36-month Results From a Randomized Controlled Trial. Ann Behav Med. 2023 Feb 4;57(2):146-154. doi: 10.1093/abm/kaac028.
citation: Butryn ML, Godfrey KM, Call CC, Forman EM, Zhang F, Volpe SL. Promotion of physical activity during weight loss maintenance: A randomized controlled trial. Health Psychol. 2021 Mar;40(3):178-187. doi: 10.1037/hea0001043.
citation: Butryn ML, Martinelli MK, Remmert JE, Roberts SR, Zhang F, Forman EM, Manasse SM. Executive Functioning as a Predictor of Weight Loss and Physical Activity Outcomes. Ann Behav Med. 2019 Aug 29;53(10):909-917. doi: 10.1093/abm/kaz001.
citation: Rosenbaum DL, Clark MH, Convertino AD, Call CC, Forman EM, Butryn ML. Examination of Nutrition Literacy and Quality of Self-monitoring in Behavioral Weight Loss. Ann Behav Med. 2018 Aug 16;52(9):809-816. doi: 10.1093/abm/kax052.