NCT02363010

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
320

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Aug 2014

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2014

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 13, 2015

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

November 17, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

March 3, 2023

Status Verified

March 1, 2023

Enrollment Period

5 years

First QC Date

September 30, 2014

Results QC Date

September 21, 2021

Last Update Submit

March 2, 2023

Conditions

ObesityWeight LossOverweight

Keywords

ObesityWeight lossOverweight

Outcome Measures

Primary Outcomes (2)

  • Change in Body Weight

    Objectively measured in the research clinic at each time point on a scale

    Baseline, 6 months, 12 months, 18 months, 24 months, 36 months

  • Change in Physical Activity

    Objectively measured at each time point using wGT3X-BT accelerometers from Actigraph

    Baseline, 6 months, 12 months, 18 months, 24 months, 36 months

Secondary Outcomes (2)

  • Cardiorespiratory Fitness

    Baseline, 6 months, 12 months, 18 months, 24 months, 36 months

  • Waist Circumference

    Baseline, 6 months, 12 months, 18 months, 24 months, 36 months

Other Outcomes (4)

  • Exploratory Moderator: Emotional Overeating

    0 months, 6 months

  • Exploratory Moderator: Disinhibited Eating.

    0 months, 6 months

  • Exploratory Moderator: Hedonic Hunger

    0 months, 6 months

  • +1 more other outcomes

Study Arms (3)

Standard Behavior Therapy for Weight Loss

ACTIVE COMPARATOR

Eighteen months of standard, group-based behavioral treatment for weight loss and weight loss maintenance.

Behavioral: Gold Standard Behavior Therapy for Weight Loss

Behavior Therapy for Weight Loss with PA emphasis

EXPERIMENTAL

Six months of standard, group-based behavioral treatment for weight loss and weight loss maintenance, followed by 12 months of standard, group-based behavioral treatment for weight loss and weight loss maintenance with a larger emphasis on physical activity goals.

Behavioral: Gold Standard Behavior Therapy for Weight LossBehavioral: Behavior Therapy for Weight Loss with Physical Activity Emphasis

Acceptance-based Behavior Therapy with PA emphasis

EXPERIMENTAL

Six months of standard, group-based behavioral treatment for weight loss and weight loss maintenance, followed by 12 months of group-based behavior therapy with acceptance-based strategies, and a larger emphasis on physical activity goals.

Behavioral: Gold Standard Behavior Therapy for Weight LossBehavioral: Acceptance-based Behavior Therapy for Weight Loss with PA emphasis

Interventions

Gold Standard Behavior Therapy for Weight LossBEHAVIORAL

Group- 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).

Acceptance-based Behavior Therapy with PA emphasisBehavior Therapy for Weight Loss with PA emphasisStandard Behavior Therapy for Weight Loss
Behavior Therapy for Weight Loss with Physical Activity EmphasisBEHAVIORAL

Group-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).

Behavior Therapy for Weight Loss with PA emphasis
Acceptance-based Behavior Therapy for Weight Loss with PA emphasisBEHAVIORAL

Group-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).

Acceptance-based Behavior Therapy with PA emphasis

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Drexel University

Philadelphia, Pennsylvania, 19130, United States

Location

Related Publications (5)

  • Chabria R, Hagerman CJ, Crane N, Ehmann M, Knudsen FM, Brown KL, Forman E, Butryn ML. Racial disparities in the efficacy of traditional versus acceptance-based behavioral weight loss. Health Psychol. 2025 Jul 24:10.1037/hea0001537. doi: 10.1037/hea0001537. Online ahead of print.

    PMID: 40705619DERIVED

  • 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.

    PMID: 35640225DERIVED

  • 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.

    PMID: 33630639DERIVED

  • 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.

    PMID: 30689688DERIVED

  • 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.

    PMID: 30124757DERIVED

MeSH Terms

Conditions

ObesityWeight LossOverweight

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Limitations and Caveats

High attrition; low power to detect small effects; no measurement of dietary intake; imperfect measurements of physical activity; conditions differed on how eating behavior was addressed; underrepresentation of men, racial groups outside of non-Hispanic White or Black, young adults, older adults, and those with low levels of education; conducted as a high-intensity BWL within an academic research clinic which may differ from lower-intensity or community-based formats.

Results Point of Contact

Title
Dr. Meghan Butryn
Organization
Drexel University
mlb34@drexel.edu
215-553-7108

Study Officials

  • Meghan Butryn, Ph.D.

    Drexel University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 30, 2014

First Posted

February 13, 2015

Study Start

August 1, 2014

Primary Completion

August 1, 2019

Study Completion

December 31, 2021

Last Updated

March 3, 2023

Results First Posted

November 17, 2021

Record last verified: 2023-03

Locations

US(1)