ObesityNCT02363010

Project Impact: An Innovative Approach to Weight Loss Maintenance

A study testing Gold Standard Behavior Therapy for Weight Loss, Behavior Therapy for Weight Loss with Physical Activity Emphasis and Acceptance-based Behavior Therapy for Weight Loss with PA emphasis in people with Obesity and Weight Loss, run by Drexel University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Obesity, Weight Loss, Overweight
What is being tested?: Gold Standard Behavior Therapy for Weight Loss, Behavior Therapy for Weight Loss with Physical Activity Emphasis and Acceptance-based Behavior Therapy for Weight Loss with PA emphasis
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 320 participants
Where: 1 siteUnited States
Study dates: 1 Aug 2014to 31 Dec 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Drexel University
Philadelphia, Pennsylvania, 19130

Other trials in United States

About this study

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

Read the 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: Obesity, Weight Loss, Overweight
Being tested: Gold Standard Behavior Therapy for Weight Loss, Behavior Therapy for Weight Loss with Physical Activity Emphasis, Acceptance-based Behavior Therapy for Weight Loss with PA emphasis
Keywords: Obesity, Weight loss, Overweight
Medical subject headings: Obesity, Weight Loss, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Gold Standard Behavior Therapy for Weight LossBehavioural
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).
Behavior Therapy for Weight Loss with Physical Activity EmphasisBehavioural
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).
Acceptance-based Behavior Therapy for Weight Loss with PA emphasisBehavioural
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).

Study groups in NCT02363010
Study group	Role	What they receive
Standard Behavior Therapy for Weight Loss	Active comparator	Eighteen months of standard, group-based behavioral treatment for weight loss and weight loss maintenance. Receives: 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. Receives: Behavioral: Gold Standard Behavior Therapy for Weight Loss; Behavioral: 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. Receives: Behavioral: Gold Standard Behavior Therapy for Weight Loss; Behavioral: Acceptance-based Behavior Therapy for Weight Loss with PA emphasis

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Body Weight
Objectively measured in the research clinic at each time point on a scale
Measured: 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
Measured: Baseline, 6 months, 12 months, 18 months, 24 months, 36 months

Secondary outcomes (2)

Cardiorespiratory Fitness
Time taken to complete a half-mile walk on the treadmill. Shorter times indicate a greater level of cardiorespiratory fitness.
Measured: Baseline, 6 months, 12 months, 18 months, 24 months, 36 months
Waist Circumference
Measured in the clinical horizontally at the umbilicus.
Measured: Baseline, 6 months, 12 months, 18 months, 24 months, 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 201431 Dec 2021

First posted13 Feb 2015 (estimated)
Study start1 Aug 2014
Primary completion1 Aug 2019
Study completion31 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for ObesityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 320 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02363010
Sponsor's protocol ID: 1402002613
Status last verified: Mar 2023
First submitted: 30 Sep 2014
Last updated: 3 Mar 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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. 2026 Feb;45(2):197-205. doi: 10.1037/hea0001537. Epub 2025 Jul 24.
PubMed 40705619
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.
PubMed 35640225
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.
PubMed 33630639
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.
PubMed 30689688
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.
PubMed 30124757

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Obesity trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 1R01DK100345-01A1: An Innovative, Physical Activity-focused Approach to Weight Loss Maintenance
ClinicalTrials.gov ID: NCT02363010
Acronym / sponsor ID: 1402002613
Conditions: Obesity, Weight Loss, Overweight
Keywords: Obesity, Weight loss, Overweight
Study type: Interventional
Recruitment status: Completed
Enrolment: 320 participants (actual)
Lead sponsor: Drexel UniversityUniversity, hospital or other
Study start: 1 Aug 2014 (actual)
Primary completion: 1 Aug 2019 (actual)
Study completion: 31 Dec 2021 (actual)
First posted: 13 Feb 2015 (estimated)
Results: Posted 17 Nov 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Standard Behavior Therapy for Weight Loss	Active comparator	Behavioral: Gold Standard Behavior Therapy for Weight LossEighteen months of standard, group-based behavioral treatment for weight loss and weight loss maintenance.
Behavior Therapy for Weight Loss with PA emphasis	Experimental	Behavioral: Gold Standard Behavior Therapy for Weight Loss, Behavioral: Behavior Therapy for Weight Loss with Physical Activity EmphasisSix 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.
Acceptance-based Behavior Therapy with PA emphasis	Experimental	Behavioral: Gold Standard Behavior Therapy for Weight Loss, Behavioral: Acceptance-based Behavior Therapy for Weight Loss with PA emphasisSix 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.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Gold 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).	Behavioural	Acceptance-based Behavior Therapy with PA emphasis, Behavior Therapy for Weight Loss with PA emphasis, Standard Behavior Therapy for Weight Loss
Behavior 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).	Behavioural	Behavior Therapy for Weight Loss with PA emphasis
Acceptance-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).	Behavioural	Acceptance-based Behavior Therapy with PA emphasis

Primary outcome

Change in Body Weight
Time frame: Baseline, 6 months, 12 months, 18 months, 24 months, 36 months
Objectively measured in the research clinic at each time point on a scale
Change in Physical Activity
Time frame: Baseline, 6 months, 12 months, 18 months, 24 months, 36 months
Objectively measured at each time point using wGT3X-BT accelerometers from Actigraph

2 secondary outcomes

Cardiorespiratory Fitness
Time frame: Baseline, 6 months, 12 months, 18 months, 24 months, 36 months
Waist Circumference
Time frame: Baseline, 6 months, 12 months, 18 months, 24 months, 36 months

Results and safety

Results posted to the registry on 17 Nov 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard Behavior Therapy for Weight Loss	110	88
Behavior Therapy for Weight Loss With PA Emphasis	105	94
Acceptance-based Behavior Therapy With PA Emphasis	105	89

Primary outcome: Change in Body Weight

Time frame: Baseline, 6 months, 12 months, 18 months, 24 months, 36 months. Mean (Standard Deviation). Unit: percent weight loss

Measure	Standard Behavior Therapy for Weight Loss n = 110	Behavior Therapy for Weight Loss With PA Emphasis n = 105	Acceptance-based Behavior Therapy With PA Emphasis n = 105
6 Months	10.5 (5.6)	10.2 (5.0)	9.9 (4.7)
12 Months	12.3 (8.9)	12.8 (8.2)	11.6 (7.8)
18 months	10.2 (11.9)	12.4 (10.1)	9.1 (10.3)

Standard Behavior Therapy for Weight Loss vs Behavior Therapy for Weight Loss With PA Emphasis vs Acceptance-based Behavior Therapy With PA Emphasis: p = .68, ANOVA
Standard Behavior Therapy for Weight Loss vs Behavior Therapy for Weight Loss With PA Emphasis vs Acceptance-based Behavior Therapy With PA Emphasis: p = .11, ANOVA

Primary outcome: Change in Physical Activity

Time frame: Baseline, 6 months, 12 months, 18 months, 24 months, 36 months. Mean (Standard Deviation). Unit: min per week of MVPA

Measure	Standard Behavior Therapy for Weight Loss n = 110	Behavior Therapy for Weight Loss With PA Emphasis n = 105	Acceptance-based Behavior Therapy With PA Emphasis n = 105
Baseline	64.2 (91.9)	64.2 (78.6)	48.6 (73.6)
6 Months	133.9 (124.5)	143.0 (121.0)	128.8 (115.7)
12 Months	129.1 (117.5)	144.6 (124.9)	127.3 (126.9)
18 Months	110.0 (134.6)	102.5 (124.0)	85.9 (101.7)

Standard Behavior Therapy for Weight Loss vs Behavior Therapy for Weight Loss With PA Emphasis: p = .41, Compound Poisson general linear models
Standard Behavior Therapy for Weight Loss vs Acceptance-based Behavior Therapy With PA Emphasis: p = .46, Compound Poisson general linear models
Behavior Therapy for Weight Loss With PA Emphasis vs Acceptance-based Behavior Therapy With PA Emphasis: p = .82, Compound Poisson general linear models

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 36 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard Behavior Therapy for Weight Loss	0 of 110 (0%)	0 of 110 (0%)	0 of 110
Behavior Therapy for Weight Loss With PA Emphasis	0 of 105 (0%)	0 of 105 (0%)	0 of 105
Acceptance-based Behavior Therapy With PA Emphasis	0 of 105 (0%)	0 of 105 (0%)	0 of 105

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40705619Chabria 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. 2026 Feb;45(2):197-205. doi: 10.1037/hea0001537. Epub 2025 Jul 24.
Derived from this study: PubMed 35640225Butryn 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.
Derived from this study: PubMed 33630639Butryn 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.
Derived from this study: PubMed 30689688Butryn 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.
Derived from this study: PubMed 30124757Rosenbaum 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.

Related trials for Obesity

RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
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Recruiting
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Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Meghan Butryn, Ph.D. principal investigator

Drexel University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Body Weight (time frame: Baseline, 6 months, 12 months, 18 months, 24 months, 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02363010, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2023.