Overweight and ObesityMYHNCT00746265
Behavioral Treatment for Weight Loss
A study testing Behavioral weight loss intervention in people with Overweight and Obesity, run by Drexel University at 1 site in United States.
Trial summary
This project compares gold standard cognitive-behavioral therapy (based on LEARN, Diabetes Prevention Program, LOOK Ahead) used in both research and clinical settings, with acceptance-based behavioral therapy for weight loss. Standard behavior treatment (SBT) focuses on modifying eating, thinking, and activity levels. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Behavioral weight loss intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ages 18 to 65
- Fluent in English
- Body mass index (BMI) of 25 kg/m2 higher
- Agrees to not join another weight loss program for 9 months
Who cannot join
- Lactating, pregnant, or planning to become pregnant in the next two years
- Currently taking a medication or having medical/psychiatric problem known to cause weight loss or weight gain (unless medication is long-term and dosage is unchanging - e.g., Synthroid)
- A medical or psychiatric condition that limits ability to comply with the program's behavioral recommendations (including physical activity)
- Current or history in the past ten years of an eating disorder
- Plans to leave the Philadelphia areas within the next nine months.
Trial locations and contacts
1 site in 1 country.
United States1 site
Drexel University, Department of Psychology, 245 N. 15th Street, MS 626
Philadelphia, Pennsylvania, 19102
About this study
Official title: Acceptance-based Behavior Treatment: An Innovative Weight Control
This project compares gold standard cognitive-behavioral therapy (based on LEARN, Diabetes Prevention Program, LOOK Ahead) used in both research and clinical settings, with acceptance-based behavioral therapy for weight loss. Standard behavior treatment (SBT) focuses on modifying eating, thinking, and activity levels. Participants limit their daily caloric intake, keep food records, increase physical activity, and practice weight control behaviors, such as stimulus control, cognitive restructuring, alternative coping skills, and distinguishing hunger from cravings. The acceptance-based approach (ABT) incorporates the behavioral and nutritional components, but replaced the cognitive and motivational components with components that are consistent with an acceptance-based approach, such as acceptance and willingness to experience cravings, cognitive defusion, mindfulness training to interrupt automatic eating, and values work. These components are drawn from Acceptance and Commitment Therapy (ACT; Hayes, Strosahl, \& Wilson, 1999), a cognitive-behavioral therapy that has been gaining increasing attention and empirical support (Bach \& Hayes, 2002; Bond \& Bunce, 2000; Hayes et al. 2004). Though relatively new, acceptance-based strategies have demonstrated effectiveness in helping individuals to respond to unwanted thoughts and feelings (Hayes, Rissett, Korn, Zettle, Rosenfarb, Cooper, \& Grundt, 1999, Keogh, Bond, Hanmer, \& Tilston, 2005) and offer a novel alternative to control-based strategies (such as distraction and confrontation).
Participants in this study will be randomly assigned to either the traditional behavioral therapy condition (SBT) or the acceptance-based behavioral therapy condition (ABT). Both conditions are delivered in group format. A total of 30, 75 minute sessions will take place over the course of 40 weeks.
Read more
Specific Aims
- To evaluate the feasibility and acceptability of the treatment, and its short and moderate-term effectiveness relative to the current gold standard behavioral treatment (SBT).
- To evaluate the effectiveness of ABT with novice clinicians and with weight control experts.
- To evaluate the effectiveness of ABT would be moderated by mood disturbance, emotional eating, disinhibition or susceptibility to food stimuli.
- Conditions
- Overweight and Obesity
- Being tested
- Behavioral weight loss intervention
- Keywords
- behavioral interventions for weight loss
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral weight loss interventionBehavioural
Participants in both conditions are provided nutritional education and behavioral strategies for weight loss (consistent with the LEARN program). Participants in SBT are taught the cognitive and motivational strategies used in LEARN while participants in ABT are taught acceptance-based strategies (e.g., acceptance, mindfulness).
| Study group | Role | What they receive |
|---|---|---|
| SBT | Active comparator | Standard behavioral treatment based on the LEARN manual. Receives: Behavioral: Behavioral weight loss intervention |
| ABT | Active comparator | Acceptance-based group that is based on the behavioral interventions contained in LEARN manual Receives: Behavioral: Behavioral weight loss intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI change
Measured: end of treatment and 6 month follow-up
Secondary outcomes (1)
Change in acceptance-based variables (e.g., mindfulness)
Measured: end of treatment and 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionNov 2011
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Overweight and 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00746265
- Sponsor's protocol ID
- 1R21DK080430
- Other IDs
- 1R21DK080430
- Acronym
- MYH
- Status last verified
- Aug 2013
- First submitted
- 2 Sep 2008
- Last updated
- 7 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
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 40705619Forman EM, Manasse SM, Butryn ML, Crosby RD, Dallal DH, Crochiere RJ. Long-Term Follow-up of the Mind Your Health Project: Acceptance-Based versus Standard Behavioral Treatment for Obesity. Obesity (Silver Spring). 2019 Apr;27(4):565-571. doi: 10.1002/oby.22412. Epub 2019 Feb 26.
PubMed 30806492Forman EM, Butryn ML, Juarascio AS, Bradley LE, Lowe MR, Herbert JD, Shaw JA. The mind your health project: a randomized controlled trial of an innovative behavioral treatment for obesity. Obesity (Silver Spring). 2013 Jun;21(6):1119-26. doi: 10.1002/oby.20169. Epub 2013 May 13.
PubMed 23666772
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptance-based Behavior Treatment: An Innovative Weight Control
- ClinicalTrials.gov ID
- NCT00746265
- Acronym / sponsor ID
- MYH / 1R21DK080430
- Conditions
- Overweight and Obesity
- Keywords
- behavioral interventions for weight loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Sep 2008
- Primary completion
- Nov 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 3 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project compares gold standard cognitive-behavioral therapy (based on LEARN, Diabetes Prevention Program, LOOK Ahead) used in both research and clinical settings, with acceptance-based behavioral therapy for weight loss. Standard behavior treatment (SBT) focuses on modifying eating, thinking, and activity levels. Participants limit their daily caloric intake, keep food records, increase physical activity, and practice weight control behaviors, such as stimulus control, cognitive restructuring, alternative coping skills, and distinguishing hunger from cravings. The acceptance-based approach (ABT) incorporates the behavioral and nutritional components, but replaced the cognitive and motivational components with components that are consistent with an acceptance-based approach, such as acceptance and willingness to experience cravings, cognitive defusion, mindfulness training to interrupt automatic eating, and values work. These components are drawn from Acceptance and Commitment Therapy (ACT; Hayes, Strosahl, \& Wilson, 1999), a cognitive-behavioral therapy that has been gaining increasing attention and empirical support (Bach \& Hayes, 2002; Bond \& Bunce, 2000; Hayes et al. 2004). Though relatively new, acceptance-based strategies have demonstrated effectiveness in helping individuals to respond to unwanted thoughts and feelings (Hayes, Rissett, Korn, Zettle, Rosenfarb, Cooper, \& Grundt, 1999, Keogh, Bond, Hanmer, \& Tilston, 2005) and offer a novel alternative to control-based strategies (such as distraction and confrontation).
Participants in this study will be randomly assigned to either the traditional behavioral therapy condition (SBT) or the acceptance-based behavioral therapy condition (ABT). Both conditions are delivered in group format. A total of 30, 75 minute sessions will take place over the course of 40 weeks.
Specific Aims
- To evaluate the feasibility and acceptability of the treatment, and its short and moderate-term effectiveness relative to the current gold standard behavioral treatment (SBT).
- To evaluate the effectiveness of ABT with novice clinicians and with weight control experts.
- To evaluate the effectiveness of ABT would be moderated by mood disturbance, emotional eating, disinhibition or susceptibility to food stimuli.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SBT | Active comparator | Behavioral: Behavioral weight loss interventionStandard behavioral treatment based on the LEARN manual. |
| ABT | Active comparator | Behavioral: Behavioral weight loss interventionAcceptance-based group that is based on the behavioral interventions contained in LEARN manual |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ages 18 to 65
- Fluent in English
- Body mass index (BMI) of 25 kg/m2 higher
- Agrees to not join another weight loss program for 9 months
Key exclusion criteria (5 listed)
- Lactating, pregnant, or planning to become pregnant in the next two years
- Currently taking a medication or having medical/psychiatric problem known to cause weight loss or weight gain (unless medication is long-term and dosage is unchanging - e.g., Synthroid)
- A medical or psychiatric condition that limits ability to comply with the program's behavioral recommendations (including physical activity)
- Current or history in the past ten years of an eating disorder
- Plans to leave the Philadelphia areas within the next nine months.
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 |
|---|---|---|
| Behavioral weight loss interventionParticipants in both conditions are provided nutritional education and behavioral strategies for weight loss (consistent with the LEARN program). Participants in SBT are taught the cognitive and motivational strategies used in LEARN while participants in ABT are taught acceptance-based strategies (e.g., acceptance, mindfulness). | Behavioural | ABT, SBT |
Primary outcome
BMI change
Time frame: end of treatment and 6 month follow-up
1 secondary outcome
Change in acceptance-based variables (e.g., mindfulness)
Time frame: end of treatment and 6 month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2013.
- 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 30806492Forman EM, Manasse SM, Butryn ML, Crosby RD, Dallal DH, Crochiere RJ. Long-Term Follow-up of the Mind Your Health Project: Acceptance-Based versus Standard Behavioral Treatment for Obesity. Obesity (Silver Spring). 2019 Apr;27(4):565-571. doi: 10.1002/oby.22412. Epub 2019 Feb 26.
- Derived from this study: PubMed 23666772Forman EM, Butryn ML, Juarascio AS, Bradley LE, Lowe MR, Herbert JD, Shaw JA. The mind your health project: a randomized controlled trial of an innovative behavioral treatment for obesity. Obesity (Silver Spring). 2013 Jun;21(6):1119-26. doi: 10.1002/oby.20169. Epub 2013 May 13.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral weight loss intervention in people with Overweight and Obesity, run by Drexel University at 1 site in United States.
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 4 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 7 Aug 2013. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
BMI change (time frame: end of treatment and 6 month follow-up). 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 NCT00746265, which also lists 3 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 7 Aug 2013.