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Behavioral Treatment for Weight Loss

NCT ID: NCT00746265

Last Updated: 2013-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2012-06-30

Brief Summary

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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

1. 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).
2. To evaluate the effectiveness of ABT with novice clinicians and with weight control experts.
3. To evaluate the effectiveness of ABT would be moderated by mood disturbance, emotional eating, disinhibition or susceptibility to food stimuli.

Detailed Description

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Conditions

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Overweight and Obesity

Keywords

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behavioral interventions for weight loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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SBT

Standard behavioral treatment based on the LEARN manual.

Group Type ACTIVE_COMPARATOR

Behavioral weight loss intervention

Intervention Type BEHAVIORAL

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).

ABT

Acceptance-based group that is based on the behavioral interventions contained in LEARN manual

Group Type ACTIVE_COMPARATOR

Behavioral weight loss intervention

Intervention Type BEHAVIORAL

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).

Interventions

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Behavioral weight loss intervention

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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Drexel University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Drexel University, Department of Psychology, 245 N. 15th Street, MS 626

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 40705619 (View on PubMed)

Forman 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.

Reference Type DERIVED
PMID: 30806492 (View on PubMed)

Forman 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.

Reference Type DERIVED
PMID: 23666772 (View on PubMed)

Other Identifiers

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1R21DK080430

Identifier Type: NIH

Identifier Source: secondary_id

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1R21DK080430

Identifier Type: NIH

Identifier Source: org_study_id

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