Behavioral Treatment for Weight Loss

NCT00746265 | Completed DMC

• 1 other identifier: 1R21DK080430
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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

Conditions

Overweight and Obesity

Keywords

behavioral interventions for weight loss

Outcome Measures

Primary Outcomes (1)

• BMI change

  end of treatment and 6 month follow-up

Secondary Outcomes (1)

• Change in acceptance-based variables (e.g., mindfulness)

  end of treatment and 6 month follow-up

Study Arms (2)

SBT

ACTIVE COMPARATOR

Standard behavioral treatment based on the LEARN manual.

Behavioral: Behavioral weight loss intervention

ABT

ACTIVE COMPARATOR

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

Behavioral: Behavioral weight loss intervention

Interventions

Behavioral weight loss intervention 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; SBT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Drexel University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

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

Philadelphia, Pennsylvania, 19102, United States

Location

Related Publications (3)

• 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: 40705619 DERIVED

• 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.

  PMID: 30806492 DERIVED

• 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.

  PMID: 23666772 DERIVED

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2008
• First Posted: September 3, 2008
• Study Start: September 1, 2008
• Primary Completion: November 1, 2011
• Study Completion: June 1, 2012
• Last Updated: August 7, 2013

Record last verified: 2013-08

Locations

US (1)