Behavioral Treatment for Weight Loss (MYH)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Drexel University
ClinicalTrials.gov Identifier:
NCT00746265
First received: September 2, 2008
Last updated: August 5, 2013
Last verified: August 2013
  Purpose

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.

Condition Intervention
Overweight and Obesity
Behavioral: Behavioral weight loss intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acceptance-based Behavior Treatment: An Innovative Weight Control

Resource links provided by NLM:


Further study details as provided by Drexel University:

Primary Outcome Measures:
  • BMI change [ Time Frame: end of treatment and 6 month follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in acceptance-based variables (e.g., mindfulness) [ Time Frame: end of treatment and 6 month follow-up ] [ Designated as safety issue: No ]

Enrollment: 128
Study Start Date: September 2008
Study Completion Date: June 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: SBT
Standard behavioral treatment based on the LEARN manual.
Behavioral: 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).
Active Comparator: ABT
Acceptance-based group that is based on the behavioral interventions contained in LEARN manual
Behavioral: 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).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00746265

Locations
United States, Pennsylvania
Drexel University, Department of Psychology, 245 N. 15th Street, MS 626
Philadelphia, Pennsylvania, United States, 19102
Sponsors and Collaborators
Drexel University
  More Information

No publications provided by Drexel University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Drexel University
ClinicalTrials.gov Identifier: NCT00746265     History of Changes
Other Study ID Numbers: 1R21DK080430, 1R21DK080430
Study First Received: September 2, 2008
Last Updated: August 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Drexel University:
behavioral interventions for weight loss

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2014