MYH: Behavioral Treatment for Weight Loss

Sponsor
Drexel University (Other)
Overall Status
Completed
CT.gov ID
NCT00746265
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
128
1
2
45
2.8

Study Details

Study Description

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. 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 or Disease Intervention/Treatment Phase
  • Behavioral: Behavioral weight loss intervention
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
128 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Acceptance-based Behavior Treatment: An Innovative Weight Control
Study Start Date :
Sep 1, 2008
Actual Primary Completion Date :
Nov 1, 2011
Actual Study Completion Date :
Jun 1, 2012

Arms and Interventions

Arm Intervention/Treatment
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).

Outcome Measures

Primary Outcome Measures

  1. BMI change [end of treatment and 6 month follow-up]

Secondary Outcome Measures

  1. Change in acceptance-based variables (e.g., mindfulness) [end of treatment and 6 month follow-up]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Drexel University, Department of Psychology, 245 N. 15th Street, MS 626 Philadelphia Pennsylvania United States 19102

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Drexel University
ClinicalTrials.gov Identifier:
NCT00746265
Other Study ID Numbers:
  • 1R21DK080430
  • 1R21DK080430
First Posted:
Sep 3, 2008
Last Update Posted:
Aug 7, 2013
Last Verified:
Aug 1, 2013
Keywords provided by Drexel University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 7, 2013