Acceptance Based Behavioral Intervention for Weight Loss: A Randomized Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by The Miriam Hospital
Sponsor:
Information provided by (Responsible Party):
Rena R. Wing, The Miriam Hospital
ClinicalTrials.gov Identifier:
NCT01461421
First received: October 25, 2011
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

The proposed project is testing two behavioral interventions designed to improve long-term weight loss among participants who struggle with eating in response to stress or emotional experiences. Group treatment lasts for 1 year, with assessments lasting 2 years. Participants must live in the greater Providence, Rhode Island area in order to be eligible.


Condition Intervention
Obesity
Behavioral: Nutrition Education
Behavioral: Behavioral Weight Loss Strategies
Behavioral: Standard Cognitive Techniques
Behavioral: Acceptance Based Techniques

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by The Miriam Hospital:

Primary Outcome Measures:
  • Change from baseline in weight [ Time Frame: 6, 12, 18, and 24 months ] [ Designated as safety issue: No ]
    Amount of weight lost (kg) from initial body weight at study entry.


Estimated Enrollment: 160
Study Start Date: July 2011
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard Behavioral Treatment
Nutrition education, behavioral weight loss techniques, and standard cognitive strategies for dealing with stress and emotions. Six months weekly, 3 months bi-weekly, 3 months monthly.
Behavioral: Nutrition Education
Participants are taught about energy balance, caloric intake, the nutrition content of foods, and diet.
Behavioral: Behavioral Weight Loss Strategies
Participants are taught self-monitoring and goal setting techniques.
Behavioral: Standard Cognitive Techniques
Participants are taught how to modify, get rid of, or distract from thoughts and also how to regulate emotions.
Experimental: Acceptance Based Behavioral Intervention
Nutrition education, behavioral weight loss techniques, and acceptance based strategies for dealing with stress and emotions. Six months weekly, 3 months bi-weekly, 3 months monthly.
Behavioral: Nutrition Education
Participants are taught about energy balance, caloric intake, the nutrition content of foods, and diet.
Behavioral: Behavioral Weight Loss Strategies
Participants are taught self-monitoring and goal setting techniques.
Behavioral: Acceptance Based Techniques
Participants are taught how to accept and change their perception of their thoughts and emotions.

Detailed Description:

Obesity is a major health problem and behavioral weight control programs are the treatment of choice for mild and moderate obesity. However, there is marked variability among participants in the weight losses achieved in these programs and the maximum weight losses are typically achieved at month 6, followed by weight regain. Thus innovative approaches are needed to improve longer-term treatment outcomes.

Currently, the same behavioral treatment program is offered to all participants, with no tailoring to meet the needs of specific subgroups. One subgroup that may need a specialized approach are those who report high levels of internal disinhibition, i.e. eating in response to negative thoughts or emotions. Over 50% of individuals entering behavioral weight loss programs report high levels of internal disinhibition on the Eating Inventory (EI), this subgroup is distinct from those with binge eating disorder, and most importantly, these individuals lose significantly less weight than other participants during weight loss treatment [particularly at 18 months]. Thus efforts are needed to develop more effective treatments for this subgroup. The proposed research is significant because it may help move the field from a "one size fits all" approach, to the development of interventions for specific subgroups of the population.

The investigators hypothesize that individuals who report problems with internal disinhibition may achieve better weight losses in an enhanced behavioral weight loss program that focuses on acceptance-based strategies. Whereas standard behavioral treatments teach patients to control their negative thoughts with techniques such as cognitive restructuring and distraction, acceptance based strategies teach patients to experience thoughts and feelings as they are, without attempting to control them and to continue to pursue their behavioral goals despite experiencing negative thoughts and feelings. Acceptance-based strategies have been shown to be helpful for a number of behavioral problems including weight loss and maintenance, however are yet untested in large trials.

The current study is a randomized controlled trial comparing standard behavioral weight loss treatment with a program which incorporates acceptance based strategies in the treatment of overweight/obese individuals with problems with internal disinhibition. A total of 160 participants will be randomly assigned to a standard behavioral weight loss treatment program (SBT) or to an innovative approach that combines standard behavioral weight loss with acceptance based strategies (referred to hereafter as "Acceptance Based Behavioral Intervention" or ABBI). Both groups will meet weekly for 6 months, biweekly for 3 months and then monthly for 3 months. Assessments will be conducted at baseline and 6 month intervals for 24 months total, with measures of weight, acceptance of negative emotions, distress tolerance, and adherence to the weight loss program.

The primary hypothesis is that participants in the ABBI program will achieve greater changes in weight (in the form of weight reductions) at 6, 12, 18, and 24 months when compared to baseline weight than participants in SBT. Secondary hypotheses are that participants in ABBI will experience greater improvements in acceptance of weight related negative thoughts and emotions and distress tolerance and better treatment adherence than participants in SBT.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must live in the greater Providence, RI area and be able to attend treatment sessions on site for 1 year
  • BMI between 30-50
  • Age between 18-70
  • meets clinical cutoff on Internal Disinhibition sub-scale of the Eating Inventory

Exclusion Criteria:

  • report a heart condition, chest pain during periods of activity or rest, or loss of consciousness
  • physically unable to exercise
  • are currently pregnant or plan to become pregnant in the next 24 months
  • are planning to move outside the state within the next 24 months
  • Cancer diagnoses in the past 5 years
  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: NCT01461421

Contacts
Contact: Rena R Wing, PhD 401-793-8959 rwing@lifespan.org

Locations
United States, Rhode Island
The Miriam Hospital Recruiting
Providence, Rhode Island, United States
Contact: Rena R Wing, PhD    401-793-8595    rwing@lifespan.org   
Sponsors and Collaborators
The Miriam Hospital
  More Information

No publications provided

Responsible Party: Rena R. Wing, Director Weight Control & Diabetes Research Center, The Miriam Hospital
ClinicalTrials.gov Identifier: NCT01461421     History of Changes
Other Study ID Numbers: 1R01DK087704-01A1
Study First Received: October 25, 2011
Last Updated: July 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by The Miriam Hospital:
Obesity
Primary Care
Behavior Modification

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 24, 2014