Acceptance Based Behavioral Intervention for Weight Loss: A Randomized Trial
NCT ID: NCT01461421
Last Updated: 2017-04-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
160 participants
INTERVENTIONAL
2011-07-31
2017-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Using Novel Behavioral Approaches to Improve Long-Term Weight Loss Outcomes
NCT02156752
Environmental and Acceptance-Based Innovations for Weight Loss Maintenance
NCT01858714
Behavioral Treatment for Weight Loss
NCT00746265
Brief Behavioral Weight Loss Treatment vs. Weight Watchers
NCT00249340
Teaching Novel Values-Based Skills to Improve Long-Term Weight Loss
NCT04256850
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Nutrition Education
Participants are taught about energy balance, caloric intake, the nutrition content of foods, and diet.
Behavioral Weight Loss Strategies
Participants are taught self-monitoring and goal setting techniques.
Standard Cognitive Techniques
Participants are taught how to modify, get rid of, or distract from thoughts and also how to regulate emotions.
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.
Nutrition Education
Participants are taught about energy balance, caloric intake, the nutrition content of foods, and diet.
Behavioral Weight Loss Strategies
Participants are taught self-monitoring and goal setting techniques.
Acceptance Based Techniques
Participants are taught how to accept and change their perception of their thoughts and emotions.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Nutrition Education
Participants are taught about energy balance, caloric intake, the nutrition content of foods, and diet.
Behavioral Weight Loss Strategies
Participants are taught self-monitoring and goal setting techniques.
Standard Cognitive Techniques
Participants are taught how to modify, get rid of, or distract from thoughts and also how to regulate emotions.
Acceptance Based Techniques
Participants are taught how to accept and change their perception of their thoughts and emotions.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* BMI between 30-50
* Age between 18-70
* meets clinical cutoff on Internal Disinhibition sub-scale of the Eating Inventory
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The Miriam Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Rena R. Wing
Director Weight Control & Diabetes Research Center
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Rena R. Wing, PhD
Role: PRINCIPAL_INVESTIGATOR
The Miriam Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Miriam Hospital
Providence, Rhode Island, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Lillis J, Niemeier HM, Ross KM, Thomas JG, Leahey T, Unick J, Kendra KE, Wing RR. Weight loss intervention for individuals with high internal disinhibition: design of the Acceptance Based Behavioral Intervention (ABBI) randomized controlled trial. BMC Psychol. 2015 May 28;3(1):17. doi: 10.1186/s40359-015-0075-2. eCollection 2015.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.