Acceptance Based Behavioral Intervention for Weight Loss: A Randomized Trial
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| ClinicalTrials.gov Identifier: NCT01461421 |
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Recruitment Status :
Completed
First Posted : October 28, 2011
Last Update Posted : April 7, 2017
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Obesity | Behavioral: Nutrition Education Behavioral: Behavioral Weight Loss Strategies Behavioral: Standard Cognitive Techniques Behavioral: Acceptance Based Techniques | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 160 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Acceptance Based Behavioral Intervention for Weight Loss: A Randomized Trial |
| Study Start Date : | July 2011 |
| Actual Primary Completion Date : | March 2017 |
| Actual Study Completion Date : | March 2017 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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. |
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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.
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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. |
- Change from baseline in weight [ Time Frame: 6, 12, 18, and 24 months ]Amount of weight lost (kg) from initial body weight at study entry.
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01461421
| United States, Rhode Island | |
| The Miriam Hospital | |
| Providence, Rhode Island, United States, 02903-4121 | |
| Principal Investigator: | Rena R. Wing, PhD | The Miriam Hospital |
| Responsible Party: | Rena R. Wing, Director Weight Control & Diabetes Research Center, The Miriam Hospital |
| ClinicalTrials.gov Identifier: | NCT01461421 |
| Other Study ID Numbers: |
1R01DK087704-01A1 ( U.S. NIH Grant/Contract ) |
| First Posted: | October 28, 2011 Key Record Dates |
| Last Update Posted: | April 7, 2017 |
| Last Verified: | April 2017 |
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Obesity Primary Care Behavior Modification |
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Weight Loss Body Weight Body Weight Changes |