- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01461421
Acceptance Based Behavioral Intervention for Weight Loss: A Randomized Trial
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02903-4121
- The Miriam Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Participants are taught about energy balance, caloric intake, the nutrition content of foods, and diet.
Participants are taught self-monitoring and goal setting 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.
|
Participants are taught about energy balance, caloric intake, the nutrition content of foods, and diet.
Participants are taught self-monitoring and goal setting techniques.
Participants are taught how to accept and change their perception of their thoughts and emotions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6, 12, 18, and 24 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rena R. Wing, PhD, The Miriam Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R01DK087704-01A1 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States
-
Fundació Sant Joan de DéuRecruitingObesity, Childhood | Obesity, AdolescentSpain
Clinical Trials on Nutrition Education
-
Loma Linda UniversityCompletedSedentary LifestyleUnited States
-
Second Affiliated Hospital, School of Medicine,...UnknownNutrition Disorders | Gastric CancerChina
-
McGill UniversityInternational Development Research Centre, CanadaCompletedImproving Young Child NutritionGhana
-
University of Ontario Institute of TechnologyCanadian Institutes of Health Research (CIHR)RecruitingNutrition, HealthyCanada
-
University of Alabama, TuscaloosaAcademy of Nutrition and DieteticsRecruitingBrain InjuriesUnited States
-
Chang Gung Memorial HospitalMinistry of Science and Technology, TaiwanActive, not recruitingRelative Energy Deficiency in SportsTaiwan
-
Lotung Poh-Ai HospitalCompletedMetabolic Syndrome | Health Education | Workplace
-
Central Washington UniversityUnknown
-
University of TorontoCompletedDiabetes, GestationalCanada