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Acceptance Based Behavioral Intervention for Weight Loss: A Randomized Trial

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nutrition Education
Behavioral Weight Loss Strategies
Standard Cognitive Techniques
Acceptance Based Techniques
Sponsored by
The Miriam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Primary Care, Behavior Modification

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Miriam Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Behavioral Treatment

Acceptance Based Behavioral Intervention

Arm Description

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, behavioral weight loss techniques, and acceptance based strategies for dealing with stress and emotions. Six months weekly, 3 months bi-weekly, 3 months monthly.

Outcomes

Primary Outcome Measures

Change from baseline in weight
Amount of weight lost (kg) from initial body weight at study entry.

Secondary Outcome Measures

Full Information

First Posted
October 25, 2011
Last Updated
April 6, 2017
Sponsor
The Miriam Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01461421
Brief Title
Acceptance Based Behavioral Intervention for Weight Loss: A Randomized Trial
Official Title
Acceptance Based Behavioral Intervention for Weight Loss: A Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Miriam Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Primary Care, Behavior Modification

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Behavioral Treatment
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Acceptance Based Behavioral Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Nutrition Education
Intervention Description
Participants are taught about energy balance, caloric intake, the nutrition content of foods, and diet.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Weight Loss Strategies
Intervention Description
Participants are taught self-monitoring and goal setting techniques.
Intervention Type
Behavioral
Intervention Name(s)
Standard Cognitive Techniques
Intervention Description
Participants are taught how to modify, get rid of, or distract from thoughts and also how to regulate emotions.
Intervention Type
Behavioral
Intervention Name(s)
Acceptance Based Techniques
Intervention Description
Participants are taught how to accept and change their perception of their thoughts and emotions.
Primary Outcome Measure Information:
Title
Change from baseline in weight
Description
Amount of weight lost (kg) from initial body weight at study entry.
Time Frame
6, 12, 18, and 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rena R. Wing, PhD
Organizational Affiliation
The Miriam Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903-4121
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26019869
Citation
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.
Results Reference
derived

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Acceptance Based Behavioral Intervention for Weight Loss: A Randomized Trial

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