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CompletedNCT01461421Updated Apr 7, 2017

Acceptance Based Behavioral Intervention for Weight Loss: A Randomized Trial

An interventional study of Nutrition Education and Behavioral Weight Loss Strategies in Obesity, sponsored by The Miriam Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-04-07.

Sponsored by The Miriam Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Obesity

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Keywords

  • Obesity
  • Primary Care
  • Behavior Modification
03

In context

Weight Loss

1,766 studies on the registry are indexed under Weight Loss; 277 are open to participants now.

This study's enrollment of 160 is above the median of 73 across 1,496 interventional studies indexed under Weight Loss.

Browse Weight Loss studies →

Lead sponsor

The Miriam Hospital is the lead sponsor of 178 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
160 participants (actual)

Study arms

  • 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 · Behavioral: Behavioral Weight Loss Strategies · Behavioral: Standard Cognitive Techniques

  • 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 · Behavioral: Behavioral Weight Loss Strategies · Behavioral: Acceptance Based Techniques

Interventions

  • BehavioralNutrition Education

    Participants are taught about energy balance, caloric intake, the nutrition content of foods, and diet.

  • BehavioralBehavioral Weight Loss Strategies

    Participants are taught self-monitoring and goal setting techniques.

  • BehavioralStandard Cognitive Techniques

    Participants are taught how to modify, get rid of, or distract from thoughts and also how to regulate emotions.

  • BehavioralAcceptance Based Techniques

    Participants are taught how to accept and change their perception of their thoughts and emotions.

06

What researchers measure

Primary outcomes

  1. Change from baseline in weight

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

    Time frame: 6, 12, 18, and 24 months

07

Study locations

1 site
  • The Miriam Hospital
    Providence, Rhode Island 02903-4121, United States
08

References and documents

Publications

  • 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. PubMed 26019869 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 7, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01461421
Lead sponsor
The Miriam Hospital
Responsible party
Rena R. Wing (Director Weight Control & Diabetes Research Center, The Miriam Hospital) — Principal investigator
First posted
Oct 28, 2011
Start date
Jul 2011
Primary completion
Mar 2017
Completion
Mar 2017
Last update
Apr 7, 2017

Study contacts

Rena R. Wing, PhD
principal investigator · The Miriam Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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