ObesityNCT01461421
Acceptance Based Behavioral Intervention for Weight Loss: A Randomized Trial
A study testing Nutrition Education, Behavioral Weight Loss Strategies and Standard Cognitive Techniques in people with Obesity, run by The Miriam Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity
- What is being tested?
- Nutrition Education, Behavioral Weight Loss Strategies and Standard Cognitive Techniques
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Miriam Hospital
Providence, Rhode Island, 02903-4121
About this study
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.
- Conditions
- Obesity
- Being tested
- Nutrition Education, Behavioral Weight Loss Strategies, Standard Cognitive Techniques, Acceptance Based Techniques
- Keywords
- Obesity, Primary Care, Behavior Modification
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition EducationBehavioural
Participants are taught about energy balance, caloric intake, the nutrition content of foods, and diet.
Behavioral Weight Loss StrategiesBehavioural
Participants are taught self-monitoring and goal setting techniques.
Standard Cognitive TechniquesBehavioural
Participants are taught how to modify, get rid of, or distract from thoughts and also how to regulate emotions.
Acceptance Based TechniquesBehavioural
Participants are taught how to accept and change their perception of their thoughts and emotions.
| Study group | Role | What they receive |
|---|---|---|
| Standard Behavioral Treatment | Active comparator | 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. Receives: Behavioral: Nutrition Education; Behavioral: Behavioral Weight Loss Strategies; Behavioral: Standard Cognitive Techniques |
| Acceptance Based Behavioral Intervention | Experimental | 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. Receives: Behavioral: Nutrition Education; Behavioral: Behavioral Weight Loss Strategies; Behavioral: Acceptance Based Techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in weight
Amount of weight lost (kg) from initial body weight at study entry.
Measured: 6, 12, 18, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2011 (estimated)
- Study startJul 2011
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rena R. Wing, The Miriam Hospital
- Investigators
- Rena R. Wing, PhD, Principal investigator, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01461421
- Sponsor's protocol ID
- 1R01DK087704-01A1
- Status last verified
- Apr 2017
- First submitted
- 25 Oct 2011
- Last updated
- 7 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptance Based Behavioral Intervention for Weight Loss: A Randomized Trial
- ClinicalTrials.gov ID
- NCT01461421
- Acronym / sponsor ID
- 1R01DK087704-01A1
- Conditions
- Obesity
- Keywords
- Obesity, Primary Care, Behavior Modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 28 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Behavioral Treatment | Active comparator | Behavioral: Nutrition Education, Behavioral: Behavioral Weight Loss Strategies, Behavioral: Standard Cognitive TechniquesNutrition 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. |
| Acceptance Based Behavioral Intervention | Experimental | Behavioral: Nutrition Education, Behavioral: Behavioral Weight Loss Strategies, Behavioral: Acceptance Based TechniquesNutrition 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrition EducationParticipants are taught about energy balance, caloric intake, the nutrition content of foods, and diet. | Behavioural | Acceptance Based Behavioral Intervention, Standard Behavioral Treatment |
| Behavioral Weight Loss StrategiesParticipants are taught self-monitoring and goal setting techniques. | Behavioural | Acceptance Based Behavioral Intervention, Standard Behavioral Treatment |
| Standard Cognitive TechniquesParticipants are taught how to modify, get rid of, or distract from thoughts and also how to regulate emotions. | Behavioural | Standard Behavioral Treatment |
| Acceptance Based TechniquesParticipants are taught how to accept and change their perception of their thoughts and emotions. | Behavioural | Acceptance Based Behavioral Intervention |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2017.
- Derived from this study: PubMed 26019869Lillis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rena R. Wing, PhD principal investigator
The Miriam Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition Education, Behavioral Weight Loss Strategies and Standard Cognitive Techniques in people with Obesity, run by The Miriam Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in weight (time frame: 6, 12, 18, and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01461421, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2017.