NCT01461421

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Jul 2011

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 28, 2011

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

April 7, 2017

Status Verified

April 1, 2017

Enrollment Period

5.7 years

First QC Date

October 25, 2011

Last Update Submit

April 6, 2017

Conditions

Obesity

Keywords

ObesityPrimary CareBehavior Modification

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in weight

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

    6, 12, 18, and 24 months

Study Arms (2)

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.

Behavioral: Nutrition EducationBehavioral: Behavioral Weight Loss StrategiesBehavioral: 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.

Behavioral: Nutrition EducationBehavioral: Behavioral Weight Loss StrategiesBehavioral: Acceptance Based Techniques

Interventions

Nutrition EducationBEHAVIORAL

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

Acceptance Based Behavioral InterventionStandard Behavioral Treatment
Behavioral Weight Loss StrategiesBEHAVIORAL

Participants are taught self-monitoring and goal setting techniques.

Acceptance Based Behavioral InterventionStandard Behavioral Treatment
Standard Cognitive TechniquesBEHAVIORAL

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

Standard Behavioral Treatment
Acceptance Based TechniquesBEHAVIORAL

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

Acceptance Based Behavioral Intervention

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Miriam Hospital

Providence, Rhode Island, 02903-4121, United States

Location

Related Publications (1)

  • 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.

    PMID: 26019869DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Rena R. Wing, PhD

    The Miriam Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Weight Control & Diabetes Research Center

Study Record Dates

First Submitted

October 25, 2011

First Posted

October 28, 2011

Study Start

July 1, 2011

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

April 7, 2017

Record last verified: 2017-04

Locations

US(1)