Addressing Emotional and Cognitive Factors in Behavioral Weight Loss Treatment
Primary Purpose
Overweight, Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Affective and Cognitive Skills Training
Sponsored by
About this trial
This is an interventional treatment trial for Overweight focused on measuring Behavioral weight loss
Eligibility Criteria
Inclusion Criteria:
- Age between 21 and 70 years
- Body mass index between 27 and 40
- Score 5 or above on the internal disinhibition scale of the Eating Inventory
Exclusion Criteria:
- Are currently participating in a weight loss program and/or are taking a weight loss medication or lost greater than or equal to 5% of body weight during the past six months
- Are pregnant, lactating, less than 6 months postpartum or plan to become pregnant during the time frame of the investigation
- Report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q). Individuals endorsing joint problems, prescription medication usage, or other medical conditions that could limit exercise will be required to obtain written physician consent to participate.
Sites / Locations
- The Miriam Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Affective and Cognitive Skills Training
Arm Description
Standard Behavioral Weight Loss Treatment Plus Affective and Cognitive Skills Training
Outcomes
Primary Outcome Measures
Body Mass Index
Secondary Outcome Measures
Internal disinhibition as measured by the Eating Inventory
The internal disinhibition subscale of the Eating Inventory ranges from 0 to 8, with high values indicating more disinhibition.
Treatment acceptability based on qualitative feedback
Attendance data
Full Information
NCT ID
NCT00533052
First Posted
September 20, 2007
Last Updated
March 12, 2018
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators
The Miriam Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00533052
Brief Title
Addressing Emotional and Cognitive Factors in Behavioral Weight Loss Treatment
Official Title
Addressing Emotional and Cognitive Factors in Behavioral Weight Loss Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
October 2007 (Actual)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators
The Miriam Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Behavioral weight loss, the current treatment of choice for moderate obesity, achieves impressive short term results, however, weight regain following treatment is a major problem. Over 50% of participants in behavioral weight loss programs report difficulty with internal antecedents to unhealthy weight control behaviors and this difficulty is associated with weight regain following treatment. Current treatment approaches do not adequately address these antecedents. The aim of this series of studies is to develop, implement, and evaluate a behavioral weight loss program modified to provide participants with skills to deal effectively with affective and cognitive difficulties. The study targets men and women with BMI of 27-40 who self-report difficulty with emotional and/or cognitive antecedents to unhealthy weight control behaviors. The study is an uncontrolled pilot study in 20 participants to initially assess acceptability and efficacy of the innovative treatment. The long-term goal of this research is to improve the weight loss maintenance outcomes of behavioral weight loss programs by addressing affective and cognitive antecedents to unhealthy weight control behaviors.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
Behavioral weight loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Affective and Cognitive Skills Training
Arm Type
Experimental
Arm Description
Standard Behavioral Weight Loss Treatment Plus Affective and Cognitive Skills Training
Intervention Type
Behavioral
Intervention Name(s)
Affective and Cognitive Skills Training
Intervention Description
24-week, weekly, group behavioral weight loss treatment with affective and cognitive skills training
Primary Outcome Measure Information:
Title
Body Mass Index
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Internal disinhibition as measured by the Eating Inventory
Description
The internal disinhibition subscale of the Eating Inventory ranges from 0 to 8, with high values indicating more disinhibition.
Time Frame
6 months
Title
Treatment acceptability based on qualitative feedback
Time Frame
6 months
Title
Attendance data
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age between 21 and 70 years
Body mass index between 27 and 40
Score 5 or above on the internal disinhibition scale of the Eating Inventory
Exclusion Criteria:
Are currently participating in a weight loss program and/or are taking a weight loss medication or lost greater than or equal to 5% of body weight during the past six months
Are pregnant, lactating, less than 6 months postpartum or plan to become pregnant during the time frame of the investigation
Report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q). Individuals endorsing joint problems, prescription medication usage, or other medical conditions that could limit exercise will be required to obtain written physician consent to participate.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather M. Niemeier, Ph.D.
Organizational Affiliation
The Miriam Hospital/The Warren Alpert Medical School of Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22440077
Citation
Niemeier HM, Leahey T, Palm Reed K, Brown RA, Wing RR. An acceptance-based behavioral intervention for weight loss: a pilot study. Behav Ther. 2012 Jun;43(2):427-35. doi: 10.1016/j.beth.2011.10.005. Epub 2011 Dec 1.
Results Reference
result
Learn more about this trial
Addressing Emotional and Cognitive Factors in Behavioral Weight Loss Treatment
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