Addressing Emotional and Cognitive Factors in Behavioral Weight Loss Treatment (Part 2)
March 12, 2018 updated by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Addressing Emotional and Cognitive Factors in Behavioral Weight Loss Treatment
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 will randomize 120 participants to receive 12 months of standard behavioral therapy for weight loss or standard behavioral treatment plus affective and cognitive skills training.
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.
Study Overview
Status
Withdrawn
Conditions
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02903
- The Weight Control and Diabetes Research Center, The Miriam Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
Standard behavioral weight loss treatment with cognitive and affective skills training
|
12-month (6-month weekly, 3-month biweekly, 3-month monthly) group treatment
|
|
Active Comparator: 2
Standard behavioral weight loss treatment
|
12-month (6-month weekly, 3-month biweekly, 3-month monthly) group treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Weight Loss
Time Frame: 12 Months
|
12 Months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Internal disinhibition as measured by the Eating Inventory
Time Frame: 12 Months
|
12 Months
|
|
Physical activity as measured by the Paffenbarger
Time Frame: 12 months
|
12 months
|
|
Dietary intake as measured by the Block Food Frequency Questionnaire
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Heather M. Niemeier, Ph.D., The Miriam Hospital/The Warren Alpert Medical School of Brown U niversity
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2009
Primary Completion (Anticipated)
January 1, 2011
Study Completion (Anticipated)
January 1, 2011
Study Registration Dates
First Submitted
November 13, 2007
First Submitted That Met QC Criteria
November 13, 2007
First Posted (Estimate)
November 14, 2007
Study Record Updates
Last Update Posted (Actual)
March 14, 2018
Last Update Submitted That Met QC Criteria
March 12, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- K23 DK73536-2
- K23DK073536 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.