- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00533052
Addressing Emotional and Cognitive Factors in Behavioral Weight Loss Treatment
March 12, 2018 updated by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
21
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 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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Affective and Cognitive Skills Training
Standard Behavioral Weight Loss Treatment Plus Affective and Cognitive Skills Training
|
24-week, weekly, group behavioral weight loss treatment with affective and cognitive skills training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Body Mass Index
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Internal disinhibition as measured by the Eating Inventory
Time Frame: 6 months
|
The internal disinhibition subscale of the Eating Inventory ranges from 0 to 8, with high values indicating more disinhibition.
|
6 months
|
Treatment acceptability based on qualitative feedback
Time Frame: 6 months
|
6 months
|
|
Attendance data
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Heather M. Niemeier, Ph.D., The Miriam Hospital/The Warren Alpert Medical School of Brown University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 (Actual)
October 1, 2007
Primary Completion (Actual)
July 1, 2008
Study Completion (Actual)
July 1, 2008
Study Registration Dates
First Submitted
September 20, 2007
First Submitted That Met QC Criteria
September 20, 2007
First Posted (Estimate)
September 21, 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 (completed)
- K23DK073536 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
Clinical Trials on Obesity
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States
-
Fundació Sant Joan de DéuRecruitingObesity, Childhood | Obesity, AdolescentSpain
Clinical Trials on Affective and Cognitive Skills Training
-
National Institute of Diabetes and Digestive and...WithdrawnObesity | OverweightUnited States
-
Combat StressEdinburgh Napier UniversityRecruitingComplex Post-Traumatic Stress DisorderUnited Kingdom
-
VA Office of Research and DevelopmentCompletedSchizophrenia | Schizoaffective DisorderUnited States
-
Columbia UniversityNational Heart, Lung, and Blood Institute (NHLBI)CompletedMedication Adherence | Acute Coronary Syndrome | FearUnited States
-
Vanderbilt UniversityRecruitingSchizophrenia | Social Skills | Schizo Affective DisorderUnited States
-
NYU Langone HealthNational Institute on Drug Abuse (NIDA)Not yet recruitingPosttraumatic Stress Disorder | Polysubstance AbuseUnited States
-
Judge Baker Children's CenterCompletedAnxiety Disorders | Disruptive Behavior Disorders | Depressive DisordersUnited States
-
Hospital Clinic of BarcelonaUniversity of BarcelonaCompleted
-
Hartford HospitalNational Institute of Mental Health (NIMH)Completed