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Addressing Emotional and Cognitive Factors in Behavioral Weight Loss Treatment

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ClinicalTrials.gov Identifier: NCT00533052
Recruitment Status : Completed
First Posted : September 21, 2007
Last Update Posted : March 14, 2018
Sponsor:
Collaborator:
The Miriam Hospital
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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.

Condition or disease Intervention/treatment Phase
Overweight Obesity Behavioral: Affective and Cognitive Skills Training Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Addressing Emotional and Cognitive Factors in Behavioral Weight Loss Treatment
Actual Study Start Date : October 2007
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Affective and Cognitive Skills Training
Standard Behavioral Weight Loss Treatment Plus Affective and Cognitive Skills Training
Behavioral: Affective and Cognitive Skills Training
24-week, weekly, group behavioral weight loss treatment with affective and cognitive skills training



Primary Outcome Measures :
  1. Body Mass Index [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. 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.

  2. Treatment acceptability based on qualitative feedback [ Time Frame: 6 months ]
  3. Attendance data [ Time Frame: 6 months ]


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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00533052


Locations
United States, Rhode Island
The Miriam Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
The Miriam Hospital
Investigators
Principal Investigator: Heather M. Niemeier, Ph.D. The Miriam Hospital/The Warren Alpert Medical School of Brown University

Publications of Results:
Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00533052     History of Changes
Other Study ID Numbers: K23 DK73536 (completed)
K23DK073536 ( U.S. NIH Grant/Contract )
First Posted: September 21, 2007    Key Record Dates
Last Update Posted: March 14, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Behavioral weight loss

Additional relevant MeSH terms:
Overweight
Weight Loss
Body Weight
Signs and Symptoms
Body Weight Changes