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Addressing Emotional and Cognitive Factors in Behavioral Weight Loss Treatment (Part 2)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00558194
First received: November 13, 2007
Last updated: March 15, 2011
Last verified: March 2011
History of Changes
  Purpose

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.


Condition Intervention
Overweight
Obesity
 Behavioral: Standard Behavioral Weight Loss Treatment with Affective and Cognitive Skills Training
Behavioral: Standard Behavioral Weight Loss Treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Addressing Emotional and Cognitive Factors in Behavioral Weight Loss Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • Weight Loss [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Internal disinhibition as measured by the Eating Inventory [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • Physical activity as measured by the Paffenbarger [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Dietary intake as measured by the Block Food Frequency Questionnaire [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: August 2009
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Standard behavioral weight loss treatment with cognitive and affective skills training
 Behavioral: Standard Behavioral Weight Loss Treatment with Affective and Cognitive Skills Training
12-month (6-month weekly, 3-month biweekly, 3-month monthly) group treatment
Active Comparator: 2
Standard behavioral weight loss treatment
 Behavioral: Standard Behavioral Weight Loss Treatment
12-month (6-month weekly, 3-month biweekly, 3-month monthly) group treatment

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00558194

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

No publications provided

Responsible Party: Heather M. Niemeier, Ph.D., The Miriam Hospital
ClinicalTrials.gov Identifier: NCT00558194     History of Changes
Other Study ID Numbers: K23 DK73536-2, 1 K23 DK073536-01
Study First Received: November 13, 2007
Last Updated: March 15, 2011
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Obesity
Weight Loss
Overweight
Overnutrition
 Nutrition Disorders
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on June 18, 2013