Clinical trial NCT00533052: 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
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Keywords: Behavioral weight loss
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
Collaborators: name: The Miriam Hospital
First posted: 2007-09-21
Enrollment: 21
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Body Mass Index
timeFrame: 6 months
Secondary outcomes:
measure: Internal disinhibition as measured by the Eating Inventory
timeFrame: 6 months
measure: Treatment acceptability based on qualitative feedback
timeFrame: 6 months
measure: Attendance data
timeFrame: 6 months
Other outcomes:
Locations:
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
Study officials:
affiliation: The Miriam Hospital/The Warren Alpert Medical School of Brown University
name: Heather M. Niemeier, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.