Behavioral Self-Regulation - Full Text View

Sponsored by:	The Miriam Hospital
Information provided by:	The Miriam Hospital
ClinicalTrials.gov Identifier:	NCT00488228

Purpose

The purpose of this pilot study is to determine whether incorporating self-regulation training using daily weighing is efficacious within a behavioral weight loss program specifically targeting young adults.

Condition	Intervention
Obesity	Behavioral: self-regulation

MedlinePlus related topics: Obesity Weight Control

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment
Official Title:	Behavioral Self-Regulation for Weight Loss in Young Adults

Further study details as provided by The Miriam Hospital:

Primary Outcome Measures:

weight change [ Time Frame: 10 weeks and 20 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

eating disorder symptoms, physical activity, body image, mood symptoms, and self-efficacy about eating behavior [ Time Frame: 10 weeks and 20 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	41
Study Start Date:	April 2007
Estimated Study Completion Date:	August 2008
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Participants in the behavioral self-regulation intervention will receive a modified standard treatment that incorporates daily weighing and training in self-regulation methods for weight loss. All treatment modules are adapted for a young adult age group.	Behavioral: self-regulation The current study involves a behavioral weight loss intervention tailored specifically to young adults. All participants receive calorie and activity prescriptions as well as training in behavior modification. In addition, one group receives training in self-regulation techniques using daily weighing.
2: Experimental Participants in the Standard group will receive a brief version of standard behavioral weight loss treatment with treatment modules tailored to better meet the needs of young adults.	Behavioral: self-regulation The current study involves a behavioral weight loss intervention tailored specifically to young adults. All participants receive calorie and activity prescriptions as well as training in behavior modification. In addition, one group receives training in self-regulation techniques using daily weighing.

Eligibility

Ages Eligible for Study:	18 Years to 35 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

body mass index between 27 and 40
age between 21 and 35

Exclusion Criteria:

report a history of eating disorder or a current eating disorder
report a heart condition or other medical condition that would limit ability to participate in an exercise program without direct supervision from physician
report major psychiatric diseases or organic brain syndromes
currently participating in another weight loss program, are taking a weight loss medication, or have lost more than 5% of body weight curing last 6 months
pregnant, lactating, or less than 6 months post-partum
intend to move out of city within the time frame of the investigation or will miss multiple meetings during the study time frame

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00488228

Locations

United States, Rhode Island
Weight Control and Diabetes Research Center
Providence, Rhode Island, United States, 02903

Sponsors and Collaborators

The Miriam Hospital

Investigators

Study Director:	Jessica G LaRose, Ph.D.	The Miriam Hospital
Principal Investigator:	Rena R Wing, PhD	The Miriam Hospital

More Information

Responsible Party:	The Miriam Hospital ( Rena R. Wing )
Study ID Numbers:	CMTT# 2096-07
Study First Received:	June 18, 2007
Last Updated:	January 22, 2008
ClinicalTrials.gov Identifier:	NCT00488228
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Weight Loss

Nutrition Disorders
Overweight
Overnutrition

ClinicalTrials.gov processed this record on January 16, 2009