Preference and Vegetarian Diet in Weight Loss Treatment - Tabular View

Tracking Information

First Received Date ^ICMJE

May 26, 2006

Last Updated Date

May 26, 2006

Start Date ^ICMJE

January 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

weight change at 18 months

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Preference and Vegetarian Diet in Weight Loss Treatment

Official Title ^ICMJE

Preference and Vegetarian Diet in Weight Loss Treatment

Brief Summary

We propose to add a treatment preference component to a larger study testing standard behavioral treatment (SBT) for weight loss without specific food group restriction vs standard behavioral treatment with gradual elimination of meat, poultry, and fish [a lacto-ovo-vegetarian (LOV) meal plan]. Eligible respondents will be randomized to one of two conditions: Treatment Preference-Yes/No. Individuals in the Treatment Preference-Yes will be assigned to their choice (SBT or SBT+LOV), those in Treatment Preference-No will be randomized to either SBT or SBT+LOV without regard to their preference.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment

Condition ^ICMJE

Obesity
Overweight

Intervention ^ICMJE

Behavioral: Standard Behavioral Treatment
Behavioral: Standard Behavior Treatment plus Lacto-ovo-vegetarian diet

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

195

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

(1) be 18 to 55 years of age; (2) have a BMI of at least 27 but not greater than 43; (3) be willing to be randomized to one of the two preference conditions (Yes/No) and one of the two treatment conditions (SBT or SBT+LOV); and (4) have successfully completed a 5-day diary

Exclusion Criteria:

(1) presence of a current serious illness or unstable condition (e.g., acute myocardial infarction or diabetes) for which physician supervision of diet and exercise prescription is needed; (2) presence of cardiovascular or orthopedic condition that would require physician clearance prior to participation; (3) limitations precluding ability to exercise; (4) pregnancy or intention to become pregnant in the next 18 months; (5) current treatment for a psychological disorder; (6) reported alcohol intake >4 drinks/day; (7) current or recent (past 6 months) participation in a weight loss treatment program or use of weight loss medication; (8) reporting no regular intake of meat, fish, and fowl; or presence of a serious binge eating problem

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00330629

Responsible Party

Study ID Numbers ^ICMJE

000674, RO1-DK58631

Study Sponsor ^ICMJE

University of Pittsburgh

Collaborators ^ICMJE

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators ^ICMJE

Principal Investigator:

Lora E. Burke, PhD, MPH, RN

University of Pittsburgh

Information Provided By

University of Pittsburgh

Verification Date

March 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP