Preference and Vegetarian Diet in Weight Loss Treatment - Full Text View

Sponsors and Collaborators:	University of Pittsburgh National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00330629

Purpose

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.

Condition	Intervention
Obesity Overweight	Behavioral: Standard Behavioral Treatment Behavioral: Standard Behavior Treatment plus Lacto-ovo-vegetarian diet

MedlinePlus related topics: Obesity Vegetarian Diet Weight Control

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment
Official Title:	Preference and Vegetarian Diet in Weight Loss Treatment

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:

weight change at 18 months

Estimated Enrollment:	195
Study Start Date:	January 2002

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00330629

Locations

United States, Pennsylvania
University of Pittsburgh School of Nursing
Pittsburgh, Pennsylvania, United States, 15261

Sponsors and Collaborators

University of Pittsburgh

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

Investigators

Principal Investigator:

Lora E. Burke, PhD, MPH, RN

University of Pittsburgh

More Information

Publications indexed to this study:

Burke LE, Hudson AG, Warziski MT, Styn MA, Music E, Elci OU, Sereika SM. Effects of a vegetarian diet and treatment preference on biochemical and dietary variables in overweight and obese adults: a randomized clinical trial. Am J Clin Nutr. 2007 Sep;86(3):588-96.

Study ID Numbers:	000674, RO1-DK58631
Study First Received:	May 26, 2006
Last Updated:	May 26, 2006
ClinicalTrials.gov Identifier:	NCT00330629
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Weight Loss

Body Weight Changes
Nutrition Disorders
Overnutrition
Overweight

ClinicalTrials.gov processed this record on January 15, 2009