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Preference and Vegetarian Diet in Weight Loss Treatment

This study has been completed.

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

Investigators
Principal Investigator:     Lora E. Burke, PhD, MPH, RN     University of Pittsburgh    
  More Information

Publications indexed to this study:

Study ID Numbers:   000674, RO1-DK58631
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 September 05, 2008




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