Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Preference and Vegetarian Diet in Weight Loss Treatment (PREFER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00330629
Recruitment Status : Completed
First Posted : May 29, 2006
Last Update Posted : July 4, 2016
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Lora Burke, University of Pittsburgh

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.

Condition or disease Intervention/treatment Phase
Obesity Overweight Behavioral: Standard Behavioral Treatment Behavioral: SBT+LOV Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preference and Vegetarian Diet in Weight Loss Treatment
Study Start Date : January 2002
Actual Primary Completion Date : September 2005
Actual Study Completion Date : September 2005

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard Behavioral Treatment

Goal setting: daily/weekly goals for calorie and fat consumption, exercise time, and behavior change.

Self-monitoring: systematically observing and recording one's behavior,45,46 which will be reviewed by the therapists, and written feedback will be provided to reinforce positive behaviors.

Feedback: therapists monitor the recorded behavior changes and provide feedback/encouragement.

Behavioral: Standard Behavioral Treatment
Participants in this condition will receive the standard behavioral treatment (SBT) described above. Food tastings will be held at the sessions and will focus on fat modified food products.

Active Comparator: SBT+LOV Group
In addition to SBT, participants will aim to eliminate all meat, poultry, and fish from their diet over the first 6 weeks, and will be taught how to select appropriate substitutes for these foods, such as low- or no-fat dairy products (cheeses, milk), and protein-containing vegetable sources (soy products, legumes). .
Behavioral: Standard Behavioral Treatment
Participants in this condition will receive the standard behavioral treatment (SBT) described above. Food tastings will be held at the sessions and will focus on fat modified food products.

Behavioral: SBT+LOV
The focus will be on the elimination of meat products as a means to reduce fat intake.




Primary Outcome Measures :
  1. weight change at 18 months [ Time Frame: 18 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00330629


Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Lora E. Burke, PhD, MPH, RN University of Pittsburgh
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Lora Burke, Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00330629    
Other Study ID Numbers: 000674
R01DK058631 ( U.S. NIH Grant/Contract )
First Posted: May 29, 2006    Key Record Dates
Last Update Posted: July 4, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Overweight
Weight Loss
Body Weight
Signs and Symptoms
Body Weight Changes