Preference and Vegetarian Diet in Weight Loss Treatment
PREFER
2 other identifiers
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable obesity
Started Jan 2002
Typical duration for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
May 26, 2006
CompletedFirst Posted
Study publicly available on registry
May 29, 2006
CompletedJuly 4, 2016
July 1, 2016
3.7 years
May 26, 2006
July 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
weight change at 18 months
18 months
Study Arms (2)
Standard Behavioral Treatment
ACTIVE COMPARATORGoal 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.
SBT+LOV Group
ACTIVE COMPARATORIn 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). .
Interventions
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.
The focus will be on the elimination of meat products as a means to reduce fat intake.
Eligibility Criteria
You may qualify if:
- (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
You may not qualify if:
- (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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Pittsburgh School of Nursing
Pittsburgh, Pennsylvania, 15261, United States
Related Publications (3)
Goode RW, Ye L, Sereika SM, Zheng Y, Mattos M, Acharya SD, Ewing LJ, Danford C, Hu L, Imes CC, Chasens E, Osier N, Mancino J, Burke LE. Socio-demographic, anthropometric, and psychosocial predictors of attrition across behavioral weight-loss trials. Eat Behav. 2016 Jan;20:27-33. doi: 10.1016/j.eatbeh.2015.11.009. Epub 2015 Nov 14.
PMID: 26609668DERIVEDWarziski MT, Sereika SM, Styn MA, Music E, Burke LE. Changes in self-efficacy and dietary adherence: the impact on weight loss in the PREFER study. J Behav Med. 2008 Feb;31(1):81-92. doi: 10.1007/s10865-007-9135-2. Epub 2007 Oct 26.
PMID: 17963038DERIVEDBurke 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. doi: 10.1093/ajcn/86.3.588.
PMID: 17823421DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lora E. Burke, PhD, MPH, RN
University of Pittsburgh
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 26, 2006
First Posted
May 29, 2006
Study Start
January 1, 2002
Primary Completion
September 1, 2005
Study Completion
September 1, 2005
Last Updated
July 4, 2016
Record last verified: 2016-07