PREFER study: a randomized clinical trial testing treatment preference and two dietary options in behavioral weight management--rationale, design and baseline characteristics.
BACKGROUND
Obesity, a disorder associated with a myriad of comorbidities, is increasing at an alarming rate around the world. Given that pharmacotherapy has limited available options and that bariatric surgery is reserved for those who are morbidly obese or who have significant comorbidities, the most common approach to the treatment of obesity is standard behavioral treatment. This approach includes behavior modification related to eating and activity habits. The purpose of this paper is to describe the rationale, design, methods and baseline sample characteristics of a randomized controlled trial of a behavioral intervention in weight loss management, referred to as the PREFER study.


METHODS
The PREFER study, using a four-group design, includes: (1) a randomization scheme that permits participants to indicate a preferred dietary treatment approach, and (2) two dietary options, one of which is a lacto-ovo-vegetarian diet that has demonstrated potential for long-term adherence. The intervention (32 treatment sessions) is delivered over 12 months and is followed by a 6-month maintenance phase; final assessment occurs at 18 months.


RESULTS
We screened 932 individuals and randomized 197 to the study: Treatment Preference-Yes (n=84) and Treatment Preference-No (n=98). To maintain a balance across the four treatment groups, 15 subjects who preferred the standard diet had to be discarded from the Treatment Preference-Yes group. Retention at 18 months for the first of three cohorts was 82%.


CONCLUSIONS
The PREFER study is a single center study and is the first randomized controlled trial examining a lacto-ovo-vegetarian diet as part of weight loss treatment. The ethnically diverse sample includes males and females with a body mass index of 27 to 43. The study has the potential to make a contribution to understanding the role of treatment preference and the potential of a lacto-ovo-vegetarian diet for long-term weight loss.
Burke
Lora E
LE
University of Pittsburgh, Health and Community Systems, 3500 Victoria Street, 415 Victoria Building, 15261 Pittsburgh, PA, USA. lbu100@pitt.edu
Choo
Jina
J
Music
Edvin
E
Warziski
Melanie
M
Styn
Mindi A
MA
Kim
Yookyung
Y
Sevick
Mary Ann
MA
D000328:Adult; D004038:Diet, Reducing / Q000523:psychology; D014676:Diet, Vegetarian / Q000523:psychology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000178:diet therapy*; D010349:Patient Compliance; D010352:Patient Dropouts; D017060:Patient Satisfaction; D015203:Reproducibility of Results; D015983:Selection Bias; D012959:Socioeconomic Factors