Olestra Containing Foods and Weight Loss and Weight Maintenance
Behavioral: dietary education
Behavioral: dietary education and provided full fat snack foods
Behavioral: dietary education and provided fat free snack foods
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|Official Title:||Benefits of Sensory-Enhanced Products in Weight Loss and Maintenance|
- blood values
- body composition
- waist/hip measurements
- blood pressure
|Study Start Date:||March 1999|
|Estimated Study Completion Date:||December 2003|
During Phase I, the three groups will attend mandatory, 1 hour, bi-weekly group meetings. Participants will keep food records for 2 weekdays and 1 weekend day during each 2 week period as well as keeping exercise, snack and sleep logs daily. At each meeting, research staff will collect the completed food records and logs and new forms will be distributed. At weeks 8 and 16 of active weight loss, participants will repeat the assessments (blood tests, body composition, and questionnaires) conducted at baseline to determine treatment-induced changes in each of the dependent measures.
During phase II, all of the groups will participate in group meetings held 1 month after beginning maintenance and quarterly over 52 weeks. Dependent upon group, participants will pick-up foods bi-weekly and body weight will be assessed every 4 weeks. The full battery of assessments will be conducted at 26 weeks and at the end of the maintenance phase at 52 weeks.
Participants will be 180 adults (male and female) between 25 and 50 years of age. The study is designed to answer questions involving an adult population. Participants must be interested in losing weight. Participants must have a body mass index between 30 and 33 because this study is designed to answer questions investigating overweight individuals that are not morbidly obese. Participants with preliminary eligibility, determined via phone screening, will be invited to the clinic for a more in-depth screening including demographic and medical history questionnaires and psychosocial measures. Participants will gibe their consent to provide this information via completing a screening consent form (a separate form from the study consent form). Once this secondary eligibility is determined, a study consent form will be completed, and participants will undergo a baseline screening of physical measures, blood tests (CBC, SMA-20), body composition assessment (via bioelectrical impedance), and complete additional psychosocial questionnaires. Any participants found to be ineligible as a result of these measures will not be permitted to continue in the study, but will be referred for medical care if appropriate. Participants deemed eligible will proceed to the weight loss phase.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00198965
|United States, Maryland|
|Johns Hopkins University|
|Lutherville, Maryland, United States, 21093|
|Principal Investigator:||Lawrence J Cheskin, MD||Johns Hopkins Bloomberg School of Public Health|