Portion Control Treatment for Obesity
|Obesity||Behavioral: portion control plate Behavioral: Usual Care||Phase 2 Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Portion Control for the Treatment of Obesity in the Primary Care Setting|
- Weight Change at 6 Months [ Time Frame: 6 months ]Weight change as a percentage of baseline at post 6 months.
- Weight Change at 3 Months [ Time Frame: 3 months ]Percentage change in weight at 3 months post study baseline
|Study Start Date:||January 2009|
|Study Completion Date:||December 2010|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
Active Comparator: Portion Control Intervention
Individuals will be given a portion control plate and dietary counseling
Behavioral: portion control plate
Individuals are provided with a portion control plate to use while eating and dietary counseling by dietician
Placebo Comparator: Usual Care
Provided with self-help booklets on diet and exercise.
Behavioral: Usual Care
Other Name: self-help booklets(exercise and lifestyle changes)
2-3 weeks prior to the patient's appointment with their primary care physician, the patient's medical record is reviewed to assess eligibility. If eligible, baseline patient characteristics are recorded, and a letter is sent to the patient informing them of the study and asking them to discuss this further with their primary care provider at their upcoming appointment.
At the primary care appointment, the patient is informed of the study and asked if they would like to participate. If the patient declines, their response is recorded. If the patient accepts, authorization is obtained and the patient is randomized by drawing a sealed envelope from either the male box or the female box, with both boxes being randomized. The envelope indicates either portion control plate or usual care. If the patient is randomized to usual care, Mayo Clinic pamphlets entitled "Lifestyle Changes for Healthy Weight" and "Exercise: Getting Started and Staying With It" are given to the patient. If the patient is randomized to the portion control plate, a 60 minute appointment with a dietician is scheduled. For pre-menopausal female patients who have not had a hysterectomy, a urine pregnancy test is performed to confirm that the patient is not pregnant prior to participation in the study.
At the dietitian appointment, the patient is given general information regarding portion size control and specific instructions on how to use a commercially calibrated portion control plate/bowl. The patient receives a handout containing instructions on how to use the plate/bowl along with food suggestions. The patient is instructed to use the plate for their largest meal of the day and encouraged to use the plate/bowl for all meals. The patient is also given a simple log-sheet to document the meals each day for which they used the plate/bowl.
The patients are then followed for 6 months. All patients are scheduled for weigh-ins at 3 months and 6 months. Patients in the portion control plate group are also contacted by phone or email (according to patient preference) at 1, 3, and 5 months by the dietitian to check-in and answer all questions. At completion of the study, patients in the portion control group are provided with a survey to assess their satisfaction with the intervention.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01451554
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Jon O Ebbert, MD||Mayo Clinic|