Obesity
Conditions
Brief summary
Randomized controlled trial to determine if a 6 months of shared medical appointments will results in clinically and statistically significant weight loss.
Detailed description
Obese patients will be randomized to either the control or intervention group. The intervention group will participate in 90-minute group visits occurring weekly for 4 weeks, then biweekly for a total of 26 weeks/15 visits. Each visit will focus on intensive lifestyle changes: calorie restriction to produce a 500-750 calorie deficit, increased physical activity, and behavioral therapies including regular self-monitoring of food intake, physical activity, and weight. Additional behavioral therapies that will be offered include techniques for reducing stress, maximizing sleep, and controlling environments. Further, these patients will each have the opportunity to meet one-on-one with a member of the research team at the end of each visit in order to discuss individual goals and progress.
Interventions
BEHAVIORALShared medical appointments for weight loss
Shared medical appointments providing education and lifestyle change recommendations to promote weight loss in obese patients
Sponsors
American College of Clinical Pharmacy
University of South Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
* Current patients of the USF Family or General Internal Medicine Clinics * BMI of 30 or greater * Able to speak and read English
Exclusion criteria
* Age over 75 years, patients with end-stage renal disease with estimated GFR less than 15 mL/min, diabetes mellitus with an A1C \> 9%, Acute Coronary Syndrome (such as unstable angina, pacemaker or defibrillator due to impedance scale), recent history of weight loss (\>5% of body weight), pregnant or breastfeeding women, dementia or unstable psychiatric disorder, participation in any structured weight loss program currently or in the previous 3 months, cancer, or anyone unable to complete study protocol (exercise amounts, food intake).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants from each group who lost at least 5% of their initial body weight | 6 months | Body weight will be measured at the initial and final visits using the Tanita DC-430 body composition analyzer for participants in both groups and documented in the medical record. Percent of body weight lost will be calculated for each participant and the percentage of participants who lose 5% of body weight will be included in the primary outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean percent weight change of each group from baseline to the final visit | 6 months | Body weight will be measure at the initial and final visits using the Tanita DC-430 body composition analyzer for participants in both groups and documented in the medical record. Percent of body weight lost will be calculated for each participant and the mean will be reported. |
| Mean change in body mass index (BMI) of each group from baseline to the final visit | 6 months | BMI will be calculated using weight and height measured at the initial and final visits and the difference will be calculated for each participant and documented in the medical record. Weights will be measured using the Tanita DC-430 body composition analyzer and heights measured using a stadiometer on a physicians scale. The mean for each group will be reported. |
| Mean change in body fat percentage of each group from baseline to final visit | 6 months | The Tanita DC-430 body composition analyzer will be used to measure body fat percentages for each participant at the initial and final visits and documented in the medical record. The change will be calculated for each participant and the mean for each group will be reported. |
| Mean change in body weight from each group from baseline to the final visit | 6 months | Body weight will be measured at the initial and final visits using the Tanita DC-430 body composition analyzer for participants in both groups and documented in the medical record. Change in weight will be calculated for each participant and the mean will be reported. |
| Mean change in doses or number of medications for hypertension or diabetes | 6 months | Weight loss or weight gain can affect the need for medications for diabetes and hypertension. The number and doses of medications for hypertension and type 2 diabetes will recorded in the medical record at the initial and final visits. The changes in number or dosage will be reported for each group. |
| Effect of visit adherence on each outcome | 6 months | We will assess if or how visit attendance affects the results of each outcome per group. Attendance will be recording in the medical record. |
| Mean percentage of participants from each group without weight gain | 6 months | Body weight will be measured at the initial and final visits using the Tanita DC-430 body composition analyzer for participants in both groups and documented in the medical record. The percentage of participants in each group who lost or does not gain weight during the study will be reported for each group. |
Countries
United States
Outcome results
None listed