| Registry | NCT04866966, acronym SMALL |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 23 (Actual) |
| Sponsor | University of South Florida (Other); collaborators: American College of Clinical Pharmacy |
| Conditions | Obesity |
| Interventions | Shared medical appointments for weight loss (Behavioral) |
| Dates | start 2019-02-27, primary completion 2019-08-21, completion 2019-08-21, first posted 2021-04-30, last updated 2021-04-30 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Obesity All trials of Shared medical appointments for weight loss
Randomized controlled trial to determine if a 6 months of shared medical appointments will results in clinically and statistically significant weight loss.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Intervention Group | Experimental | Behavioral: Shared medical appointments for weight loss | The group undergoing the intervention 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. 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. Pharmacotherapy therapy changes will be recommended to reduce or avoid use of medication which may contribute to weight gain and medications for weight loss will be prescribed as an individualized treatment strategy during one-on-one time with the pharmacist or physician if the patient can afford it and no contraindications exists. |
| Control Group | No intervention | The control group will have their measurements done at the beginning and end of the study. They will continue with usual medicare care during the study and will not receive any education from the investigators during the study. They will be offered the option of a delayed intervention after the completion of the study. |
Sex: All, ages: 18 Years to 74 Years
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).
| Facility | City | Country | Status |
|---|---|---|---|
| Byrd Institute | Tampa, Florida | United States |