Clinical trial NCT04866966: Shared Medical Appointments for Weight Loss
Official title: Shared Medical Appointments for Weight Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: American College of Clinical Pharmacy
First posted: 2021-04-30
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Percentage of participants from each group who lost at least 5% of their initial body weight
timeFrame: 6 months
Secondary outcomes:
measure: Mean change in body weight from each group from baseline to the final visit
timeFrame: 6 months
measure: Mean percent weight change of each group from baseline to the final visit
timeFrame: 6 months
measure: Mean change in body mass index (BMI) of each group from baseline to the final visit
timeFrame: 6 months
measure: Mean change in body fat percentage of each group from baseline to final visit
timeFrame: 6 months
measure: Mean percentage of participants from each group without weight gain
timeFrame: 6 months
measure: Mean change in doses or number of medications for hypertension or diabetes
timeFrame: 6 months
measure: Effect of visit adherence on each outcome
timeFrame: 6 months
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Byrd Institute
state: Florida
Study officials:
affiliation: University of South Florida Health
name: Rachel B Franks, PharmD
role: PRINCIPAL_INVESTIGATOR
References: