Shared Medical Appointments for Weight Loss

NCT04866966 | Completed

• 1 other identifier: 00033354
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized controlled trial to determine if a 6 months of shared medical appointments will results in clinically and statistically significant weight loss.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Percentage of participants from each group who lost at least 5% of their initial body weight

  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.

  6 months

Secondary Outcomes (7)

• Mean change in body weight from each group from baseline to the final visit

  6 months

• Mean percent weight change of each group from baseline to the final visit

  6 months

• Mean change in body mass index (BMI) of each group from baseline to the final visit

  6 months

• Mean change in body fat percentage of each group from baseline to final visit

  6 months

• Mean percentage of participants from each group without weight gain

  6 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Behavioral: Shared medical appointments for weight loss

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.

Interventions

Shared medical appointments for weight loss BEHAVIORAL

Shared medical appointments providing education and lifestyle change recommendations to promote weight loss in obese patients

Also known as: SMALL Study

Intervention Group

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Current patients of the USF Family or General Internal Medicine Clinics
• BMI of 30 or greater
• Able to speak and read English

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of South Florida: lead
• American College of Clinical Pharmacy: collaborator

Study Sites (1)

Byrd Institute

Tampa, Florida, 33613, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Shared Medical Appointments; Small-Area Analysis

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Appointments and Schedules; Organization and Administration; Health Services Administration; Practice Management, Medical; Practice Management; Professional Practice; Cluster Analysis; Statistics as Topic; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Rachel B Franks, PharmD

  University of South Florida Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 3, 2018
• First Posted: April 30, 2021
• Study Start: February 27, 2019
• Primary Completion: August 21, 2019
• Study Completion: August 21, 2019
• Last Updated: April 30, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)