Shared Medical Appointments for Weight Loss

NCT ID: NCT04866966

Last Updated: 2021-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-27

Study Completion Date

2019-08-21

Brief Summary

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

Detailed Description

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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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention Group

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.

Group Type EXPERIMENTAL

Shared medical appointments for weight loss

Intervention Type BEHAVIORAL

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

Control Group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Shared medical appointments for weight loss

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

Intervention Type BEHAVIORAL

Other Intervention Names

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SMALL Study

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American College of Clinical Pharmacy

OTHER

Sponsor Role collaborator

University of South Florida

OTHER

Sponsor Role lead

Responsible Party

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Rachel B. Franks

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rachel B Franks, PharmD

Role: PRINCIPAL_INVESTIGATOR

University of South Florida Health

Locations

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Byrd Institute

Tampa, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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00033354

Identifier Type: -

Identifier Source: org_study_id