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OpenTrials
Completed

NCT Number: NCT04866966

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.

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Key information

Conditions

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

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Byrd Institute

Tampa, Florida, 33613, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Shared medical appointments for weight loss

Behavioral

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

Other names: SMALL Study

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

  5. Mean percentage of participants from each group without weight gain

    Time frame: 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.

  6. Mean change in doses or number of medications for hypertension or diabetes

    Time frame: 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.

  7. Effect of visit adherence on each outcome

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Collaborators

  • American College of Clinical Pharmacy

Registry information

Acronym: SMALL

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 30, 2021
Registry last updated
Apr 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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