Flipped Classroom for Weight Management

Not Applicable

Completed

• Conditions: Obesity; Weight Loss

• Registration Number: NCT06622278
• Lead Sponsor: University of Kansas Medical Center

Brief Summary

This study is a 24-week, single-arm trial investigating the feasibility of a flipped classroom behavioral intervention for weight management. The investigators will recruit up to 30 adults ages 18+ with a body mass index greater than or equal to 25 kg/m2 to participate in weekly, 1-hour group weight management education delivered remotely via Zoom with a trained health educator. Participants will receive a dietary prescription of 1200-1500 calories/day (5 portion-controlled meals and 5+ servings of fruits and vegetables) and exercise prescription of 150-300 minutes exercise/week. Additionally, participants will be asked to self-monitor diet and exercise adherence weekly. Feasibility outcomes will be collected at baseline, 12-weeks, and 24-weeks.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-29
• Status Verified: 2022-06
• Study First Submitted: 2022-06-13
• Primary Completion: 2023-03-01
• Study Completion: 2023-03-01
• Study First Submitted QC: 2024-09-30
• Last Update Submitted: 2024-10-01
• Study First Posted: 2024-10-02
• Last Update Posted: 2024-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Body Mass Index greater than or equal to 25
• Age 18 to 75 years
• Wireless internet connection in the home
• Ability to engage in moderate to vigorous intensity exercise

Exclusion Criteria

• Unable to commit to weekly group education
• Food allergy/intolerance that would hinder ability to adhere to dietary prescription

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Attendance	24 weeks	Attendance to the group education sessions will be measured weekly and evaluated by the health educator. Attendance records will be entered into the study REDCap database.
Attrition	24 weeks	Attrition rate will be measured at the end of the intervention measured as the percent of participants who completed all 24 weeks of the weight loss program.

Secondary Outcome Measures

Name	Time	Method
Body Mass Index	24 weeks	Body Mass Index will be calculated as weight (kg) divided by height (cm) squared.
Weight	24 weeks	Participants will be weighed at the outpatient weight management clinic in a private room by a registered nurse prior to the participant seeing a clinic physician. Weight will be collected to the nearest 0.1 kg.
Height	24 weeks	Participant height will be measured at the outpatient weight management clinic in a private room by a registered nurse prior to the participant seeing a clinic physician. Standing height will be measured using a stadiometer and collected to the nearest 1 cm.
Diet Adherence	24 weeks	Adherence to the diet prescription will be measured weekly via participant self-report. Participants will report daily total number of shakes, number of entrees, servings of fruit and vegetables, and days off plan. The self-monitoring sheet will be submitted via email to the health educator prior to each group session. The health educator will provide individual feedback based on self-reported adherence.
Exercise Adherence	24 weeks	Adherence to the diet and exercise prescription will be measured weekly via participant self-report. Participants will report daily minutes of exercise and steps taken. The self-monitoring sheet will be submitted via email to the health educator prior to each group session. The health educator will provide individual feedback based on self-reported adherence.

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States