Flipped Classroom for Weight Management

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Weight Loss
• Intervention / Treatment: Behavioral: Flipped Classroom

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Group Health Education; Participants will be complete a total of 24, 1-hour group sessions with a health educator (exercise physiologist). The group size will be 10-15 participants and will be completed via Zoom. Prior to each group meeting, participants will email their weekly self-monitoring sheets to their health educator to review diet and exercise adherence. Each group session will follow a pre-determined structure: group discussion, review of adherence, 5 to 10 minutes of physical activity, and an active learning-based activity.

Behavioral: Flipped Classroom; The flipped classroom educational model requires participants to independently review educational material before class, and class time with the health educator is spent engaging in group and individual skills-based activities and problem-solving assignments. The theoretical basis for the development of active learning is to elicit higher cognitive learning, according to the revised Bloom's taxonomy and shift independent student time to passive learning (remembering and understanding) and collaborative student and educator time to active learning (applying, analyzing, evaluating, and creating). Thus, the weight management education will include: case vignettes, group debates/discussions, think-pair-share activities, gamification of health-related topics, creation of meal and physical activity, problem-solving barriers to a healthy diet and physical activity, and hands-on worksheets.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attendance	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.	24 weeks
Attrition	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.	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	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.	24 weeks
Height	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.	24 weeks
Body Mass Index	Body Mass Index will be calculated as weight (kg) divided by height (cm) squared.	24 weeks
Diet Adherence	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.	24 weeks
Exercise Adherence	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.	24 weeks

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2022
• Primary Completion (Actual): March 1, 2023
• Study Completion (Actual): March 1, 2023

Study Registration Dates

• First Submitted: June 13, 2022
• First Submitted That Met QC Criteria: September 30, 2024
• First Posted (Actual): October 2, 2024

Study Record Updates

• Last Update Posted (Actual): October 3, 2024
• Last Update Submitted That Met QC Criteria: October 1, 2024
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight Changes; Weight Loss; Body Weight
• Other Study ID Numbers: WCRP - S1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No