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CompletedNCT06622278Updated Oct 3, 2024

Flipped Classroom for Weight Management

An interventional study of Flipped Classroom in Obesity and Weight Loss, sponsored by University of Kansas Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-10-03.

Sponsored by University of Kansas Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Obesity
  • Weight Loss
03

In context

Body Weight

1,223 studies on the registry are indexed under Body Weight; 131 are open to participants now.

This study's enrollment of 18 is below the median of 64 across 947 interventional studies indexed under Body Weight.

Browse Body Weight studies →

Lead sponsor

University of Kansas Medical Center is the lead sponsor of 483 studies on the registry; 113 are open to participants now.

Of its 38 completed or terminated interventional studies of FDA-regulated products, 24 (63%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Unable to commit to weekly group education
  • Food allergy/intolerance that would hinder ability to adhere to dietary prescription
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
18 participants (actual)

Study arms

  • 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

Interventions

  • BehavioralFlipped 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 24 weeks

  2. 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.

    Time frame: 24 weeks

Secondary outcomes

  1. 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.

    Time frame: 24 weeks

  2. 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.

    Time frame: 24 weeks

  3. Body Mass Index

    Body Mass Index will be calculated as weight (kg) divided by height (cm) squared.

    Time frame: 24 weeks

  4. 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.

    Time frame: 24 weeks

  5. 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.

    Time frame: 24 weeks

07

Study locations

1 site
  • University of Kansas Medical Center
    Kansas City, Kansas 66160, United States
08

References and documents

Study documents

  • Protocol and statistical analysis plan · May 18, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06622278
Lead sponsor
University of Kansas Medical Center
Responsible party
Joseph Donnelly (Director, Division for Physical Activity and Weight Management, University of Kansas Medical Center) — Principal investigator
First posted
Oct 2, 2024
Start date
Mar 29, 2022
Primary completion
Mar 1, 2023
Completion
Mar 1, 2023
Last update
Oct 3, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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