ObesityNCT06622278
Flipped Classroom for Weight Management
A study testing Flipped Classroom in people with Obesity and Weight Loss, run by University of Kansas Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity, Weight Loss
- What is being tested?
- Flipped Classroom
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2022to 1 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unable to commit to weekly group education
- Food allergy/intolerance that would hinder ability to adhere to dietary prescription
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
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.
- Conditions
- Obesity, Weight Loss
- Being tested
- Flipped Classroom
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flipped ClassroomBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Group Health Education | Experimental | 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. Receives: Behavioral: Flipped Classroom |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 24 weeks
Secondary outcomes (5)
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.
Measured: 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.
Measured: 24 weeks
Body Mass Index
Body Mass Index will be calculated as weight (kg) divided by height (cm) squared.
Measured: 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.
Measured: 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.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start29 Mar 2022
- Primary completion1 Mar 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Donnelly, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06622278
- Sponsor's protocol ID
- WCRP - S1
- Status last verified
- Jun 2022
- First submitted
- 13 Jun 2022
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flipped Classroom for Weight Management
- ClinicalTrials.gov ID
- NCT06622278
- Acronym / sponsor ID
- WCRP - S1
- Conditions
- Obesity, Weight Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 29 Mar 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 2 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group Health Education | Experimental | Behavioral: Flipped ClassroomParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Unable to commit to weekly group education
- Food allergy/intolerance that would hinder ability to adhere to dietary prescription
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flipped ClassroomThe 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. | Behavioural | Group Health Education |
Primary outcome
Attendance
Time frame: 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
Time frame: 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.
5 secondary outcomes
Weight
Time frame: 24 weeks
Height
Time frame: 24 weeks
Body Mass Index
Time frame: 24 weeks
Diet Adherence
Time frame: 24 weeks
Exercise Adherence
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flipped Classroom in people with Obesity and Weight Loss, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attendance (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2024.