NCT06622278

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 29, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

October 2, 2024

Completed
Last Updated

October 3, 2024

Status Verified

June 1, 2022

Enrollment Period

11 months

First QC Date

June 13, 2022

Last Update Submit

October 1, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • Weight

    24 weeks

  • Height

    24 weeks

  • Body Mass Index

    24 weeks

  • Diet Adherence

    24 weeks

  • Exercise Adherence

    24 weeks

Study Arms (1)

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.

Behavioral: Flipped Classroom

Interventions

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.

Group Health Education

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

ObesityWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Division for Physical Activity and Weight Management

Study Record Dates

First Submitted

June 13, 2022

First Posted

October 2, 2024

Study Start

March 29, 2022

Primary Completion

March 1, 2023

Study Completion

March 1, 2023

Last Updated

October 3, 2024

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations