- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06406985
Developing a Weight Management Class as a Recruitment Tool for an Online Weight Loss Program to Rural Illinois Residents
May 28, 2025 updated by: University of Illinois at Urbana-Champaign
Developing a Weight Management Class as Curriculum for Rural Illinois Extension Nutrition Educators and as a Reach-Out Tool for an Online Weight Loss Program to Rural Residents
The purpose of this study is to identify how to maintain a sustainable collaboration Illinois Extension Nutrition and Wellness Educators while continuing to offer an online weight-loss program, EMPOWER, to rural Illinois residents.
- The primary aim of the study is to determine if an Extension-delivered introductory weight management class will be successful in recruiting rural individuals interested in losing weight to the EMPOWER weight-loss program.
- The secondary aim is to enroll interested rural participants in an online weight loss intervention that focuses on promoting dietary and lifestyle behavioral changes to achieve ≥5 percent weight loss.
Participants who participate in the EMPOWER weight-loss intervention will:
- Complete 12 online educational sessions over a 3-month period followed by a 9-month follow-up period.
- Participate in daily self-weighing using a provided WiFi-enabled scale.
- Will have a monthly nutrition coaching call once per month for the 12-month duration of the study.
- Will complete food records and self-report waist and hip circumference measures at baseline, 3-months, and 12-months.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
The purpose of the investigators' study is to identify how to maintain a sustainable collaboration with the investigator-developed weight-loss program, EMPOWER, and rural Illinois Extension Nutrition and Wellness Educators.
The investigators are aiming to identify potential barriers of recruitment, rolling enrollment, and intervention methods to enhance the success of maintaining this collaboration at a distance and continue to offer weight management services to rural areas.
If the investigators can demonstrate continual, successful collaboration with the Extension educators, they can work towards expanding EMPOWER to even more communities.
In objective 1, the investigators will create an introductory weight management curriculum in collaboration with three Illinois Extension nutrition and wellness educators that can be disseminated to their respective rural populations (Christian, Jersey, Macoupin, Montgomery, Jo-Daviess, Stephenson, Clark, Crawford, and Edgar counties).
The class will also be supplemented with healthy recipe handouts.
The class serves to fulfill curricula requirements for Extension educators in the area of chronic disease prevention and management while simultaneously serving as a recruitment method for the investigators' EMPOWER program.
This objective serves to answer the research question of whether offering a weight management class through Extension is a feasible way to recruit those in need of weight-loss to EMPOWER while maintaining long-term collaboration with Extension.
The data obtained from this objective includes an exit interview with each of the Extension educators, the number of attendees from each Extension class, as well as an optional survey provided to the Extension class attendees.
No identifiable information will be obtained from the Extension class attendees unless they express interest in the study recruitment flyer and proceed to fill out an eligibility form.
Objective 2 of the study is to enroll interested rural participants into a 3-month intervention and 9- month follow-up EMPOWER weight loss trial with statistically significant weight loss being the expected outcome at the end of the 12 months.
EMPOWER is an online weight-loss program that aims to achieve safe weight-loss through sustainable dietary and lifestyle changes.
Participants of EMPOWER will be provided online educational materials through Illinois eText and nutrition coaching from registered dietitians and nutrition students via email/messaging correspondence and monthly phone/video calls.
Participants will be asked to self-weigh everyday as a method to monitor energy balance.
MealPlot, a web- application developed by the investigators, will be available for participants to submit food records, message their coach, see their weight data, and monitor their protein and fiber intake.
Overall, successful EMPOWER recruitment from the Extension class and following success of EMPOWER enrollees losing statistically significant weight would lead to an improvement of health among rural residents where weight care strategies are typically limited and would demonstrate the feasibility of long-term collaboration with Extension educators.
Study Type
Interventional
Enrollment (Estimated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Urbana, Illinois, United States, 61801
- University of Illinois Urbana-Champaign
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- BMI greater than or equal to 28 kg/m^2
- age 18-75
- ability to access the internet and smartphone
- fluent in English
- having primary residence in a rural Illinois county
Exclusion Criteria:
- Pregnant or lactating
- previous or planned bariatric surgery
- BMI less than 28 kg/m^2
- Age less than 18 or greater than 75
- no access to internet and smartphone/smart device
- on GLP-1 Receptor Agonist weight loss medication
- Diagnosed with an eating disorder
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: EMPOWER Weight-Loss Participants
All weight-loss participants will receive the same protocol and weight-loss education materials.
Nutrition coaching is individualized to participant needs, but emphasizes the program's core themes throughout.
|
Weight-loss participants will complete one online, self-paced education session each week for 12 weeks.
Education sessions focus on topics such as self-monitoring weight, meal routines, and dietary habits with an emphasis on protein and fiber intake.
During these 12 weeks, participants will receive weekly messages from nutrition coaches as well as a monthly nutrition coaching call.
After the first 12 weeks, participants will enter a follow-up period where nutrition coaching messaging will occur as needed and with the opportunity to still participate in a monthly nutrition coaching call.
Participants are asked to weigh daily on a provided WiFi scale that automatically uploads their weight data to a website for researchers and coaches to monitor.
Participants will also submit food records and self-reported weight and hip circumferences.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recruitment feasibility
Time Frame: 3 months
|
Recruitment Goal: Recruitment will be completed within 3-months and 50% or more of submitted eligibility forms will be from those who attended the introductory weight-management class with Extension.
|
3 months
|
|
Sustainability of collaboration
Time Frame: end of 12-month study
|
Exit interviews will be conducted with collaborators to identify themes surrounding the nature of the collaboration.
|
end of 12-month study
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weight-loss
Time Frame: end of 12-month study
|
Weight-loss of greater than or equal to 5 percent total body weight when compared to baseline in each participant.
|
end of 12-month study
|
|
Dietary change
Time Frame: end of 12-month study
|
Statistically significant increase in dietary protein and fiber density (grams/100 kilocalories) when compared to baseline 3-day food records.
|
end of 12-month study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 7, 2024
Primary Completion (Estimated)
December 1, 2025
Study Completion (Estimated)
December 1, 2025
Study Registration Dates
First Submitted
May 6, 2024
First Submitted That Met QC Criteria
May 6, 2024
First Posted (Actual)
May 9, 2024
Study Record Updates
Last Update Posted (Actual)
June 3, 2025
Last Update Submitted That Met QC Criteria
May 28, 2025
Last Verified
May 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB24-0474
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
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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