Overweight and ObesityNCT06406985
Developing a Weight Management Class as a Recruitment Tool for an Online Weight Loss Program to Rural Illinois Residents
A study testing Weight-loss through dietary and lifestyle changes in people with Overweight and Obesity, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Weight-loss through dietary and lifestyle changes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois Urbana-Champaign
Urbana, Illinois, 61801
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Overweight and Obesity
- Being tested
- Weight-loss through dietary and lifestyle changes
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight-loss through dietary and lifestyle changesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| EMPOWER Weight-Loss Participants | Experimental | 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. Receives: Behavioral: Weight-loss through dietary and lifestyle changes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment feasibility
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.
Measured: 3 months
Sustainability of collaboration
Exit interviews will be conducted with collaborators to identify themes surrounding the nature of the collaboration.
Measured: end of 12-month study
Secondary outcomes (2)
Weight-loss
Weight-loss of greater than or equal to 5 percent total body weight when compared to baseline in each participant.
Measured: end of 12-month study
Dietary change
Statistically significant increase in dietary protein and fiber density (grams/100 kilocalories) when compared to baseline 3-day food records.
Measured: end of 12-month study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start7 May 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06406985
- Sponsor's protocol ID
- IRB24-0474
- Status last verified
- May 2025
- First submitted
- 6 May 2024
- Last updated
- 3 Jun 2025
- 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 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06406985
- Acronym / sponsor ID
- IRB24-0474
- Conditions
- Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Study start
- 7 May 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 9 May 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EMPOWER Weight-Loss Participants | Experimental | Behavioral: Weight-loss through dietary and lifestyle changesAll 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Weight-loss through dietary and lifestyle changesWeight-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. | Behavioural | EMPOWER Weight-Loss Participants |
Primary outcome
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.
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.
2 secondary outcomes
Weight-loss
Time frame: end of 12-month study
Dietary change
Time frame: end of 12-month study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- EMPOWER Study WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Overweight and Obesity
Not yet recruiting
Transcutaneous Auricular Vagus Nerve Stimulation Combined With Lifestyle Intervention for Visceral Fat Reduction in Adults With Overweight or Obesity
Overweight, Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Not yet recruitingPhase 3
ELEVATE-LIVER: A Study to Test Whether Survodutide Helps Improve Heart Structure and Function in People With Overweight or Obesity and Fatty Liver Disease
Obesity, Metabolic Dysfunction-associated Steatotic Liver Disease
Not yet recruitingObservational study
A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity
Obesity
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 Weight-loss through dietary and lifestyle changes in people with Overweight and Obesity, run by University of Illinois at Urbana-Champaign 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 5 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 3 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Recruitment feasibility (time frame: 3 months). 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 Jun 2025.