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:

  1. Complete 12 online educational sessions over a 3-month period followed by a 9-month follow-up period.
  2. Participate in daily self-weighing using a provided WiFi-enabled scale.
  3. Will have a monthly nutrition coaching call once per month for the 12-month duration of the study.
  4. Will complete food records and self-report waist and hip circumference measures at baseline, 3-months, and 12-months.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Weight-loss through dietary and lifestyle changes
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Illinois at Urbana-Champaign

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 7, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 6, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 9, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 3, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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