ObesityNCT05587790
EMPOWER Rural Extension Weight Management Pilot Study
A study testing Weight Management Intervention in people with Obesity and Overweight, run by University of Illinois at Urbana-Champaign at 3 sites in United States.
Trial summary
This research is to expand a virtual weight loss and weight maintenance program to rural counties of Illinois. The program uses dietary and lifestyle modifications for adults with obesity. The EMPOWER weight loss program has proven to be effective in 3 previous trials. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity, Overweight, Weight Loss
- What is being tested?
- Weight Management Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 3 sitesUnited States
- Study dates
- 9 May 2022to 23 May 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
- age 18-75 years;
- BMI in overweight to above range;
- not currently pregnant or lactating;
- willing to access Wi-Fi via home or free public Wi-Fi location at least once a week for 45 minutes
- access to a working email
- willing to weigh daily and provide data either via Bluetooth, Wi-Fi, or manual input
Show all 10Show fewer
- willing to lose 20 lb. or more and maintain a healthy weight for one year thereafter;
- Continue daily-weighing for 12-months after the year-long intervention (Daily weigh for a total of 2 years);
- fluent in reading and writing English.
- live within one of the counties of the covered Extension Education offices: Eastern (Clark, Crawford, Edgar), Northern (Jo Daviess, Stephenson, Winnebago), Western (Macoupin, Christian, Jersey, Montgomery)
Who cannot join
- age <18 or >75 years;
- severe chronic diseases;
- underweight to normal BMI;
- currently pregnant;
- currently lactating;
- failed to commit to daily weighing;
- failed to submit 3, 24 hour records;
- underwent bariatric surgery or planning on having bariatric surgery within the next year including: Roux-en-Y Gastric Bypass, Sleeve Gastrectomy, Duodenal Jejunal Bypass with Sleeve Gastrectomy, Duodenal Switch, Laparoscopic Adjustable Gastric Banding.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
UIUC Extension
Freeport, Illinois, 61032
UIUC Extension
Hillsboro, Illinois, 62049
UIUC Extension
Marshall, Illinois, 62441
About this study
Official title: EMPOWER Weight Loss Program for Obesity in Rural and Underserved Areas Pilot Study
This research is to expand a virtual weight loss and weight maintenance program to rural counties of Illinois. The program uses dietary and lifestyle modifications for adults with obesity. The EMPOWER weight loss program has proven to be effective in 3 previous trials. In this research, we target a rural participant population. Individuals in rural locations are more likely to be affected by obesity and have unique barriers to weight loss related to geographic isolation including access to health care, preventative care, grocery stores, social networks, internet, and cell service.
Read the detailed description
EMPOWER is a remote weight management program that uses an online textbook platform, E-Text, and mobile web application, MealPlot. This pilot study will test for feasibility of the EMPOWER program in a rural population prior to launching a full-scale study. Acceptability measurements will be collected at 3 months to evaluate for needed changes; Participants of the pilot study will be permitted to continue on with the full program.
EMPOWER is a 1-year intervention. Data is collected via 24-hour record and daily weighing using a Wi-Fi-enabled scale. 24-hour records and daily weights are collected within the program's proprietary MealPlot website. EMPOWER consists of 17 online sessions (45 minutes/each) and 12 individual advising sessions with a nutrition coach.
- Conditions
- Obesity, Overweight, Weight Loss
- Being tested
- Weight Management Intervention
- Keywords
- Obesity, Overweight, Weight Loss, Rural, Nonmetropolitan, Protein, Fiber
- Medical subject headings
- Obesity, Overweight, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight Management InterventionBehavioural
Participants attend virtual dietary education sessions and over time create a diet plan that satisfies their individual needs. Participants aim to lose 1-2 pounds weekly until a BMI of 25 is reached. Participants are evaluated through daily self-weighing, dietary records, and anthropometric measures of waist and hip circumference, and body composition.
| Study group | Role | What they receive |
|---|---|---|
| Weight Management Intervention | Experimental | During a 12-month period, participants will attend a total of 17 diet improvement sessions, each of which will last approximately 45-minutes. Twelve sessions will be held in the first 5 months and will be focused on safe and efficient weight loss. The participants will learn to create a personalized weight loss diet from their kitchen based on their diet practice and food preference. The next 10 sessions will be held in the last 7 months and will be focused on weight maintenance and healthy eating. The participants will build skills to select foods and create meals that prevent them from overeating. Flexibility in session completion will be allowed to accommodate busy schedules, vacation, and potential internet access challenges. Receives: Behavioral: Weight Management Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment
Achieving target enrollment 16
Measured: 3 Months
Retention
Successful retention dropout <20% (13/16)
Measured: 3 Months
Completion of eText
Completion of eText (75% completion)
Measured: 12 Months
Completion of study measures
Completion of 80% of study measures (24-hour records, in-person anthropometric testing)
Measured: 12 Months
Acceptability
4/5 on average for all program components and overall program using Likert scales (ranging 1-5) of acceptability (comprehensive program, MealPlot, eText, nutrition coaching) collected via survey.
Measured: 3 Months
Secondary outcomes (3)
Weight loss
Change in weight
Measured: 1 Year
Dietary habits - protein density
protein density change from baseline to 12 months.
Measured: 1 Year
Dietary Habits - fiber density
Fiber density change from baseline to 12 months.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start9 May 2022
- Primary completion15 May 2023
- Study completion23 May 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
- Model description
- Before and after study design with one interventional group and no control or placebo group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
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
- NCT05587790
- Sponsor's protocol ID
- 22642
- Status last verified
- Mar 2025
- First submitted
- 18 Jul 2022
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All researchers must pass Core Human Subjects training through CITI. Confidentiality of data collected will be maintained by assigning each participant a three-digit identification (ID) code which will be used to enter all data in an electronic database. ID codes will be used on all documents and materials as the only form of identification; no names will be used. All files and participant documentation will be stored in locked filing cabinets. Electronic documents, forms and data will be stored in a Health Data folder on Box. Only the primary investigator, co-investigator, and research team will have access to stored data. Any data collected via email will be completed using ID codes and deleted and emptied from trash following data collection. The primary investigator will immediately destroy documents that are obtained from individuals who do not qualify for the study, as determined during the pre-screening and screening steps. These documents will be shredded.
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EMPOWER Weight Loss Program for Obesity in Rural and Underserved Areas Pilot Study
- ClinicalTrials.gov ID
- NCT05587790
- Acronym / sponsor ID
- 22642
- Conditions
- Obesity, Overweight, Weight Loss
- Keywords
- Obesity, Overweight, Weight Loss, Rural, Nonmetropolitan, Protein, Fiber
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Study start
- 9 May 2022 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 23 May 2023 (actual)
- First posted
- 20 Oct 2022 (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 research is to expand a virtual weight loss and weight maintenance program to rural counties of Illinois. The program uses dietary and lifestyle modifications for adults with obesity. The EMPOWER weight loss program has proven to be effective in 3 previous trials. In this research, we target a rural participant population. Individuals in rural locations are more likely to be affected by obesity and have unique barriers to weight loss related to geographic isolation including access to health care, preventative care, grocery stores, social networks, internet, and cell service.
Detailed description
EMPOWER is a remote weight management program that uses an online textbook platform, E-Text, and mobile web application, MealPlot. This pilot study will test for feasibility of the EMPOWER program in a rural population prior to launching a full-scale study. Acceptability measurements will be collected at 3 months to evaluate for needed changes; Participants of the pilot study will be permitted to continue on with the full program.
EMPOWER is a 1-year intervention. Data is collected via 24-hour record and daily weighing using a Wi-Fi-enabled scale. 24-hour records and daily weights are collected within the program's proprietary MealPlot website. EMPOWER consists of 17 online sessions (45 minutes/each) and 12 individual advising sessions with a nutrition coach.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Before and after study design with one interventional group and no control or placebo group
| Arm | Type | Receives |
|---|---|---|
| Weight Management Intervention | Experimental | Behavioral: Weight Management InterventionDuring a 12-month period, participants will attend a total of 17 diet improvement sessions, each of which will last approximately 45-minutes. Twelve sessions will be held in the first 5 months and will be focused on safe and efficient weight loss. The participants will learn to create a personalized weight loss diet from their kitchen based on their diet practice and food preference. The next 10 sessions will be held in the last 7 months and will be focused on weight maintenance and healthy eating. The participants will build skills to select foods and create meals that prevent them from overeating. Flexibility in session completion will be allowed to accommodate busy schedules, vacation, and potential internet access challenges. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- age 18-75 years;
- BMI in overweight to above range;
- not currently pregnant or lactating;
- willing to access Wi-Fi via home or free public Wi-Fi location at least once a week for 45 minutes
- access to a working email
Key exclusion criteria (8 listed)
- age <18 or >75 years;
- severe chronic diseases;
- underweight to normal BMI;
- currently pregnant;
- currently lactating;
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 Management InterventionParticipants attend virtual dietary education sessions and over time create a diet plan that satisfies their individual needs. Participants aim to lose 1-2 pounds weekly until a BMI of 25 is reached. Participants are evaluated through daily self-weighing, dietary records, and anthropometric measures of waist and hip circumference, and body composition. | Behavioural | Weight Management Intervention |
Primary outcome
Enrollment
Time frame: 3 Months
Achieving target enrollment 16
Retention
Time frame: 3 Months
Successful retention dropout <20% (13/16)
Completion of eText
Time frame: 12 Months
Completion of eText (75% completion)
Completion of study measures
Time frame: 12 Months
Completion of 80% of study measures (24-hour records, in-person anthropometric testing)
Acceptability
Time frame: 3 Months
4/5 on average for all program components and overall program using Likert scales (ranging 1-5) of acceptability (comprehensive program, MealPlot, eText, nutrition coaching) collected via survey.
3 secondary outcomes
Weight loss
Time frame: 1 Year
Dietary habits - protein density
Time frame: 1 Year
Dietary Habits - fiber density
Time frame: 1 Year
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 2 Apr 2025.
- Individual participant dataSharing planned: No. All researchers must pass Core Human Subjects training through CITI. Confidentiality of data collected will be maintained by assigning each participant a three-digit identification (ID) code which will be used to enter all data in an electronic database. ID codes will be used on all documents and materials as the only form of identification; no names will be used. All files and participant documentation will be stored in locked filing cabinets. Electronic documents, forms and data will be stored in a Health Data folder on Box. Only the primary investigator, co-investigator, and research team will have access to stored data. Any data collected via email will be completed using ID codes and deleted and emptied from trash following data collection. The primary investigator will immediately destroy documents that are obtained from individuals who do not qualify for the study, as determined during the pre-screening and screening steps. These documents will be shredded.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight Management Intervention in people with Obesity and Overweight, run by University of Illinois at Urbana-Champaign at 3 sites 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 10 inclusion and 8 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 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Enrollment (time frame: 3 Months). The study lists 5 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 2 Apr 2025.