Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06406985 |
| Other study ID # |
IRB24-0474 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 7, 2024 |
| Est. completion date |
September 2025 |
Study information
| Verified date |
May 2024 |
| Source |
University of Illinois at Urbana-Champaign |
| Contact |
Kayla Lammy |
| Phone |
(217) 333-1267 |
| Email |
klamm3[@]illinois.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
- 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.
Description:
The purpose of our study is to identify how to maintain a sustainable collaboration with our
lab's weight-loss program, EMPOWER, and rural Illinois Extension Nutrition and Wellness
Educators. We 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 our services to rural areas. If we can demonstrate continual,
successful collaboration with the Extension educators, we can work towards expanding EMPOWER
to even more communities. In objective 1, we 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 our lab's 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 our recruitment flyer and proceed to fill out an
eligibility form. Objective 2 of our 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/text 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 our lab, 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.
