EMPOWER Rural Extension Weight Management Pilot Study

Not Applicable

Completed

• Conditions: Obesity; Overweight; Weight Loss
• Interventions: Behavioral: Weight Management Intervention

• Registration Number: NCT05587790
• Lead Sponsor: University of Illinois at Urbana-Champaign

Brief 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. 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 Timeline

• Study Start: 2022-05-09
• Study First Submitted: 2022-07-18
• Study First Submitted QC: 2022-10-19
• Study First Posted: 2022-10-20
• Primary Completion: 2023-05-15
• Study Completion: 2023-05-23
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-27
• Last Update Posted: 2025-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• 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
• 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)

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Weight Management Intervention	Weight Management Intervention	During a 12-month period, participants will attend a total of 22 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. Participants will be followed by daily self-weighing for 1 year after intervention.

Primary Outcome Measures

Name	Time	Method
Completion of study measures	12 Months	Completion of 80% of study measures (24-hour records, in-person anthropometric testing)
Enrollment	3 Months	Achieving target enrollment 16
Retention	3 Months	Successful retention dropout \<20% (13/16)
Completion of eText	12 Months	Completion of eText (75% completion)
Acceptability	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.

Secondary Outcome Measures

Name	Time	Method
Dietary Habits - fiber density	1 Year	Fiber density change from baseline to 12 months.
Weight loss	1 Year	Change in weight
Dietary habits - protein density	1 Year	protein density change from baseline to 12 months.

Trial Locations

Locations (1)

UIUC Extension; 🇺🇸 Marshall, Illinois, United States