Clinical trial NCT05587790: EMPOWER Rural Extension Weight Management Pilot Study
Official title: EMPOWER Weight Loss Program for Obesity in Rural and Underserved Areas Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Weight Loss
Keywords: Obesity
Overweight
Weight Loss
Rural
Nonmetropolitan
Protein
Fiber
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
First posted: 2022-10-20
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Before and after study design with one interventional group and no control or placebo group
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Enrollment
timeFrame: 3 Months
measure: Retention
timeFrame: 3 Months
measure: Completion of eText
timeFrame: 12 Months
measure: Completion of study measures
timeFrame: 12 Months
measure: Acceptability
timeFrame: 3 Months
Secondary outcomes:
measure: Weight loss
timeFrame: 1 Year
measure: Dietary habits - protein density
timeFrame: 1 Year
measure: Dietary Habits - fiber density
timeFrame: 1 Year
Other outcomes:
Locations:
city: Freeport
country: United States
facility: UIUC Extension
state: Illinois
city: Hillsboro
country: United States
facility: UIUC Extension
state: Illinois
city: Marshall
country: United States
facility: UIUC Extension
state: Illinois
Study officials:
References: