EMPOWER Rural Extension Weight Management Pilot Study

NCT ID: NCT05587790

Last Updated: 2025-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-09
• Study Completion Date: 2023-05-23

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.

Conditions

Obesity; Overweight; Weight Loss

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Weight Management Intervention

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.

Group Type: EXPERIMENTAL

Weight Management Intervention

Intervention Type: BEHAVIORAL

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.

Interventions

Weight Management Intervention

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Illinois at Urbana-Champaign

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UIUC Extension

Freeport, Illinois, United States

UIUC Extension

Hillsboro, Illinois, United States

UIUC Extension

Marshall, Illinois, United States

Countries

United States

Other Identifiers

22642

Identifier Type: -

Identifier Source: org_study_id