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Clinical Trials/NCT05587790
NCT05587790
Completed
Not Applicable

EMPOWER Weight Loss Program for Obesity in Rural and Underserved Areas Pilot Study

University of Illinois at Urbana-Champaign1 site in 1 country16 target enrollmentMay 9, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
University of Illinois at Urbana-Champaign
Enrollment
16
Locations
1
Primary Endpoint
Enrollment
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 9, 2022
End Date
May 23, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Enrollment

Time Frame: 3 Months

Achieving target enrollment 16

Completion of study measures

Time Frame: 12 Months

Completion of 80% of study measures (24-hour records, in-person anthropometric testing)

Retention

Time Frame: 3 Months

Successful retention dropout \<20% (13/16)

Completion of eText

Time Frame: 12 Months

Completion of eText (75% completion)

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.

Secondary Outcomes

  • Dietary Habits - fiber density(1 Year)
  • Weight loss(1 Year)
  • Dietary habits - protein density(1 Year)

Study Sites (1)

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