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Completed

NCT Number: NCT05587790

EMPOWER Rural Extension Weight Management Pilot Study

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.

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Key information

Conditions

Obesity Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UIUC Extension, Freeport, Illinois, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Weight Management Intervention

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.

Primary outcomes

  1. Enrollment

    Time frame: 3 Months

    Achieving target enrollment 16

  2. Retention

    Time frame: 3 Months

    Successful retention dropout <20% (13/16)

  3. Completion of eText

    Time frame: 12 Months

    Completion of eText (75% completion)

  4. Completion of study measures

    Time frame: 12 Months

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

  5. 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

  1. Weight loss

    Time frame: 1 Year

    Change in weight

  2. Dietary habits - protein density

    Time frame: 1 Year

    protein density change from baseline to 12 months.

  3. Dietary Habits - fiber density

    Time frame: 1 Year

    Fiber density change from baseline to 12 months.

Sponsors and collaborators

Lead sponsor

University of Illinois at Urbana-Champaign

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 20, 2022
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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