EMPOWER Rural Extension Weight Management Pilot Study

Study Overview
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Brief Summary
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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
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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 applied 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 two-year program: 1-year intervention, 1-year follow up. 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 19 online sessions (45 minutes/each) and 3 individual advising sessions with a nutrition coach.

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

Conditions
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Obesity, Overweight, Weight Loss

Intervention / Treatment
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* Behavioral: Weight Management Intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Before and after study design with one interventional group and no control or placebo group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Weight Management Intervention<br>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. | Behavioral: Weight Management Intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Enrollment | Achieving target enrollment 16 | 3 Months | 
| Retention | Successful retention dropout <20% (13/16) | 3 Months | 
| Completion of eText | Completion of eText (75% completion) | 3 Months | 
| Completion of study measures | Completion of 80% of study measures (24-hour records, in-person anthropometric testing) | 3 Months | 
| Acceptability | 4/5 on average for all program components using likert scales (ranging 1-5) of acceptability of each of the individual components (MealPlot, eText, Zoom, Nutrition Coaching) collected via interview. | 3 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss | Change in weight | 2 Years | 
| Dietary habits - protein density | protein density change from baseline to 24 months. | 2 Years | 
| Dietary Habits - fiber density | Fiber density change from baseline to 24 months. | 2 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Overweight, Weight Loss, Rural, Nonmetropolitan, Protein, Fiber