EMPOWER Rural Extension Weight Management Pilot Study

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05587790
• Other study ID #: 22642
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 9, 2022
• Est. completion date: May 15, 2024

Study information

• Verified date: October 2022
• Source: University of Illinois at Urbana-Champaign
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 16
• Est. completion date: May 15, 2024
• Est. primary completion date: May 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight
• Obesity
• Overweight
• Weight Loss

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	UIUC Extension	Freeport	Illinois
United States	UIUC Extension	Hillsboro	Illinois
United States	UIUC Extension	Marshall	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Urbana-Champaign

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enrollment	Achieving target enrollment 16	3 Months
Primary	Retention	Successful retention dropout <20% (13/16)	3 Months
Primary	Completion of eText	Completion of eText (75% completion)	3 Months
Primary	Completion of study measures	Completion of 80% of study measures (24-hour records, in-person anthropometric testing)	3 Months
Primary	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	Weight loss	Change in weight	2 Years
Secondary	Dietary habits - protein density	protein density change from baseline to 24 months.	2 Years
Secondary	Dietary Habits - fiber density	Fiber density change from baseline to 24 months.	2 Years