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EMPOWER Rural Extension Weight Management Pilot Study

Primary Purpose

Obesity, Overweight, Weight Loss

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Weight Management Intervention
Sponsored by
University of Illinois at Urbana-Champaign
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Overweight, Weight Loss, Rural, Nonmetropolitan, Protein, Fiber

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UIUC Extension
  • UIUC Extension
  • UIUC Extension

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Weight Management Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

Enrollment
Achieving target enrollment 16
Retention
Successful retention dropout <20% (13/16)
Completion of eText
Completion of eText (75% completion)
Completion of study measures
Completion of 80% of study measures (24-hour records, in-person anthropometric testing)
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.

Secondary Outcome Measures

Weight loss
Change in weight
Dietary habits - protein density
protein density change from baseline to 24 months.
Dietary Habits - fiber density
Fiber density change from baseline to 24 months.

Full Information

First Posted
July 18, 2022
Last Updated
October 19, 2022
Sponsor
University of Illinois at Urbana-Champaign
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1. Study Identification

Unique Protocol Identification Number
NCT05587790
Brief Title
EMPOWER Rural Extension Weight Management Pilot Study
Official Title
EMPOWER Weight Loss Program for Obesity in Rural and Underserved Areas Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 9, 2022 (Actual)
Primary Completion Date
May 15, 2024 (Anticipated)
Study Completion Date
May 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Illinois at Urbana-Champaign

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight, Weight Loss
Keywords
Obesity, Overweight, Weight Loss, Rural, Nonmetropolitan, Protein, Fiber

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Before and after study design with one interventional group and no control or placebo group
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Weight Management Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Weight Management Intervention
Intervention Description
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 Outcome Measure Information:
Title
Enrollment
Description
Achieving target enrollment 16
Time Frame
3 Months
Title
Retention
Description
Successful retention dropout <20% (13/16)
Time Frame
3 Months
Title
Completion of eText
Description
Completion of eText (75% completion)
Time Frame
3 Months
Title
Completion of study measures
Description
Completion of 80% of study measures (24-hour records, in-person anthropometric testing)
Time Frame
3 Months
Title
Acceptability
Description
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.
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
Weight loss
Description
Change in weight
Time Frame
2 Years
Title
Dietary habits - protein density
Description
protein density change from baseline to 24 months.
Time Frame
2 Years
Title
Dietary Habits - fiber density
Description
Fiber density change from baseline to 24 months.
Time Frame
2 Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
UIUC Extension
City
Freeport
State/Province
Illinois
ZIP/Postal Code
61032
Country
United States
Facility Name
UIUC Extension
City
Hillsboro
State/Province
Illinois
ZIP/Postal Code
62049
Country
United States
Facility Name
UIUC Extension
City
Marshall
State/Province
Illinois
ZIP/Postal Code
62441
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
All researchers must pass Core Human Subjects training through CITI. Confidentiality of data collected will be maintained by assigning each participant a three-digit identification (ID) code which will be used to enter all data in an electronic database. ID codes will be used on all documents and materials as the only form of identification; no names will be used. All files and participant documentation will be stored in locked filing cabinets. Electronic documents, forms and data will be stored in a Health Data folder on Box. Only the primary investigator, co-investigator, and research team will have access to stored data. Any data collected via email will be completed using ID codes and deleted and emptied from trash following data collection. The primary investigator will immediately destroy documents that are obtained from individuals who do not qualify for the study, as determined during the pre-screening and screening steps. These documents will be shredded.

Learn more about this trial

EMPOWER Rural Extension Weight Management Pilot Study

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