NCT05587790

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started May 2022

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 9, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 20, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2023

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2023

Completed
Last Updated

April 2, 2025

Status Verified

March 1, 2025

Enrollment Period

1 year

First QC Date

July 18, 2022

Last Update Submit

March 27, 2025

Conditions

ObesityOverweightWeight Loss

Keywords

ObesityOverweightWeight LossRuralNonmetropolitanProteinFiber

Outcome Measures

Primary Outcomes (5)

  • Enrollment

    Achieving target enrollment 16

    3 Months

  • Retention

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

    3 Months

  • Completion of eText

    Completion of eText (75% completion)

    12 Months

  • Completion of study measures

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

    12 Months

  • Acceptability

    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.

    3 Months

Secondary Outcomes (3)

  • Weight loss

    1 Year

  • Dietary habits - protein density

    1 Year

  • Dietary Habits - fiber density

    1 Year

Study Arms (1)

Weight Management Intervention

EXPERIMENTAL

During a 12-month period, participants will attend a total of 17 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. Flexibility in session completion will be allowed to accommodate busy schedules, vacation, and potential internet access challenges.

Behavioral: Weight Management Intervention

Interventions

Weight Management InterventionBEHAVIORAL

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.

Weight Management Intervention

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

UIUC Extension

Freeport, Illinois, 61032, United States

Location

UIUC Extension

Hillsboro, Illinois, 62049, United States

Location

UIUC Extension

Marshall, Illinois, 62441, United States

Location

MeSH Terms

Conditions

ObesityOverweightWeight Loss

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Before and after study design with one interventional group and no control or placebo group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2022

First Posted

October 20, 2022

Study Start

May 9, 2022

Primary Completion

May 15, 2023

Study Completion

May 23, 2023

Last Updated

April 2, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

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.

Locations

US(3)