NCT06406985

Brief Summary

The purpose of this study is to identify how to maintain a sustainable collaboration Illinois Extension Nutrition and Wellness Educators while continuing to offer an online weight-loss program, EMPOWER, to rural Illinois residents.

  • The primary aim of the study is to determine if an Extension-delivered introductory weight management class will be successful in recruiting rural individuals interested in losing weight to the EMPOWER weight-loss program.
  • The secondary aim is to enroll interested rural participants in an online weight loss intervention that focuses on promoting dietary and lifestyle behavioral changes to achieve ≥5 percent weight loss. Participants who participate in the EMPOWER weight-loss intervention will:
  • Complete 12 online educational sessions over a 3-month period followed by a 9-month follow-up period.
  • Participate in daily self-weighing using a provided WiFi-enabled scale.
  • Will have a monthly nutrition coaching call once per month for the 12-month duration of the study.
  • Will complete food records and self-report waist and hip circumference measures at baseline, 3-months, and 12-months.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

First Submitted

Initial submission to the registry

May 6, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

May 7, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 9, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

June 3, 2025

Status Verified

May 1, 2025

Enrollment Period

1.6 years

First QC Date

May 6, 2024

Last Update Submit

May 28, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Recruitment feasibility

    Recruitment Goal: Recruitment will be completed within 3-months and 50% or more of submitted eligibility forms will be from those who attended the introductory weight-management class with Extension.

    3 months

  • Sustainability of collaboration

    Exit interviews will be conducted with collaborators to identify themes surrounding the nature of the collaboration.

    end of 12-month study

Secondary Outcomes (2)

  • Weight-loss

    end of 12-month study

  • Dietary change

    end of 12-month study

Study Arms (1)

EMPOWER Weight-Loss Participants

EXPERIMENTAL

All weight-loss participants will receive the same protocol and weight-loss education materials. Nutrition coaching is individualized to participant needs, but emphasizes the program's core themes throughout.

Behavioral: Weight-loss through dietary and lifestyle changes

Interventions

Weight-loss participants will complete one online, self-paced education session each week for 12 weeks. Education sessions focus on topics such as self-monitoring weight, meal routines, and dietary habits with an emphasis on protein and fiber intake. During these 12 weeks, participants will receive weekly messages from nutrition coaches as well as a monthly nutrition coaching call. After the first 12 weeks, participants will enter a follow-up period where nutrition coaching messaging will occur as needed and with the opportunity to still participate in a monthly nutrition coaching call. Participants are asked to weigh daily on a provided WiFi scale that automatically uploads their weight data to a website for researchers and coaches to monitor. Participants will also submit food records and self-reported weight and hip circumferences.

EMPOWER Weight-Loss Participants

Eligibility Criteria

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

You may qualify if:

  • BMI greater than or equal to 28 kg/m\^2
  • age 18-75
  • ability to access the internet and smartphone
  • fluent in English
  • having primary residence in a rural Illinois county

You may not qualify if:

  • Pregnant or lactating
  • previous or planned bariatric surgery
  • BMI less than 28 kg/m\^2
  • Age less than 18 or greater than 75
  • no access to internet and smartphone/smart device
  • on GLP-1 Receptor Agonist weight loss medication
  • Diagnosed with an eating disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois Urbana-Champaign

Urbana, Illinois, 61801, United States

Location

Related Links

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2024

First Posted

May 9, 2024

Study Start

May 7, 2024

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

June 3, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations