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Clinical Trials/NCT04635722
NCT04635722
Active, Not Recruiting
N/A

EMPOWER: Individualized Dietary Improvement Program

University of Illinois at Urbana-Champaign1 site in 1 country31 target enrollmentJune 11, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Obesity
Sponsor
University of Illinois at Urbana-Champaign
Enrollment
31
Locations
1
Primary Endpoint
Body weight
Status
Active, Not Recruiting
Last Updated
2 years ago

Overview

Brief Summary

This research is to develop a virtual weight loss and weight maintenance program through dietary modifications for adults with obesity. Although scientific studies have shown the feasibility of rapid and safe dietary weight loss and subsequent weight maintenance, no efficacious dietary weight management program is widely available, and thus bariatric surgery remains the most reliable approach for weight loss/management. Safe and effective dietary weight loss and subsequent weight maintenance require flexible, individualized advice by an experienced dietitian/nutritionist.

Detailed Description

EMPOWER is a remote weight management program utilizing an online textbook platform, E-Text, and mobile web application. EMPOWER is a two-year program: 1-year intervention, 1-year follow up. Data is collected via FFQ (NIH DHQIII), daily weighing using a wifi-enabled scale, and 24-hour dietary records via the web application. EMPOWER consists of 19 online sessions (45 minutes/each) and 3 individual advising sessions with an RD. EMPOWER aims to improve health parameters related to obesity, such as hyperlipidemia and hypertension. Health parameters will be monitored primarily by the subject's personal physician. Any test results will be sent to the EMPOWER research team for analysis via REDCap. EMPOWER team consists of social workers in addition to nutrition experts. The social work team aims to monitor and improve lifestyle, stress management, and behavior.

Registry
clinicaltrials.gov
Start Date
June 11, 2021
End Date
August 11, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mindy Lee

Graduate Research Assistant

University of Illinois at Urbana-Champaign

Eligibility Criteria

Inclusion Criteria

  • body mass index in the overweight or obese range (BMI) \>28 kg/m2 (if Asian, BMI \>25kg/m2);
  • not currently pregnant or lactating;
  • have Wi-Fi at home, a working email, and an iPhone or Android smartphone;
  • self-reported obesity co-morbidities (such as diabetes type 2 or hyperlipidemia);
  • be a Carle Foundation Hospital patient and have regular contact with a primary care physician;
  • not using insulin injection;
  • able to attend the 22 (1 hour) diet improvement sessions;
  • willing and safe to lose 20 lb. or more for 6 months and maintain a healthy weight for one year;
  • keep weighing their weight for two years;
  • fluent in reading and writing English.

Exclusion Criteria

  • age \<18 or \>75 years;
  • body mass index of \<28 kg/m2 (if Asian, BMI \<25kg/m2);
  • currently pregnant;
  • currently lactating;
  • use insulin injection;
  • not able to attend the 22 (1 hour) diet improvement sessions for 1 year;
  • failed to set up a Wi-Fi scale;
  • failed to submit a FFQ.

Outcomes

Primary Outcomes

Body weight

Time Frame: Change from baseline (0 month) to 6 month, 12 month, 18 month, and 24 month

Body weight in kilograms measured on a standard scale (Withings, US)

Secondary Outcomes

  • Fiber Intake(Periodically from baseline (0 month) to 12 month)
  • Waist circumference(Change from baseline (0 month) to 6 month,12 month, 24 month)
  • Hip circumference(Change from baseline (0 month) to 6 month, 12 month, 24 month)
  • Body composition(Change from baseline (0 month) to 6 month, 12 month, 24 month)
  • Protein Intake(Periodically from baseline (0 month) to 12 month)
  • Health parameters as identified by subject's personal physician(As ordered by personal physician from baseline (0 month) to 24 months)
  • Blood pressure(Change from baseline (0 month) to 6 month, 12 month, 24 month)

Study Sites (1)

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