Skip to content

EMPOWER Weight Management

EMPOWER: Individualized Dietary Improvement Program

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04635722
Enrollment
31
Registered
2020-11-19
Start date
2021-06-11
Completion date
2023-08-11
Last updated
2023-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diet Habit, Obesity, Overweight, Weight Loss

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.

Interventions

Participants attend group and individual dietary education sessions. Participants create a diet plan that satisfies their needs. Participants aim to lose 1 pound weekly until a BMI of 25 is reached. Participants are evaluated through daily self-weighing, dietary records, and food frequency questionnaires.

Sponsors

University of Illinois at Urbana-Champaign
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Before and after study design with one interventional group and no control or placebo group

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Body weightChange from baseline (0 month) to 6 month, 12 month, 18 month, and 24 monthBody weight in kilograms measured on a standard scale (Withings, US)

Secondary

MeasureTime frameDescription
Hip circumferenceChange from baseline (0 month) to 6 month, 12 month, 24 monthHip circumference in centimeters measured using a standard measuring tape
Body compositionChange from baseline (0 month) to 6 month, 12 month, 24 monthBody fat measured using InBody 270
Protein IntakeChange from baseline (0 month) to 12 monthProtein intake in grams and grams/100 kilo-calories using a food frequency questionnaire (FFQ)
Waist circumferenceChange from baseline (0 month) to 6 month,12 month, 24 monthWaist circumference in centimeters measured using a standard measuring tape
Health parameters as identified by subject's personal physicianAs ordered by personal physician from baseline (0 month) to 24 monthsTests may include but are not limited to CBC, CMP, Lipid panel
Blood pressureChange from baseline (0 month) to 6 month, 12 month, 24 monthBlood pressure measured as systolic/diastolic. Two measurements will be taken with subjects at rest. Measurements will be averaged.
Fiber IntakeChange from baseline (0 month) to 12 monthFiber intake in grams and grams/100 kilo-calories using a food frequency questionnaire (FFQ)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026