EMPOWER Weight Management

Obesity Clinical Trial

Official title:

EMPOWER: Individualized Dietary Improvement Program

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04635722
• Other study ID #: 18069_Empower
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 11, 2021
• Est. completion date: August 11, 2023

Study information

• Verified date: July 2023
• Source: University of Illinois at Urbana-Champaign
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 31
• Est. completion date: August 11, 2023
• Est. primary completion date: August 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diet Habit
• Obesity
• Overweight
• Weight Loss

Intervention

Behavioral:
• Weight Management Intervention
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.

Locations

Country	Name	City	State
United States	University of Illinois at Urbana-Champaign	Urbana	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Urbana-Champaign

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight	Body weight in kilograms measured on a standard scale (Withings, US)	Change from baseline (0 month) to 6 month, 12 month, 18 month, and 24 month
Secondary	Waist circumference	Waist circumference in centimeters measured using a standard measuring tape	Change from baseline (0 month) to 6 month,12 month, 24 month
Secondary	Hip circumference	Hip circumference in centimeters measured using a standard measuring tape	Change from baseline (0 month) to 6 month, 12 month, 24 month
Secondary	Body composition	Body fat measured using InBody 270	Change from baseline (0 month) to 6 month, 12 month, 24 month
Secondary	Body composition	lean mass measured using InBody 270	Change from baseline (0 month) to 6 month, 12 month, 24 month
Secondary	Protein Intake	Protein intake in grams and grams/100 kilo-calories using a food frequency questionnaire (FFQ)	Change from baseline (0 month) to 12 month
Secondary	Protein Intake	Protein intake in grams and grams/100 kilo-calories using a 24-hour record	Periodically from baseline (0 month) to 12 month
Secondary	Fiber Intake	Fiber intake in grams and grams/100 kilo-calories using a food frequency questionnaire (FFQ)	Change from baseline (0 month) to 12 month
Secondary	Fiber Intake	Fiber intake in grams and grams/100 kilo-calories using a 24-hour record	Periodically from baseline (0 month) to 12 month
Secondary	Health parameters as identified by subject's personal physician	Tests may include but are not limited to CBC, CMP, Lipid panel	As ordered by personal physician from baseline (0 month) to 24 months
Secondary	Blood pressure	Blood pressure measured as systolic/diastolic. Two measurements will be taken with subjects at rest. Measurements will be averaged.	Change from baseline (0 month) to 6 month, 12 month, 24 month