EMPOWER Weight Management

EMPOWER: Individualized Dietary Improvement Program

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity; Overweight; Weight Loss; Diet Habit
• Intervention / Treatment: Behavioral: Weight Management Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Urbana, Illinois, United States, 61801
      • University of Illinois at Urbana-Champaign

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Weight Management Intervention; During a 12-month period, participants will attend a total of 22 diet improvement sessions, each of which will last approximately 1 hour. 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. Participants will be followed by daily self-weighing for 1 year after 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hip circumference	Hip circumference in centimeters measured using a standard measuring tape	Change from baseline (0 month) to 6 month, 12 month, 24 month
Body composition	Body fat measured using InBody 270	Change from baseline (0 month) to 6 month, 12 month, 24 month
Waist circumference	Waist circumference in centimeters measured using a standard measuring tape	Change from baseline (0 month) to 6 month,12 month, 24 month
Body composition	lean mass measured using InBody 270	Change from baseline (0 month) to 6 month, 12 month, 24 month
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
Protein Intake	Protein intake in grams and grams/100 kilo-calories using a 24-hour record	Periodically from baseline (0 month) to 12 month
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
Fiber Intake	Fiber intake in grams and grams/100 kilo-calories using a 24-hour record	Periodically from baseline (0 month) to 12 month
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
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

Collaborators and Investigators

• Sponsor: University of Illinois at Urbana-Champaign

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2021
• Primary Completion (Estimated): August 11, 2023
• Study Completion (Estimated): August 11, 2023

Study Registration Dates

• First Submitted: November 13, 2020
• First Submitted That Met QC Criteria: November 18, 2020
• First Posted (Actual): November 19, 2020

Study Record Updates

• Last Update Posted (Actual): July 13, 2023
• Last Update Submitted That Met QC Criteria: July 12, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Body Weight Changes; Weight Loss; Overweight
• Other Study ID Numbers: 18069_Empower

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No