EMPOWER Weight Management

• ClinicalTrials.gov Identifier: NCT04635722
• Recruitment Status: Active, not recruiting
• First Posted: November 19, 2020
• Last Update Posted: July 23, 2021
• Sponsor: University of Illinois at Urbana-Champaign
• Information provided by (Responsible Party): Mindy Lee, University of Illinois at Urbana-Champaign

Tracking Information

• First Submitted Date: November 13, 2020
• First Posted Date: November 19, 2020
• Last Update Posted Date: July 23, 2021
• Actual Study Start Date: June 8, 2021
• Estimated Primary Completion Date: August 7, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 18, 2020)

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)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 18, 2020)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: EMPOWER Weight Management
• Official Title: EMPOWER: Individualized Dietary Improvement Program
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

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

Masking: None (Open Label)
Primary Purpose: Treatment

Condition

• Obesity
• Overweight
• Weight Loss
• Diet Habit

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.

Study Arms

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.

Intervention: Behavioral: Weight Management Intervention

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: July 22, 2021): 35
• Original Estimated Enrollment (submitted: November 18, 2020): 45
• Estimated Study Completion Date: August 7, 2023
• Estimated Primary Completion Date: August 7, 2023 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04635722
• Other Study ID Numbers: 18069_Empower
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Mindy Lee, University of Illinois at Urbana-Champaign
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Illinois at Urbana-Champaign
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University of Illinois at Urbana-Champaign
• Verification Date: July 2021