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EMPOWER Weight Management

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04635722
Recruitment Status : Active, not recruiting
First Posted : November 19, 2020
Last Update Posted : July 23, 2021
Sponsor:
Information provided by (Responsible Party):
Mindy Lee, University of Illinois at Urbana-Champaign

Study Description
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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.

Condition or disease Intervention/treatment Phase
Obesity Overweight Weight Loss Diet Habit Behavioral: Weight Management Intervention Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
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
Official Title: EMPOWER: Individualized Dietary Improvement Program
Actual Study Start Date : June 8, 2021
Estimated Primary Completion Date : August 7, 2023
Estimated Study Completion Date : August 7, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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

  3. Body composition [ Time Frame: Change from baseline (0 month) to 6 month, 12 month, 24 month ]
    Body fat measured using InBody 270

  4. Body composition [ Time Frame: Change from baseline (0 month) to 6 month, 12 month, 24 month ]
    lean mass measured using InBody 270

  5. 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)

  6. 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

  7. 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)

  8. 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

  9. 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

  10. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04635722


Locations
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United States, Illinois
University of Illinois at Urbana-Champaign
Urbana, Illinois, United States, 61801
Sponsors and Collaborators
University of Illinois at Urbana-Champaign
More Information
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Responsible Party: Mindy Lee, Graduate Research Assistant, University of Illinois at Urbana-Champaign
ClinicalTrials.gov Identifier: NCT04635722    
Other Study ID Numbers: 18069_Empower
First Posted: November 19, 2020    Key Record Dates
Last Update Posted: July 23, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Overweight
Weight Loss
Body Weight
 Overnutrition
Nutrition Disorders
Body Weight Changes