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EMPOWER Weight Management

Primary Purpose

Obesity, Overweight, Weight Loss

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Weight Management Intervention
Sponsored by
University of Illinois at Urbana-Champaign
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Illinois at Urbana-Champaign

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Weight Management Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

Body weight
Body weight in kilograms measured on a standard scale (Withings, US)

Secondary Outcome Measures

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

Full Information

First Posted
November 13, 2020
Last Updated
July 12, 2023
Sponsor
University of Illinois at Urbana-Champaign
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1. Study Identification

Unique Protocol Identification Number
NCT04635722
Brief Title
EMPOWER Weight Management
Official Title
EMPOWER: Individualized Dietary Improvement Program
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 11, 2021 (Actual)
Primary Completion Date
August 11, 2023 (Anticipated)
Study Completion Date
August 11, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Urbana-Champaign

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight, Weight Loss, Diet Habit

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Before and after study design with one interventional group and no control or placebo group
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
University of Illinois at Urbana-Champaign
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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EMPOWER Weight Management

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