Clinical trial NCT04635722: EMPOWER Weight Management
Official title: EMPOWER: Individualized Dietary Improvement Program
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obesity
Overweight
Weight Loss
Diet Habit
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
First posted: 2020-11-19
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Before and after study design with one interventional group and no control or placebo group
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Body weight
timeFrame: Change from baseline (0 month) to 6 month, 12 month, 18 month, and 24 month
Secondary outcomes:
measure: Waist circumference
timeFrame: Change from baseline (0 month) to 6 month,12 month, 24 month
measure: Hip circumference
timeFrame: Change from baseline (0 month) to 6 month, 12 month, 24 month
measure: Body composition
timeFrame: Change from baseline (0 month) to 6 month, 12 month, 24 month
measure: Body composition
timeFrame: Change from baseline (0 month) to 6 month, 12 month, 24 month
measure: Protein Intake
timeFrame: Change from baseline (0 month) to 12 month
measure: Protein Intake
timeFrame: Periodically from baseline (0 month) to 12 month
measure: Fiber Intake
timeFrame: Change from baseline (0 month) to 12 month
measure: Fiber Intake
timeFrame: Periodically from baseline (0 month) to 12 month
measure: Health parameters as identified by subject's personal physician
timeFrame: As ordered by personal physician from baseline (0 month) to 24 months
measure: Blood pressure
timeFrame: Change from baseline (0 month) to 6 month, 12 month, 24 month
Other outcomes:
Locations:
city: Urbana
country: United States
facility: University of Illinois at Urbana-Champaign
state: Illinois
Study officials:
References: