EMPOWER Weight Management
- Conditions
- ObesityOverweightWeight LossDiet Habit
- Interventions
- Behavioral: Weight Management Intervention
- Registration Number
- NCT04635722
- Lead Sponsor
- University of Illinois at Urbana-Champaign
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 31
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Weight Management Intervention 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.
- Primary Outcome Measures
Name Time Method Body weight 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
Name Time Method Fiber Intake Periodically from baseline (0 month) to 12 month Fiber intake in grams and grams/100 kilo-calories using a 24-hour record
Waist circumference Change from baseline (0 month) to 6 month,12 month, 24 month Waist circumference in centimeters measured using a standard measuring tape
Hip circumference Change from baseline (0 month) to 6 month, 12 month, 24 month Hip circumference in centimeters measured using a standard measuring tape
Body composition Change from baseline (0 month) to 6 month, 12 month, 24 month lean mass measured using InBody 270
Protein Intake Periodically from baseline (0 month) to 12 month Protein intake in grams and grams/100 kilo-calories using a 24-hour record
Health parameters as identified by subject's personal physician 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 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.
Trial Locations
- Locations (1)
University of Illinois at Urbana-Champaign
🇺🇸Urbana, Illinois, United States