EMPOWER Weight Management

University of Illinois at Urbana-Champaign

Status: Active, not recruiting

Conditions: Weight Loss; Overweight; Diet Habit; Obesity

Treatments: Behavioral: Weight Management Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04635722

18069_Empower

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

Weight Management Intervention

Experimental group

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.

Treatment:

Behavioral: Weight Management Intervention