Pilot Study of the HWL Program

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Overweight and Obesity

Treatments: Behavioral: Home weight loss program

Study type: Interventional

Funder types: Other

Identifiers

NCT03439579

Pro00070941

Details and patient eligibility

About

The goal of the project is to test a remotely delivered, standalone behavioral weight loss intervention designed to help adults initiate the important dietary, physical activity (PA) and behavioral changes necessary to achieve weight loss.

Full description

The Weight Management Center currently offers a remotely delivered (smart phone, tablet, computer) program to assist patients with maintaining weight losses already achieved, which includes multi-channel self-monitoring and asynchronous individually recorded feedback from clinical staff. The goal of the presently proposed project is to build on this existing maintenance-focused program to create a remotely delivered, standalone behavioral weight loss intervention designed to help participants initiate the important dietary, physical activity (PA) and behavioral changes necessary to achieve weight loss. We recently developed the Home Weight Loss (HWL) program by repackaging existing clinical educational materials as instructional lifestyle change modules to be delivered remotely for participant weight loss

The aim of the proposed project are to pilot test the effects of the HWL program among a sample of overweight and obese adults (N=30). The digital platform currently used in the maintenance program will be used for the HWL program

Enrollment: 30 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• aged 18-70 years
• BMI = 25.0- 40 kg/m2
• Internet access via desktop or laptop computer
• valid email address
• smart phone ownership
• women of childbearing potential must agree to use effective contraception during the study

Exclusion criteria

• currently dieting (>10-pound weight loss in past 3 months)
• another member of the household is participating in this pilot study
• inability to engage in physical activity
• inability to read and speak English
• diagnosis of diabetes (other than treated by diet alone),
• uncontrolled thyroid condition or other endocrine disorder
• major depressive disorder or other severe psychiatric disorder (e.g., bipolar disorder) within the past two years
• past suicide attempt
• current use of prescription or over-the-counter weight loss medications
• current/planned pregnancy
• drug and/or alcohol abuse
• use of steroid medication for more than 10 days in the past three months *implanted electronic devices

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Home weight loss program

Experimental group

Description:

Participants will be instructed to daily monitor their body weight, minutes of activity, number of steps, and calories consumed for the duration of the pilot study, and they will receive recorded individualized feedback on this self-monitored data from Weight Management Center clinicians (registered dietitians, exercise psychologists, and behavioral specialists).

Treatment:

Behavioral: Home weight loss program