Clinical trial NCT03439579: Pilot Study of the HWL Program
Official title: Pilot Study of the Home Weight Loss Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Keywords: Telehealth
Remote weight loss
Self-monitoring
Diet
Physical activity
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: South Carolina Telehealth Alliance
First posted: 2018-02-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group pilot study
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Body weight change
timeFrame: 12 weeks
Secondary outcomes:
measure: changes in body weight as a percentage of start weight
timeFrame: 12 weeks
measure: changes in body mass index
timeFrame: 12 weeks
measure: program satisfaction
timeFrame: 12 weeks
measure: changes in body fat percentage
timeFrame: 12 weeks
measure: changes in waist and hip measurements
timeFrame: 12 weeks
measure: usability of program components
timeFrame: 12 weeks
measure: changes in eating behavior scores
timeFrame: 12 weeks
measure: changes in scores on the power of food scale
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Patrick M O'Neil, PhD
role: PRINCIPAL_INVESTIGATOR
References: