Pilot Study of the HWL Program

Overweight and Obesity Clinical Trial

— HWL  

Official title:

Pilot Study of the Home Weight Loss Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03439579
• Other study ID #: Pro00070941
• Status: Completed
• Phase: N/A
• Start date: February 6, 2018
• Est. completion date: September 21, 2018

Study information

• Verified date: November 2018
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 21, 2018
• Est. primary completion date: July 3, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

Behavioral:
• Home weight loss program
Patient remote self-monitoring of diet, activity, and weight with clinician feedback provided remotely based on self-monitored data.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	South Carolina Telehealth Alliance

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight change	body weight change (kg) from pre-to post	12 weeks
Secondary	changes in body weight as a percentage of start weight	percent body weight change	12 weeks
Secondary	changes in body mass index	weight in kgs divided by height in meters squared to obtain BMI (kg/m^2)	12 weeks
Secondary	program satisfaction	program satisfaction obtained from multiple choice items developed by study staff. Subjects are asked to rate their level of agreement with items assessing their satisfaction with the overall program, available responses range from extremely satisfied to not at all satisfied.	12 weeks
Secondary	changes in body fat percentage	changes in body fat percentage	12 weeks
Secondary	changes in waist and hip measurements	changes in waist and hip measurements	12 weeks
Secondary	usability of program components	examine usage of tracking components including step, exercise, diet, and weight tracking	12 weeks
Secondary	changes in eating behavior scores	use of the Eating Behavior Inventory (EBI). This is a validated 26-item scale assessing eating and weight control behaviors. Subjects indicate agreement with statements with reponse options ranging in values from 1 (never or hardly ever) to 5 (always or almost). Higher values are indicative of those most associated with weight loss (e.g., self-monitoring caloric intake) and are therefore associated with better weight loss outcomes following behavioral weight management intervention.	12 weeks
Secondary	changes in scores on the power of food scale	use of the Power of Food Scale (PFS). This is a validated 15-item scale with responses scored and ranging between 1 (do not agree) and 5 (strongly agree) with the statements. Higher scores indicate less favorable outcomes, as higher scores indicate increased patient susceptibility to food in the environment.	12 weeks