Pilot Study of the HWL Program (HWL)

Pilot Study of the Home Weight Loss Program

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.

Study Overview

• Status: Completed
• Conditions: Overweight and Obesity
• Intervention / Treatment: Behavioral: Home weight loss program

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

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Home weight loss program; 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).

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight change	body weight change (kg) from pre-to post	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in body weight as a percentage of start weight	percent body weight change	12 weeks
changes in body mass index	weight in kgs divided by height in meters squared to obtain BMI (kg/m^2)	12 weeks
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
changes in body fat percentage	changes in body fat percentage	12 weeks
changes in waist and hip measurements	changes in waist and hip measurements	12 weeks
usability of program components	examine usage of tracking components including step, exercise, diet, and weight tracking	12 weeks
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
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

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: South Carolina Telehealth Alliance
• Investigators: Principal Investigator: Patrick M O'Neil, PhD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2018
• Primary Completion (Actual): July 3, 2018
• Study Completion (Actual): September 21, 2018

Study Registration Dates

• First Submitted: February 7, 2018
• First Submitted That Met QC Criteria: February 13, 2018
• First Posted (Actual): February 20, 2018

Study Record Updates

• Last Update Posted (Actual): November 9, 2018
• Last Update Submitted That Met QC Criteria: November 8, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Physical activity; Telehealth; Diet; Remote weight loss; Self-monitoring
• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: Pro00070941

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No individual data is planned to be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No