search
Back to results

Pilot Study of the HWL Program (HWL)

Primary Purpose

Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Home weight loss program
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight and Obesity focused on measuring Telehealth, Remote weight loss, Self-monitoring, Diet, Physical activity

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Home weight loss program

Arm 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).

Outcomes

Primary Outcome Measures

Body weight change
body weight change (kg) from pre-to post

Secondary Outcome Measures

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

Full Information

First Posted
February 7, 2018
Last Updated
November 8, 2018
Sponsor
Medical University of South Carolina
Collaborators
South Carolina Telehealth Alliance
search

1. Study Identification

Unique Protocol Identification Number
NCT03439579
Brief Title
Pilot Study of the HWL Program
Acronym
HWL
Official Title
Pilot Study of the Home Weight Loss Program
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
February 6, 2018 (Actual)
Primary Completion Date
July 3, 2018 (Actual)
Study Completion Date
September 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
South Carolina Telehealth Alliance

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
Telehealth, Remote weight loss, Self-monitoring, Diet, Physical activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single group pilot study
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Home weight loss program
Arm Type
Experimental
Arm 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).
Intervention Type
Behavioral
Intervention Name(s)
Home weight loss program
Intervention Description
Patient remote self-monitoring of diet, activity, and weight with clinician feedback provided remotely based on self-monitored data.
Primary Outcome Measure Information:
Title
Body weight change
Description
body weight change (kg) from pre-to post
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
changes in body weight as a percentage of start weight
Description
percent body weight change
Time Frame
12 weeks
Title
changes in body mass index
Description
weight in kgs divided by height in meters squared to obtain BMI (kg/m^2)
Time Frame
12 weeks
Title
program satisfaction
Description
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.
Time Frame
12 weeks
Title
changes in body fat percentage
Description
changes in body fat percentage
Time Frame
12 weeks
Title
changes in waist and hip measurements
Description
changes in waist and hip measurements
Time Frame
12 weeks
Title
usability of program components
Description
examine usage of tracking components including step, exercise, diet, and weight tracking
Time Frame
12 weeks
Title
changes in eating behavior scores
Description
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.
Time Frame
12 weeks
Title
changes in scores on the power of food scale
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick M O'Neil, PhD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No individual data is planned to be shared with other researchers.

Learn more about this trial

Pilot Study of the HWL Program

We'll reach out to this number within 24 hrs