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Pilot Study of the HWL Program (HWL)

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ClinicalTrials.gov Identifier: NCT03439579
Recruitment Status : Completed
First Posted : February 20, 2018
Last Update Posted : November 9, 2018
Sponsor:
Collaborator:
South Carolina Telehealth Alliance
Information provided by (Responsible Party):
Patrick O'Neil, Medical University of South Carolina

Tracking Information
First Submitted Date  ICMJE February 7, 2018
First Posted Date  ICMJE February 20, 2018
Last Update Posted Date November 9, 2018
Actual Study Start Date  ICMJE February 6, 2018
Actual Primary Completion Date July 3, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 13, 2018)
Body weight change [ Time Frame: 12 weeks ]
body weight change (kg) from pre-to post
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2018)
  • changes in body weight as a percentage of start weight [ Time Frame: 12 weeks ]
    percent body weight change
  • changes in body mass index [ Time Frame: 12 weeks ]
    weight in kgs divided by height in meters squared to obtain BMI (kg/m^2)
  • program satisfaction [ Time Frame: 12 weeks ]
    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 [ Time Frame: 12 weeks ]
    changes in body fat percentage
  • changes in waist and hip measurements [ Time Frame: 12 weeks ]
    changes in waist and hip measurements
  • usability of program components [ Time Frame: 12 weeks ]
    examine usage of tracking components including step, exercise, diet, and weight tracking
  • changes in eating behavior scores [ Time Frame: 12 weeks ]
    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 [ Time Frame: 12 weeks ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 13, 2018)
  • changes in body weight as a percentage of start weight [ Time Frame: 12 weeks ]
    percent body weight change
  • changes in body mass index [ Time Frame: 12 weeks ]
    weight in kgs divided by height in meters squared to obtain BMI (kg/m^2)
  • program satisfaction [ Time Frame: 12 weeks ]
    program satisfaction obtained from multiple choice items developed by study staff
  • changes in body fat percentage [ Time Frame: 12 weeks ]
    changes in body fat percentage
  • changes in waist and hip measurements [ Time Frame: 12 weeks ]
    changes in waist and hip measurements
  • usability of program components [ Time Frame: 12 weeks ]
    examine usage of tracking components including step, exercise, diet, and weight tracking
  • changes in eating behavior scores [ Time Frame: 12 weeks ]
    use of the Eating Behavior Inventory
  • changes in scores on the power of food scale [ Time Frame: 12 weeks ]
    use of the Power of Food Scale
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pilot Study of the HWL Program
Official Title  ICMJE Pilot Study of the Home Weight Loss Program
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Single group pilot study
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Overweight and Obesity
Intervention  ICMJE Behavioral: Home weight loss program
Patient remote self-monitoring of diet, activity, and weight with clinician feedback provided remotely based on self-monitored data.
Study Arms  ICMJE 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).
Intervention: Behavioral: Home weight loss program
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 13, 2018)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 21, 2018
Actual Primary Completion Date July 3, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03439579
Other Study ID Numbers  ICMJE Pro00070941
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No individual data is planned to be shared with other researchers.
Responsible Party Patrick O'Neil, Medical University of South Carolina
Study Sponsor  ICMJE Medical University of South Carolina
Collaborators  ICMJE South Carolina Telehealth Alliance
Investigators  ICMJE
Principal Investigator: Patrick M O'Neil, PhD Medical University of South Carolina
PRS Account Medical University of South Carolina
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP