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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

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.

Condition or disease Intervention/treatment Phase
Overweight and Obesity Behavioral: Home weight loss program Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single group pilot study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of the Home Weight Loss Program
Actual Study Start Date : February 6, 2018
Actual Primary Completion Date : July 3, 2018
Actual Study Completion Date : September 21, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Body weight change [ Time Frame: 12 weeks ]
    body weight change (kg) from pre-to post


Secondary Outcome Measures :
  1. changes in body weight as a percentage of start weight [ Time Frame: 12 weeks ]
    percent body weight change

  2. changes in body mass index [ Time Frame: 12 weeks ]
    weight in kgs divided by height in meters squared to obtain BMI (kg/m^2)

  3. 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.

  4. changes in body fat percentage [ Time Frame: 12 weeks ]
    changes in body fat percentage

  5. changes in waist and hip measurements [ Time Frame: 12 weeks ]
    changes in waist and hip measurements

  6. usability of program components [ Time Frame: 12 weeks ]
    examine usage of tracking components including step, exercise, diet, and weight tracking

  7. 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.

  8. 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03439579


Locations
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United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
South Carolina Telehealth Alliance
Investigators
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Principal Investigator: Patrick M O'Neil, PhD Medical University of South Carolina
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Responsible Party: Patrick O'Neil, Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT03439579    
Other Study ID Numbers: Pro00070941
First Posted: February 20, 2018    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No individual data is planned to be shared with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Patrick O'Neil, Medical University of South Carolina:
Telehealth
Remote weight loss
Self-monitoring
Diet
Physical activity
Additional relevant MeSH terms:
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Overweight
Body Weight
Signs and Symptoms