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Clinical Trials/NCT03439579
NCT03439579
Completed
N/A

Pilot Study of the Home Weight Loss Program

Medical University of South Carolina1 site in 1 country30 target enrollmentFebruary 6, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Overweight and Obesity
Sponsor
Medical University of South Carolina
Enrollment
30
Locations
1
Primary Endpoint
Body weight change
Status
Completed
Last Updated
7 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
February 6, 2018
End Date
September 21, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Patrick O'Neil

Professor

Medical University of South Carolina

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

Outcomes

Primary Outcomes

Body weight change

Time Frame: 12 weeks

body weight change (kg) from pre-to post

Secondary Outcomes

  • changes in body fat percentage(12 weeks)
  • program satisfaction(12 weeks)
  • changes in body mass index(12 weeks)
  • usability of program components(12 weeks)
  • changes in scores on the power of food scale(12 weeks)
  • changes in eating behavior scores(12 weeks)
  • changes in body weight as a percentage of start weight(12 weeks)
  • changes in waist and hip measurements(12 weeks)

Study Sites (1)

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