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Smart Technology for Weight Loss and Metabolic Health

Primary Purpose

Obesity, Overweight, Prediabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Wearable technology, smartscale
Smartphone applications
Standard Weight Management Visits
Sponsored by
Temple University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring Obesity, Overweight, Prediabetes, Smartphone application, Technology, Weight Loss, Lifestyle Intervention

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Overweight or obese BMI 25-42 kg/m2
  • Employed in sedentary occupations
  • Own a personal smartphone with unlimited data plan or >4 GigaByte data
  • Proficient with use of smartphone applications and technology with current daily usage
  • Ability to engage in moderate intensity exercise
  • Weight stability for the last 2 months
  • Participants must be willing to comply with all study-related procedures

Exclusion Criteria:

  • Current or planned pregnancy
  • Cardiovascular, pulmonary, renal disease, joint disease
  • Uncontrolled thyroid disease
  • History of eating disorders, psychiatric disease
  • History of substance abuse or dependence in the last 1 year
  • Diabetes
  • Shift work
  • Previous weight loss surgery
  • Use of weight loss drugs/diet/program in the last 6 weeks
  • Inability to increase walking as a form of exercise and to engage in moderate intensity exercise
  • Other conditions or medications that affect body weight/appetite/metabolism
  • Serious or unstable medical or psychological conditions that would compromise the subject's safety for successful participation
  • Incapable of adhering with an intensive lifestyle intervention using technology and smartphone applications

Sites / Locations

  • Temple University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Smart Technology Group

Standard Weight Management Group

Arm Description

The Smart Technology Group will receive a technology-based lifestyle intervention program which uses wearable technology, smartscales and smartphone applications to track and deliver feedback on caloric expenditure, physical activity, caloric intake and body weight. Participants will receive information through smartphone applications on strategies to make changes to their diet, physical activity, and weight-related behaviors along with standard 3 monthly in-person weight management visits.

The Standard Weight Management Group will receive 3 monthly in-person weight management visits during which they will receive standard of care lifestyle recommendations in accordance with the 2013 American Heart Association/American College of Cardiology/The Obesity Society Guideline.

Outcomes

Primary Outcome Measures

Change in body weight in kg

Secondary Outcome Measures

Change from baseline blood pressure
Change from baseline waist circumference
Change from baseline insulin resistance by homeostasis model assessment (HOMA-IR)
Change from baseline hemoglobin A1c
Change from baseline plasma triglycerides
Change from baseline body weight in kg
Change from baseline body weight in kg
Change from baseline blood pressure
Change from baseline waist circumference
Change in Quality of Life
SF36 Questionnaire in wait-listed control group after the intervention
Change in insulin resistance by homeostasis model assessment (HOMA-IR)
Wait-listed control group
Change in hemoglobin A1c
Wait-listed control group
Change in plasma triglycerides
Wait-listed control group

Full Information

First Posted
April 7, 2016
Last Updated
February 13, 2018
Sponsor
Temple University
Collaborators
The Obesity Treatment Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02742662
Brief Title
Smart Technology for Weight Loss and Metabolic Health
Official Title
Smart Technology for Weight Loss and Metabolic Health- A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Temple University
Collaborators
The Obesity Treatment Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The study will evaluate whether a technology-based lifestyle intervention program using primarily a smartphone platform is an acceptable and effective way for treating obesity. The goal of the program is to achieve weight loss and enhance the health of overweight or obese subjects by improving their diet and activity via smartphone applications as compared with conventional in-person weight management programs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight, Prediabetes, Weight Loss, Lifestyle
Keywords
Obesity, Overweight, Prediabetes, Smartphone application, Technology, Weight Loss, Lifestyle Intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Smart Technology Group
Arm Type
Experimental
Arm Description
The Smart Technology Group will receive a technology-based lifestyle intervention program which uses wearable technology, smartscales and smartphone applications to track and deliver feedback on caloric expenditure, physical activity, caloric intake and body weight. Participants will receive information through smartphone applications on strategies to make changes to their diet, physical activity, and weight-related behaviors along with standard 3 monthly in-person weight management visits.
Arm Title
Standard Weight Management Group
Arm Type
Other
Arm Description
The Standard Weight Management Group will receive 3 monthly in-person weight management visits during which they will receive standard of care lifestyle recommendations in accordance with the 2013 American Heart Association/American College of Cardiology/The Obesity Society Guideline.
Intervention Type
Device
Intervention Name(s)
Wearable technology, smartscale
Intervention Type
Behavioral
Intervention Name(s)
Smartphone applications
Intervention Type
Behavioral
Intervention Name(s)
Standard Weight Management Visits
Primary Outcome Measure Information:
Title
Change in body weight in kg
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change from baseline blood pressure
Time Frame
6 months
Title
Change from baseline waist circumference
Time Frame
6 months
Title
Change from baseline insulin resistance by homeostasis model assessment (HOMA-IR)
Time Frame
6 months
Title
Change from baseline hemoglobin A1c
Time Frame
6 months
Title
Change from baseline plasma triglycerides
Time Frame
6 months
Title
Change from baseline body weight in kg
Time Frame
3 months
Title
Change from baseline body weight in kg
Time Frame
12 months
Title
Change from baseline blood pressure
Time Frame
12 months
Title
Change from baseline waist circumference
Time Frame
12 months
Title
Change in Quality of Life
Description
SF36 Questionnaire in wait-listed control group after the intervention
Time Frame
6 months after receiving the intervention
Title
Change in insulin resistance by homeostasis model assessment (HOMA-IR)
Description
Wait-listed control group
Time Frame
12 months compared to baseline and 6 months after receiving the intervention
Title
Change in hemoglobin A1c
Description
Wait-listed control group
Time Frame
12 months compared to baseline and 6 months after receiving the intervention and from baseline
Title
Change in plasma triglycerides
Description
Wait-listed control group
Time Frame
12 months compared to baseline and 6 months after receiving the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Overweight or obese BMI 25-42 kg/m2 Employed in sedentary occupations Own a personal smartphone with unlimited data plan or >4 GigaByte data Proficient with use of smartphone applications and technology with current daily usage Ability to engage in moderate intensity exercise Weight stability for the last 2 months Participants must be willing to comply with all study-related procedures Exclusion Criteria: Current or planned pregnancy Cardiovascular, pulmonary, renal disease, joint disease Uncontrolled thyroid disease History of eating disorders, psychiatric disease History of substance abuse or dependence in the last 1 year Diabetes Shift work Previous weight loss surgery Use of weight loss drugs/diet/program in the last 6 weeks Inability to increase walking as a form of exercise and to engage in moderate intensity exercise Other conditions or medications that affect body weight/appetite/metabolism Serious or unstable medical or psychological conditions that would compromise the subject's safety for successful participation Incapable of adhering with an intensive lifestyle intervention using technology and smartphone applications
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cherie Vaz, MD Dipl ABOM
Organizational Affiliation
Temple University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Temple University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Smart Technology for Weight Loss and Metabolic Health

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