Smart Technology for Weight Loss and Metabolic Health

Smart Technology for Weight Loss and Metabolic Health- A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight; Weight Loss; Prediabetes; Lifestyle
• Intervention / Treatment: Device: Wearable technology, smartscale; Behavioral: Smartphone applications; Behavioral: Standard Weight Management Visits

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Smart Technology Group; 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.	Device: Wearable technology, smartscale; Behavioral: Smartphone applications; Behavioral: Standard Weight Management Visits
Other: Standard Weight Management Group; 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.	Behavioral: Standard Weight Management Visits

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in body weight in kg	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline blood pressure		6 months
Change from baseline waist circumference		6 months
Change from baseline insulin resistance by homeostasis model assessment (HOMA-IR)		6 months
Change from baseline hemoglobin A1c		6 months
Change from baseline plasma triglycerides		6 months
Change from baseline body weight in kg		3 months
Change from baseline body weight in kg		12 months
Change from baseline blood pressure		12 months
Change from baseline waist circumference		12 months
Change in Quality of Life	SF36 Questionnaire in wait-listed control group after the intervention	6 months after receiving the intervention
Change in insulin resistance by homeostasis model assessment (HOMA-IR)	Wait-listed control group	12 months compared to baseline and 6 months after receiving the intervention
Change in hemoglobin A1c	Wait-listed control group	12 months compared to baseline and 6 months after receiving the intervention and from baseline
Change in plasma triglycerides	Wait-listed control group	12 months compared to baseline and 6 months after receiving the intervention

Collaborators and Investigators

• Sponsor: Temple University
• Collaborators: The Obesity Treatment Foundation
• Investigators: Principal Investigator: Cherie Vaz, MD Dipl ABOM, Temple University

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: April 7, 2016
• First Submitted That Met QC Criteria: April 14, 2016
• First Posted (Estimate): April 19, 2016

Study Record Updates

• Last Update Posted (Actual): February 15, 2018
• Last Update Submitted That Met QC Criteria: February 13, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Obesity; Prediabetes; Overweight; Weight Loss; Lifestyle Intervention; Technology; Smartphone application
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Body Weight Changes; Hyperglycemia; Weight Loss; Prediabetic State; Glucose Intolerance; Overweight; Body Weight
• Other Study ID Numbers: 23217

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No