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

Temple University1 site in 1 country29 target enrollmentApril 2016

ConditionsObesity Overweight Prediabetes Weight Loss Lifestyle

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Obesity
Sponsor: Temple University
Enrollment: 29
Locations: 1
Primary Endpoint: Change in body weight in kg
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2016

End Date

November 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Temple University

Responsible Party

Sponsor

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
•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

Outcomes

Primary Outcomes

Change in body weight in kg

Time Frame: 6 months

Secondary Outcomes

Change from baseline blood pressure(12 months)
Change from baseline waist circumference(12 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(12 months)
Change in Quality of Life(6 months after receiving the intervention)
Change in insulin resistance by homeostasis model assessment (HOMA-IR)(12 months compared to baseline and 6 months after receiving the intervention)
Change in hemoglobin A1c(12 months compared to baseline and 6 months after receiving the intervention and from baseline)
Change in plasma triglycerides(12 months compared to baseline and 6 months after receiving the intervention)