Clinical trial NCT02742662: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Prediabetes
Weight Loss
Lifestyle
Keywords: Obesity
Overweight
Prediabetes
Smartphone application
Technology
Weight Loss
Lifestyle Intervention
Lead sponsor: Temple University
Sponsor class: OTHER
Collaborators: name: The Obesity Treatment Foundation
First posted: 2016-04-19
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Change in body weight in kg
timeFrame: 6 months
Secondary outcomes:
measure: Change from baseline blood pressure
timeFrame: 6 months
measure: Change from baseline waist circumference
timeFrame: 6 months
measure: Change from baseline insulin resistance by homeostasis model assessment (HOMA-IR)
timeFrame: 6 months
measure: Change from baseline hemoglobin A1c
timeFrame: 6 months
measure: Change from baseline plasma triglycerides
timeFrame: 6 months
measure: Change from baseline body weight in kg
timeFrame: 3 months
measure: Change from baseline body weight in kg
timeFrame: 12 months
measure: Change from baseline blood pressure
timeFrame: 12 months
measure: Change from baseline waist circumference
timeFrame: 12 months
measure: Change in Quality of Life
timeFrame: 6 months after receiving the intervention
measure: Change in insulin resistance by homeostasis model assessment (HOMA-IR)
timeFrame: 12 months compared to baseline and 6 months after receiving the intervention
measure: Change in hemoglobin A1c
timeFrame: 12 months compared to baseline and 6 months after receiving the intervention and from baseline
measure: Change in plasma triglycerides
timeFrame: 12 months compared to baseline and 6 months after receiving the intervention
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
Study officials:
affiliation: Temple University
name: Cherie Vaz, MD Dipl ABOM
role: PRINCIPAL_INVESTIGATOR
References: