Smart Technology for Weight Loss and Metabolic Health

Not Applicable

Completed

• Conditions: Obesity; Weight Loss; Overweight; Prediabetes; Lifestyle

• Registration Number: NCT02742662
• Lead Sponsor: Temple University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-07
• Study First Submitted QC: 2016-04-14
• Study First Posted: 2016-04-19
• Primary Completion: 2017-06
• Study Completion: 2017-11
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-13
• Last Update Posted: 2018-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in body weight in kg	6 months

Secondary Outcome Measures

Name	Time	Method
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	SF36 Questionnaire in wait-listed control group after the intervention
Change in insulin resistance by homeostasis model assessment (HOMA-IR)	12 months compared to baseline and 6 months after receiving the intervention	Wait-listed control group
Change in hemoglobin A1c	12 months compared to baseline and 6 months after receiving the intervention and from baseline	Wait-listed control group
Change in plasma triglycerides	12 months compared to baseline and 6 months after receiving the intervention	Wait-listed control group

Trial Locations

Locations (1)

Temple University; 🇺🇸 Philadelphia, Pennsylvania, United States