Smart Technology for Weight Loss and Metabolic Health

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02742662
• Other study ID #: 23217
• Status: Completed
• Phase: N/A
• First received: April 7, 2016
• Last updated: February 13, 2018
• Start date: April 2016
• Est. completion date: November 2017

Study information

• Verified date: February 2018
• Source: Temple University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: November 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Glucose Intolerance
• Lifestyle
• Obesity
• Overweight
• Prediabetes
• Prediabetic State
• Weight Loss

Intervention

Device:
• Wearable technology, smartscale

Behavioral:
• Smartphone applications

• Standard Weight Management Visits

Locations

Country	Name	City	State
United States	Temple University	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Temple University	The Obesity Treatment Foundation

Country where clinical trial is conducted

United States, 

Outcome

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