Smart Technology for Weight Loss and Metabolic Health

Sponsor

Temple University (Other)

Overall Status

Completed

CT.gov ID

NCT02742662

Collaborator

The Obesity Treatment Foundation (Other)

Enrollment

Location

Arms

Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity Overweight Prediabetes Weight Loss Lifestyle	Device: Wearable technology, smartscale Behavioral: Smartphone applications Behavioral: Standard Weight Management Visits	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

29 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Apr 1, 2016

Actual Primary Completion Date :

Jun 1, 2017

Actual Study Completion Date :

Nov 1, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in body weight in kg [6 months]

Secondary Outcome Measures

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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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