Smart Technology for Weight Loss and Metabolic Health

Study Overview
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Brief Summary
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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.

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

Conditions
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Obesity, Overweight, Prediabetes, Weight Loss, Lifestyle

Intervention / Treatment
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* Device: Wearable technology, smartscale
* Behavioral: Smartphone applications
* Behavioral: Standard Weight Management Visits


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Smart Technology Group<br>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<br> <br> Behavioral: Smartphone applications<br> <br> Behavioral: Standard Weight Management Visits<br> <br> |
| Other: Standard Weight Management Group<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight in kg |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | SF36 Questionnaire in wait-listed control group after the intervention | 6 months after receiving the intervention | 
| 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 | 
| Change in hemoglobin A1c | Wait-listed control group | 12 months compared to baseline and 6 months after receiving the intervention and from baseline | 
| Change in plasma triglycerides | Wait-listed control group | 12 months compared to baseline and 6 months after receiving the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Overweight, Prediabetes, Smartphone application, Technology, Weight Loss, Lifestyle Intervention