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Completed

NCT Number: NCT02742662

Smart Technology for Weight Loss and Metabolic Health

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.

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Key information

Conditions

Obesity Body Weight Body Weight Changes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Lifestyle Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms PreDiabetes Prediabetic State Signs and Symptoms Weight Loss

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Temple University

Philadelphia, Pennsylvania, 19140, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Wearable technology, smartscale

Device

Smartphone applications

Behavioral

Standard Weight Management Visits

Behavioral

Primary outcomes

  1. Change in body weight in kg

    Time frame: 6 months

Secondary outcomes

  1. Change from baseline blood pressure

    Time frame: 6 months

  2. Change from baseline waist circumference

    Time frame: 6 months

  3. Change from baseline insulin resistance by homeostasis model assessment (HOMA-IR)

    Time frame: 6 months

  4. Change from baseline hemoglobin A1c

    Time frame: 6 months

  5. Change from baseline plasma triglycerides

    Time frame: 6 months

  6. Change from baseline body weight in kg

    Time frame: 3 months

  7. Change from baseline body weight in kg

    Time frame: 12 months

  8. Change from baseline blood pressure

    Time frame: 12 months

  9. Change from baseline waist circumference

    Time frame: 12 months

  10. Change in Quality of Life

    Time frame: 6 months after receiving the intervention

    SF36 Questionnaire in wait-listed control group after the intervention

  11. Change in insulin resistance by homeostasis model assessment (HOMA-IR)

    Time frame: 12 months compared to baseline and 6 months after receiving the intervention

    Wait-listed control group

  12. Change in hemoglobin A1c

    Time frame: 12 months compared to baseline and 6 months after receiving the intervention and from baseline

    Wait-listed control group

  13. Change in plasma triglycerides

    Time frame: 12 months compared to baseline and 6 months after receiving the intervention

    Wait-listed control group

Sponsors and collaborators

Lead sponsor

Temple University

Other

Collaborators

  • The Obesity Treatment Foundation

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 19, 2016
Registry last updated
Feb 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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