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OpenTrials
Completed

NCT Number: NCT02774655

New Health Devices to Improve Adherence to Physical Activity in Overweight Inactive Adults

The purpose of this study is to test in overweight and inactive adults whether the new PAI eHealh APP leads to better adherence to a physical activity regimen than the wearable step counter App from the market leader FitBit, and to evaluate if improved adherence will be reflected in a better cardiovascular profile in this group.

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Key information

Conditions

Cardiovascular Diseases Behavior Body Weight Health Behavior Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance Signs and Symptoms Treatment Adherence and Compliance

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institutt for sirkulasjon og bildediagnostikk

Trondheim, Norway

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Body mass index > 25
  • self reported exercise one time or less per week

Exclusion criteria

  • inability to use a SmartPhone
  • illness or disabilities that preclude or hinder completion of the study
  • cancer that makes participation impossible or exercise contraindicated (considered individually, in consultation with physician)
  • test results indicating that study participation is unsafe
  • participation in other studies conflicting with participation in this study
  • symptomatic valvular, hypertrophic cardiomyopathy, unstable angina, primary pulmonary hypertension, uncontrolled hypertension, heart failure or sever arrhythmia
  • diagnosed dementia
  • chronic communicable infectious diseases
  • Bariatric surgery
  • Medication for thyroid disease, diabetes, blood pressure or lipid lowering medication

Treatment and study plan

Pai APP

Device

prescribed 100 PAI weekly

Other names: personal activity Intelligence (PAI) application, Mio Fuse wristband

FitBit APP

Device

prescribed 10000 steps daily

Other names: FitBit zip step counter

Primary outcomes

  1. The proportion of the participants obtaining 80 % or more of the prescribed physical activity for one year

    Time frame: 1 year

    Prescribed 100 PAI weekly (PAI app group), or 10 000 steps daily (step counter app)

Secondary outcomes

  1. Cardiorespiratory fitness

    Time frame: 1 year

    Peak oxygen uptake assessed by Jaeger oxycon pro; Erich Jaeger GmbH, Hoechberg, Germany

  2. Cardiorespiratory fitness

    Time frame: 16 weeks

    Peak oxygen uptake assessed by Jaeger oxycon pro; Erich Jaeger GmbH, Hoechberg, Germany

  3. Resting blood pressure

    Time frame: 16 weeks

    Left upper arm, right upper arm, orthostatic hypotension

  4. Resting blood pressure

    Time frame: 1 year

    Left upper arm, right upper arm, orthostatic hypotension

  5. Resting heart rate

    Time frame: 16 weeks

  6. Resting heart rate

    Time frame: 1 year

  7. Body mass index

    Time frame: 16 weeks

    Height, weight

  8. Body mass index

    Time frame: 1 year

    Height, weight

  9. Waist line

    Time frame: 16 weeks

    in centimeters

  10. Waist line

    Time frame: 1 year

    in centimeters

  11. Body composition

    Time frame: 16 weeks

    body composition measured by bioelectrical impedance (InBody 720, BIOSPACE, Seoul, Korea)

  12. Body composition

    Time frame: 1 year

    body composition measured by bioelectrical impedance (InBody 720, BIOSPACE, Seoul, Korea)

  13. Activity questionnaire

    Time frame: 16 weeks

    HUNT-1 questionnaire 2 "exercise"

  14. Activity questionnaire

    Time frame: 1 year

    HUNT-1 questionnaire 2 "exercise"

  15. glucose concentration in blood

    Time frame: 16 weeks

  16. glucose concentration in blood

    Time frame: 1 year

  17. glycosylated haemoglobin (HbA1c) concentration in blood

    Time frame: 16 weeks

  18. glycosylated haemoglobin (HbA1c) concentration in blood

    Time frame: 1 year

  19. c-peptide concentration in blood

    Time frame: 16 weeks

  20. c-peptide concentration in blood

    Time frame: 1 year

  21. concentration of triglycerides in blood serum

    Time frame: 16 weeks

  22. concentration of triglycerides in blood serum

    Time frame: 1 year

  23. concentration of total cholesterol in blood

    Time frame: 16 weeks

  24. concentration of total cholesterol in blood

    Time frame: 1 year

  25. concentration of low density lipid (LDL) cholesterol in blood

    Time frame: 16 weeks

  26. concentration of low density lipid (LDL) cholesterol in blood

    Time frame: 1 year

  27. concentration of high density lipid (HDL) cholesterol in blood

    Time frame: 16 weeks

  28. concentration of high density lipid (HDL) cholesterol in blood

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 17, 2016
Registry last updated
Sep 25, 2017

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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