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Completed

NCT Number: NCT03053336

App-technology to Increase Physical Activity Among Patients With Type 2 Diabetes

The aim of this study is to investigate the effect of using new app-based technology to improve self-care, compared to usual care in patients with type 2 diabetes. The hypothesis is that the intervention, i.e. using the new technology, will have a greater positive effect on physical activity levels and outcomes of HbA1c than usual care.

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Key information

Conditions

Type 2 Diabetes Mellitus Behavior Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Exercise Glucose Metabolism Disorders Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska Institutet

Stockholm, Sweden

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Have a diagnosis of type 2 diabetes
  • 18 years of age or older
  • Ability to communicate in Swedish
  • Have and be able to use a smartphone

Exclusion criteria

  • Not being able to walk

Treatment and study plan

App-technology to increase physical activity

Behavioral

Access to the smartphone-app during 12 weeks. A personal step goal is set for each individual in the app.

Primary outcomes

  1. Change in physical activity level (counts/min from accelerometers)

    Time frame: baseline and month 3, 6 and 12

Secondary outcomes

  1. HbA1c (mmol/mol)

    Time frame: Baseline and month 3, 6 and 12

  2. Steps/day

    Time frame: Baseline and month 3, 6 and 12

  3. Total cholesterol (mmol/L)

    Time frame: Baseline and month 3, 6 and 12

  4. HDL-cholesterol (mmol/L)

    Time frame: Baseline and month 3, 6 and 12

  5. Triglycerides (mmol/L)

    Time frame: Baseline and month 3, 6 and 12

  6. Apolipoprotein A1 (g/l)

    Time frame: Baseline and month 3, 6 and 12

  7. Apolipoprotein B (g/l)

    Time frame: Baseline and month 3, 6 and 12

  8. Body weight (kg)

    Time frame: Baseline and month 3, 6 and 12

  9. Body Mass Index (BMI, kg/m2)

    Time frame: Baseline and month 3, 6 and 12

  10. Body composition

    Time frame: Baseline and month 3, 6 and 12

    Including: %Body Fat, Fat free mass (kg), Muscle mass (kg), Total body water (kg, %)

  11. Waist circumference (cm)

    Time frame: Baseline and month 3, 6 and 12

  12. Blood pressure (mmHg)

    Time frame: Baseline and month 3, 6 and 12

Other outcomes

  1. Change in dietary habits assessed using a food frequency questionnaire

    Time frame: Baseline and month 3, 6 and 12

  2. Change in tobacco use habits (smoking and Swedish snuff use)

    Time frame: Baseline and month 3, 6 and 12

  3. Change in sleeping habits assessed using a 13 item questionnaire

    Time frame: Baseline and month 3, 6 and 12

  4. Change in perceived purpose in life

    Time frame: Baseline and month 3, 6 and 12

  5. Change in perceived stress levels using the perceived stress scale

    Time frame: Baseline and month 3, 6 and 12

  6. Change in reported self-efficacy for exercise

    Time frame: Baseline and month 3, 6 and 12

    One's confidence in walking is assessed

  7. Change in reported self-efficacy diabetes is assessed using a 20 item questionnaire

    Time frame: Baseline and month 3, 6 and 12

  8. Change in RAND-36

    Time frame: Baseline and month 3, 6 and 12

  9. Change in neighborhood Environment assessed by questions on safety and walking environment

    Time frame: Baseline and month 3, 6 and 12

  10. Social support for exercise assessed using a 6 item questionnaire

    Time frame: Baseline and month 3, 6 and 12

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Region Stockholm

Registry information

Official study title

App-technology to Enhance Self-care for Patients With Diabetes Type 2 - A Randomized Controlled Trial

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Feb 15, 2017
Registry last updated
Sep 29, 2020

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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