Clinical trial NCT03053336: App-technology to Increase Physical Activity Among Patients With Type 2 Diabetes
Official title: App-technology to Enhance Self-care for Patients With Diabetes Type 2 - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Exercise
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
First posted: 2017-02-15
Enrollment: 181
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in physical activity level (counts/min from accelerometers)
timeFrame: baseline and month 3, 6 and 12
Secondary outcomes:
measure: HbA1c (mmol/mol)
timeFrame: Baseline and month 3, 6 and 12
measure: Steps/day
timeFrame: Baseline and month 3, 6 and 12
measure: Total cholesterol (mmol/L)
timeFrame: Baseline and month 3, 6 and 12
measure: HDL-cholesterol (mmol/L)
timeFrame: Baseline and month 3, 6 and 12
measure: Triglycerides (mmol/L)
timeFrame: Baseline and month 3, 6 and 12
measure: Apolipoprotein A1 (g/l)
timeFrame: Baseline and month 3, 6 and 12
measure: Apolipoprotein B (g/l)
timeFrame: Baseline and month 3, 6 and 12
measure: Body weight (kg)
timeFrame: Baseline and month 3, 6 and 12
measure: Body Mass Index (BMI, kg/m2)
timeFrame: Baseline and month 3, 6 and 12
measure: Body composition
timeFrame: Baseline and month 3, 6 and 12
measure: Waist circumference (cm)
timeFrame: Baseline and month 3, 6 and 12
measure: Blood pressure (mmHg)
timeFrame: Baseline and month 3, 6 and 12
Other outcomes:
measure: Change in dietary habits assessed using a food frequency questionnaire
timeFrame: Baseline and month 3, 6 and 12
measure: Change in tobacco use habits (smoking and Swedish snuff use)
timeFrame: Baseline and month 3, 6 and 12
measure: Change in sleeping habits assessed using a 13 item questionnaire
timeFrame: Baseline and month 3, 6 and 12
measure: Change in perceived purpose in life
timeFrame: Baseline and month 3, 6 and 12
measure: Change in perceived stress levels using the perceived stress scale
timeFrame: Baseline and month 3, 6 and 12
measure: Change in reported self-efficacy for exercise
timeFrame: Baseline and month 3, 6 and 12
measure: Change in reported self-efficacy diabetes is assessed using a 20 item questionnaire
timeFrame: Baseline and month 3, 6 and 12
measure: Change in RAND-36
timeFrame: Baseline and month 3, 6 and 12
measure: Change in neighborhood Environment assessed by questions on safety and walking environment
timeFrame: Baseline and month 3, 6 and 12
measure: Social support for exercise assessed using a 6 item questionnaire
timeFrame: Baseline and month 3, 6 and 12
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet and Stockholm County Councill
name: Ylva Trolle Lagerros, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bonn SE, Alexandrou C, Hjorleifsdottir Steiner K, Wiklander K, Ostenson CG, Lof M, Trolle Lagerros Y. App-technology to increase physical activity among patients with diabetes type 2 - the DiaCert-study, a randomized controlled trial. BMC Public Health. 2018 Jan 10;18(1):119. doi: 10.1186/s12889-018-5026-4.