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

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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus; Exercise
• Intervention / Treatment: Behavioral: App-technology to increase physical activity

• Study Type: Interventional
• Enrollment (Actual): 181
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden
    • Karolinska Institutet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: App-technology group; Participants in the intervention group (App-technology) will use a newly developed smartphone application ("app") in which steps are automatically measured and laboratory values from blood sampling within primary care will be shown. Intervention: App-technology to increase physical activity	Behavioral: App-technology to increase physical activity; Access to the smartphone-app during 12 weeks. A personal step goal is set for each individual in the app.
NO_INTERVENTION: Control group; The control group will receive standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in physical activity level (counts/min from accelerometers)	baseline and month 3, 6 and 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c (mmol/mol)		Baseline and month 3, 6 and 12
Steps/day		Baseline and month 3, 6 and 12
Total cholesterol (mmol/L)		Baseline and month 3, 6 and 12
HDL-cholesterol (mmol/L)		Baseline and month 3, 6 and 12
Triglycerides (mmol/L)		Baseline and month 3, 6 and 12
Apolipoprotein A1 (g/l)		Baseline and month 3, 6 and 12
Apolipoprotein B (g/l)		Baseline and month 3, 6 and 12
Body weight (kg)		Baseline and month 3, 6 and 12
Body Mass Index (BMI, kg/m2)		Baseline and month 3, 6 and 12
Body composition	Including: %Body Fat, Fat free mass (kg), Muscle mass (kg), Total body water (kg, %)	Baseline and month 3, 6 and 12
Waist circumference (cm)		Baseline and month 3, 6 and 12
Blood pressure (mmHg)		Baseline and month 3, 6 and 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in dietary habits assessed using a food frequency questionnaire		Baseline and month 3, 6 and 12
Change in tobacco use habits (smoking and Swedish snuff use)		Baseline and month 3, 6 and 12
Change in sleeping habits assessed using a 13 item questionnaire		Baseline and month 3, 6 and 12
Change in perceived purpose in life		Baseline and month 3, 6 and 12
Change in perceived stress levels using the perceived stress scale		Baseline and month 3, 6 and 12
Change in reported self-efficacy for exercise	One's confidence in walking is assessed	Baseline and month 3, 6 and 12
Change in reported self-efficacy diabetes is assessed using a 20 item questionnaire		Baseline and month 3, 6 and 12
Change in RAND-36		Baseline and month 3, 6 and 12
Change in neighborhood Environment assessed by questions on safety and walking environment		Baseline and month 3, 6 and 12
Social support for exercise assessed using a 6 item questionnaire		Baseline and month 3, 6 and 12

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Region Stockholm
• Investigators: Principal Investigator: Ylva Trolle Lagerros, MD, PhD, Karolinska Institutet and Stockholm County Councill

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 21, 2017
• Primary Completion (ACTUAL): June 30, 2019
• Study Completion (ACTUAL): June 30, 2019

Study Registration Dates

• First Submitted: February 7, 2017
• First Submitted That Met QC Criteria: February 14, 2017
• First Posted (ACTUAL): February 15, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 29, 2020
• Last Update Submitted That Met QC Criteria: September 28, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: Dnr: 2016/2041-31/2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No