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A digital health program combined with an activity tracker to improve llifestyle behavior.


- candidate number22043
- NTR NumberNTR5215
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR30-apr-2015
- Secondary IDsNL  49925.042.14
- Public TitleA digital health program combined with an activity tracker to improve llifestyle behavior.
- Scientific TitleBlood glucose regulation in people with diabetes after three months of information about nutrition and feedback on physical activity behavior.
- ACRONYM
- hypothesisThe alternative hypothesis: there will be a significant difference in HbA1c after receiving a digital health program with information about nutrition and feedback about physical activity behavior, relative to the control group which receives care as usual.

De 0-hypothese luidt dat er geen verschil is in HbA1c na het ontvangen van enerzijds drie maanden een digitaal gezondheidsprogramma met informatie over leefstijl en feedback op het beweeggedrag plus care as usual en anderzijds care as usual alleen.
De alternatieve hypothese luidt dat het ontvangen van drie maanden care as usual plus een digitaal gezondheidsprogramma met informatie over leefstijl en feedback op het beweeggedrag zorgt voor een significante daling in HbA1c ten opzichte van de care as usual alleen.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus Type 2 (DM type II), Self test, Life style
- Inclusion criteria- People with type 2 diabetes
- Most recent HbA1c-value ≥ 58 mmols/mol (7.5%)
- Age ≥18 jaar
- Access to a PC and the internet
- some expercience with the use of a computer and the internet.
- Exclusion criteria- Pregnancy
- Already exercising more than 3 hours per week
- Severe co-morbidity
- Cognitive or mental problems
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 24-apr-2015
- planned closingdate30-jun-2016
- Target number of participants96
- InterventionsA digital health program combined with an activity tracker (Fitbit Zip). Participants receive weekly information about physcial activity, nutrition and diabetes. They gain insight in their physical activity behavior through the digital program, and receive stimulating feedback messages.
- Primary outcomeHbA1c.
- Secondary outcomeMood (Pick A Mood; PAM)
Motivational questionnaire (measured in four determinants: intention, attitude, self-efficacy and social norm)
Physcial activity (measured by the Fitbit, and by the 1-item questionnaire)
BMI
Waist and hip circumference (cm)
Compliance use of the digital health program
Use of the Fitbit Zip 
- TimepointsT0 (week 0)
T 1 (week 12)
T 2 (week 24)
T 3 (week 36)
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Thea Kooiman
- CONTACT for SCIENTIFIC QUERIES Thea Kooiman
- Sponsor/Initiator Hanze University of Applied Sciences Groningen, Allied health care and Nursing
- Funding
(Source(s) of Monetary or Material Support)
Hanze University of Applied Sciences
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD30-apr-2015 - 27-jul-2015


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