The primary aim of the present research is to determine if a digital health program, with information about nutrition/physical activity/diabetes and feedback on physical activity behaviour by an activity tracker leads to improvement of glycemic…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is HbA1c.
Secondary outcome
o VAS perceived health
o Mood (PAM; pick a mood)
o Motivational questionairre (measured in four determinants: intention,
attitude, self-efficacy and social norm)
o Physical activity (measurend by an activity tracker and by the1-item
questionnaire)
o BMI
o Waist and hip circumference (cm)
o Compliance (use of the digital healh program);
* - Number of login times care giver
- Number of login times participant
- Percentage *activities completed' within the digital
program*
- Number of e-consults conducted between the care giver and
participant
* - Use of the activity tracker ( percentage use relative to the complete
studie)
Background summary
For people with diabetes optimal glycemic control is of big improtance in order
to prevent different complications and comorbidiy. A healthy lifestyle, which
means sufficient physical activity and a balanced diet has been proven to be
effective for decreasing the risk for complications. However, self-mangament
and long term behaviour change towards a healthy lifestyle are hard to reach
for people with chronic disease. Digital health care (e-health) and real-time
feedback on physical activity behaviour are mentioned lately as a possible
solution to improve lifestyle and physical activity behaviour for diverse
populations.
Study objective
The primary aim of the present research is to determine if a digital health
program, with information about nutrition/physical activity/diabetes and
feedback on physical activity behaviour by an activity tracker leads to
improvement of glycemic control.
Study design
A randomized clinical trial, with one intervention group and one control group.
Intervention
The intervention group receives during 12 weeks in additon to the regular care
a digital health program. Central in the program are a web application and an
activity tracker. Using the internet application the subject set their own
goals with regard to physical activity, the receive feedback with regard to
their own physcial activity behaviour (feedback from the activity tracker) and
they receive information about diabetes, lifestyle and nutrition. Through the
web application the subjects have contact with their care giver.
Study burden and risks
The e-health intervention does not bring any risks with it. A possible risk for
hypoglycemia for patients that use insulin is low, becasue only patients with
an HbA1c of >= 58 mmol/mol are included. Furthermore, the subjects receive the
regular advizes for hypoglycemia.
The measurements are non-invasive. In total there will be three real life
consults with the health care provider. In these consults, the body weight, hip
and waist circumference are measured. Other secondary outcome measures are
digitally completed within the e-health program at baseline, week 6, 12 and 24.
The HbA1c is obtained by the care giver in week 0,12, 24 en week 48 for the
intervention group and in week 0, 12, 24, 36 en 60 for the control group.
Eyssoniusplein 18
Groningen 9701 DC
NL
Eyssoniusplein 18
Groningen 9701 DC
NL
Listed location countries
Age
Inclusion criteria
- people with type 2 diabetes
- Moste recent HbA1c-value >= 58 mmol/mol (7.5%)
- Age >=18 years
- Access to a computer and the internet
- Some experience with the use of a computer and the internet
Exclusion criteria
- Pregancy
- More than 3 hours of intensive sports per week
- Severe comorbidity
- Cognitive or mental problems
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL49925.042.14 |