To evaluate if the program *Run2gether* can change physical behavior in children with obesity and/or diabetes, and thereby increase physical fitness level and insulin sensitivity en reduce body weight. An additional goal for children with diabetes,…
ID
Source
Brief title
Condition
- Other condition
- Diabetic complications
- Diabetic complications
Synonym
Health condition
secundaire preventie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
* Percentage of finishers and active participation in the programm ;
* Physical fitness, tested with the Bruce protocol on a treadmill;
* Anthropometry: BMI and waist circumference;
* Insulin sensitivity: HbAIC and insulin/carbohydrate ratio.
Secondary outcome
* Level of activity measured with *activity diary and activitymonitor*. BMI and
waist circumference of the elder;
* Diabetes management: Fluctuations in blood glucose levels;
* Blood vessel characteristics and endothelial function
Evaluation of the process
A questionnaire with questions about the contentment of both child and elder
about the program, will be conducted at the end of the program. Specific
feedback towards possible improvements about the program will be request. On a
website available for all parents, communication about possible incidents and
problems will be possible. With all information gathered, analysis about strong
and weak points of the program will be made, with which it is possible to
redesign the program for future events. These analysis will be conducted by all
participants and professionals who participated in this project.
Main topics of this evaluation will be:
- A report of the amount of contacts with the diabetes nurse . In addition more
specific questions will be asked about the quality and contentment of the
participants with the advice and care provided by this nurse;
- The amount of occasions that participants visited the website;
- The amount of bilateral contact between the participants;
- How much time needed to coach all participants, to make cost-effectiveness
analyses possible;
- Evaluation about analogue events in future, supported by government funding,
insurance companies, employees and sport clubs, to make sure that appropriate
future funding is not an issue anymore.
Background summary
The prevalence of diabetes in children in the Netherlands is approximately 5000
individuals, with an increase of 250 patients every year. In addition, the
prevalence of childhood obesity is increasing enormously in the Netherlands.
Also these individuals are already early in lifetime prone to be at risk for
developing diabetes. Children in the western world are becoming less physical
active, while it is especially important for these two groups to be physical
active on a regular base. An active lifestyle has got important benefits for
good health. Main goals for these two groups are to increase sensitivity of
insulin and to reduce the risks for cardiovascular diseases on the mid-long
term. Because parental influence are of great importance during early lifespan,
this project aims on a intervention with a child supported by the active
participation by one of the parents. Because parents contribute to a large
extend to the education and development of a child and because physical
inactivity is often based on a family culture, parental support is very
important for a growing child. By providing a program that aims at both child
and elder, parents retain their roles as important determinants of risk and
protective behavior, but this time in a good healthy manner.
Study objective
To evaluate if the program *Run2gether* can change physical behavior in
children with obesity and/or diabetes, and thereby increase physical fitness
level and insulin sensitivity en reduce body weight. An additional goal for
children with diabetes, is to improve their diabetes management. Besides a risk
profile for possible future cardiovascular problems is made, by assessing
characteristics of the blood vessels and the endothelial function.
Because this is a pilot-oriented study, main goals are to test how many
participants are able to finish the 6 months of training and to measure the
effectiveness of the intervention. In addition, the program is evaluated
afterwards and adjusted if necessary. We consider the program as a success, if
at least 70% of the participants are able to accomplish the 6 months of
training. We assume that long-term lifestyle changes are possible, if the
participant are able to conduct our 6 months of training. To be successful, our
intervention most be also proven effective on body characteristics and physical
fitness.
Study design
What is the effect of the exercise program on children with diabetes and/or
obesity with active parental support on:
* Percentage finishers after the 6 months of training;
* Physical fitness, activity level, BMI, waist circumference and insulin
sensitivity.
This pilot study will be conducted as a pre-post design with a convenient
cohort, with one baseline measurement at start and one measurement after
finishing the 6 months program.
Intervention
The intervention consists of a workshop, a 6 months training period, online
feedback and a final event as a reward.
The program will kick off with a workshop in which the importance of good
nutrition will be explained, along with the role of insulin and the effect on
the blood sugar levels. Next, exercise capacity for the participating children
is tested. Based on these results, children will be divided in different
training groups. The training program will be conducted both under supervision
in groups and on an individual base (child and parent). Group lessons are
performed once a week, with a decreasing frequency in time and an increasing
occurrence of individual training sessions following a prescribed training
schedule. Children will report their results in a personal online web-dossier,
which is accessible for child, parents, investigator and the diabetes nurse.
The diabetes nurse will be available for children to ask questions about their
diabetes management in relationship to sport.
Study burden and risks
This program is aimed at healthy changes in behavior towards physical activity,
to provide participants with opportunities to create a better medical condition
and to provide important tools and information about secondary prevention of
different kind of diseases. The minimal risks regarding this program are less
significant than possible improvements of healthiness of the participants. With
this program, promising long-term changes of the physical condition are
possible.
Postbus 9101
6500 HB Nijmegen
NL
Postbus 9101
6500 HB Nijmegen
NL
Listed location countries
Age
Inclusion criteria
Both groups
* Aged 8-12 years
* Signed informed consent
* participation of 1 parent guaranted
Obesity/overweight
* Proposed BMI-values in relationship to age as stated by Cole et al. (Ref = attachment C1)
diabetes mellitus type 1
* Diagnosed with diabetes mellitus type 1
Exclusion criteria
* Mental retardation
* Contraindication for physical activity
* Contraindication for running
Design
Recruitment
Medical products/devices used
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 | NL29164.091.09 |