This study contributes to the evaluation of the Detection- and Prevention-protocol, as applied by YHC to 5 to 6-year-olds.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
niet van toepassing
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Evaluation of the prevention protocol:
· Change in waist circumference 24 months after the *PGO-5 to 6-year-olds* in
children with *overweight not obesity* in the Intervention group relative to
the Control group.
· Relative change in Body Mass Index 24 months after the *PGO-5-year-olds* in
children with *overweight not obesity* in the Intervention group relative to
the Control group.
Evaluation of the detection protocol:
· Predictive value of the labels *normal weight*, *overweight but not obesity*,
and *obesity* at the *PGO-5-year-olds* according to the Detection-protocol for
the presence of these labels at age 7 years.
Secondary outcome
Baseline measurements:
· Demographic and general characteristics;
· Data concerning pregnancy, birth weight, breastfeeding and medical history;
· Body mass index, and behaviors of parents themselves;
· Body mass index relative to sex and age specific norms and waist
circumference
· Presence of overweight reducing and inducing behaviors (specific behaviors
targeted in the intervention)
· Health-related quality of life
· Attitudes of parents regarding the specific health behaviors
· Baseline levels of indicators of negative side effects.
· Presence of label *overweight* (respectively *obesity*) according to
Detection-protocol at age 7 (yes/no) (Bulk-Bunschoten et al, 2005);
· Levels of the five target overweight reducing and inducing behaviors (Promis
questionnaires; van de Laar et al, 2006). For example: Change in average daily
number of minutes watching TV, video, DVD or playing on a computer, 24 months
after the *PGO-5-year-olds* in children with *overweight not obesity* in the
Intervention group relative to the Control group (Doak et al., 2006; Renders et
al., 2004);
- Health-related quality of life (CHQ-PF28; Raat et al, 2005);
- Attitudes of parents regarding the specific health behaviors (Promis
questionnaires; van de Laar et al, 2006)
- Absence/presence of indicators of negative side effects (worry,
stigmatization, lowered self-esteem, and development of relative underweight)
(Doak et al., 2006).
Evaluation of the detection protocol:
- Sensitivity and specificity of the Detection-protocol at the *PGO-5-
year-olds* for *overweight but not obesity*, and *obesity* at the age of 7
years, in the absence of weight-management interventions.
- Furthermore it will be assessed in how far this is modified by the five
relevant target behaviors and by specific measures of body fatness other than
Body Mass Index, such as waist circumference.
Measures regarding the Process evaluation:
- Adherence to the distinct elements of the interventions;
- Satisfaction of the parents with the interventions (modified Patient
Satisfaction questionnaire) (Martinali et al, 2001);
- Understandability of program elements for parents (Promis questionnaire, van
de Laar et al, 2006);
- Rating of possibility for application in day-to-day life by parents (van de
Laar et al., 2006);
- Time investments of parents and YHC-professionals for YHC- visits;
Acceptability for the YHC-professionals of the interventions (van de Laar et
al., 2006).
Measures regarding the Cost-effectiveness evaluation.
With regard to costs of the Prevention-protocol we will assess the costs of
counseling visits, education of YHC-personnel, other program costs (e.g.
non-client related time investments of YHC-personnel with respect to program),
and time and travel costs of parents and children. Data on time investments,
expenditures and program costs will be collected by questionnaires among
YHC-personnel and parents, and from YHC administrative data sources.
Background summary
Overweight and obesity are main determinants of the ZonMw priority diseases.
The prevalence of overweight and obesity among children has at least doubled in
the past 25 years, especially in socially disadvantaged and specific ethnic
subgroups. The current study proposes to evaluate a monitoring intervention and
a counseling intervention in the setting of Dutch Youth Health Care (YHC),
aiming at the prevention of obesity in childhood and at the prevention of
overweight and obesity in adulthood. Dutch Youth Health Care (YHC) may
contribute to the prevention of overweight and obesity by the recently
developed YHC Overweight Detection-protocol (Signaleringsprotocol Overgewicht)
and Prevention-protocol (Overbruggingsplan Overgewicht). The Detection-protocol
identifies children with *overweight but no obesity*, and these children and
their parents are offered the Prevention-protocol with three visits with a
program of non-directing behavioral counseling to improve health behaviors and
to reduce body fatness. These protocols have proven to be feasible and
acceptable in the recent VUMC Promis study. The Prevention-protocol, however,
has not yet been subjected to a rigorous effect evaluation.
Study objective
This study contributes to the evaluation of the Detection- and
Prevention-protocol, as applied by YHC to 5 to 6-year-olds.
Study design
We propose a cluster-randomized trial with YHC-teams as unit of randomization.
In the Intervention group both the Detection-protocol and the
Prevention-protocol will be applied, while in the Control group the
Detection-protocol will be applied in combination with *usual care*.
Intervention
The detection-protocol will be applied to all children participating in the
study. Subsequently, in the intervention group the prevention-protocol will be
applied. In the control group the usual care of the Municipal Health Services
will be applied.
Study burden and risks
The measures for weight, height and waist circumference will be applied to all
children participating in the study. These measures will be repeated after 2
years of follow-up in a subgroup. Furthermore, the parents of a subgroup of
children will receive a questionnaire to obtain additional information about
lifestyle behaviors and determinants of lifestyle behaviours. After 1 and 2
years of follow-up this subgroup of parents will receive these questionnaires
again.
Postbus 2040
3000 CA Rotterdam
NL
Postbus 2040
3000 CA Rotterdam
NL
Listed location countries
Age
Inclusion criteria
All 5-6 year old children in the second year of primary school during school year 2007/2008, which are invited for the 'PGO' will be invited to participate in the study.
Exclusion criteria
The children and their parents should be able to read and understand the basics of the Dutch language, because questionnaires and consults will be used in the study. Severely mentally or physically disabled children will be excluded. In these cases the YHC-professional should make a well-considered decision to invite or not invite these children and their parents to participate in the study.
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 |
|---|---|
| ISRCTN | ISRCTN04965410 |
| CCMO | NL16845.078.07 |