Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The effects of dark chocolate on children's blood pressure: a pilot randomised controlled trial
Acronym
ChocHealth for Kids!
Study hypothesis
The aims of this pilot randomised controlled trial are to:
1. Determine whether a school-based program promoting daily low dose consumption of dark chocolate by healthy Grade 5 and 6 children on school days over 8 weeks could be an acceptable and feasible intervention in Melbourne metropolitan primary schools for reducing blood pressure
2. Identify and fine-tune the easiest and most acceptable methods of delivery
3. Document any barriers in the implementation and uptake of such a program
4. Establish the feasibility of measuring endovascular function by pulse wave analysis using SphygmoCor in schools
5. Estimate variability in blood pressure and conduct preliminary comparisons between the intervention and control groups on key outcomes, both of which will inform sample size estimates for a larger trial should it proceed
We hypothesise that:
1. The intervention will be feasible and acceptable for 10 - 12 year old children, their parents, and their schools
2. At 2 months post-randomisation the intervention group, when compared with the non-intervention group, will show:
2.1. Trends towards a lower mean systolic and diastolic blood pressure, and
2.2. No difference in the mean body weight, body mass index, body percentage fat or reported health-related quality of life
Ethics approval
Human Research and Ethics Committee of the Royal Children's Hospital Melbourne approved on the 26th July 2010 (ref: 30049)
Study design
Pilot randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Hypertension
Intervention
6 - 7 g of dark chocolate rich in antioxidants will be delivered by teachers to each participant in intervention arm classes on school days over School Term 4, in 2010 (about 8 weeks), and none will be given to participants in control arm classes. Outcome assessments will be performed before and after intervention.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Measured at baseline and 8 weeks:
1. Acceptability and feasibility of the study as assessed by recruitment rate and participant
(students and teachers) feedback
2. Blood pressure outcomes between intervention and control groups
Secondary outcome measures
Measured at baseline and 8 weeks:
1. Anthropometry - weight, height, BMI and waist girth
2. Percentage body fat, as measured by multiple frequency bioelectrical impedance analysis (BIA)
3. Health-related quality of life and body image - assessed through the 23-item PEDS QL 4.0 Child Self-Report, a validated measure of child quality of life, and a pictorial body perception and preference scale used in many of our previous studies
Overall trial start date
02/08/2010
Overall trial end date
31/12/2011
Reason abandoned
Eligibility
Participant inclusion criteria
All Grade 5 and 6 children (aged between 10 - 13 years old, either sex) in participating classes whose parents consent
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
Around 200 students (intervention: 120; control: 80)
Participant exclusion criteria
1. Hypertension under pharmacological treatment
2. Major medical or developmental condition(s) limiting participation in the study (at the discretion of the research team and child's family)
3. Anaphylaxis to nuts (hazelnut or almond) or dairy in children who carry Epipen(s). Dark chocolate does not contain milk, and we will use varieties that do not contain nuts. However, chocolate manufacturers usually state that their chocolate is manufactured on equipment that is also used for foods that contain nuts and/or milk. Therefore, we think it prudent to exclude children with serious nut or milk allergy.
Recruitment start date
02/08/2010
Recruitment end date
31/12/2011
Locations
Countries of recruitment
Australia
Trial participating centre
The Royal Children's Hospital Melbourne
Parkville
3052
Australia
Sponsor information
Organisation
Murdoch Childrens Research Institute (MCRI) (Australia)
Sponsor details
Royal Children's Hospital Melbourne
Flemington Road
Parkville
3052
Australia
Sponsor type
Research organisation
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Royal Children's Hospital Melbourne (Australia) - Centre for Community Child Health
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary