ChocHealth for Kids! The effects of dark chocolate on childrens blood pressure

ISRCTN	ISRCTN60409644
DOI	https://doi.org/10.1186/ISRCTN60409644
Secondary identifying numbers	N/A

Submission date: 24/07/2010
Registration date: 27/09/2010
Last edited: 27/09/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Melissa Wake
Scientific

The Royal Children's Hospital Melbourne
Centre for Community Child Health
Flemington Road
Parkville VIC
Parkville
3052
Australia

Study information

Study design	Pilot randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	The effects of dark chocolate on children's blood pressure: a pilot randomised controlled trial
Study acronym	ChocHealth for Kids!
Study objectives	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(s)	Human Research and Ethics Committee of the Royal Children's Hospital Melbourne approved on the 26th July 2010 (ref: 30049)
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	02/08/2010
Completion date	31/12/2011

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	10 Years
Upper age limit	13 Years
Sex	Both
Target number of participants	Around 200 students (intervention: 120; control: 80)
Key inclusion criteria	All Grade 5 and 6 children (aged between 10 - 13 years old, either sex) in participating classes whose parents consent
Key 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.
Date of first enrolment	02/08/2010
Date of final enrolment	31/12/2011

Locations

Countries of recruitment

Australia

Study participating centre

The Royal Children's Hospital Melbourne

Parkville
3052
Australia

Sponsor information

Murdoch Childrens Research Institute (MCRI) (Australia)
Research organisation

Royal Children's Hospital Melbourne
Flemington Road
Parkville
3052
Australia

Website	http://www.mcri.edu.au
"ROR"	https://ror.org/048fyec77

Funders

Funder type

Hospital/treatment centre

Royal Children's Hospital Melbourne (Australia) - Centre for Community Child Health

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

ChocHealth for Kids! The effects of dark chocolate on childrens blood pressure