Condition category
Circulatory System
Date applied
24/07/2010
Date assigned
27/09/2010
Last edited
27/09/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Melissa Wake

ORCID ID

Contact details

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

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

http://www.mcri.edu.au

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

Publication citations

Additional files

Editorial Notes