Condition category
Nutritional, Metabolic, Endocrine
Date applied
09/01/2004
Date assigned
26/04/2004
Last edited
15/12/2006
Prospective/Retrospective
Prospectively 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

Dr Melissa Wake

ORCID ID

Contact details

Centre for Community Child Health
Royal Children's Hospital
Flemington Road
Parkville
Melbourne
3052
Australia
+61 (0)3 9345 5761
melissa.wake@rch.org.au

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

AHMAC PDR 2001/15

Study information

Scientific title

Acronym

LEAP

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Overweight and mild obesity

Intervention

Arm A: Four consultations with the family doctor, employing a brief family-centred, solution-focussed approach aiming to increase physical activity and reduce fat and sugar intake.
Arm B: Standard identification and care.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/07/2004

Overall trial end date

31/12/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Healthy children aged 5.0-9.11 years who are overweight or mildly obese (International Obesity Task Force [IOTF] cutpoints; children with UK Body Mass Index [BMI] z-score ≥3.0 excluded).
Sample drawn from BMI survey of all chidren aged 5.0-9.11 years attending their family doctor in 29 participating practices May-Dec 2002.

Participant type

Patient

Age group

Child

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

children with UK Body Mass Index [BMI] z-score ≥3.0 excluded

Recruitment start date

01/07/2004

Recruitment end date

31/12/2005

Locations

Countries of recruitment

Australia

Trial participating centre

Centre for Community Child Health
Melbourne
3052
Australia

Sponsor information

Organisation

Murdoch Children's Research Institute (Australia)

Sponsor details

Royal Children's Hospital
Flemington Road
Parkville
Melbourne
3052
Australia
+61 (0)3 8341 6200
mcri@mcri.edu.au

Sponsor type

Research organisation

Website

Funders

Funder type

Government

Funder name

AHMAC (Australian Health Ministers' Advisory Council) Priority Driven Research Grant 2001/15

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