Australian New Zealand Clinical Trials Registry

Trial Details

indicate updates made to monitored data item(s) since trial registration. These data item(s) are monitored to ensure they comply with the WHO / journal editors standards.

Request Number:

000424

ACTR Number:

ACTRN12605000578606

Trial Status:

Registered

Date Submitted:

6/09/2005

Date Registered:

4/10/2005

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Public title:

Preventing obesity in children via environmental intervention: the APPLE study

ANZCTR registration title:

Preventing obesity in children via environmental intervention: the APPLE study

Secondary ID:

UTN:

Trial acronym:

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Health condition(s) or problem(s) studied:
Prevention of obesity

Diet and nutrition	Health promotion/education
Condition category:	Condition code:

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Description of intervention(s) / exposure:

Two year community-based intervention aimed at increasing physical activity and healthy eating in primary school aged children through a variety of initiatives 4 intervention and 3 control schools (100% response rate) were involved from 2 distinct geographical areas in Otago, New Zealand. The nature of the community-based project precluded randomisation, but the two areas were selected on the basis of comparability with regard to sociodemographic variables.

Intervention code:

None

Comparator / control treatment:

Control group:

Active

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Primary outcome:	Two-year change in BMI z-score in intervention compared with control children
Timepoint:
Secondary outcome 1:	Participation in physical activity as measured using accelerometers.
Timepoint:
Secondary outcome 2:	Dietary intake of selected foods and beverages.
Timepoint:
Secondary outcome 3:	Quality of life.
Timepoint:

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Key inclusion criteria:

All healthy children attending the intervention and control schools.

Minimum Age:

5 Years

Maximum Age:

12 Years

Gender:

Both males and females

Healthy volunteers?

Key exclusion criteria:

No exclusion criteria

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Study type:

Interventional

Purpose of the study:

Prevention

Allocation to intervention:

Nonrandomised trial

Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures):

Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation):

Masking / blinding:

Open (masking not used)

Assignment:

Parallel

Other design features (specify):

Type of endpoint(s):

Efficacy

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Phase

Phase 3

Anticipated or actual date of first participant enrolement:

8/01/2003

Target sample size:

500

Recruitment status:

Closed: follow-up continuing

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Funding source 1:

Government funding body e.g. Australian Research Council

Name:

Health Research Council

Address:

Country:

New Zealand

Funding source 2:

Charities/Societies/Foundations

Name:

National Heart Foundation,

Address:

Country:

New Zealand

Funding source 3:

Charities/Societies/Foundations

Name:

Community Trust of Otago

Address:

Country:

New Zealand

Funding source 4:

University

Name:

University of Otago

Address:

Country:

New Zealand

Funding source 5:

Charities/Societies/Foundations

Name:

Otago Diabetes Research Trust

Address:

Country:

New Zealand

Primary sponsor:

University

Name:

University of Otago

Address:

Country:

New Zealand

Secondary sponsor:

Individual

Name:

Dr Rachael Taylor

Address:

Country:

Other collaborator:

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Has the study received approval from at least one ethics committee?

Yes

Ethics Committee:

Countries of recruitment:

Outside Australia

New Zealand

Brief summary:

Trial website:

Presentations / publication list:

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Contact person for public queries

Name:

Dr Rachael Taylor

Address:

Department of Human Nutrition University of Otago PO Box 56 Dunedin 9001

Country:

New Zealand

Tel:

+64 3 4795262

Fax:

Email:

rachael.taylor@stonebow.otago.ac.nz

Contact person for scientific queries

Name:

Dr Rachael Taylor

Address:

Department of Human Nutrition University of Otago PO Box 56 Dunedin 9001

Country:

New Zealand

Tel:

+64 3 4795262

Fax:

Email:

rachael.taylor@stonebow.otago.ac.nz

Contact person responsible for updating information

Name:

Address:

Country:

Tel:

Fax:

Email:

Trial Details

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