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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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16 March 2020 |
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Main ID: |
ISRCTN97000586 |
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Date of registration:
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19/05/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A study to assess the effectiveness and value for money of a programme to prevent primary school age children becoming overweight and obese
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Scientific title:
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A cluster randomised controlled trial of the effectiveness and cost-effectiveness of an obesity prevention intervention in primary school age children |
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Date of first enrolment:
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01/09/2010 |
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Target sample size:
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1922 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN97000586 |
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Study type:
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Interventional |
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Study design:
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Single-centre open-label cluster (school-level) randomised controlled trial (Prevention)
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Phase:
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Not Applicable
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Peymane
Adab |
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Address:
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Department of Public Health, Epidemiology & Biostatistics
The University of Birmingham
Edgbaston
B15 2TT
Birmingham
United Kingdom |
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Telephone:
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- |
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Email:
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p.adab@bham.ac.uk |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: All children (boys and girls) in year 1 (age 5-6) in schools participating in the trial
Exclusion criteria: Does not meet inclusion criteria
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Childhood obesity
Nutritional, Metabolic, Endocrine
Obesity
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Intervention(s)
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A childhood obesity prevention programme will be delivered to schools in the intervention arm for 1 year. The programme consists of:
1. Activities to increase the time spent doing physical activity within the school day
2. School participation in the 'Villa Vitality' programme, which provides interactive learning and opportunities for physical activity and healthy eating, delivered by an iconic sport institution (Aston Villa Football Club; an English Premier League club)
3. Healthy cooking sessions in school time for parents and children
4. Provision of information to families signposting local leisure opportunities
The schools in the control arm will receive 'usual practice' with regard to healthy eating and physical activity.
Schools will be divided into two waves, the first wave will be followed up at 3 timepoints following the intervention (immediately after the intervention year, one year later and two years later). The second wave will be followed up at two timepoints (immediately after the intervention year, and one year later).
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Primary Outcome(s)
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The difference in percentage of children categorised as normal weight, overweight and obese in control compared to intervention schools.
1. The categorisation will be based primarily on height and weight measures and defined by BMI using cut-offs at the 85th and 95th percentiles on the UK 1990 reference charts for BMI centiles for boys and girls.
2. Additional measures of obesity will also be used:
2.1. Waist circumference
2.2. Skinfold thickness at 4 sites (biceps, suprailiac, subscapular and thigh)
2.3. Body fat calculated from a measure of bioimpedance (obtained from a Tanita body composition analyser)
All participants will undergo these measures at baseline, 1 year and 2 years. Wave one participants will undergo these measures a further time at 3 years.
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Secondary Outcome(s)
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1. 24 hour dietary assessment using a Child and Diet Evaluation Tool (CADET) tick list
2. Physical activity levels measured over 5 days using an Actiheart monitor (combined heart rate monitor and accelerometer)
3. Health-related quality of life measured by the Pediatric Quality of Life Inventory (PedsQL)
4. Body image measure using an adapted version of the Collins Figure Rating Scale
5. A further quality of life measure for use in the cost-effectiveness study will be developed at the start of the trial
All participants will undergo these measures at baseline, 1 year and 2 years. Wave one participants will undergo these measures a further time at 3 years.
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Secondary ID(s)
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HTA 06/85/11
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Source(s) of Monetary Support
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Health Technology Assessment Programme
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Ethics review
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Status:
Approval date:
Contact:
Application for ethical approval will be submitted to one of the Research Ethics Committees in Birmingham (Birmingham East, North and Solihull, or South Birmingham), in the coming month – submission pending
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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31/08/2015 |
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URL:
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