A study to assess the effectiveness and value for money of a programme to prevent primary school age children becoming overweight and obese

Not Applicable

Completed

• Conditions: Childhood obesity; Obesity; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN97000586
• Lead Sponsor: niversity of Birmingham (UK)

Brief Summary

2013 pilot study results in: http://www.ncbi.nlm.nih.gov/pubmed/22302618 2014 process evaluation design in: http://www.ncbi.nlm.nih.gov/pubmed/25212062 2014 teacher experiences results in: http://hej.sagepub.com/content/early/2014/11/06/0017896914556907.abstract 2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25968599 2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26671226 2015 parent and child perceptions in: http://www.ncbi.nlm.nih.gov/pubmed/26654046 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29436364 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29437667 2019 results in https://www.ncbi.nlm.nih.gov/pubmed/31291330 (added 27/02/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-05-19
• Study Completion: 2015-08-31
• Last Update Posted: 16 March 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1397

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> The difference in percentage of children categorised as normal weight, overweight and obese in control compared to intervention schools.<br> 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.<br> 2. Additional measures of obesity will also be used:<br> 2.1. Waist circumference<br> 2.2. Skinfold thickness at 4 sites (biceps, suprailiac, subscapular and thigh)<br> 2.3. Body fat calculated from a measure of bioimpedance (obtained from a Tanita body composition analyser)<br><br> 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.<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. 24 hour dietary assessment using a Child and Diet Evaluation Tool (CADET) tick list<br> 2. Physical activity levels measured over 5 days using an Actiheart monitor (combined heart rate monitor and accelerometer)<br> 3. Health-related quality of life measured by the Pediatric Quality of Life Inventory (PedsQL)<br> 4. Body image measure using an adapted version of the Collins Figure Rating Scale<br> 5. A further quality of life measure for use in the cost-effectiveness study will be developed at the start of the trial<br><br> 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.<br>