Obesity, ChildhoodNCT03104777
A Trial to Improve the Healthiness of Packed Lunches in Primary School Aged Children
A study testing Behaviourally Informed Intervention Materials in people with Obesity, Childhood and Diet Modification, run by Public Health England at 1 site in United Kingdom.
Trial summary
Public Health England's (PHE) Behavioural Insights Team are leading and fully funding a randomised controlled research trial in collaboration with Derby City Council's Public Health Team and the Health and Social Care Research Centre at Derby University to test an intervention designed to help families provide… Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- Obesity, Childhood, Diet Modification
- What is being tested?
- Behaviourally Informed Intervention Materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Nov 2016to 30 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All primary schools in Derby City
- Children in Years 3-6
Who cannot join
- Children in Years 1 - 2 due to universal provision of free school meals.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Cluster Randomised Controlled Trial Using Behavioural Insights to Improve the Healthiness of Packed Lunches in Primary Schools in Derby
Public Health England's (PHE) Behavioural Insights Team are leading and fully funding a randomised controlled research trial in collaboration with Derby City Council's Public Health Team and the Health and Social Care Research Centre at Derby University to test an intervention designed to help families provide healthier packed lunches for Primary School aged children.
Read the detailed description
Children in Derby gain more weight during primary school than the national average. For 4-5 year olds, Derby is in the best performing quartile of English councils, with 20% having excess weight. However, by the age of 10-11 Derby drops to the second lowest quartile, with 35% of children having excess weight . In order to reduce childhood obesity in Derby, primary schools are a key area to focus on. Furthermore, it is a priority to focus on children living in deprived areas, as there is a strong relationship between deprivation and childhood obesity.
Research shows that packed lunches are higher in sugar, salt and saturated fat than school meals. , Furthermore, the nutritional gap between packed lunches and school meals has widened since the introduction of the food-based standards for school meals in 2006. A cross sectional survey, assessing packed lunches of 1,294 children in 87 primary schools, found only 1% met the standards for school meals in England, with 82% containing restricted snacks, i.e., crisps or confectionary, and 61% including sugar sweetened drinks. Therefore, significantly improving the quality of packed lunches could be an important step to reducing childhood obesity rates in Derby.
Previous research has highlighted that improving the quality of packed lunches can be challenging. For example, a UK-wide randomised controlled trial found that a "SMART lunch box" intervention had a positive impact on certain food groups but failed to reduce the overall calories in lunchboxes. The intervention, which included an extensive set of approaches, e.g., lunch bags, food boxes, wall charts, food games and stickers, increased vegetables packed by 11% and decreased savoury snacks packed by 14%, but failed to reduce confectionary and sweetened drinks . Other interventions, using educational videos and incentives aimed at children, had similar small, yet positive effects over a 12-month period . However, research has shown that relatively small, sustained behavioural changes can have a big cumulative impact: reducing calorie consumption by just 30-100 calories a day would have a considerable effect on obesity levels . The small effects of previous studies also highlight the importance of robustly evaluating any approach that is introduced.
In order to reduce childhood obesity in Derby, primary schools are a key area to focus on. Research shows that packed lunches are higher in sugar, salt and saturated fat than school meals, and a survey found only 1% of packed lunches met the standards for school meals in England . Therefore, significantly improving the quality of packed lunches could be an important step to reducing childhood obesity rates in Derby.
This trial is designed to test whether a multiple component intervention, focused on parents and developed with an understanding of the drivers behind behaviour, can increase the healthiness of packed lunches brought into school by reducing the presence of unhealthy items.
- Conditions
- Obesity, Childhood, Diet Modification
- Being tested
- Behaviourally Informed Intervention Materials
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behaviourally Informed Intervention MaterialsBehavioural
The intervention consists of 7 separate components. The intervention components are to be delivered at three time-points (referred to as bundles). The bundles consist of:
Bundle 1a - Letter to parents of children bringing a packed lunch to school, 'spot the difference' lunch box tag (attached to all lunchboxes) and a Handy Swaps Card.
Bundle 1b - Letter to parents of children only having school meals and a Handy Swaps Card.
Bundle 2 - Lunch box mixer with ideas for creating nutritious packed lunches. Bundle 3 - Shopping list, packed lunch planner and reward chart to support planning and monitoring progress.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | No intervention materials will be distributed in the control schools during the intervention period. |
| Intervention Group | Experimental | Intervention materials will be distributed to parents of children in years 3 - 6. Receives: Behavioral: Behaviourally Informed Intervention Materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of lunchboxes that contain a sugary snack post-intervention
The proportion of lunchboxes that contain a sugary snack post-intervention
Measured: Data collected up to 6 months post intervention
Proportion of lunchboxes that contain a chilled sugary dessert post-intervention
The proportion of lunchboxes that contain a chilled sugary dessert post-intervention
Measured: Data collected up to 6 months post intervention
Secondary outcomes (6)
Proportion of lunch boxes that contain any sugary food
The proportion of lunch boxes that contain any sugary food (i.e. either a sugary snack or chilled sugary dessert).
Measured: Data collected up to 6 months post intervention
Total number of sugary food items
The total number of sugary food items (i.e. either a sugary snack or chilled sugary dessert)
Measured: Data collected up to 6 months post intervention
Proportion of lunch boxes that contain crisps
The proportion of lunch boxes that contain crisps
Measured: Data collected up to 6 months post intervention
Proportion of lunch boxes that contain a sugary drink
The proportion of lunch boxes that contain a sugary drink
Measured: Data collected up to 6 months post intervention
Proportion of lunch boxes that contain fruit or vegetables
The proportion of lunch boxes that contain fruit or vegetables
Measured: Data collected up to 6 months post intervention
The average nutritional value of sugary food items
The average nutritional value (e.g. grams of sugar, calories) of sugary food items
Measured: Data collected up to 6 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2017
- Study start9 Nov 2016
- Primary completion30 Sep 2017
- Study completion30 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- cluster randomised controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Public Health England
- Sponsor type
- Other government
- Collaborators
- Derby City Council, University of Derby
- Responsible party
- Sponsor
- Investigators
- Tim Chadborn, PhD, Study director, Public Health EnglandAmanda K Bunten, Doctorate, Principal investigator, Public Health England
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03104777
- Sponsor's protocol ID
- Derby Packed Lunch Trial
- Status last verified
- Jan 2017
- First submitted
- 26 Jan 2017
- Last updated
- 3 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster Randomised Controlled Trial Using Behavioural Insights to Improve the Healthiness of Packed Lunches in Primary Schools in Derby
- ClinicalTrials.gov ID
- NCT03104777
- Acronym / sponsor ID
- Derby Packed Lunch Trial
- Conditions
- Obesity, Childhood, Diet Modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Public Health EnglandOther government
- Collaborators
- Derby City Council, University of Derby
- Study start
- 9 Nov 2016 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 30 Oct 2017 (actual)
- First posted
- 7 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Public Health England's (PHE) Behavioural Insights Team are leading and fully funding a randomised controlled research trial in collaboration with Derby City Council's Public Health Team and the Health and Social Care Research Centre at Derby University to test an intervention designed to help families provide healthier packed lunches for Primary School aged children.
Detailed description
Children in Derby gain more weight during primary school than the national average. For 4-5 year olds, Derby is in the best performing quartile of English councils, with 20% having excess weight. However, by the age of 10-11 Derby drops to the second lowest quartile, with 35% of children having excess weight . In order to reduce childhood obesity in Derby, primary schools are a key area to focus on. Furthermore, it is a priority to focus on children living in deprived areas, as there is a strong relationship between deprivation and childhood obesity.
Research shows that packed lunches are higher in sugar, salt and saturated fat than school meals. , Furthermore, the nutritional gap between packed lunches and school meals has widened since the introduction of the food-based standards for school meals in 2006. A cross sectional survey, assessing packed lunches of 1,294 children in 87 primary schools, found only 1% met the standards for school meals in England, with 82% containing restricted snacks, i.e., crisps or confectionary, and 61% including sugar sweetened drinks. Therefore, significantly improving the quality of packed lunches could be an important step to reducing childhood obesity rates in Derby.
Previous research has highlighted that improving the quality of packed lunches can be challenging. For example, a UK-wide randomised controlled trial found that a "SMART lunch box" intervention had a positive impact on certain food groups but failed to reduce the overall calories in lunchboxes. The intervention, which included an extensive set of approaches, e.g., lunch bags, food boxes, wall charts, food games and stickers, increased vegetables packed by 11% and decreased savoury snacks packed by 14%, but failed to reduce confectionary and sweetened drinks . Other interventions, using educational videos and incentives aimed at children, had similar small, yet positive effects over a 12-month period . However, research has shown that relatively small, sustained behavioural changes can have a big cumulative impact: reducing calorie consumption by just 30-100 calories a day would have a considerable effect on obesity levels . The small effects of previous studies also highlight the importance of robustly evaluating any approach that is introduced.
In order to reduce childhood obesity in Derby, primary schools are a key area to focus on. Research shows that packed lunches are higher in sugar, salt and saturated fat than school meals, and a survey found only 1% of packed lunches met the standards for school meals in England . Therefore, significantly improving the quality of packed lunches could be an important step to reducing childhood obesity rates in Derby.
This trial is designed to test whether a multiple component intervention, focused on parents and developed with an understanding of the drivers behind behaviour, can increase the healthiness of packed lunches brought into school by reducing the presence of unhealthy items.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- cluster randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –No intervention materials will be distributed in the control schools during the intervention period. |
| Intervention Group | Experimental | Behavioral: Behaviourally Informed Intervention MaterialsIntervention materials will be distributed to parents of children in years 3 - 6. |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- All primary schools in Derby City
- Children in Years 3-6
Key exclusion criteria (1 listed)
- Children in Years 1 - 2 due to universal provision of free school meals.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behaviourally Informed Intervention MaterialsThe intervention consists of 7 separate components. The intervention components are to be delivered at three time-points (referred to as bundles). The bundles consist of: Bundle 1a - Letter to parents of children bringing a packed lunch to school, 'spot the difference' lunch box tag (attached to all lunchboxes) and a Handy Swaps Card. Bundle 1b - Letter to parents of children only having school meals and a Handy Swaps Card. Bundle 2 - Lunch box mixer with ideas for creating nutritious packed lunches. Bundle 3 - Shopping list, packed lunch planner and reward chart to support planning and monitoring progress. | Behavioural | Intervention Group |
Primary outcome
Proportion of lunchboxes that contain a sugary snack post-intervention
Time frame: Data collected up to 6 months post intervention
The proportion of lunchboxes that contain a sugary snack post-intervention
Proportion of lunchboxes that contain a chilled sugary dessert post-intervention
Time frame: Data collected up to 6 months post intervention
The proportion of lunchboxes that contain a chilled sugary dessert post-intervention
6 secondary outcomes
Proportion of lunch boxes that contain any sugary food
Time frame: Data collected up to 6 months post intervention
Total number of sugary food items
Time frame: Data collected up to 6 months post intervention
Proportion of lunch boxes that contain crisps
Time frame: Data collected up to 6 months post intervention
Proportion of lunch boxes that contain a sugary drink
Time frame: Data collected up to 6 months post intervention
Proportion of lunch boxes that contain fruit or vegetables
Time frame: Data collected up to 6 months post intervention
The average nutritional value of sugary food items
Time frame: Data collected up to 6 months post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tim Chadborn, PhD study director
Public Health England
Amanda K Bunten, Doctorate principal investigator
Public Health England
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behaviourally Informed Intervention Materials in people with Obesity, Childhood and Diet Modification, run by Public Health England at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of lunchboxes that contain a sugary snack post-intervention (time frame: Data collected up to 6 months post intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2020.