Childhood ObesityProAskNCT02314494
Proactve Assessment of Overweight Risk During Infancy
An observational study of Childhood Obesity, run by Anglia Ruskin University at 2 sites in United Kingdom.
Trial summary
Children who are above healthy weight are more likely to be ill and to miss time off school. Being overweight in childhood can also sow the seeds for health problems in later life such as heart disease and diabetes. Most overweight children become overweight adults. Read more about this study
- Who is it for?
- Ages 6 to 12 weeksHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- ProAsk
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 83 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- May 2015to Mar 2016
- Phase
- Observational
- 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 6 to 12 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: Infants 6-8 weeks old living in the study areas (Cambridshire and Nottingham City)
Who may be able to join
- Parents/legal guardians/carers of infants aged 6-8 weeks
- First or subsequent born infants
Who cannot join
- Parents/legal guardians/carers of infants with known medical conditions requiring special diets
- Mothers who have a diagnosis of post-natal depression (PND) or who score moderate PND or above on health visitor applied screening tools (EPDS >13) (PHQ-9 >10) or anxiety (GAD-7 score >10)
- Infants born <32 weeks gestation
- Infants born 32-40 weeks whose birth weight is less than 2nd centile
- Infants born at term (40 weeks) who weigh less than 2.5 kg
- Parents/legal guardians/carers who lack sufficient command of English to complete questionnaires where no face to face translation is available
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Cambridgeshire Community Services
Cambridgeshire
Nottingham City Care Partnership
Nottingham
About this study
Official title: A Feasibility Study of an Interactive, Educational Programme to Facilitate Proactive Assessment of Overweight Risk During Infancy
Children who are above healthy weight are more likely to be ill and to miss time off school. Being overweight in childhood can also sow the seeds for health problems in later life such as heart disease and diabetes. Most overweight children become overweight adults. One solution is to try to prevent children becoming overweight by intervening very early in life. The risk factors for childhood overweight are known and this project aims to facilitate parents' (and other carers') understanding about this for their infant and to enable them to access intervention. UK health visitors (public health nurses) will use an interactive, multimedia programme (Proactive Assessment of Overweight Risk during infancy (ProAsk)), with parents to calculate their infant's risk and to discuss strategies for risk reduction as appropriate. Health visitors will be trained to communicate obesity risk and in Motivational Interviewing techniques to enable them to offer intervention to parents of infants identified as at risk.
A feasibility study of ProAsk will take place in two health provider organisations in the UK. The purpose of this is to a) determine the acceptability and utility of the ProAsk intervention with health visitors and parents and b) gather information to inform the trial design and data collection procedures for a future Randomised Controlled Trial (RCT).
Read the detailed description
Globally, overweight and obesity is a significant public health issue affecting more than 40 million children under the age of five in 2011. There is broad agreement around the aetiology of childhood overweight and obesity and risk factors have been identified prenatally, during pregnancy and early infancy. Clearly, from the point of view of the infant, risk factors that are present prenatally or during pregnancy are non-modifiable but those identified during infancy are potentially modifiable. Between 25%-33% of infants gain weight more rapidly than desirable during the first 6 months of life and this is the strongest risk factor for childhood overweight at 3 years. Rapid weight gain is potentially modifiable with interventions to facilitate better infant diet, feeding practices and exposure to physical activity. To facilitate identification of infants that might be at greater risk of developing childhood overweight and obesity a number of models have been developed. The Infant Risk of Obesity Checklist (IROC) was developed by the research team using data from the Millennium Cohort Study (MCS) and Avon Longitudinal Study of Parents and Children (ALSPAC) to potentially screen infants at 4 months of age for risk factors for childhood overweight and obesity at 3 years. However, it has not yet been tested in clinical practice.
Concerns have been expressed about using tools developed from the epidemiological literature to identify overweight and obesity risk where there are few effective evidence-based interventions for those affected. There is evidence that complex interventions targeting diet and feeding delivered to parents of infants <2 years old show some positive intervention effects on feeding practices and physical activity, although many of these interventions do not tackle the psycho-emotional aspects of feeding and are not underpinned by behavioural change theory. The impact on weight outcomes is less certain, and in some cases this may be due to intervention components and behaviour change techniques targeted at the parent rather than infant level. Universal eligibility for overweight and obesity prevention is costly and may be unnecessary for those with a low baseline risk. However, targeting of certain groups where overweight and obesity is more prevalent (for example, lower socio-economic status, minority ethnic groups) has raised concerns around stigmatisation. Preliminary work with parents/legal guardians/carers suggests that targeting may be appropriate provided the person conveying the information has appropriate knowledge and sensitivity. his suggests a novel approach to such discussions is needed. Digital technologies are being used to provide information to patients about health care related areas. The findings of a recent review suggest that interactive multimedia programmes have the capacity to facilitate communication between health professionals and patients, but further research in this field is needed.
A pragmatic research design is planned with three linked phases. The first involved the development of an interactive multimedia programme, namely ProActive Assessment of Overweight Risk during Infancy (ProAsk) which includes the IROC and a therapeutic wheel, to facilitate health professionals' discussions with parents/legal guardians/carers about overweight risk and prevention during infancy. This phase is a feasibility study of the ProAsk intervention with parents/legal guardians/carers and health professionals. The study will gather information to inform the trial design and data collection procedures for a Randomised Controlled Trial (RCT) of overweight risk identification and intervention during infancy by UK health visiting teams.
The third phase will be conducted at the end of the feasibility trial .Qualitative work will be undertaken to determine the acceptability and utility of ProAsk with the health professionals working in a health visiting team and parents/legal guardians/carers.
- Conditions
- Childhood Obesity
- Being tested
- ProAsk
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProAskBehavioural
The intervention is a computer programme ProActive Assessment of Overweight Risk to identify infants at risk of developing childhood overweight and obesity. Parents of infants identified as at risk will be offered strategies for prevention by UK health visitors (public health nurses)
| Study group | Role | What they receive |
|---|---|---|
| Infants at risk | Infants identified as at risk of obesity using the ProAsk intervention Receives: Behavioral: ProAsk | |
| Infants not at risk | Infants identified as not at risk of obesity using the ProAsk intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability and utility of the ProAsk intervention
Recruitment, retention, intervention delivery and attrition rates. Proportion of infants calculated as at risk of developing childhood overweight/obesity
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2014 (estimated)
- Study startMay 2015
- Primary completionFeb 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Childhood ObesityStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anglia Ruskin University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nottingham, University of Lincoln, University of Cambridge, Nottingham University Hospitals NHS Trust
- Responsible party
- Sponsor
- Investigators
- Sarah Redsell, PhD, Study director, Anglia Ruskin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02314494
- Sponsor's protocol ID
- FHSCE001
- Acronym
- ProAsk
- Status last verified
- Dec 2015
- First submitted
- 5 Dec 2014
- Last updated
- 12 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Rose J, Glazebrook C, Wharrad H, Siriwardena AN, Swift JA, Nathan D, Weng SF, Atkinson P, Ablewhite J, McMaster F, Watson V, Redsell SA. Proactive Assessment of Obesity Risk during Infancy (ProAsk): a qualitative study of parents' and professionals' perspectives on an mHealth intervention. BMC Public Health. 2019 Mar 12;19(1):294. doi: 10.1186/s12889-019-6616-5.
PubMed 30866879Redsell SA, Rose J, Weng S, Ablewhite J, Swift JA, Siriwardena AN, Nathan D, Wharrad HJ, Atkinson P, Watson V, McMaster F, Lakshman R, Glazebrook C. Digital technology to facilitate Proactive Assessment of Obesity Risk during Infancy (ProAsk): a feasibility study. BMJ Open. 2017 Sep 6;7(9):e017694. doi: 10.1136/bmjopen-2017-017694.
PubMed 28882926
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of an Interactive, Educational Programme to Facilitate Proactive Assessment of Overweight Risk During Infancy
- ClinicalTrials.gov ID
- NCT02314494
- Acronym / sponsor ID
- ProAsk / FHSCE001
- Conditions
- Childhood Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Anglia Ruskin UniversityUniversity, hospital or other
- Collaborators
- University of Nottingham, University of Lincoln, University of Cambridge, Nottingham University Hospitals NHS Trust
- Study start
- May 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 11 Dec 2014 (estimated)
- 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.
Children who are above healthy weight are more likely to be ill and to miss time off school. Being overweight in childhood can also sow the seeds for health problems in later life such as heart disease and diabetes. Most overweight children become overweight adults. One solution is to try to prevent children becoming overweight by intervening very early in life. The risk factors for childhood overweight are known and this project aims to facilitate parents' (and other carers') understanding about this for their infant and to enable them to access intervention. UK health visitors (public health nurses) will use an interactive, multimedia programme (Proactive Assessment of Overweight Risk during infancy (ProAsk)), with parents to calculate their infant's risk and to discuss strategies for risk reduction as appropriate. Health visitors will be trained to communicate obesity risk and in Motivational Interviewing techniques to enable them to offer intervention to parents of infants identified as at risk.
A feasibility study of ProAsk will take place in two health provider organisations in the UK. The purpose of this is to a) determine the acceptability and utility of the ProAsk intervention with health visitors and parents and b) gather information to inform the trial design and data collection procedures for a future Randomised Controlled Trial (RCT).
Detailed description
Globally, overweight and obesity is a significant public health issue affecting more than 40 million children under the age of five in 2011. There is broad agreement around the aetiology of childhood overweight and obesity and risk factors have been identified prenatally, during pregnancy and early infancy. Clearly, from the point of view of the infant, risk factors that are present prenatally or during pregnancy are non-modifiable but those identified during infancy are potentially modifiable. Between 25%-33% of infants gain weight more rapidly than desirable during the first 6 months of life and this is the strongest risk factor for childhood overweight at 3 years. Rapid weight gain is potentially modifiable with interventions to facilitate better infant diet, feeding practices and exposure to physical activity. To facilitate identification of infants that might be at greater risk of developing childhood overweight and obesity a number of models have been developed. The Infant Risk of Obesity Checklist (IROC) was developed by the research team using data from the Millennium Cohort Study (MCS) and Avon Longitudinal Study of Parents and Children (ALSPAC) to potentially screen infants at 4 months of age for risk factors for childhood overweight and obesity at 3 years. However, it has not yet been tested in clinical practice.
Concerns have been expressed about using tools developed from the epidemiological literature to identify overweight and obesity risk where there are few effective evidence-based interventions for those affected. There is evidence that complex interventions targeting diet and feeding delivered to parents of infants <2 years old show some positive intervention effects on feeding practices and physical activity, although many of these interventions do not tackle the psycho-emotional aspects of feeding and are not underpinned by behavioural change theory. The impact on weight outcomes is less certain, and in some cases this may be due to intervention components and behaviour change techniques targeted at the parent rather than infant level. Universal eligibility for overweight and obesity prevention is costly and may be unnecessary for those with a low baseline risk. However, targeting of certain groups where overweight and obesity is more prevalent (for example, lower socio-economic status, minority ethnic groups) has raised concerns around stigmatisation. Preliminary work with parents/legal guardians/carers suggests that targeting may be appropriate provided the person conveying the information has appropriate knowledge and sensitivity. his suggests a novel approach to such discussions is needed. Digital technologies are being used to provide information to patients about health care related areas. The findings of a recent review suggest that interactive multimedia programmes have the capacity to facilitate communication between health professionals and patients, but further research in this field is needed.
A pragmatic research design is planned with three linked phases. The first involved the development of an interactive multimedia programme, namely ProActive Assessment of Overweight Risk during Infancy (ProAsk) which includes the IROC and a therapeutic wheel, to facilitate health professionals' discussions with parents/legal guardians/carers about overweight risk and prevention during infancy. This phase is a feasibility study of the ProAsk intervention with parents/legal guardians/carers and health professionals. The study will gather information to inform the trial design and data collection procedures for a Randomised Controlled Trial (RCT) of overweight risk identification and intervention during infancy by UK health visiting teams.
The third phase will be conducted at the end of the feasibility trial .Qualitative work will be undertaken to determine the acceptability and utility of ProAsk with the health professionals working in a health visiting team and parents/legal guardians/carers.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infants at risk | – | Behavioral: ProAskInfants identified as at risk of obesity using the ProAsk intervention |
| Infants not at risk | – | –Infants identified as not at risk of obesity using the ProAsk intervention. |
Who may qualify
- Ages
- 6 to 12 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Infants 6-8 weeks old living in the study areas (Cambridshire and Nottingham City)
Key inclusion criteria (2 listed)
- Parents/legal guardians/carers of infants aged 6-8 weeks
- First or subsequent born infants
Key exclusion criteria (6 listed)
- Parents/legal guardians/carers of infants with known medical conditions requiring special diets
- Mothers who have a diagnosis of post-natal depression (PND) or who score moderate PND or above on health visitor applied screening tools (EPDS >13) (PHQ-9 >10) or anxiety (GAD-7 score >10)
- Infants born <32 weeks gestation
- Infants born 32-40 weeks whose birth weight is less than 2nd centile
- Infants born at term (40 weeks) who weigh less than 2.5 kg
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 |
|---|---|---|
| ProAskThe intervention is a computer programme ProActive Assessment of Overweight Risk to identify infants at risk of developing childhood overweight and obesity. Parents of infants identified as at risk will be offered strategies for prevention by UK health visitors (public health nurses) | Behavioural | Infants at risk |
Primary outcome
Acceptability and utility of the ProAsk intervention
Time frame: 12 months
Recruitment, retention, intervention delivery and attrition rates. Proportion of infants calculated as at risk of developing childhood overweight/obesity
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 12 Jul 2016.
- Derived from this study: PubMed 30866879Rose J, Glazebrook C, Wharrad H, Siriwardena AN, Swift JA, Nathan D, Weng SF, Atkinson P, Ablewhite J, McMaster F, Watson V, Redsell SA. Proactive Assessment of Obesity Risk during Infancy (ProAsk): a qualitative study of parents' and professionals' perspectives on an mHealth intervention. BMC Public Health. 2019 Mar 12;19(1):294. doi: 10.1186/s12889-019-6616-5.
- Derived from this study: PubMed 28882926Redsell SA, Rose J, Weng S, Ablewhite J, Swift JA, Siriwardena AN, Nathan D, Wharrad HJ, Atkinson P, Watson V, McMaster F, Lakshman R, Glazebrook C. Digital technology to facilitate Proactive Assessment of Obesity Risk during Infancy (ProAsk): a feasibility study. BMJ Open. 2017 Sep 6;7(9):e017694. doi: 10.1136/bmjopen-2017-017694.
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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.
Sarah Redsell, PhD study director
Anglia Ruskin University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood Obesity, run by Anglia Ruskin University at 2 sites 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 6 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 12 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Acceptability and utility of the ProAsk intervention (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02314494, which also lists 2 linked publications.
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 12 Jul 2016.