Proactve Assessment of Overweight Risk During Infancy

Childhood Obesity Clinical Trial

— ProAsk  

Official title:

A Feasibility Study of an Interactive, Educational Programme to Facilitate Proactive Assessment of Overweight Risk During Infancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02314494
• Other study ID #: FHSCE001
• Status: Completed
• Phase: N/A
• First received: December 5, 2014
• Last updated: July 11, 2016
• Start date: May 2015
• Est. completion date: March 2016

Study information

• Verified date: December 2015
• Source: Anglia Ruskin University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: March 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Weeks to 12 Weeks

Eligibility

Inclusion Criteria:

• Parents/legal guardians/carers of infants aged 6-8 weeks

• First or subsequent born infants

Exclusion Criteria:

• 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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Childhood Obesity
• Overweight
• Pediatric Obesity

Intervention

Behavioral:
• ProAsk
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)

Locations

Country	Name	City	State
United Kingdom	Cambridgeshire Community Services	Cambridgeshire
United Kingdom	Nottingham City Care Partnership	Nottingham

Sponsors (5)

Lead Sponsor	Collaborator
Anglia Ruskin University	Nottingham University Hospitals NHS Trust, University of Cambridge, University of Lincoln, University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 months	No