Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Proactve Assessment of Overweight Risk During Infancy (ProAsk)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02314494
Recruitment Status : Completed
First Posted : December 11, 2014
Last Update Posted : July 12, 2016
Sponsor:
Collaborators:
University of Nottingham
University of Lincoln
University of Cambridge
Nottingham University Hospitals NHS Trust
Information provided by (Responsible Party):
Anglia Ruskin University

Tracking Information
First Submitted Date December 5, 2014
First Posted Date December 11, 2014
Last Update Posted Date July 12, 2016
Study Start Date May 2015
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 12, 2014)
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
Original Primary Outcome Measures
 (submitted: December 9, 2014)
Acceptability and utility of the ProAsk intervention with UK health professionals and parents: Data to inform the trial design and data collection procedures for a future Randomised Controlled Trial. [ Time Frame: 10 months ]
Change History Complete list of historical versions of study NCT02314494 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Proactve Assessment of Overweight Risk During Infancy
Official Title A Feasibility Study of an Interactive, Educational Programme to Facilitate Proactive Assessment of Overweight Risk During Infancy
Brief 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).

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 Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Infants 6-8 weeks old living in the study areas (Cambridshire and Nottingham City)
Condition Childhood 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)
Study Groups/Cohorts
  • Infants at risk
    Infants identified as at risk of obesity using the ProAsk intervention
    Intervention: Behavioral: ProAsk
  • Infants not at risk
    Infants identified as not at risk of obesity using the ProAsk intervention.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 23, 2015)
83
Original Estimated Enrollment
 (submitted: December 9, 2014)
100
Actual Study Completion Date March 2016
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 6 Weeks to 12 Weeks   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT02314494
Other Study ID Numbers FHSCE001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Anglia Ruskin University
Study Sponsor Anglia Ruskin University
Collaborators
  • University of Nottingham
  • University of Lincoln
  • University of Cambridge
  • Nottingham University Hospitals NHS Trust
Investigators
Study Director: Sarah Redsell, PhD Anglia Ruskin University
PRS Account Anglia Ruskin University
Verification Date December 2015