Proactve Assessment of Overweight Risk During Infancy

NCT02314494 | Completed

• 1 other identifier: FHSCE001
• Study Type: observational
• Target: 83
• Locations: 1 country
• Sites: 2

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).

Conditions

Childhood Obesity

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Infants at risk

Infants identified as at risk of obesity using the ProAsk intervention

Behavioral: ProAsk

Infants not at risk

Infants identified as not at risk of obesity using the ProAsk intervention.

Interventions

ProAsk BEHAVIORAL

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)

Infants at risk

Eligibility Criteria

• Age: 6 Weeks - 12 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants 6-8 weeks old living in the study areas (Cambridshire and Nottingham City)

You may qualify if:

• Parents/legal guardians/carers of infants aged 6-8 weeks
• First or subsequent born infants

You may not qualify if:

• 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

Sponsors & Collaborators

• Anglia Ruskin University: lead
• University of Nottingham: collaborator
• University of Lincoln: collaborator
• University of Cambridge: collaborator
• Nottingham University Hospitals NHS Trust: collaborator

Study Sites (2)

Cambridgeshire Community Services

Cambridgeshire, United Kingdom

Location

Nottingham City Care Partnership

Nottingham, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 30866879 DERIVED

• Redsell 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.

  PMID: 28882926 DERIVED

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sarah Redsell, PhD

  Anglia Ruskin University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2014
• First Posted: December 11, 2014
• Study Start: May 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: March 1, 2016
• Last Updated: July 12, 2016

Record last verified: 2015-12

Locations

GB (2)