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Proactve Assessment of Overweight Risk During Infancy (ProAsk)

2016년 7월 11일 업데이트: Anglia Ruskin University

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).

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

관찰

등록 (실제)

83

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

      • Cambridgeshire, 영국
        • Cambridgeshire Community Services
      • Nottingham, 영국
        • Nottingham City Care Partnership

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

1개월 (어린이)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

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

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
Infants at risk
Infants identified as at risk of obesity using the ProAsk intervention
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 not at risk
Infants identified as not at risk of obesity using the ProAsk intervention.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Acceptability and utility of the ProAsk intervention
기간: 12 months
Recruitment, retention, intervention delivery and attrition rates. Proportion of infants calculated as at risk of developing childhood overweight/obesity
12 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 연구 책임자: Sarah Redsell, PhD, Anglia Ruskin University

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2015년 5월 1일

기본 완료 (실제)

2016년 2월 1일

연구 완료 (실제)

2016년 3월 1일

연구 등록 날짜

최초 제출

2014년 12월 5일

QC 기준을 충족하는 최초 제출

2014년 12월 9일

처음 게시됨 (추정)

2014년 12월 11일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2016년 7월 12일

QC 기준을 충족하는 마지막 업데이트 제출

2016년 7월 11일

마지막으로 확인됨

2015년 12월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • FHSCE001

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다