Specialist health visitor intervention for failure to thrive

ISRCTN ISRCTN81276508
DOI https://doi.org/10.1186/ISRCTN81276508
Secondary identifying numbers N/A
Submission date
23/01/2004
Registration date
23/01/2004
Last edited
17/09/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Mary Rudolf
Scientific

Community Paediactrics
Leeds Community and Mental Health Trust
Belmont House
3-5 Belmont Grove
Leeds
LS2 9NP
United Kingdom

Phone +44 0113 392 6352
Email mary.rudolf@leedsth.nhs.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Scientific title
Study objectivesTo determine whether home intervention by a specialist health visitor affects the outcome of children with failure to thrive
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedOther nutritional, metabolic and endocrine disease
InterventionConventional care vs conventional care plus specialist home visiting for 12 months
Intervention typeOther
Primary outcome measure1. Growth
2. Eating difficulties
3. Diet
4. Health service utilitilization including hospital admission
5. Maternal mental health
Secondary outcome measuresNot provided at time of registration
Overall study start date01/04/1994
Completion date28/02/1997

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants42 (added 17/09/09)
Key inclusion criteriaChildren referred to a failure to thrive clinic - aged 4-30 months and weight below third centile, or deceleration in weight gain over two centile channels
Key exclusion criteria1. Chronic illness affecting growth
2. Parents non-english speakers
Date of first enrolment01/04/1994
Date of final enrolment28/02/1997

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Community Paediactrics
Leeds
LS2 9NP
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.doh.gov.uk

Funders

Funder type

Government

NHS Executive Northern and Yorkshire (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/06/1999 Yes No