Condition category
Nutritional, Metabolic, Endocrine
Date applied
09/07/2007
Date assigned
19/07/2007
Last edited
21/01/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http:www.ucl.ac.uk/dph

Contact information

Type

Scientific

Primary contact

Prof Richard Watt

ORCID ID

Contact details

Department of Epidemiology and Public Health
University College London (UCL)
1-19 Torrington Place
London
WC1E 6BT
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N09016

Study information

Scientific title

Acronym

Study hypothesis

Nutrition in early life is a key determinant of growth, development and health status, both in childhood and later adult life. Current UK recommendations advise all mothers to exclusively breastfeed for six months, and to delay introducing solids until at least six months. Data from national surveys show that infant feeding practices in the UK are, however, highly variable. This study aimed to evaluate the effectiveness of peer support on infant feeding outcomes and in particular weaning practices.

The research hypothesis was that compared with standard professional infant feeding support alone, the provision of peer support plus standard professional care will increase the consumption of vitamin C from fruit, and have a positive impact on other infant feeding practices with infants aged 3 months to 12 months living in lower income homes.

Ethics approval

Approval given by the North London Community Research Consortium: Camden and Islington Community Health Service on the 1st February 2002 (ref: LREC 02113).

Study design

Randomised single-blind controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Quality of life

Patient information sheet

Patient information can be found at: http://www.ucl.ac.uk/dph/IFPST%20PDF/Resources/subject%20information%20sheet.pdf

Condition

Nutrition, infant feeding practices

Intervention

A group of local volunteers were recruited and trained to provide non-judgemental support and practical assistance on infant feeding, and in particular weaning practices. Home-based support was offered over a nine-month period until the infants were 12 months old. In total, 758 home visits were made and the mean length of each visit was 60 minutes. On average each mother in the intervention group received five volunteer visits. Mothers in the control group received standard professional care only.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The primary outcome was vitamin C in fruit.

All outcomes were measured at baseline when infants were 10 weeks old, post intervention when subjects were 12 months old and follow up when they were 18 months old.

Secondary outcome measures

Secondary outcomes were:
1. Macro- and selected micro-nutrient intakes
2. Fruit and vegetable consumption
3. Feeding practices
4. Child growth and health
5. Use of health services

In addition, information was also gathered on the mother's health, well-being, fruit and
vegetable consumption and nutritional knowledge and confidence.

All outcomes were measured at baseline when infants were 10 weeks old, post intervention when subjects were 12 months old and follow up when they were 18 months old.

Overall trial start date

01/02/2002

Overall trial end date

01/04/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women from social classes II - V
2. Babies born greater than 37 weeks
3. Babies birth weight above 2500 g
4. Women able to understand written and oral English
5. Women resident in the Camden and Islington areas

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

318 women across control and intervention groups

Participant exclusion criteria

1. Women who were under 17 years
2. Infants who were diagnosed with a serious medical condition or who were on special diets due to medical problems
3. Infants aged over 12 weeks
4. Professional households from social class I
5. Women unable to communicate effectively in English

Recruitment start date

01/02/2002

Recruitment end date

01/04/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Epidemiology and Public Health
London
WC1E 6BT
United Kingdom

Sponsor information

Organisation

Food Standards Agency (UK)

Sponsor details

Aviation House
125 Kingsway
London
WC2B 6NH
United Kingdom

Sponsor type

Government

Website

http://www.food.gov.uk

Funders

Funder type

Government

Funder name

Food Standards Agency (UK) (ref: N09016)

Alternative name(s)

FSA

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. Protocol in http://www.ncbi.nlm.nih.gov/pubmed/16925876
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19141661

Publication citations

  1. Protocol

    Watt RG, McGlone P, Russell JJ, Tull KI, Dowler E, The process of establishing, implementing and maintaining a social support infant feeding programme., Public Health Nutr, 2006, 9, 6, 714-721.

  2. Results

    Watt RG, Tull KI, Hardy R, Wiggins M, Kelly Y, Molloy B, Dowler E, Apps J, McGlone P, Effectiveness of a social support intervention on infant feeding practices: randomised controlled trial., J Epidemiol Community Health, 2009, 63, 2, 156-162, doi: 10.1136/jech.2008.077115.

Additional files

Editorial Notes