| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN55500035 |
| Date ISRCTN assigned | 19/07/2007 |
| Local reference number(s) | N09016 |
| Public title | Promoting recommended infant feeding practices in a low income sample - randomised controlled trial of a peer support intervention |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Nutrition, infant feeding practices |
| 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. |
| Design/methodology | Randomised single-blind controlled trial |
| Research ethics review | Approval given by the North London Community Research Consortium: Camden and Islington Community Health Service on the 1st February 2002 (ref: LREC 02113). |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - 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 |
| Patient information material | Patient information can be found at: http://www.ucl.ac.uk/dph/IFPST%20PDF/Resources/subject%20information%20sheet.pdf |
| Anticipated start date | 01/02/2002 |
| Anticipated end date | 01/04/2006 |
| Status of trial | Completed |
| Target number of participants | 318 women across control and intervention groups |
| Interventions | 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. |
| Primary outcome measure(s) | 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 measure(s) | 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. |
| Trial website | http:www.ucl.ac.uk/dph |
| Publications | Protocol in http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=16925876 |
| Sources of funding | Food Standards Agency (UK) (ref: N09016) |
| Sponsor name | Food Standards Agency (UK) |
| Sponsor details | Aviation House
125 Kingsway
London
United Kingdom
WC2B 6NH |
| Sponsor website | http://www.food.gov.uk |
| Contact name | Prof Richard Watt |
| Contact details | Department of Epidemiology and Public Health
University College London (UCL)
1-19 Torrington Place
London
United Kingdom
WC1E 6BT |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN55500035 |
| Date last extracted from ISRCTN register | 17/04/2008 |
