Development and testing of a multi-component intervention to reduce infant formula-milk intake and excess weight gain.

Excess weight in childhood causes problems both in the short term and in the long term. The number of people who are overweight or obese has been increasing and this is now even seen in preschool children. Research suggests that gaining a lot of weight in the first year of life may lead to obesity in childhood and adulthood. Research also suggests that the amount of milk currently recommended for infants is 15-20% more than what they actually need. This may be the reason why formula-fed babies are more likely to gain excess weight. We want to see if we can help parents feed their infants appropriately so that they do not consume more than they need and therefore put on excess weight. A group of doctors and psychologists will develop a programme after reviewing the literature and consulting with mothers, midwives and health visitors. Mothers on the programme will be given a new feeding schedule and educated on how to monitor the growth of their babies. Monitoring growth is an important way of picking up early if there is excessive weight gain and to prevent obesity. We will test this programme in a trial and if successful, develop this approach further for future use in the wider community.

Background Recent systematic reviews describe a consistent positive association between infant weight gain and obesity risk in children and adults. Those observational studies are supported by randomised trials of early nutrition in preterm infants indicating long-term adverse consequences of rapid weight gain on adult metabolic disease risk.

In 2004, based on new scientific data the FAO/WHO/UNU reduced their recommended energy requirements for infants by 15-20%. Furthermore, by placing growth of the breast-fed infant as the norm, the 2006 WHO International Growth Standard recommends a lower plane of infant weight gain compared to current UK infants. Neither recommendation has yet been adopted in the UK.

Aim To develop and test a multi-component intervention to reduce infant formula-milk intake and weight gain between birth to age 6 months.

Design and Methods

Stage I: To understand the factors associated with variation in energy intake of bottle-fed babies, I will conduct a systematic literature review of determinants of quantity of formula milk that mothers give their infants. I will also carry out a qualitative study using focus groups and individual semi-structured interviews with mothers of formula milk fed infants to explore their attitudes, beliefs and sources of advice on this topic.

Stage II: Development of the multi-component intervention: I will develop the intervention and pilot it to test acceptability and to further refine it prior to the main trial. Parents participating in the pilot study will be contacted regularly and interviewed in order to identify factors affecting delivery of the intervention. Various aspects of the trial protocol will also be piloted.

Stage III: Within an ongoing prospective birth cohort study, I will test the efficacy of a multi-component intervention (involving parental education on optimal infancy energy intake and weight gain, lowered recommendations on quantities of formula milk at different ages and feedback on infant weight gain using the WHO 2006 growth charts) using a single blind explanatory randomised control trial [design] to reduce energy intakes and infancy weight gain between 0-6 months [outcomes].

Outcomes: The main outcome is weight gain between 0-6 months. Secondary outcomes include parental attitudes, beliefs and knowledge regarding infant weight gain and intakes.

Scientific and medical opportunities: This study will improve understanding of why some infants are fed more than others and will help in the development of a pragmatic intervention for future testing in the broader community setting with longer-term follow-up to assess its impact on childhood obesity risk.