|Title:||Establishing a healthy growth trajectory from birth: Randomised Controlled Trial of a theory-based, multi-component intervention to reduce formula milk intake and prevent excess weight gain during infancy|
|Project Description:||Infancy is a period of rapid growth and habit formation hence could be a critical period for obesity prevention. Excess weight gain during infancy is associated with later obesity and formula-fed babies are more likely to gain excess weight compared to breastfed babies.
We will recruit approximately 700 mothers who introduce formula-milk feeds within 14 weeks of their baby’s birth to a single (assessor) blind, parallel group, individually randomised controlled trial. The focus of the intervention is the care-giver (usually mother) and the focus of the primary outcome is the infant. The intervention group will receive the behavioural intervention which aims to reduce formula-milk intake, promote responsive feeding and healthy weaning, and prevent excessive weight gain during infancy. The intervention is based on Social Cognitive Theory and action planning (‘iImplementation ‘Iintentions’). It consists of three components: (1) a motivational component to strengthen the parents’ motivation to follow the Baby Milk feeding guidelines, (2) an action planning component to help translate motivation into action; and (3) a coping planning component to help parents cope deal with difficult situations. It is delivered by trained facilitators over six months through 3 face-to-face contacts, 2 telephone contacts and written materials. The control group will have the same number of contacts with facilitators and general issues about feeding will be discussed. Anthropometric outcomes will be measured by trained research staff at baseline, six months and 12 months following standard operating procedures. Validated questionnaires to will assess milk intake, temperament, appetite, sleep, health-service utilisation , maternal quality of life and maternal psychological factors will be collected. A 4-Day food diary will be completed at 8 months. The primary outcome is change in weight standard deviation score from birth to 1 year. Secondary objectives are to quantify the effects of the intervention on infant energy intake and diet at age 8 months and changes in infant adiposity during the first year of life.
The results of the trial will help to inform infant feeding guidelines and to understand the links between infant feeding, behaviour, appetite and growth.
|UK ISRCT Number:||20814693|
|Start date:||1st April 2012|
|End date:||1st April 2016|
|Contact person:||Dr Ed Wilson|
|Contact Details:||Primary Care Unit
Institute of Public Health
University Forvie Site, Robinson Way
Fax: 01223 762515
|Collaborative:||Rajalakshmi Lakshman, Fiona Whittle, Wendy Hardeman, Marc Suhrcke, Ed Wilson, Simon Griffin and Ken Ong|
|Funding Organisation:||Medical Research Council|
|Further Information, References and Publications|
|Run by the MRC Epidemiology Unit, HSR economists are leading the economic evaluation alongside the study.
Study Website : http://www.mrc-epid.cam.ac.uk/research/studies/babymilk