Baby Milk Study: establishing a healthy growth trajectory from birth

• Register: ISRCTN
• Last refreshed on: 26 August 2019
• Main ID: ISRCTN20814693
• Date of registration: 13/01/2011
• Prospective Registration: No
• Primary sponsor: Medical Research Council (MRC) (UK) - Epidemiology Unit
• Public title: Baby Milk Study: establishing a healthy growth trajectory from birth
• Scientific title: Establishing a healthy growth trajectory from birth: a randomised controlled trial of a theory-based, multi-component intervention to reduce formula-milk intake and prevent excess weight gain during infancy
• Date of first enrolment: 01/01/2011
• Target sample size: 700
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN20814693
• Study type: Interventional
• Study design: Single (assessor) blind parallel-group individually randomised controlled trial (Prevention)
• Phase: Not Applicable

Countries of recruitment

United Kingdom

Contacts

• Name: Rajalakshmi Lakshman

Key inclusion & exclusion criteria

Inclusion criteria: Participants will be male and female babies aged 2 - 10 weeks at recruitment, and their parents. All healthy, singleton, term infants who are already receiving some formula-milk will be eligible to participate.
Exclusion criteria:
1. Low birth weight (less than 2,500 g)
2. Pre-term infants (less than 37 weeks gestation)
3. Infants with major malformations, hormonal or metabolic diseases which might interfere with nutrition or growth


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Public health, obesity prevention
Nutritional, Metabolic, Endocrine
Obesity

Intervention(s)

We have developed an intervention to support mothers to feed their babies appropriately based on 2004 WHO recommendations for energy requirement. The intervention consists of three components:
1. A motivational component based on Social Cognitive Theory
2. A component to help translate motivations into actions (including goal setting, action plans and self-monitoring)
3. A component to help mothers to cope with barriers
The intervention comprises 3 x 30 - 45 minute face-to-face contacts (at baby's ages 2, 4 and 6 months) and 2 x 15 - 20 minute telephone contacts (at 3 and 5 months) in addition to theory-based intervention leaflets (at 2 and 4 months).

The control group (usual care) will have the same number of contacts as the intervention group during which general information about formula-milk feeding and infant health will be discussed and continued participation in the study will be encouraged.

Primary Outcome(s)

Change in weight standard deviation score from birth to age 12 months

Secondary Outcome(s)

Secondary objectives of the trial are to quantify the effects of the intervention on:
1. Infant energy intake and diet at age 8 months
2. Changes in infant adiposity during the first year of life
3. Health service utilisation during the first year of life
4. Maternal wellbeing
5. Maternal body composition

We will test the hypothesised mechanism (based on Social Cognitive Theory) underlying any effect of the intervention on behaviour. Data from the trial will also allow cohort analyses to:
1. Quantify the associations between the underlying psychological correlates, such as parental attitudes about growth, intentions, confidence (self efficacy)and outcome expectancies (constructs of the Social Cognitive Theory), and feeding behaviour and weight gain. We will perform qualitative studies to explore how parents make feeding decisions during the first year of a baby's life.
2. Understand where parents get information and advice about formula-feeding and what advice they follow
3. Quantify the association between formula milk intake and infant weight gain, length, body mass index (BMI), abdominal circumference and adiposity in the first year of life
4. Quantify the associations between infant temperament, sleep and eating behaviour on infant growth and feeding

In order to assess cost-effectiveness we will measure the costs of delivering the intervention and model the reduction in the burden of obesity if we are successful in preventing rapid weight gain (a difference of 0.67 standard deviation score or one centile line between the groups).

Secondary ID(s)

R090204/123

Source(s) of Monetary Support

Medical Research Council - National Prevention Research Initiative (Grant no. MR/J000361/1)

Ethics review

Status:
Approval date:
Contact:

Cambridgeshire 4 Research Ethics Committee, 30/04/2010, ref: 10/HO305/9

Results

• Results available: Yes
• Date Completed: 28/12/2015