Baby Milk Study: establishing a healthy growth trajectory from birth

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN20814693

Enrollment

700

Registered

2011-01-13

Start date

2011-01-01

Completion date

Unknown

Last updated

2019-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Public health, obesity prevention Nutritional, Metabolic, Endocrine Obesity

Interventions

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:

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
Change in weight standard deviation score from birth to age 12 months	—

Secondary

Measure	Time frame
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).	—

Measure

Time frame

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).

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 24, 2026