Variable | Definition/explanatory text/examples* |
Primary outcome | |
BMI z-score at age 24 months (±6 months) | Determined in accordance with WHO growth standards60 |
Secondary outcomes | |
BMI z-score at 12 months (±3 months) | Determined in accordance with WHO growth standards60 |
BMI z-score at 48 months (±12 months) | Determined in accordance with WHO growth standards60 |
BMI z-score beyond 60 months | Determined in accordance with WHO growth standards60 |
Other weight-related measures | For example, prevalence of overweight/obesity (defined as BMI z-score of at least 2 SD above the WHO reference), per cent fat content/ adiposity, skinfold thickness, abdominal circumference, waist-to-height ratio, velocity of weight gain, weight-for-length, per cent excess BMI >95th percentile, adiposity rebound |
Infant feeding | For example, breast feeding initiation and duration, exclusivity of breast feeding, age at introduction of solid foods (complementary feeding) |
Dietary intake | For example, energy intake, intake of fruit, vegetables, energy dense nutrient poor foods, and sugar-sweetened beverages |
Sedentary behaviours | For example, screen time, restrained time while awake (in prams/strollers, high-chairs, strapped on a caregiver’s back or chest) |
Physical activity | For example, active play duration, prone play (‘tummy time’), device assessed physical activity time |
Sleep | For example, sleep duration, measures of sleep quality such as frequency and duration of waking at night |
Parental/caregiver measures | General and domain-specific parenting styles and practices, for example, parenting self-efficacy, parenting styles, parent feeding practices, parent physical activity practices, parent sleep practices, stress |
Adverse events | For example, underweight, injuries, infection |
Individual-level subgroups | |
Socioeconomic position | For example, household income/country median household income, parent/caregiver highest education level, employment status |
Parental weight status | For example, maternal prepregnancy BMI, paternal BMI |
Race/ethnicity | Trialist defined |
Maternal age | At recruitment |
Maternal gestational weight gain | In kilograms |
Parity | Primipara, multiparous |
Mode of delivery at birth | Caesarean, vaginal |
Birth weight | In grams |
Weight for gestational age | Small for gestational age, appropriate for gestational age, large for gestational age |
Sex | Female, male, uncertain/other |
Gestational age at birth | Preterm, term |
Household composition | For example, 2 versus 1 adult household, siblings, marital status |
Type of pregnancy | Singleton, multiple |
Maternal diabetes | Gestational, type 1, type 2 |
Smoking during pregnancy | yes/no |
Infant’s age at enrolment | In months |
Child’s age at final assessment | In months |
Child care attendance | yes/no |
Trial-level subgroups | |
Delivery mode (intervention) | For example, face-to-face, letter, mobile digital device, individual versus group |
Intervention setting | For example, household residence, community healthcare facility |
Intervention dose/intensity | For example, total number of contacts, frequency of contact, duration of contact |
Fidelity | Planned, actual |
Timing of intervention onset | Preconception, antenatal, postnatal |
Timing of intervention completion | Child age in months |
Current level of background care in the community | Descriptive, categorisation to be determined, for example, expected number of health contacts between birth and 1 year, expectation of attending prenatal programmes (yes/no), etc. |
Country | Low, middle, high income |
Behavioural±other intervention type | Behavioural intervention(s) alone versus behavioural+other intervention type (eg, supplement) |
*Exact measures and definitions will depend on what the individual trials have collected and the degree to which harmonisation is possible. Specific details of all outcome measures will be elaborated on in our forthcoming statistical analysis plan, which will be agreed and signed off by the Collaboration before any data are analysed.
BMI, body mass index.