TABLE 1.
Inclusion and exclusion criteria established for the selection of studies to include in SRs on infant milk-feeding practices and diabetes outcomes in offspring1
| Category | Inclusion criteria | Exclusion criteria |
|---|---|---|
| Study design | Randomized controlled trials Nonrandomized controlled trials Prospective cohort studies Retrospective cohort studies Case-control studies |
Cross-sectional studies Before-and-after studies Uncontrolled studies Narrative reviews Systematic reviews Meta-analyses |
| Publication status | Published in peer-reviewed journals | Grey literature, including unpublished data, manuscripts, reports, abstracts, and conference proceedings |
| Language | Published in English | Published in languages other than English |
| Date range | Published from 1980 to December 20152 | Published prior to 1980 |
| Source of foods, beverages, or nutrients | Human milk: mother's own milk, i.e., human milk fed at the breast or expressed and fed fresh or after refrigeration/freezing Infant formula: commercially prepared infant formula meeting FDA (31) and/or Codex Alimentarius (32) food standards |
Human milk from third parties (e.g., banked/donor milk) Infant formulas that are not commercially prepared or that do not meet FDA (31) and/or Codex Alimentarius (32) food standards |
| Study setting | Countries listed as Very High or High on the 2014 Human Development Index3 (33, 34) | Countries listed as Medium or Low on the 2014 Human Development Index (33) |
| Study participants |
Human participants Males Females |
Nonhuman participants (e.g., animal studies, in vitro studies) Hospitalized patients, not including birth and immediate postpartum hospitalization of healthy babies |
| Age of study participants |
Exposure age: infants (0–12 mo), toddlers (12–24 mo) Outcome age: infants (0–12 mo), toddlers (12–24 mo), children (2–12 y), adolescents (13–18 y) adults (≥19 y) |
|
| Size of study groups | Studies with ≥30 participants per study group or a power analysis indicating that the study is appropriately powered for the outcome(s) of interest | Studies with <30 participants per study group with no power analysis indicating that the study is appropriately powered for the outcome(s) of interest |
| Health status of study participants | Studies done in generally healthy populations Studies done in populations where infants were full term (≥37 and 0/7 wk gestational age) Studies done in populations with elevated chronic disease risk, or that enroll some participants with a disease or with the health outcome of interest |
Studies that exclusively enroll participants with a disease or the health outcome of interest Studies done in hospitalized participants (except for birth and immediate post-partum hospitalization of healthy babies) or malnourished participants Studies of exclusively pre-term babies (gestational age <37 wk), exclusively babies that have low birth weight (<2500 g) and/or exclusively babies that are small for gestational age |