Tershakovec 1998 (cohort).

Methods	Study design: RCT (cohort analysis). Analyses methods for cohort: children divided into quintiles by mean caloric intake as fat. Repeated measures analyses of variance and covariance performed to compare changes in height‐for‐age z‐score, weight‐for‐age z‐score, weight‐for‐height median, sum of skinfolds, caloric intake and fat intake over time. Potential influence of age and sex assessed in these analyses. How were missing data handled? Attrition rate 5.8% (20/342). Authors stated that pattern of dropouts over time did not differ with respect to age, sex and ethnicity or study group. Because some children did not have available data for all 4 evaluation points, used BMDP‐5V for repeated measures ANOVA to include all possible participants. Number of study contacts: 4 (baseline, 3, 6 and 12 months). Period of follow‐up (total period of observation): 1 year. Periods of recruitment: 1990‐1992. Sample size justification adequately described? NR. Sampling method: convenience sample. Cholesterol screening programme conducted in 9 suburban paediatric practices to identify "at‐risk" children (plasma total cholesterol > 4.55 mmol/L). If mean LDL‐C was elevated (mean fasting plasma LDL‐C 2.77‐4.24 mmol/L for boys and 2.90‐4.24 mmol/L for girls) and children consented they were randomised into 1 of 2 nutrition education intervention groups or an at‐risk control group. Study objective: to evaluate growth of children with hypercholesterolaemia completing an innovative, physician‐initiated, home‐based nutrition education programme or standard nutrition counselling that aimed to lower dietary fat intake. Study population: children aged 4‐10 years with hypercholesterolaemia from suburban paediatric practices in Philadelphia, USA.
Participants	Baseline characteristics (reported for 1 overall group) Age: "At baseline, the four groups were balanced." Sex (% girls): "At baseline, the four groups were balanced." Ethnicity: at baseline, there was a "difference in racial distribution" in the 4 groups. Education: NR. Income: NR. Pubertal stage: NR. Parental BMI: NR. Child total energy: "At baseline, the four groups were balanced." Child total fat intake: "At baseline, the four groups were balanced." Child total protein intake: NR. Child total CHO intake: NR. Child physical activity: NR. Child physical inactivity or screen time or both: NR. Child CVD risk (excluding fatness):LDL‐C: "At baseline, the four groups were balanced." Child body fatness, weight‐for‐age z‐score: NR. Child saturated fat intake: "At baseline, the four groups were balanced." Child body fatness, sum of skinfolds: NR. Child body fatness, % weight‐for‐height: NR. Included criteria: children aged 3.9‐9.9 years with elevated plasma total cholesterol > 4.55 mmol/L, fasting plasma LDL‐C 2.77‐4.24 mmol/L for boys and 2.90‐4.24 mmol/L for girls; ≥ 85% of ideal bodyweight. Excluded criteria: secondary causes of hypercholesterolaemia; < 130% of ideal bodyweight. Pretreatment: NR. Brief description of participants: children aged 4‐10 years with hypercholesterolaemia. Total number completed in RCT: intervention group: n = 73/86 and control group: n = 78/87. Total number randomised: n = 271.
Interventions	Description of exposure for cohort Time span: 1 year. Dietary assessment method: 3 × 24‐hour dietary recalls per assessment period. Frequency of assessment: baseline, 3, 6 and 12 months. Intervention and control group data pooled, and quintiles less‐exposed and more‐exposed to total fat intake compared in relation to eligible outcomes. See Table 9; Table 10; Table 11; Table 12; Table 13; Table 14; Table 15; Table 16; Table 17; Table 18 for details of total fat intake exposure per outcome.
Outcomes	Weight: Weight‐for‐age z‐score. Skinfold thickness Sum of 4 skinfolds (biceps, triceps, subscapular and supra‐iliac skinfolds) (mm).
Identification	Sponsorship source: National Heart, Lung, and Blood Institute (HL43880‐03), the Howard Heinz Endowment, and the University of Pennsylvania Research Foundation. Country: USA. Setting: suburban paediatric practice offices, Philadelphia, PA. Comments: NA. Author's name: Andrew M Tershakovec. Institution: Division of Gastroenterology and Nutrition, Children's Hospital of Philadelphia, PA, USA. Email: NR. Declaration of Interests: no. Study ID: Children's Health Project. Type of record: journal articles.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Were adequate outcome data for cohorts available? All outcomes	Unclear risk	5.8% (20/342) lost over 1 year. Authors stated that pattern of dropouts over time did not differ with respect to age, sex and ethnicity or study group but no analyses provided.
Was there matching of less‐exposed and more‐exposed participants for prognostic factors associated with outcome or were relevant statistical adjustments done? All outcomes	High risk	Data analyses only adjusted for age.
Did the exposures between groups differ in components other than only total fat? All outcomes	High risk	Children allocated to intervention groups received various dietary interventions.
Can we be confident in the assessment of outcomes? All outcomes	Low risk	Standardised methods used to assess height, weight and skinfold thickness.
Can we be confident in the assessment of exposure? All outcomes	Low risk	Repeated dietary assessments done using 3 × 24‐hour dietary recalls per assessment period.
Can we be confident in the assessment of presence or absence of prognostic factors? All outcomes	Low risk	Prognostic factors such as physical activity and parental BMI not assessed.
Was selection of less‐exposed and more‐exposed groups from the same population? All outcomes	Low risk	All participants of an RCT (Children's Health Project)