Tershakovec 1998 (RCT).

Methods	Study design: RCT. Study grouping: parallel group. Allocation ratio: 1:1. Analyses methods: "Repeated measures analyses of variance and covariance compared group changes in growth over time related to the intervention (analysis 1) or dietary fat intake (analysis 3)." Description of randomisation: "At‐risk children who met the study criteria and agreed to participate were randomised to study groups using a permuted blocks within strata design. Stratifying on age and gender, we employed an adaptive allocation procedure that yielded balance within first order interactions with season and pediatric practice." Allocation concealment NR. NR who enrolled and assigned participants. How were missing data handled? "Because some subjects did not have available data for all four evaluation points, BMDP‐5V was used for the repeated measures analysis of variance to include all possible participants." Number of study contacts: 4. Period of follow‐up (from when duration of active intervention period ended): 9 months. Periods of recruitment: "Subject enrollment began in October 1990 and continued through December 1992." Sample size justification adequately described? NR. Sampling method: 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 the growth of children with hypercholesterolaemia completing an innovative, physician‐initiated, home‐based nutrition education program or standard nutrition counselling that aims to lower dietary fat intake. Study population: children with hypercholesterolaemia aged 4‐10 years from suburban paediatric practices in Philadelphia, PA, USA.
Participants	Baseline characteristics (reported for 2 groups and overall group) Lower fat intake (≤ 30%TE) Age (mean in years): 6.2 (SD 1.76). Sex: 50% girls. Ethnicity: white 89.5%; African‐American 8.1%; other 1.2%. Education: NR. Income: NR. Pubertal stage: NR. Parental BMI: NR. Child total energy (kJ): 6506 (SD 176). Child total fat intake: in g: 52.1 (SD 13.9); in %TE: 29.6 (SD 5.6). 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 (mmol/L): 3.3 (SD 0.37). Child body fatness, weight‐for‐age z‐score: 0.04 (SD 1.02). Child saturated fat intake (%TE): 11.5 (SD 3.2). Child body fatness, sum of skinfolds (mm); 26.3 (95% CI 24.5 to 28.2). Child body fatness, % weight‐for‐height: 103.4 (SD 10.2). Usual or modified fat intake Age (mean in years): 6.4 (SD 1.77). Sex (% girls): 48. Ethnicity: white 83.9%; African‐American 11.5%; other 4.6%. Education: NR. Income: NR. Pubertal stage: NR. Parental BMI: NR. Child total energy (kJ): 7138 (SD 410). Child total fat intake:in g: 56.2 (SD 14); in %TE: 29.5 (SD 5.6). 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 (mmol/L): 3.34 (SD 0.28). Child body fatness, weight‐for‐age z‐score: 0.26 (SD 0.93). Child saturated fat intake (%TE): 11.1 (SD 3.0). Child body fatness, sum of skinfolds (mm): 26.3 (95% CI 24.7 to 28.0). Child body fatness, % weight‐for‐height: 104.5 (SD 11.9). Overall 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	Intervention characteristics Lower fat intake (≤ 30%TE) Energy prescription: NR. Total fat prescription: total fat ≤ 30%TE. SFA, PUFA, MUFA prescription: SFA, PUFA and MUFA: 10% for each. Total protein prescription: NR. Total CHO prescription: NR. Other diet prescription details: cholesterol: ≤ 100 mg/100 calories with a max 300 mg/day. Received standardised guidance using the AHA booklet "Eating for a Healthy Heart." Method number of dietary assessments: 4 visits in total (baseline, 3, 6 and 12 months), 3 × 24‐hour dietary recalls per assessment period (2 weekdays, 1 weekend day chosen randomly) obtained with standardised microcomputer Nutrition Data System (Food Data Base Versions 4 19; developer: University of Minnesota). A parent (usually mother) of children aged 4‐6 years interviewed with child available for questions; children aged 8‐10 years interviewed with a parent available for questions. Other components prescribed: NR. Duration of intervention: 3 months. Implementation: children and parents attended a counselling session with registered dietician, trained by paediatric dietician (45‐60 minutes). Study dietician available via telephone during following 3 months. Usual or modified fat intake Energy prescription: NR. Total fat prescription: NR. SFA, PUFA, MUFA prescription: NR. Total protein prescription: NR. Total CHO prescription: NR. Other diet prescription details: NR. Method number of dietary assessments: 3 × 24‐hour dietary recalls per assessment period (at baseline, 3, 6 and 12 months). Other components prescribed: NR. Duration of intervention: 3 months. Implementation: "Children and parents in the at‐risk control group were not provided educational information or materials."
Outcomes	Weight Weight‐for‐age z‐score. Height Height‐for‐age z‐score.
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 article.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Permuted blocks within strata design used with minimisation. Authors reported that at baseline, the 4 groups were balanced, except for race, but no statistical test for differences reported.
Allocation concealment (selection bias)	Unclear risk	NR.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	NR.
Incomplete outcome data (attrition bias) All outcomes	High risk	Loss to follow‐up at 12 months: intervention group: 13/86 (15.1%) and control group: 9/87 (10.3%). Reasons for loss to follow‐up NR, except for withdrawal of consent (intervention group 4 and control group 2). Missing data not imputed but authors reported that BMDP‐5V was used for the repeated measures ANOVA to include all possible participants.
Selective reporting (reporting bias)	Unclear risk	Primary and secondary outcomes not clearly defined in methods. Study protocol not available.
Other bias	Unclear risk	Limited information on control diet prescription; unable to judge if prescribed diets being compared differed in components other than total fat.

%TE: percentage of total energy intake; AAP: American Academy of Pediatrics; AHA: American Heart Association; ALSPAC: Avon Longitudinal Study of Parents and Children; ANOVA: analysis of variance; BC: body composition; BIA: bioelectrical impedance analysis; BMI: body mass index; BMI‐SDS: body mass index‐standard deviation score; BP: blood pressure; CDC: Centers for Disease Control and Prevention; CHD: coronary heart disease; CHO: carbohydrate; CI: confidence interval; CIF: Children in Focus; CVD: cardiovascular disease; DBP: diastolic blood pressure; DED: dietary energy density; DEXA: dual energy X‐ray absorptiometry; DONALD: Dortmund Nutritional and Anthropometric Longitudinally Designed; DP: dietary pattern; DR: dietary record; FD: fibre density; FFQ: Food Frequency Questionnaire; FM: fat mass; FMI: fat mass index; GEE: generalised estimating equation; GLM: general linear model; HDL‐C: high‐density lipoprotein cholesterol; HF: high fat; HOMA: Homeostasis Model Assessment; HOMA‐IR: Homeostasis Model Assessment‐Insulin Resistance; IFG: impaired fasting glucose; IQR: interquartile range; IR: insulin resistance; ITT: intention to treat; LDL‐C: low‐density lipoprotein cholesterol; LF: low fat; LTPA: leisure‐time physical activity; max: maximum; MD: mean difference; MET: metabolic equivalent; min: minimum; MUFA: monounsaturated fatty acid; n: number of participants; NA: not applicable; NCEP: National Centers for Environmental Prediction; NGHS: National Heart, Lung and Blood institute Growth and Health Study; NHLBI: National Heart, Lung and Blood Institute; NR: not reported; NS: not significant; PEP: Prevention Education Program; PUFA: polyunsaturated fatty acid; RCT: randomised controlled trial; SBP: systolic blood pressure; SD: standard deviation; SDS: standard deviation score; SE: standard error; SES: socioeconomic status; SFA: saturated fatty acid; SS‐SDS: subscapular skinfold‐standard deviation score; STRIP: Special Turku Coronary Risk Factor Intervention Project; T2DM: type 2 diabetes mellitus; TAAG: Trial of Activity for Adolescent Girls Cohort; TC‐SDS: triceps skinfold‐standard deviation score; TG: triglyceride; TV: television; WC: waist circumference.