Schwandt 2011.

Methods	Study design: prospective cohort study. Analyses methods for cohorts: bivariate and multivariate regression analysis used for age and gender adjustments. As some families had > 1 child in analysis or child pairs with both biological father and mother (or both), GEE used to generate age and gender adjusted odds ratios that accounted for correlation among multiple within‐family observations. How were missing data handled? 575 parents and 411 children (36.1%) completed study at 2 years. Authors did not state how many started study. They only stated that many did not accept the invitation to participate and mentioned incomplete data as a reason for the final numbers of participants. Reported that characteristics of non‐participants and participants were not significantly different (variables not stated). Number of study contacts: 2 (baseline/year 1; year 2). Period of follow‐up (total period of observation): 1 year. Periods of recruitment: NR. Sampling method: convenience sample. 2690 parents and children with complete CVD risk factor profiles and lifestyle data, who participated in a previous PEP substudy. Study objective: to examine whether associations between improved CVD risk profiles and lifestyle changes persist over 1 year in a real‐life setting. Study population: healthy German grade 1 children of elementary schools in Nuremberg, Germany.
Participants	Baseline characteristics (reported for 1 overall group) Age (mean in years): overall 6.8 (SD 1.75); boys 6.8 (SD 1.7); girls 6.8 (SD 1.8). Sex: 52.6% girls. Ethnicity: 100% German. Education: NR. Income: NR. Pubertal stage: NR. Parental BMI (kg/m2): overall 24.4 (SD 3.6); father 25.3 (SD 3.2); mother 23.7 (SD 3.7). Child total energy (kJ): overall 6374 (SD 1317); boys 6692 (SD 1431); girls 6087 (SD 1129). Child total fat: in g: overall 60.3 (SD 15.4); boys 63.1 (SD 17.1); girls 57.8 (SD 13.2); in %TE:overall 36.7; boys 36.5; girls 36.9. Child total protein: in g: overall 48.3 (SD 11.4); boys 50.7 (SD 12.1); girls 46.2 (SD 10.3); in %TE:overall 13.0; boys 13.0; girls 13.0. Child total CHO: in g: overall 191.9 (SD 43.4); boys 201.9 (SD 46.4); girls 182.8 (SD 38.3); %TE: overall 51.7; boys 51.9; girls 51.5. Child physical activity: total LTPA (hours/week): overall 3.6 (SD 3.9); boys 3.8 (SD 3.8); girls 3.4 (SD 3.9); light LTPA (hours/week): overall 2.4 (SD 2.0); boys 2.7 (SD 2.0); girls 2.2 (SD 2.0); moderate LTPA (hours/week): overall 2.4 (SD 2.0); boys 2.8 (SD 2.0); girls 2.1 (SD 2.0); intense LTPA (hours/week): overall 3.6 (SD 3.9); boys 3.8 (SD 3.8); girls 3.4 (SD 3.9); total METs (per week): overall 1455 (SD 1300); boys 1624.5 (SD 1368.6); girls 1302 (SD 1214.7). Child physical inactivity or screen time or both (hours/day): overall 3.56 (SD 1.12); boys 3.4 (SD 1.0); girls 3.7 (SD 1.2). Child CVD risk (excluding fatness): SBP (mmHg): overall 103.1 (SD 9.2); boys 102.7 (SD 8.5); 103.4 (SD 9.7); DBP (mmHg): overall 67.5 (SD 8.3); boys 67.2 (SD 8.1); girls 67.7 (SD 8.5); total cholesterol (mg/dL): overall 173.7 (SD 28.3); boys 171.7 (SD 29.6); girls 175.5 (SD 26.9); LDL‐C (mg/dL): overall 104.4 (SD 25.4); boys 102.0 (SD 26.6); girls 106.5 (SD 24.1); HDL‐C (mg/dL): overall 56.5 (SD 13.9); boys 57.7 (SD 12.4); girls 55.5 (SD 15.0); TG (mg/dL): overall 63.9 (SD 24.5); boys 59.8 (SD 24.6); girls 67.6 (SD 23.9); glucose (mg/dL): overall 95.8 (SD 9.9); boys 96.1 (SD 10.5); girls 95.5 (SD 9.3). Child body fatness:weight (kg): overall 25.3 (SD 7.3); boys 25.3 (SD 7.1); girls 25.3 (SD 7.5); BMI (kg/m2): overall 15.85 (SD 2.0); boys 15.9 (SD 2.0); girls 15.8 (SD 2.0); WC (cm): overall 56.7 (SD 5.8); boys 57.2 (SD 5.8); girls 56.3 (SD 5.8); sum of skinfolds (mm): overall 20.4 (SD 7.4); boys 18.5 (SD 6.7); girls 22.2 (SD 7.6); % body fat: overall 22.1 (SD 3.3); boys 21.3 (SD 3.0); girls 22.8 (SD 3.4). Included criteria: children who did not met exclusion criteria. Excluded criteria: non‐German children; self‐reported cardiovascular, metabolic, endocrine and malignant disorders; extreme physical activity; special nutritional habits and medication. Brief description of participants: healthy German children and parents participating in PEP study. Total number completed in cohort study: 411 (195 boys; 216 girls). 36.1% lost (invited parent‐child pairs), author indicated that characteristics of non‐participants and participants were not significantly different. Total number enrolled in cohort study: 1150 children from 2001 PEP substudy invited. Number enrolled NR.
Interventions	Description of exposure for cohorts Time span: 1 year. Dietary assessment method used: weighed DR. Frequency of dietary assessments: single 7‐day weighed DR at baseline and after 1 year' follow‐up. 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 (kg). BMI BMI (kg/m2). Body fat Body fat (%).
Identification	Sponsorship source: Foundation for the Prevention of Atherosclerosis, Nuremberg, Germany; Ludwig Maximilian University, Munich, Germany; Bavarian Ministry of Health, Munich; City of Nuremberg. Country: Germany. Setting: community in Nuremberg. Comments: PEP Family Heart Study. Author's name: Peter Schwandt. Institution: Arteriosklerose Präventions Institut and Ludwig Maximilians University, Munich. Email: API.Schwandt.Haas@t‐online.de. Declaration of Interests: no. Study ID: Schwandt 2010. Type of record: journal article.
Notes	Authors provided separate regression data on children only, since regression data in text referred to both children and adults.
Risk of bias
Bias	Authors' judgement	Support for judgement
Were adequate outcome data for cohorts available? All outcomes	Unclear risk	Author indicated that characteristics of non‐participants were similar to those who participated in present study but specific variables and analyses NR. Study also had a high non‐response rate as only 36.1% of the invited parent‐child pairs completed follow‐up after 1 year.
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	Although age, gender and physical activity were adjusted in the data analyses, parental BMI, SES and energy intake were not adjusted for.
Did the exposures between groups differ in components other than only total fat? All outcomes	Low risk
Can we be confident in the assessment of outcomes? All outcomes	Low risk	Outcome measures undertaken using standardised methods (weight, height, skinfold thickness measurements, BP).
Can we be confident in the assessment of exposure? All outcomes	Low risk	7‐day weighed DRs assessed at baseline and 1 year.
Can we be confident in the assessment of presence or absence of prognostic factors? All outcomes	Low risk	Data collection done using acceptable methods. Physical activity assessed by validated questionnaires with a 7‐day recall period at baseline and at 1 year.
Was selection of less‐exposed and more‐exposed groups from the same population? All outcomes	Low risk	All participants from the PEP Healthy Heart study.