Cunningham‐Sabo 2003.

Study characteristics
Methods	Trial name: Pathways Study design: cluster‐RCT (implementation outcome at group level – based of study design paper) Intervention duration: 3 years Length of follow‐up from baseline Food service component: 22 months Health behaviour and anthropometric outcomes:3 years (spring 1997 to spring 2000). Differences in baseline characteristics: not reported Unit of allocation: school Unit of analysis: school
Participants	School type: primary schools Region: Arizona, New Mexico and South Dakota, USA Demographic/socioeconomic characteristics: not reported Inclusion/exclusion criteria Inclusion: ‐ A projected third grader enrolment of > 15 children ‐ > 90% of third‐grade children of American Indian ethnicity ‐ Retention from third to fifth grade over the past 3 years of > 70% ‐ School meals prepared and administered on‐site ‐ Availability of minimum facilities to deliver a PA programme at the school ‐ Approval of the study by school, community and tribal authorities Exclusion criteria ‐ Schools that were considering closing or merging in the next 3 years Number of schools allocated 39 schools (with a breakfast and lunch programme); 19 intervention, 20 control Numbers by trial group n (controls baseline) = 20 n (controls follow‐up) = 20 n (interventions baseline) = 19 n (interventions follow‐up) = 19 Recruitment Schools:cohort of > 1700 students in 41 schools (39 of which also had a breakfast programme) were followed from the third through the fifth grade. Students: not reported Recruitment rate: not reported
Interventions	Number of experimental conditions: 2 (1 intervention, 1 control) Policies, practices or programmes targeted by the intervention The practices targeted by the implementation intervention strategies were: ‐ to lower the fat in school breakfast and lunch ‐ to reduce the fat contribution in meals to ≥ 30% of calories over 5 consecutive days Implementation strategies EPOC: clinical practice guidelines ‐ The food service intervention included the development of nutrient guidelines operationalised as behavioural guidelines. These behavioural guidelines included specific steps and skill‐building techniques for lowering the fat content of menu items. EPOC: educational outreach visits ‐ To support the behavioural guidelines, training sessions were conducted twice each school year with all food service staff. These training sessions were reinforced by ≥ 5 kitchen visits in the first year and ≥ 8 visits to each school in the second and third years. EPOC: educational materials ‐ Materials and activities for the training sessions and kitchen visits were developed to reinforce the behavioural guidelines, and included posters, a videotape, food demonstrations, taste‐testing lower‐fat food items and food quantity estimation activities. EPOC: educational meetings ‐ The food service working group, made up of nutrition research staff, some of whom were from the tribal communities involved in the study, met annually and held monthly conference calls to establish and carry out the intervention. Theoretical underpinning: Social Learning Theory and Principles of American Indian culture and practices. Description of control: not reported, but assume usual practice.
Outcomes	Outcome relating to the implementation of school policies, practices or programmes ‐ % calories total fat breakfast (%) ‐ % energy from total fat Lunch (%) Data collection method: data collection included information on all school breakfast and lunch meal items. Data on all foods offered were recorded on data forms completed by the school food service manager. Data included menus; recipes; vendor products with labels and nutrient information on all prepared, processed and packaged foods. All schools had a Pathways notebook with forms to be completed for each meal per day. On the form, each food item was listed with a complete description of the food (e.g. raw carrots, canned whole kernel corn, etc.), the serving size, and the number of students served the food. Separate forms were completed for breakfast and lunch. The lead Pathways nutritionist at each of the four sites had overall responsibility for the data collection at their site. School breakfast menus and recipes were entered into the NUTRITION DATA SYSTEM. The nutrient composition was computed by taking the weighted nutrient mean of all food items offered and served within each meal component category (milk, breads, fruits, vegetables, entrées, desserts (if served) and condiments) and summing the nutrient means for all meal components to generate a nutrient total for a single school breakfast and for a single school lunch. 5‐day school breakfast means were then calculated as well as 5‐day school lunch means. Validity of measures used: not reported/self‐report methods. While the authors reported that the data collector and cook/manager reviewed all data forms together for accuracy and completeness and that an individual with an advanced degree in nutrition or related area or a registered dietitian (or both) cross‐checked all forms for completeness and clarity, it is not explicitly reported that the tool/measurement methods were validated or that a validated nutrition collection tool was used. Outcome relating to cost: not reported Outcome relating to adverse consequences: adverse effects of the intervention on growth Data collection method: weight and height were measured annually Validity of measures used: not reported Outcome relating to child diet, PA or weight status: anthropometric data and dietary intake of total energy intake, percentage energy from fat Data collection method Anthropometric data: height, weight, BMI and percentage body fat: ‐ Weight was measured with the use of self‐calibrating precision digital scales (Seca 770; Vogel and Halke GmbH, Hamburg, Germany) ‐ Height was measured with a fixed Shorr measuring board (Shorr Productions, Olney, Maryland, USA). ‐ 2 measurements were obtained and the mean was recorded. ‐ % body fat: estimated from bioelectrical impedance and anthropometry with the use of an equation developed and validated specifically for this study. Bioelectrical impedance was measured in duplicate with a single‐frequency tetrapolar plethysmograph (Valhalla Scientific, Valhalla, New York, USA). Dietary intake:24 dietary recall and direct observation Validity of measures used Anthropometric data: % body fat equation was validated specifically for this study. Dietary intake:not reported
Notes	Other intervention components included the following. Classroom curriculum: 2 × 45‐minute lessons were delivered by teachers each week for 12 weeks during the third and fourth grades. This component was decreased to 8 weeks during fifth grade to allow for the follow‐up measurements during the final 2 months of the school year. PA was also a component of the intervention; however, it is not reported on as Pathways research staff delivered some of this component to the school students. Consequently, this trial is reported as nutrition only trial. Family involvement: consisted of 1. family action packs, which were take‐home materials related to the Pathways intervention, including snack packs with samples of low‐fat foods and tips for preparing healthful snacks at home; and 2. family events at schools, which included cooking demonstrations and activities for healthier lifestyle, with the direct involvement of children. Research funding: supported by funding grants HL‐50867, HL‐50869, HL50905, HL50885, and HL‐50907 from the National Heart, Lung, and Blood Institute. Conflicts of interest: authors reported no competing financial interests.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Random sequence generation procedure not described.
Allocation concealment (selection bias)	Unclear risk	No information provided about allocation concealment and, therefore, it was unclear if allocation was concealed.
Blinding of participants and personnel (performance bias) Implementation outcome	High risk	Outcome group: all/menu and recipes (nutrient and food groups) and school menu data collection. Given the nature of the intervention, participants and study personnel are likely to have been aware of study allocation and, therefore, high risk of performance bias. Outcome: child BMI and adverse effects, Low: objectively measured.
Blinding of outcome assessment (detection bias) Implementation outcome	High risk	Outcome group: all/menu and recipe (nutrient and food groups) and school menu data collection. No blinding of outcome assessment, and the outcome measurement is likely to be influenced by lack of blinding; self‐report considered high risk. Outcome group: objective measures (BMI and adverse effects). Low: blinding would not impact objective measure.
Incomplete outcome data (attrition bias) Implementation outcome	Low risk	Outcome group: all outcomes. Low risk of attrition bias given that 39/41 schools that included breakfast were included in analysis. Loss to follow‐up among students similar (about 17%) for intervention and control groups. ITT analysis only conducted on body fat % outcome.
Selective reporting (reporting bias)	Low risk	Design paper available and outcomes reported are consistent. ajcn.nutrition.org/content/69/4/760S.full.pdf+html
Other bias	Unclear risk	Unclear if at risk of contamination due to unclear randomisation procedures.
Overall risk of bias assessment	Unclear risk	Most domains were at low or unclear risk of bias.