Lin 2017a.

Methods	Study design: cluster‐randomized controlled trial Study grouping: parallel group Study aim: this study aims "to evaluate the short‐ and long‐term effects of two behavioral interventions based on the HAPA [Health Action Process Approach] on F&V [fruit and vegetable] intake compared to a ‘no treatment’ control condition. The first intervention only targeted adolescents; while the second intervention also included mothers to investigate the incremental effects of involving family members..." (quote) Study period: September 2015 to March 2016 Total number of arms: 3 Description of intervention arms: 1. Intervention for mothers and children (child + caregiver); 2. Intervention for children (child only); 3. No intervention control (not eligible) Number of clusters per arm: 16 Average cluster size: 58.77 children Sample size justification and outcome used: "power analysis suggested that recruiting 464 participants at baseline in each group (1392 total) would provide 95% power to detect a medium‐sized difference (d = .40) in outcomes between groups, assuming a 10% dropout rate and a design effect of 2.24. With an estimated average class size of 29, students from 48 schools were randomly selected from the 66 eligible schools and invited to participate in the trial" (quote) The outcome used for this analysis was mean fruit and vegetable intake Unit of allocation: high schools Missing data handling: multiple imputation was used to handle missing data Reported limitations: 1. Most outcome measures were developed for this study and have not been validated before; 2. Fruit and vegetable intake was measured using a retrospective, self‐report instrument, and the test‐retest reliability of the instrument was not examined; 3. The findings may not generalize to Western countries due to differences between Eastern and Western cultures; 4. The findings may not generalize to other age groups; 5. Home and school food environments may be important determinants of adolescent fruit and vegetable intake but were not considered in the design of this study Randomization ratio and stratification: 1:1:1; stratified by educational district and gender of students in the schools (no high schools in Iran are mixed‐gender) Participant compensation or incentives: pool tickets were provided as compensation
Participants	Baseline characteristics Child + caregiver arm (intervention group) Female (PROGRESS‐Plus): n (%): 240/462 (52) Age in years (PROGRESS‐Plus): mean (SD): 14.49 (3.24) Race/ethnicity/language/culture (PROGRESS‐Plus): not reported Place of residence (PROGRESS‐Plus): not reported Caregiver education (PROGRESS‐Plus): years, mean (SD): 5.83 (1.93) Religion (PROGRESS‐Plus): not reported Household income/socioeconomic status (PROGRESS‐Plus): monthly income in rials (in April 2016, 3500 rials was equivalent to 1 US dollar), mean (SD): 962.21 (321.61) Social capital (PROGRESS‐Plus): not reported Caregiver work hours and other characteristics that may indicate disadvantage (PROGRESS‐Plus): not reported Disability (PROGRESS‐Plus): not reported Sexual orientation (PROGRESS‐Plus): not reported Child weight status: not reported Child diet: fruit intake (servings/d), mean (SD): 3.42 (1.29): vegetable intake (servings/d), mean (SD): 2.11 (1.13) Child physical activity: not reported Caregiver weight status: not reported Caregiver diet: not reported Caregiver physical activity: not reported Caregiver civil status (PROGRESS‐Plus): not reported Child‐only arm (control group) Female (PROGRESS‐Plus): n (%): 239/510 (47) Age in years (PROGRESS‐Plus): mean (SD): 14.62 (3.01) Race/ethnicity/language/culture (PROGRESS‐Plus): not reported Place of residence (PROGRESS‐Plus): not reported Caregiver education (PROGRESS‐Plus): years, mean (SD): 5.70 (1.37) Religion (PROGRESS‐Plus): not reported Household income/socioeconomic status (PROGRESS‐Plus): monthly income in rials, mean (SD): 981.63 (382.22) Social capital (PROGRESS‐Plus): not reported Caregiver work hours and other characteristics that may indicate disadvantage (PROGRESS‐Plus): not reported Disability (PROGRESS‐Plus): not reported Sexual orientation (PROGRESS‐Plus): not reported Child weight status: not reported Child diet: fruit intake (servings/d), mean (SD): 3.03 (1.46); vegetable intake (servings/d), mean (SD): 2.00 (0.99) Child physical activity: not reported Caregiver weight status: not reported Caregiver diet: not reported Caregiver physical activity: not reported Caregiver civil status (PROGRESS‐Plus): not reported Recruitment methods: a list of high schools was provided by the Organization for Education in Qazvin. Sixty‐six high schools were identified as potential candidates for recruitment; 48 of these schools were "randomly selected" (quote) and were invited to participate. All schools agreed to participate; 1537 students from these schools were invited to take part in the trial, of whom 1455 (94.7%) agreed. It is not reported how adolescents were recruited within schools Inclusion criteria: cluster: high school in Qazvin that was not already involved with a nutritional program; participant: adolescent attending high school and possessing the ability to understand Persian language Exclusion criteria: cluster: current involvement in a nutrition program; participant: not reported Age of participating children at baseline: 13 to 18 years Total number randomized by relevant group: total across all study arms: n = 215; child + caregiver arm: n = 94; child‐only arm: n = 59 Baseline imbalances between relevant groups: study authors report demographic characteristics of participants in the 3 groups to be "similar"; no significant differences were identified for the following variables: age, mother's education, monthly household income, or sex Total number analyzed by relevant group: "all available data were analyzed" (quote). At the 1‐month follow‐up, this appears to be all adolescents with consent except those lost to follow‐up: child + caregiver arm: n = 502; child‐only arm: n = 456. At the 6‐month follow‐up, this appears to be all adolescents with consent except those lost to follow‐up (as indicated above) plus those who dropped out: child + caregiver arm: n = 493; child‐only arm: n = 449 Attrition by relevant group: attrition rates were calculated by summing the number of adolescents who were lost to follow‐up (by the 1‐month post‐intervention assessment) or dropped out (by the 6‐month assessment) and dividing this number by the total number of consented adolescents: child + caregiver arm: 3.3% (17/510); child‐only arm: 2.8% (13/462) Description of sample for baseline characteristics reported above: consented children (child + caregiver arm: n = 510; child‐only arm: n = 462)
Interventions	Intervention characteristics Child + caregiver arm (intervention group) Brief name/description (TIDieR #1): Health Action Process Approach (HAPA) intervention to increase FV intake plus a component for mothers Focus of intervention: diet Behavior change techniques: in addition to the child‐only intervention, the following techniques were applied separately or differently in the child + caregiver arm: "goals and planning," "feedback and monitoring," "natural consequences," "comparison of outcomes" Why: rationale, theory, or goal (TIDieR #2): although HAPA is an individual approach, study authors note that "there is increasing recognition" that family members, especially mothers, influence children's and adolescents' dietary attitudes and behaviors How, where, and when and how much (TIDieR #6 to 8): in addition to the child‐only arm, mothers participated in a 30‐minute discussion on FV intake and were asked to complete an action planning brochure Who: providers (TIDieR #5): research staff Economic variables and resources required for replication: not reported Strategies to address disadvantage: not reported Subgroups: not reported Assessment time points: baseline, 1 month (end of intervention), 6 months Co‐interventions: not reported What: materials and procedures (TIDieR #3 to 4): in addition to the child‐only arm, mothers attended a discussion on the importance of healthy eating and consuming sufficient fruits and vegetables. Mothers also completed a brochure similar to the one provided to adolescents Tailoring (TIDieR #9): not reported Modifications (TIDieR #10): not reported How well: planned and actual (TIDieR #11 to 12): not reported, but differences in methods between the trial registration and the published paper are not evident Sensitivity analyses: not reported Child‐only arm (control group) Brief name/description (TIDieR #1): HAPA intervention to increase FV intake Focus of intervention: diet Behavior change techniques: "goals and planning," "feedback and monitoring," "natural consequences," "comparison of outcomes" Why: rationale, theory, or goal (TIDieR #2): the present intervention was informed by the HAPA, which outlines 2 phases of behavior change: (1) motivational, and (2) self‐regulatory. Previous interventions have used the HAPA to successfully improve health behaviors. However, no studies have examined the use of this approach to promote fruit and vegetable consumption among adolescents, particularly among East Asian adolescents How, where, and when and how much (TIDieR #6 to 8): adolescents participated in a 20‐minute discussion about fruit and vegetable intake and were asked to complete an action planning brochure. Participants were also given a calendar to record daily fruit and vegetable consumption for 1 month Who: providers (TIDieR #5): research staff Economic variables and resources required for replication: not reported Strategies to address disadvantage: not reported Subgroups: not reported Assessment time points: baseline, 1 month (end of intervention), 6 months Co‐interventions: not reported What: materials and procedures (TIDieR #3 to 4): the discussion focused on the importance of healthy eating and recommendations for fruit and vegetable intake. The brochure included the following sections: (1) risks of inadequate fruit and vegetable intake; (2) benefits of fruit and vegetable intake; (3) action plans to increase fruit and vegetable intake; (4) barriers to increasing fruit and vegetable intake and coping strategies. The monthly calendar was used to record the types and amounts of fruit and vegetables consumed each day Tailoring (TIDieR #9): not reported Modifications (TIDieR #10): not reported How well: planned and actual (TIDieR #11 to 12): not reported, but differences in methods between the trial registration and the published paper are not evident Sensitivity analyses: not reported
Outcomes	The following instruments were used to measure outcomes relevant to this review at baseline, 1 month (end of intervention), and 6 months (follow‐up) Children's dietary intake: self‐reported questionnaire including 2 open‐ended questions that queried the servings of fruits or vegetables eaten "on an average day," followed by a description of what constitutes a serving. Study authors reported validating the measure by comparing the adolescent's self‐reported intake to parent‐reported intake Data for child fruit intake and vegetable intake are available for end‐of‐intervention and follow‐up assessments
Identification	Study name: not reported Country: Islamic Republic of Iran Setting: high schools in Qazvin, Iran Types of reports: published journal article; trial registration Comments: used the following reports: (1) Lin 2017, and (2) trial registration (Clinicaltrials.gov registration number: NCT02405611), as well as unpublished information provided by Amir Pakpour, the corresponding author (Pakpour 2019 [pers comm]) Author's name: Amir Pakpour Email: apakpour@qums.ac.ir; pakpour_amir@yahoo.com Conflicts of interest: "no potential conflict of interest was reported by the authors" (quote) Sponsorship source: not reported
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation	Low risk	Quote: "an independent statistician used a computer‐generated list of random numbers to randomise schools to the three arms" (p 1453)
Allocation concealment	Low risk	Quote: "an independent statistician used a computer‐generated list of random numbers to randomise schools to the three arms" (p 1453)
Blinding of participants and personnel All outcomes	Unclear risk	Judgment comment: no information on blinding of participants was provided, and it is unclear whether personnel who delivered the intervention were blinded. However, given the nature of the intervention, there would have been no way to blind participants and personnel. Given that the children were aged 13 to 18 years, their performance may or may not have been influenced by lack of blinding
Blinding of outcome assessment All outcomes	Unclear risk	Quote: "all research assistants and statisticians were blinded to group allocation" (p 1453) Judgment comment: no information on how blinding was done was reported. Although fruit and vegetable intake was self‐reported by adolescents, the reports were checked against parental reports of intake and the level of agreement was found to be "fair" (quote; p 1456). These data may or may not have been influenced by lack of blinding
Incomplete outcome data All outcomes	Low risk	Judgment comment: we calculated attrition rates by dividing the number of dropouts and participants lost to follow‐up by the number of participating children at baseline. Total attrition was 2.9% (42/1455) for the study overall and 3.1% (30/972) for the 2 relevant study arms. Differential attrition for the 2 relevant study arms was 0.5% (17/510 vs 13/462)
Selective reporting	Low risk	Judgment comment: the trial was registered. Expected outcomes were pre‐specified and were addressed in the article
Recruitment bias	Low risk	Quote: "after baseline assessment, the participating schools were randomly allocated…" (p 1452)
Baseline imbalance	Unclear risk	Judgment comment: study authors report that the following characteristics were "similar" (quote; p 1457) across study arms: age, mother's education, monthly household income, sex, number of classes, and average number of students in the classes. Whether there were differences between clusters of the same arm is not reported
Loss of clusters	Low risk	Judgment comment: no clusters were lost (Pakpour 2019 [pers comm])
Incorrect analysis	Low risk	Quote: "several mulilevel linear mixed models with three levels (clustered in schools and repeated measures in person) were used to examine the efficacy of the intervention(s)" (p 1457)
Comparability with individually randomized trials	Unclear risk	Judgment comment: information was insufficient to permit judgment
Other sources of bias	Low risk	Judgment comment: no other sources of bias were detected