Frenn 2013a.

Methods	Study design: cluster‐randomized controlled trial Study grouping: parallel group Study aim: "... to examine the feasibility and initial efficacies of parent‐ and/or child‐focused online interventions and variables correlated with child body mass index percentile change" (quote) Study period: not reported Total number of arms: 4 Description of intervention arms: 1. Both parent and child online condition (child + caregiver); 2. Child online condition (child only); 3. Parent online condition (not eligible); 4. No intervention control (not eligible) Number of clusters per arm: child + caregiver arm: n = 2; child‐only arm: n = 1; parent‐only: n = 2; no intervention control: n = 1 Average cluster size: 10.33 children Sample size justification and outcome used: this was a pilot study. No sample size justification was given and study authors noted that the study was not adequately powered to examine between‐group differences in the 3 primary outcome variables: body mass index (BMI) percentile, physical activity, and dietary fat intake. Using the data collected, study authors calculated the sample sizes needed for future research Unit of allocation: classroom Missing data handling: an on‐protocol analysis was used rather than intention‐to‐treat. All children assigned completed the online program and their data were analyzed in line with the arm to which they were randomized. Nine parents assigned to complete online modules did not. Data for 4 of these dyads were analyzed as if they were assigned to the child‐only arm rather than to the child + caregiver arm. Data for 5 of these dyads were analyzed as if they were assigned to the "usual class control" arm (i.e. no intervention) rather than to the parent‐only arm. Caregivers and children with missing data were not included in the analysis Reported limitations: 1. A large number of caregivers did not respond to the invitation to participate; 2. Requirement of Internet access was a barrier to some caregivers' participation; 3. Some caregivers appeared to be confused regarding the request for their height and weight information and did not provide usable data to calculate caregiver BMI Randomization ratio and stratification: 2:1:2:1; stratification not reported Participant compensation or incentives: children who returned completed consents were entered into a drawing for small gifts, regardless of whether consent was provided or withheld. Child/caregiver dyads were offered US dollar (USD) 25 for completing intervention components or USD 10 for completing only the measures
Participants	Baseline characteristics Child + caregiver arm (intervention group) Female (PROGRESS‐Plus): not reported Age in years (PROGRESS‐Plus): not reported Race/ethnicity/language/culture (PROGRESS‐Plus): not reported Place of residence (PROGRESS‐Plus): not reported Caregiver education (PROGRESS‐Plus): not reported Religion (PROGRESS‐Plus): not reported Household income/socioeconomic status (PROGRESS‐Plus): not reported 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: not reported 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): not reported Age in years (PROGRESS‐Plus): not reported Race/ethnicity/language/culture (PROGRESS‐Plus): not reported Place of residence (PROGRESS‐Plus): not reported Caregiver education (PROGRESS‐Plus): not reported Religion (PROGRESS‐Plus): not reported Household income/socioeconomic status (PROGRESS‐Plus): not reported 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: not reported 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 Although not reporting by intervention arm, study authors did provide additional information on the overall study sample and noted that children were from low‐ and middle‐income households and attended urban schools Female (PROGRESS‐Plus): %: 57 Race/ethnicity/language/culture (PROGRESS‐Plus): Asian, %: 7; African American, %: 28%; Hispanic, %: 7; Caucasian, %: 33; Other, %: 14 Child weight status: underweight, %: 0; normal weight, %: 62; overweight %: 20; obese, %: 18 Caregiver weight status: underweight, %: 12; normal weight, %: 31; overweight %: 33; obese, %: 24 Recruitment methods: at one school, the study was explained to parents as they waited for parent‐teacher conferences. In the other 2 schools, the project was explained to students, and packets with return postage were sent home to parents Inclusion criteria: cluster: not reported; participants: child in fifth, seventh, or eighth grade and caregiver Exclusion criteria: not reported Age of participating children at baseline: fifth, seventh, or eighth grade (estimated to be 9 to 14 years old) Total number randomized by relevant group: total across all study arms: n = 62; child + caregiver arm: n = 15; child‐only arm: n = 18 Baseline imbalances between relevant groups: not reported Total number analyzed by relevant group: based on data presented in the CONSORT diagram (which contains inconsistencies): child BMI percentile (child + caregiver arm: n = 2, child‐only arm: n = 14); caregiver BMI (child + caregiver arm: n = 2, child‐only arm: n = 2) Attrition by relevant group: based on data presented in the CONSORT diagram (which contains inconsistencies), attrition rates were calculated by summing those who were lost to follow‐up and, for the child + caregiver arm, those whose parents discontinued participation: child + caregiver arm: 33.3% (5/15); child‐only arm: 16.7% (3/18) Description of sample for baseline characteristics reported above: not reported
Interventions	Intervention characteristics Child + caregiver arm (intervention group) Brief name/description (TIDieR #1): Project FUN and Project FUN for Parents Focus of intervention: physical activity and diet Behavior change techniques: in addition to the child‐only intervention, the following techniques were applied separately or differently in the child + caregiver arm: "feedback and monitoring," "social support," "shaping knowledge," "natural consequences," "comparison of behavior," "identity" Why: rationale, theory, or goal (TIDieR #2): prior research indicates the need for further examination of authoritative feeding and parental support and modeling in relation to child weight status, and the need for further research on how caregivers might best be included in childhood obesity prevention. Study authors did not explicitly describe the use of theory in development of this intervention but did note that “parental involvement in obesity prevention could be guided by a variety of theories, but authoritative approaches show promise” (quote) How, where, and when and how much (TIDieR #6 to 8): in addition to the child‐only intervention, caregivers were asked to complete 6 online modules at home during the same time period. Each caregiver module could be completed in 5 to 10 minutes Who: providers (TIDieR #5): delivered online Economic variables and resources required for replication: not reported Strategies to address disadvantage: not reported Subgroups: not reported Assessment time points: baseline, 6 to 9 months (follow‐up) Co‐interventions: not reported What: materials and procedures (TIDieR #3 to 4): in addition to the modules provided in the child‐only arm, caregivers were invited to complete 6 online modules. The first introduced the key intervention concepts and the discussion boards. The second focused on authoritative parenting and links with healthy eating. The third focused on healthy diets and supporting children's healthy food choices. The fourth introduced the importance of modeling physical activity. The fifth gave meal and snack ideas for healthy eating. The sixth provided a direct link to Project FUN and encouraged caregivers to talk about the modules with their child. Additional online discussion opportunities, recipes, and website recommendations were provided Tailoring (TIDieR #9): not reported Modifications (TIDieR #10): not reported How well: planned and actual (TIDieR #11 to 12): fidelity was assessed by completion of the intervention and follow‐up data. Nine caregivers allocated to participate in the online program (i.e. randomized to the child + caregiver arm or the non‐relevant caregiver‐only arm) did not complete it. Reasons given included lack of time and inconsistent Internet. All children assigned to this arm completed the online program Sensitivity analyses: not reported Child‐only arm (control group) Brief name/description (TIDieR #1): Project FUN Focus of intervention: physical activity and diet Behavior change techniques: "goals and planning," "feedback and monitoring," "shaping knowledge," "comparison of behavior," "repetition and substitution" Why: rationale, theory, or goal (TIDieR #2): the intervention aimed to increase physical activity and reduce dietary fat intake among ethnic minority middle school students. It was based on the health promotion and transtheoretical models How, where, and when and how much (TIDieR #6 to 8): the intervention was an 8‐module online program delivered in classroom settings where each child had a computer. Depending on reading speed, each module took 10 to 30 minutes to complete. Children were asked to answer questions online and in a workbook. Each child progressed through the modules at his or her own pace over a 3‐ to 4‐week period Who: providers (TIDieR #5): delivered online; unclear whether teachers or study staff were responsible for getting children started Economic variables and resources required for replication: not reported Strategies to address disadvantage: not reported Subgroups: not reported Assessment time points: baseline, 6 to 9 months (follow‐up) Co‐interventions: not reported What: materials and procedures (TIDieR #3 to 4): participating children completed 8 modules. The first involved a 1‐day food diary and dietary feedback. The second introduced MyPlate, reading food labels, and considering healthy types and amounts of food. The third addressed requesting healthy foods. The fourth focused on energy balance from a dietary perspective. The fifth focused on the importance of breakfast and included a game about healthy eating that provided feedback. The sixth emphasized healthy snacking. The seventh module focused on accessible and safe activities. The final module focused on energy balance from a physical activity perspective. The intervention included 4 short videos (2 to 3 minutes) in which culturally diverse child actors from similar schools illustrated the concepts. Additional websites were available for further exploration Tailoring (TIDieR #9): not reported Modifications (TIDieR #10): not reported How well: planned and actual (TIDieR #11 to 12): fidelity was assessed by completion of the intervention and follow‐up data. All children assigned to this arm completed the online program Sensitivity analyses: not reported
Outcomes	No end‐of‐intervention data were collected in this study. The following instruments were used to measure outcomes relevant to this review at baseline and 6 to 9 months Children's dietary intake: 21‐item self‐reported screener: Dietary Fat Screening—adolescents measure to assess dietary fat intake; study authors reported results of tests of internal consistency, test‐retest reliability, and validity with a 3‐day food record Data from the 6 to 9−month assessment were not reported and could not be retrieved from the study authors Children's physical activity levels: 2‐item, 7‐day measure: PACE+ Physical Activity Measure (adolescents); study authors reported the instrument to be correlated with accelerometry data Data from the 6 to 9−month assessment were not reported and could not be retrieved from the study authors Children's anthropometry: height measured with Seca 214 portable stadiometer and weight measured with the Seca 869 portable medical grade scale Study authors reported that CDC algorithms were used to determine standardized BMI. However, data from the 6 to 9−month assessment were not reported and could not be retrieved from the study authors Caregivers' dietary intake: National Cancer Institute Quick Food Scan was used to measure percentage energy from fat; study authors reported this instrument to be correlated with a 24‐hour diet history Data from the 6 to 9−month assessment were not reported and could not be retrieved from the study authors Caregivers' physical activity levels: International Physical Activity Questionnaire (IPAQ) to assess MVPA; study authors reported the test‐retest reliability and validity of this instrument Data from the 6 to 9−month assessment were not reported and could not be retrieved from the study authors
Identification	Study name: Project FUN Country: USA Setting: urban schools in the Midwest Types of reports: published journal article Comments: used only 1 report: Frenn 2013b, as well as unpublished information provided by the study authors (Frenn 2018 [pers comm]). The CONSORT diagram includes discrepancies (numbers for analysis and attrition do not add up to total enrollment) Author's name: Marilyn Frenn Email: marilyn.frenn@marquette.edu Conflicts of interest: "the authors report no actual or potential conflicts of interest" (quote) Sponsorship source: Regrier Faculty Award
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation	Low risk	Judgment comment: randomization of schools was determined by coin toss. Selection and randomization of classrooms at each school also was determined by coin toss (Frenn 2018 [pers comm])
Allocation concealment	Unclear risk	Judgment comment: methods used to conceal the allocation sequence were not described
Blinding of participants and personnel All outcomes	Unclear risk	Judgment comment: participants were not blinded, and knowledge of the intervention may or may not have influenced children's performance. Because the intervention was delivered online, blinding of personnel is not a concern
Blinding of outcome assessment All outcomes	Unclear risk	Judgment comment: no information on blinding of outcome assessors was provided. Height and weight were measured. Other relevant outcomes were measured by self‐report. These outcomes may or may not have been influenced by lack of blinding
Incomplete outcome data All outcomes	High risk	Judgment comment: based on data presented in the trial's CONSORT diagram (which contains inconsistencies), we calculated attrition rates by summing those who were lost to follow‐up and those whose parents discontinued participation, and dividing this by the number of children randomized. Total attrition was 24.2% for both the study overall (15/62) and the 2 relevant study arms (8/33). Differential attrition for the 2 relevant arms was 16.6% (5/15 vs 3/18)
Selective reporting	High risk	Judgment comment: the trial was not registered and no protocol was cited that could be retrieved. Dietary, physical activity, and anthropometric outcomes were reported incompletely and could not be entered into meta‐analysis. We were not able to retrieve relevant data from the study authors
Recruitment bias	High risk	Judgment comment: randomization occurred before recruitment
Baseline imbalance	Unclear risk	Judgment comment: study authors reported that no significant differences were found between study arms with respect to age, race, gender, or weight status. Between the 2 clusters in the child + caregiver arm, the study authors did not report whether there were similarities or differences
Loss of clusters	Low risk	Judgment comment: no clusters were lost (Frenn 2018 [pers comm])
Incorrect analysis	High risk	Judgment comment: study authors did not report adjusting for clustering in the analysis and did not report intraclass correlation coefficients (ICCs)
Comparability with individually randomized trials	Unclear risk	Judgment comment: information was insufficient to permit judgment
Other sources of bias	High risk	Judgment comment: of the relevant intervention arms, 1 had 1 cluster and the other had 2. The study authors reported that the sample size was not sufficient to examine between‐group differences in the outcomes of interest. Also, "an on‐protocol analysis was used" (quote; p 69), so if a caregiver in the child + caregiver group did not want to participate in the online program but was willing to complete the assessments, data for the dyad were analyzed with the child‐only data or with data from the no‐intervention control arm