Voll 2013.
Methods |
Study design: cluster‐randomized controlled trial Study grouping: parallel group Study aim: "... to determine whether parental involvement in a physical activity intervention delivered to children in‐school could result in positive behavior change in parents, as measured by increased physical activity and reduced sedentary behavior" (quote) Study period: baseline data collection start: February 2012; post‐test assessment: March 2012 Total number of arms: 2 Description of intervention arms: 1. School‐based screen time tracking with family homework (child + caregiver); 2. School‐based screen time tracking (child only) Number of clusters per arm: not reported Average cluster size: 5.38 children Sample size justification and outcome used: not reported Unit of allocation: school Missing data handling: only participants who completed baseline and post‐test assessments were included in the analysis Reported limitations: 1. Small sample size as a result of difficulties in recruitment and attrition; 2. Failure to collect demographic information; 3. Self‐selected participation Randomization ratio and stratification: not reported Participant compensation or incentives: participating children were entered into a drawing with physical activity−related prizes (e.g. jump ropes, basketballs, volleyballs, frisbees). To thank caregivers for participation, drawings were held for a massage gift certificate and a trigger point foam roller |
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Participants |
Baseline characteristics Child + caregiver arm (intervention group)
Child‐only arm (control group)
Although not reporting by intervention arm, study authors did indicate that across the 2 intervention arms, 81% (22/27) of participants were female Recruitment methods: names of elementary schools in the Waterloo Region School District were randomly selected for recruitment. School principals were the first point of contact by phone or email, and this was followed up with a package of study materials and documentation. If the principal declined participation or contact could not be established after 1.5 weeks, another school was selected and contacted. Eight schools agreed to participate. Some schools had more than 1 eligible class (n = 14 classes). The researcher visited each school to give students a 10‐minute presentation on the study and to distribute cover letters and consent forms Inclusion criteria: cluster: school located within the Waterloo Region District School Board; participant: child enrolled in fourth/fifth, fifth, or fifth/sixth grade with a caregiver with a working email address Exclusion criteria: not reported Age of participating children at baseline: fourth to sixth grade (estimated to be 8 to 12 years old) Total number randomized by relevant group: total across all study arms: n = 43; samples per arm were not reported and therefore were estimated: child + caregiver arm: n = 22; child‐only arm: n = 22 Baseline imbalances between relevant groups: no significant differences were reported, but study authors note higher levels of physical activity in the child‐only arm Total number analyzed by relevant group: child physical activity score (child + caregiver arm: n = 11; child‐only arm: n = 5); caregiver physical activity score (child + caregiver arm: n = 12; child‐only arm: n = 6) Attrition by relevant group: attrition rates by intervention arm were not reported and cannot be calculated because study authors did not report the number of children by intervention arm at baseline Description of sample for baseline characteristics reported above: child physical activity score: those who completed measures at baseline and post‐test assessments (child + caregiver arm: n = 11; child‐only arm: n = 5); caregiver physical activity score: those who completed measures at baseline and post‐test assessments (child + caregiver arm: n = 12; child‐only arm: n = 6) |
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Interventions |
Intervention characteristics Child + caregiver arm (intervention group)
Child‐only arm (control group)
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Outcomes | The following instruments were used to measure outcomes relevant to this review at baseline and at 2 weeks (end of intervention)
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Identification |
Study name: Determining the "Spread of Effects" of Physical Activity Interventions From Children to Parents/Guardians Country: Canada Setting: primary schools in Waterloo Region, Ontario, Canada Types of reports: Masters thesis Comments: used 1 report only: Voll 2013 Author's name: Jess Voll Email: jess@greo.ca Conflicts of interest: not reported Sponsorship source: not reported |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation | Low risk | Quote: "each classroom (or school, if more than one class per school wished to participate) was randomly assigned to the treatment or control group using random number generation in Microsoft Excel" (p 47) |
Allocation concealment | Unclear risk | Judgment comment: methods used to conceal the allocation sequence were not described |
Blinding of participants and personnel All outcomes | Low risk | Judgment comment: participating parents and children were informed that they would be assigned to 1 of 2 groups; however, the true purpose of the study was concealed until after the intervention. Although outcome data were collected via self‐report, concealment of the study hypothesis may have helped to minimize bias |
Blinding of outcome assessment All outcomes | Unclear risk | Judgment comment: no information on blinding of outcome assessors was provided. Because all data were self‐reported by study participants, outcomes may or may not have been influenced by lack of blinding |
Incomplete outcome data All outcomes | High risk | Judgment comment: attrition rates by intervention arm were not reported and could not be calculated because the study author did not report the number of children by intervention arm at baseline. Overall, no data were available for 37.2% (16/43) of caregiver‐child dyads; this includes 15 dyads that provided no data and 1 dyad that withdrew data after they were informed of the true intent of the study. Matched baseline and post‐test data were not available for 62.8% (27/43) of children and 58.1% (25/43) of caregivers |
Selective reporting | Unclear risk | Judgment comment: the trial was not registered and no protocol was cited that could be retrieved. Physical activity scores for both children and caregivers were reported in a format that could be entered into meta‐analysis |
Recruitment bias | Unclear risk | Judgment comment: it is unclear whether randomization occurred before or after recruitment. However, wording provided in the cover letter to caregivers suggests that they may not have been made aware of assignment before consenting to take part in the study |
Baseline imbalance | Unclear risk | Judgment comment: study authors did not report on similarities and differences between intervention arms or clusters |
Loss of clusters | High risk | Judgment comment: study authors did not report on whether any clusters were lost. However, given the very small number of participants and the high level of attrition and missing data, it is likely that clusters were lost |
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: study authors noted that some clusters (i.e. classrooms) had 1 or 2 study participants |