| Methods |
Study design: cluster‐randomized controlled trial
Study grouping: parallel group
Study aim: " ... to test the impact of the Chicago Heart Healthy curriculum on pre‐adolescent students" and "to evaluate the efficacy of a parent‐participation component in conjunction with the student curriculum" (quote)
Study period: 1982‐1983 school year
Total number of arms: 3
Description of intervention arms: 1. School‐based curriculum with parent participation (child + caregiver); 2. School‐based program (child only); 3. No intervention control (not eligible)
Number of clusters per arm: child + caregiver arm: n = 9; child‐only arm: n = 8; no intervention control arm: n = 9
Average cluster size: cannot be calculated
Sample size justification and outcome used: not reported
Unit of allocation: school
Missing data handling: the number of cases for each outcome variable differed due to missing data. This suggests that pair‐wise deletion was used rather than list‐wise deletion (i.e. complete case analysis)
Reported limitations: not reported
Randomization ratio and stratification: 1:1:1, but 3 schools were guaranteed random assignment to the child + caregiver or child‐only arm because they participated in a heart‐health education project the previous year. Stratification was not reported
Participant compensation or incentives: not reported |
| 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 do provide additional information on the overall study sample
Female (PROGRESS‐Plus): n (%): 305/647 (47.2) Age in years (PROGRESS‐Plus): mean (SD): 11.1 (0.42) Race/ethnicity/language/culture (PROGRESS‐Plus): White, n (%): 596/647 (92.1); Black, n (%): 38/647 (37.5); other racial groups, n (%): 14/647 (2.1) Place of residence (PROGRESS‐Plus): rural, n (%): 169/647 (26.1); suburban, n (%): 292/647 (45.2); urban, n (%): 186/647 (28.7) Caregiver education (PROGRESS‐Plus): university, n (%): 48/322 (14.9)
Recruitment methods: not reported
Inclusion criteria: cluster: unclear sampling approach, but schools were from 5 school districts in northeast Ohio (2 rural, 1 suburban, 2 residential urban); participants: sixth grade students and caregivers
Exclusion criteria: not reported
Age of participating children at baseline: sixth grade (estimated to be 10 to 12 years old)
Total number randomized by relevant group: the number of children randomized was not reported overall or by study arm. The total number reflects children who completed the study. The sample by study arm was estimated from this total. Across all study arms: n = 647; child + caregiver arm: n = 162; child‐only arm: n = 162
Baseline imbalances between relevant groups: not reported
Total number analyzed by relevant group: not reported
Attrition by relevant group: attrition was not reported and cannot be calculated because study authors did not report the number of children per intervention arm at baseline
Description of sample for baseline characteristics reported above: not reported |
| Interventions |
Intervention characteristics
Child + caregiver arm (intervention group)
Brief name/description (TIDieR #1): the Chicago Heart Health Curriculum's "Body Power!" school‐based program with caregiver participation Focus of intervention: physical activity and diet Behavior change techniques: in addition to the child‐only arm, the following techniques were applied separately or differently in the child + caregiver arm: "feedback and monitoring," "shaping knowledge," "natural consequences" Why: rationale, theory, or goal (TIDieR #2): in addition to the goal of the child‐only arm, researchers wanted to assess the impact of including a caregiver participation component in conjunction with the Chicago Heart Health Curriculum. Because caregivers have an important social influence on children, researchers sought to assess the impact of a co‐ordinated school and home intervention compared to a school intervention alone. As with the child‐only intervention, study authors did not explicitly describe the use of theory in development of this intervention, but social learning theory was introduced in the introduction How, where, and when and how much (TIDieR #6 to 8): in addition to the child‐only intervention, 17 newsletters with health tips were sent home with students. Families also were sent a health booklet/log Who: providers (TIDieR #5): same as child‐only arm Economic variables and resources required for replication: not reported Strategies to address disadvantage: not reported Subgroups: not reported Assessment time points: baseline, post‐test (time not specified, but assumed to be end of intervention at 1 year) Co‐interventions: in addition to the child‐only arm, families received information about smoking What: materials and procedures (TIDieR #3 to 4): in addition to materials provided to the child‐only arm, families received newsletters corresponding to the material taught in the Body Power program. Each family also received a family health activity log, containing information on nutrition, exercise, smoking, and other cardiovascular disease risk factors Tailoring (TIDieR #9): not reported Modifications (TIDieR #10): not reported How well: planned and actual (TIDieR #11 to 12): not reported Sensitivity analyses: not reported
Child‐only arm (control group)
Brief name/description (TIDieR #1): Chicago Heart Health Curriculum's "Body Power!" school‐based program Focus of intervention: physical activity and diet Behavior change techniques: "feedback and monitoring," "shaping knowledge," "natural consequences," "comparison of behavior" Why: rationale, theory, or goal (TIDieR #2): this intervention arm sought to test the impact of the Chicago Heart Health Curriculum on sixth grade students’ behaviors and attitudes relevant to heart health. Health behaviors adopted in childhood are important determinants of future health, and heart health education can help children make informed choices with respect to disease prevention. The program was based on effective education. Study authors did not explicitly describe the use of theory in development of this intervention but did introduce social learning theory in the introduction How, where, and when and how much (TIDieR #6 to 8): the Body Power Program consisted of 5 modules, each of which was designed to be taught through two 40‐minute sessions per week for 5 to 6 weeks (or the equivalent) Who: providers (TIDieR #5): teachers delivered the intervention to students following an intervention manual. To support consistent implementation, teachers received 14 hours of training workshops. The first (6 hours) was an all‐day orientation. This was followed by 4 subsequent workshops spaced throughout the school year Economic variables and resources required for replication: not reported Strategies to address disadvantage: not reported Subgroups: not reported Assessment time points: baseline, post‐test (time not specified but assumed to be end of intervention at 1 year) Co‐interventions: of the 5 educational modules in the Body Power Program, 1 focused on the dangers of smoking What: materials and procedures (TIDieR #3 to 4): the educational modules focused on healthy eating, physical activity, and other risk factors for cardiovascular disease. The first addressed feelings and health and functions of the circulatory system; the second addressed diet, nutrition, and functions of the digestive system; the third stressed the importance of exercise and the structure and function of the skeletal and muscular systems; the fourth dealt with smoking; and the fifth addressed various cardiovascular disease risk factors. Teachers were provided with a manual of suggested activities and teaching guidelines, as well as with audiovisual materials to supplement the curriculum. With each module, children received activity sheets containing a variety of activities and cartoon presentations. Students also received personal health logs to record medical information and feelings on the value of the material covered in the curriculum Tailoring (TIDieR #9): not reported Modifications (TIDieR #10): not reported How well: planned and actual (TIDieR #11 to 12): teachers were observed 6 times during the program to assess program delivery and implementation Sensitivity analyses: not reported
|
| Outcomes |
The following instruments were used to measure outcomes relevant to this review at baseline and post‐test
-
Children's dietary intake: Student Health Questionnaire, which includes questions on behaviors related to cardiovascular risk factors, including heart‐healthy nutrition; study authors reported that the instrument was validated and tested for reliability in previous studies
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Children's physical activity levels: Student Health Questionnaire, which includes questions on behaviors related to cardiovascular risk factors, including exercise behaviors; study authors reported that the instrument was validated and tested for reliability in previous studies
Of note, study authors did not analyze all of the child + caregiver data together because some of the caregivers did not participate. However, this does not impact the findings of the present systematic review because this trial did not contribute any data |
| Identification |
Study name: not reported
Country: USA
Setting: schools in northeast Ohio
Types of reports: published journal article
Comments: used 1 report only: Petchers 1987
Author's name: Marcia K Petchers
Email: not reported
Conflicts of interest: not reported
Sponsorship source: American Heart Association, Northeast Ohio Affiliate, Inc., and the Schoolsite Committee, with funds granted by the Northeast Ohio Affiliate, the Martha Holden Jennings Foundation, and the Cleveland Foundation |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation |
High risk |
Quote: “…schools were assigned to treatment conditions using modified random assignment strategy…It should be noted that three schools in the sample participated as control groups in a heart health education project the previous year. As a result of their prior participation, they had been guaranteed participation by random assignment in one of the two curriculum conditions…The remaining schools were then randomly assigned to one of the three study conditions so that there were approximately equal numbers of schools in each condition" (p 451) |
| Allocation concealment |
High risk |
Judgment comment: the method used to conceal the allocation sequence was not described. However, 3 of the schools were guaranteed assignment to the child + caregiver or child‐only arm before randomization |
| Blinding of participants and personnel
All outcomes |
Unclear risk |
Judgment comment: no information on blinding of participants and personnel was provided. However, given the nature of the intervention, there would have been no way to blind participants and personnel. Also, the children were aged approximately 10 to 12 years, and their performance may or may not have been influenced by lack of blinding |
| Blinding of outcome assessment
All outcomes |
Unclear risk |
Judgment comment: there was no information on blinding of outcome assessors. 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 |
Unclear risk |
Judgment comment: attrition rates were not reported and could not be calculated because study authors did not report the number of children per intervention arm at baseline. The study authors noted that for different analyses, "the number of cases differs due to missing data" (quote; p 456) |
| Selective reporting |
High risk |
Judgment comment: the trial was not registered and no protocol was cited that could be retrieved. Although dietary and physical activity outcomes were measured, they were reported incompletely and did not align with outcomes analyzed in this review |
| Recruitment bias |
Unclear risk |
Judgment comment: study authors did not specify if the children were recruited before or after the schools were randomized |
| Baseline imbalance |
Unclear risk |
Judgment comment: study authors did not report on similarities and differences between intervention arms or clusters |
| Loss of clusters |
Unclear risk |
Judgment comment: trial authors did not report whether any 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 |
Low risk |
Judgment comment: we detected no other sources of bias |
