| Methods |
Study design: cluster‐randomized controlled trial
Study grouping: parallel group
Study aim: "...to test the effectiveness of a school‐based parent program (SPP) as an adjunct to a school‐based program (SMART) for 7th grade students on dietary changes in adults and their adolescent children over a one year period" (quote)
Study period: study start: January 1987; study end: January 1988
Total number of arms: 2
Description of intervention arms: 1. School‐based intervention and parent intervention (child + caregiver); 2. School‐based intervention (child only)
Number of clusters per arm: 3
Average cluster size: 15 children
Sample size justification and outcome used: not reported
Unit of allocation: school
Missing data handling: participants with missing data were excluded from the main analysis, but a number of methods were applied to assess potential attrition biases and threats to internal and external validity. First, the study author assessed differences between those who dropped out and those who stayed in the study, and found few differences. Second, she kept all dropouts in the post‐test analyses and used their pre‐test scores. This resulted in similar findings
Reported limitations: 1. Selection bias, as participants were different than non‐participants and caregivers knew the details of the intervention to which they would be allocated (“the study attracted primarily White, highly educated, health conscious individuals with high incomes” [quote]); 2. High attrition rate
Randomization ratio and stratification: 1:1, stratified by socioeconomic status (low, medium, high)
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): reported for caregivers only: Asian, %: 6.1; Black/Other, %: 1.1; Hispanic, %: 7.6; White, %: 84.7 (numbers not reported) Place of residence (PROGRESS‐Plus): not reported Caregiver education (PROGRESS‐Plus): eighth grade or less, %: 2.1; some high school, %: 0.0; high school graduate or general education diploma (GED), %: 5.2; some college, %: 35.1; college graduate, %: 26.8; professional/post‐graduate, %: 30.9 (numbers not reported) Religion (PROGRESS‐Plus): not reported Household income/socioeconomic status (PROGRESS‐Plus): yearly pretax income: less than US dollar (USD) 10,000, %: 1.2; USD 10,001 to USD 25,000, %: 4.7; USD 25,001 to USD 40,000, %: 11.8; USD 40,001 to USD 65,000, %: 31.8; USD 65,001 to USD 80,000, %: 9.4; over USD 80,000, %: 41.2 (numbers 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: % energy from fat, mean (SD): 41.8 (4.9); % energy from saturated fat, mean (SD): 10.6 (1.5); fruit (servings/d), mean (SD): 0.92 (0.7); vegetables (servings/d), mean (SD): 0.58 (0.3); regular soda (servings/d), mean (SD): 0.58 (0.5) Child physical activity: not reported Caregiver weight status: body mass index (BMI; kg/m2), mean (SD): 24.6 (4) Caregiver diet: total calories (kcal), mean (SD): 2219 (782); % energy from fat, mean (SD): 41 (8); % energy from saturated fat, mean (SD): 10 (3); % energy from carbohydrates, mean (SD): 41 (9); % energy from protein, mean (SD): 16 (3) Caregiver physical activity: not reported Caregiver civil status (PROGRESS‐Plus): married, %: 80.4; unmarried, %: 19.6 (numbers 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): reported for caregivers only: Asian, %: 3.4; Black/Other, %: 1.1; Hispanic, %: 15.1; White, %: 80.5 (numbers not reported) Place of residence (PROGRESS‐Plus): not reported Caregiver education (PROGRESS‐Plus): eighth grade or less, %: 0.7; some high school, %: 1.3; high school graduate or GED, %: 7.3; some college, %: 37.1; college graduate, %: 25.2; professional/post‐graduate, %: 28.5 (numbers not reported) Religion (PROGRESS‐Plus): not reported Household income/socioeconomic status (PROGRESS‐Plus): yearly pretax income: less than USD 10,000, %: 0.8; USD 10,001 to USD 25,000, %: 6.3; USD 25,001 to USD 40,000, %: 12.6; USD 40,001 to USD 65,000, %: 38.6; USD 65,001 to USD 80,000, %: 12.6; over USD 80,000, %: 29.0 (numbers 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: % energy from fat, mean (SD): 38.7 (4.9); % energy from saturated fat, mean (SD): 10.1 (1.6); fruit (servings/d), mean (SD): 0.71 (0.5); vegetables (servings/d), mean (SD): 0.60 (0.4); regular soda (servings/d), mean (SD): 0.51 (0.5) Child physical activity: not reported Caregiver weight status: BMI (kg/m2), mean (SD): 24.7 (3.7) Caregiver diet: total calories (kcal), mean (SD): 2217 (758); % energy from fat, mean (SD): 39 (8); % energy from saturated fat, mean (SD): 9 (2); % energy from carbohydrates, mean (SD): 44 (8); % energy from protein, mean (SD): 16 (4) Caregiver physical activity: not reported Caregiver civil status (PROGRESS‐Plus): married, %: 84.9; unmarried, %: 15.1 (numbers not reported)
Recruitment methods: caregivers of students in sixth, seventh, and eighth grades at Project SHARP schools were sent a recruitment letter. Those interested returned a printed form or requested more information. A second letter was sent to all interested caregivers describing the relevant intervention arm in greater detail and asking them to sign an agreement to participate and a waiver regarding physical activity. Only seventh grade children were eligible if they had a caregiver participating in the SMART Parent Program; they were enrolled only if their caregiver provided data at both of the first 2 health status assessments
Inclusion criteria: cluster: unclear sampling approach, but junior high schools in the Greater Los Angeles area (2 low socioeconomic status [SES], 2 middle SES, and 2 high SES) participating in the Project SHARP program; participants: seventh grade students and caregivers (Note: the child‐only intervention was for seventh grade students, but caregivers of students in the sixth and eighth grades were invited to participate to increase the number of participating caregivers. Because the sample of caregivers was not restricted to those with children in the study, caregiver outcomes were not extracted)
Exclusion criteria: not reported
Age of participating children at baseline: sixth to eighth grade (estimated to be 10 to 14 years old)
Total number randomized by relevant group: adolescents were not randomized and all received the school‐based intervention; only caregivers were randomized. Adolescents with caregivers in the SMART Parent Program: across both study arms: n = 90; child + caregiver arm: n = 31; child‐only arm: n = 59
Baseline imbalances between relevant groups: not reported
Total number analyzed by relevant group: total number analyzed for relevant outcomes was not reported but was assumed to be those with data at the final assessment: child + caregiver arm: n = 20 children; child‐only arm: n = 47
Attrition by relevant group: children were considered in the sample only if their caregiver had data at the second caregiver health status assessment (child + caregiver arm: n = 31; child‐only arm: n = 59). Attrition rates were calculated as those for whom matched baseline and post‐test data were not available, divided by children considered in the sample: child + caregiver arm: 35.5% (11/31); child‐only arm: 20.3% (12/59).
Description of sample for baseline characteristics reported above: children with caregivers with data at the second health status assessment: child + caregiver arm: n = 31; child‐only arm: n = 59. Caregiver sample included individuals without a participating child |
| Interventions |
Intervention characteristics
Child + caregiver arm (intervention group)
Brief name/description (TIDieR #1): Project SHARP school‐based program plus the "SMART Parent Program" 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: "goals and planning," "feedback and monitoring," "shaping knowledge," "natural consequences," "comparison of behavior," "repetition and substitution," "comparison of outcomes," "reward and threat" Why: rationale, theory, or goal (TIDieR #2): study authors noted that at the time of their work, few school‐based studies directly involving caregivers had been reported, but those that were available showed support for including caregivers. The goal of the child + caregiver arm was “to test the effectiveness of a healthy lifestyle program for adults on dietary behaviors related to heart disease and cancer.” Study authors report drawing on several behavioral theories, including social learning theory and social support and family theories How, where, and when and how much (TIDieR #6 to 8): in addition to the intervention provided to the child‐only arm, caregivers participated in 4 intervention sessions offered 1 evening per week for 4 consecutive weeks (location not reported). Each session consisted of 30 minutes of low‐impact aerobic activity set to music followed by a snack and a 1‐hour presentation. Two maintenance (“booster”) sessions were offered to caregivers approximately 3 and 6 months following the fourth lesson. Caregivers also received 4 monthly newsletters in the summer and early fall Who: providers (TIDieR #5): session leaders were selected based on their qualifications and included an exercise physiologist, registered dietitians, and a physician; a procedure manual was used to support program integrity Economic variables and resources required for replication: not reported Strategies to address disadvantage: not reported Subgroups: not reported Assessment time points: baseline, 9 months Co‐interventions: same as child‐only arm What: materials and procedures (TIDieR #3 to 4): the first session focused only on fitness, but the second, third, and fourth sessions included both fitness and nutrition content. At each session, caregivers received the portion of their results from the baseline health status assessment pertaining to the session topic. As with the child‐only arm, these results were normative and were compared to others of the same age and sex. They included recommendations to improve the individual’s personal risk profile. Participants received a 3‐ring notebook to keep written educational materials and health status results. The 2 booster sessions also focused on fitness and nutrition topics. Each newsletter was 4 pages long, and sought to encourage and reinforce positive diet and activity behaviors in a “light and upbeat” style Tailoring (TIDieR #9): not reported Modifications (TIDieR #10): not reported How well: planned and actual (TIDieR #11 to 12): not reported Sensitivity analyses: same as child‐only arm
Child‐only arm (control group)
Brief name/description (TIDieR #1): Project SHARP school‐based program Focus of intervention: physical activity and diet Behavior change techniques: "goals and planning," "feedback and monitoring," "shaping knowledge," "natural consequences," "comparison of behavior" Why: rationale, theory, or goal (TIDieR #2): Project SMART was a school‐based healthy lifestyle promotion program targeting physical activity, diet, smoking, and substance use among children. Study authors did not describe the use of theory in development of this intervention How, where, and when and how much (TIDieR #6 to 8): children received 15 classroom sessions. Additional information on how, where, when, and how much was not reported. Who: providers (TIDieR #5): classroom teachers who had received training Economic variables and resources required for replication: not reported Strategies to address disadvantage: not reported Subgroups: not reported Assessment time points: baseline, 9 months Co‐interventions: in addition to physical activity and diet, Project SHARP targeted smoking and substance use What: materials and procedures (TIDieR #3 to 4): children received 15 classroom sessions. Diet and exercise lessons applied “psychosocial, behavioral, and knowledge‐based approaches, such as goal setting, assertiveness training, and nutrition information about the fat content of foods, and knowledge about the benefits of aerobic exercise" (quote). Caregivers who completed the health status assessments (study data collection) were mailed the results (compared to norms for persons of the same age and sex) approximately 1 month after each assessment Tailoring (TIDieR #9): not reported Modifications (TIDieR #10): not reported How well: planned and actual (TIDieR #11 to 12): not reported Sensitivity analyses: study authors conducted attrition analyses in which dropouts were kept in the post‐test analysis and were assigned their baseline values. These analyses resulted in similar results to those using only participants with complete data
|
| Outcomes |
The following instruments were used to measure outcomes relevant to this review at baseline and 9 months (end of intervention)
Data for caregivers' dietary intake also were collected but could not be used for this review because the caregiver sample had different inclusion criteria than the child sample |
| Identification |
Study name: SMART Parent Program
Country: USA
Setting: junior high schools in the Greater Los Angeles area
Types of reports: PhD thesis
Comments: used only 1 report: Dietsch 1990
Author's name: Barbara J Dietsch
Email: bdietsc@wested.org
Conflicts of interest: not reported
Sponsorship source: not reported |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation |
Unclear risk |
Judgment comment: a method for randomization was not reported. However, the trial author did note that "six junior high schools were stratified by socioeconomic status (low, medium, or high), matched, and assigned randomly from matched pairs to intervention or control conditions" (quote; p 37) |
| 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: 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, children were aged 10 to 14 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: dietary data were measured by self‐report and may or may not have been influenced by lack of blinding. No information was provided on whether or not study staff were blinded |
| Incomplete outcome data
All outcomes |
High risk |
Judgment comment: the trial author considered children to be in the sample only if their caregiver had data at the second caregiver health status assessment "Time 2" (child + caregiver arm: n = 31; child‐only arm: n = 59). We calculated attrition rates as those for whom matched baseline and end‐of‐intervention data were not available, divided by children considered in the sample. Total attrition was 25.6% and differential attrition was 15.2% (11/31 vs 12/59) |
| Selective reporting |
High risk |
Judgment comment: the trial was not registered and no protocol was cited that could be retrieved. Child dietary outcomes were reported incompletely, and not all could be entered into meta‐analysis. We could not retrieve relevant data from the study author |
| Recruitment bias |
High risk |
Judgment comment: recruitment of caregivers occurred after cluster‐randomization |
| Baseline imbalance |
Unclear risk |
Judgment comment: the number of clusters was low (n = 6), and study authors did not report similarities or differences between clusters. They did report the characteristics of caregivers at baseline, and the 2 arms appear to have been relatively balanced |
| Loss of clusters |
Unclear risk |
Judgment comment: the trial author did not report whether any clusters were lost |
| Incorrect analysis |
High risk |
Judgment comment: the study author 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 |
