Thompson 2012.
Study characteristics | ||
Methods |
Study design: RCT, 2 arms Geographic location: Maryland, USA Ethical approval: yes Recruitment setting: urban hospital‐based academic paediatric clinic Method of recruitment: 2 trained bilingual, bicultural research assistants recruited parents in the clinic waiting room; interested parents were consented by the use of an oral consent process. Length of follow‐up: no follow‐up Dropouts: no dropouts A priori calculation of effect size/power?: yes |
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Participants |
Description: low‐income Spanish‐speaking parents of infants and toddlers Health topic
Inclusion criteria
Exclusion criteria
Intervention group
Control group
Note: 2 participants in the control group were excluded from the analysis because they were missing any responses to the knowledge questionnaire. However, these participants were included in the analysis for the secondary outcome 'planned changes in behaviour'. PROGRESS‐Plus Place of residence: urban, USA Time living in host country (years), mean (n = 158): 6.02 Race/ethnicity: Latinos/Latinas Gender (n = 148):
Education (years) (n = 159): 41.0% 6 y or less, 51.0% 7 to 12 y, 8.0% some or all of university degree Socioeconomic status/income: "low‐income" population (Thompson 2012) Health insurance: "More than 95% of clinic patients are publicly insured" (Thompson 2012, p. 413) Social capital (number of children), mean: 2.3 Age (years), mean: 27.55 Health literacy (baseline) Not measured |
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Interventions |
Intervention: nutrition education via touchscreen Theoretical framework: behavioural, cognitive and humanistic learning theories, Health Belief Model, cultural targeting strategies Description: the intervention group members viewed 5 culturally and linguistically adapted modules on nutrition and feeding presented on an interactive platform using a touchscreen computer. The modules contained a series of short educational messages and included text, pictures and audio material that accounted for the educational levels and health literacy of the participants. The modules were interactive, meaning questions requiring participants' responses with feedback given. Content was partly tailored based upon these responses.
Comparator Type: usual care (no additional intervention) Description: participants in the control group did not receive any intervention. |
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Outcomes | Outcomes assessed in the study: parental nutrition and feeding knowledge, planned changes in behaviour Outcomes considered in this review
Methods of assessing outcomes Face‐to‐face orally administered questionnaires by trained bilingual research assistants
Language of assessment: language concordant Translation procedure (if necessary): back‐translation technique Reliability/validity: developed for the study, no psychometric properties reported Timing of outcome assessment: baseline, short‐term (immediately after intervention) |
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Health literacy |
Definition: not reported Health literacy components addressed by the intervention Prerequisites and tools
Steps of information processing
Health domain: disease prevention (prevent childhood diseases through nutritional failure) |
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Notes |
Trial ID: NCT01272492 Funding: funding was provided by Johns Hopkins University. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Participants were randomized by the use of a block randomization process. We used block randomization, 10‐per‐block, to prevent sample size imbalances which could affect the study’s power. At the start of the trial, an opaque container was filled with 10 envelopes with equal representation of intervention and control assignments. The research assistant removed an envelope from this container to determine each participant’s group assignment. After ten participants, she repeated the process." |
Allocation concealment (selection bias) | Low risk | The randomisation procedure used indicates a low risk of selection bias. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Blinding of participants and personnel was not reported and behaviour intent was subjectively measured. It is unclear whether the results were affected. |
Blinding of outcome assessment (detection bias) subjective outcome measures | Unclear risk | Participants were probably not blinded to group allocation and behaviour intent was assessed using a verbally administered questionnaire. |
Blinding of outcome assessment (detection bias) objective outcome measures | Low risk | Unclear blinding but knowledge was objectively measured and not subject to interpretation. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | "Only 2 participants were missing any responses to the knowledge questions.These individuals were not included in the analyses for the total summed knowledge score and the breastfeeding domain‐specific summed knowledge score." No participant was lost to follow‐up and only 2 participants were excluded from the analysis due to missing responses. |
Selective reporting (reporting bias) | Low risk | All prespecified outcomes reported at clinicaltrials.gov are reported in the published reports. |