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. 2019 Jan 28;2019(1):CD011651. doi: 10.1002/14651858.CD011651.pub2

Kouba 2012.

Methods Included as process evaluation
Intervention study design: quasi‐experimental single‐group study examining change pre‐post intervention
Unit of allocation: N/A
Process evaluation methods: descriptive and bivariate methods of analyses of survey‐based data (as well as administrative records)
Participants Setting: 2 urban high schools in the USA
Age of children: ninth through 12th grade; average age was 15.9 years
Child characteristics (BME/SES): 92% African American, 4% Hispanic, 4% mixed ethnicity. Combined median family income ranged from USD30,000 to USD39,000
Asthma status: asthmatic only; 66% of children were deemed to have control of their asthma at baseline according to ACT tests
Intervention recipients: children only (targeted overweight/obese children)
Interventions School type: 2 high schools
Intervention description: I Can Control Asthma and Nutrition Now (ICAN): the ICAN programme was developed as an adaptation of an existing intervention and is composed of 3 elements: (I) asthma education; (ii) coping skills training; and (iii) nurse practitioner‐reinforcement visits. In this study, 60% of students were overweight or obese. Because of concerns about the increasing prevalence of both youth asthma and obesity, study authors added a nutrition component to the intervention, so that the intervention could address these comorbidities. The ICAN programme is thus composed of 4 elements: (I) asthma education, (ii) nutrition education synthesised with CST, targeting obesity prevention and management, (iii) reinforcement visits with a registered nurse (RN) and a dietetic intern, and (iv) a family information meeting
Control description: N/A
Theoretical framework: Orem's self‐care deficit theory (SCDT)
Outcomes Core processes evaluated (child level): attrition, dosage
Notes Process evaluation category: integrated within outcome evaluation
Breadth and depth: depth ‐ not breadth
Voice of children given prominence: voice and views of children not featured
Funding source: Loyola University Chicago Niehoff School of Nursing
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk N/A
Allocation concealment (selection bias) Unclear risk N/A
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk N/A
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk N/A
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk N/A
Selective reporting (reporting bias) Unclear risk N/A
Other bias Unclear risk N/A
Transparent and clearly stated aims Low risk Study aims were clearly stated
Explicit theories underpinning and/or literature review Low risk Orem's self‐care deficit theory guided the intervention
Transparent and clearly stated methods and tools Low risk Methods and tools were fully described
Selective reporting Low risk All planned outcomes were reported on
Harmful effects Unclear risk Generalisability was not considered. Some of the challenges of working with obese kids who are not adherent were not reported
Population and sample described well Low risk Population demographics were clearly described
Continuous evaluation Low risk Two follow‐ups post intervention
Evaluation participation equity and sampling Unclear risk No evidence of satisfaction evaluation and no child perspectives given
Design and methods overall approach Unclear risk Everything required for a good process evaluation was not captured
Tools and methods of data collection reliable/credible Unclear risk Nothing suggests that this study was at high risk of bias; however no study steps were described
Tools and methods of data analysis reliable/credible Low risk All methods of data analysis are appropriate for the study
Performance bias/neutrality/credibility/conformability Unclear risk Not much evidence of this; however analysis was carried out by research associates under the supervision of the statistician
Reliability of findings and recommendations Unclear risk This included a small sample, and the voice of children did not feature prominently
Transferability of findings High risk Small sample size limits the transferability of findings
Overall risk of bias of process evaluation Unclear risk As a process evaluation, this study was limited, and the breadth of the study in including nutrition alongside asthma education was not evaluated