| Study characteristics |
| Methods |
Parallel RCT.
Examine the effectiveness of 2 nutritional interventions.
Hypotheses:
1. children participating in both groups will increase their calorie intake;
2. children participating in both groups will show significant increases in weight.
Sequence of randomisation ‐ number drawn from a box. |
| Participants |
N = 12.
Less than 3 years old.
Confirmed diagnosis of CF with pancreatic insufficiency.
No other disease or condition known to affect growth. |
| Interventions |
1. Nutrition intervention with strategies for enhancing calorie intake ‐ behavioral management training for parents designed to encourage children to eat food consistent with CF dietary recommendations (N = 7).
2. Nutrition intervention only (N = 5).
Both groups received 8 sessions (45 to 60 minutes) over 1 year:
Sessions 1 to 4 (3 months) intensive education;
Sessions 5 to 8 (9 months) review of education material. |
| Outcomes |
1. Average number of calories consumed per day.
2. Weight (kg).
Assessments at baseline and follow up 1 year later. |
| Notes |
POI: daily calorie intake.
Attrition: one family failed to complete follow‐up assessment at 1 year. 3 familles withdrew after the third treatment session.
No significant difference between those that completed study and those that dropped out.
Groups were comparable with regard to age, parent's marital status and SES of family.
Equivalence at baseline doubtful. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Not reported. |
| Allocation concealment (selection bias) |
Unclear risk |
Not reported. |
| Blinding (performance bias and detection bias)
All outcomes |
High risk |
Unclear. |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
The authors recorded the drop‐outs (33%) and presented the reasons. However, reasons for drop‐outs are not reported separately for both conditions. They additionally reported that a comparison of children who withdrew from the study and those who completed the study protocol yielded no significant differences on demographic and anthropometric data' (Powers 2003 p. 304). |
