Imes 1988.
| Methods | Randomised controlled trial. Duration 6 months. | |
| Participants | Adults (n = 137, 62 men and 75 women, aged 17.5 ‐ 71.0 years) with Crohn's disease. CDAI (mean (SD) 110 (96) range 0 ‐ 463). People taking medication (42% taking prednisolone, 45% salazopyrin) or vitamin supplements (50%) and with active and inactive disease included. |
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| Interventions | Monthly dietary counselling sessions aiming to achieve the 'Canadian Recommended Dietary Allowances' (n = 67). Control group no dietary intervention (n = 70). |
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| Outcomes | Energy* and protein intake, vitamin and mineral intake, assessments of clinical condition, survival*, MAMC*, MUAC*, TSF*, hospital admissions*. | |
| Notes | Additional outcomes and longer follow up reported in separate papers. Additional data and information on quality obtained from author. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Author cannot recall how the sequence was generated. |
| Allocation concealment (selection bias) | Low risk | Sealed envelopes. |
| Blinding (performance bias and detection bias) Clinical outcomes | Low risk | Blind assessments of clinical outcomes. |
| Blinding (performance bias and detection bias) Functional outcomes | Unclear risk | No functional assessments made. |
| Blinding (performance bias and detection bias) Nutritional outcomes | High risk | Assessment of nutritional outcomes not blinded. |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Information obtained from the author. 137 participants randomised, 125 completed 6 months of study, 8 drop‐outs in the dietary advice group and 4 in the no dietary advice group. There were no deaths. Reasons for drop‐outs not reported. |
| Selective reporting (reporting bias) | Unclear risk | Data on mortality and hospital admissions could not be extracted from the papers and have been obtained from author. Additional outcomes and longer follow‐up reported in separate papers. |
| Other bias | Unclear risk | Baseline variables given, advice group were younger and had a lower CDAI that the no advice group. |