Diouf 2016.
Study characteristics | ||
Methods | RCT. Parallel design with 2 arms. Duration: intervention during hospitalisation and then 9 weeks following discharge. Location: single centre in Senegal. |
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Participants |
Inclusion criteria: people living with HIV/AIDS (any stage, taking or not‐taking antiretroviral treatment). Exclusion criteria: psychiatric illness, diabetes, physical disability, unable to eat. Number randomised: 65 participants (intervention group n = 32, control group n = 33). Gender split: 32% males, 68% females. Age: mean (SD) intervention 40 (12) years; control 42 (12) years. Nutritional status: severe malnutrition (BMI < 16 kg/m²): intervention group n = 34% and control group n = 24%. |
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Interventions |
Intervention: participants received dietary advice and ONS in the form of standard hospital diet supplemented with supplement of 200 g/day* plus dietary counselling to improve diet at home (after discharge); supplementation was continued for 9 weeks at home. Control: participants received dietary advice alone in the form of standard hospital diet alone plus dietary counselling to improve diet at home (after discharge). *200 g of supplement made up of 100 g ready to use food mixed with 100 g of rice porridge. Ready to use food is composed of peanut butter and skimmed milk powder fortified with a vitamin‐mineral complex commercialised by Nutriset. The rice porridge (9.1 g rice flour per 100 mL water) was prepared extemporaneously, mixed with the ready to use food and served immediately. |
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Outcomes | Body weight, fat‐free mass, % body fat, dietary intake. Individual dietary intakes were measured and compared to the Recommended Dietary Allowances. Body composition was determined using Bio‐Impedance Analysis. |
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Publication details |
Language: English. Funding: Universite Cheikh Anta Dio de Dakar, Senegal. UNICEF Senegal provided the products. Publication status: peer‐reviewed journal. |
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Notes | Both well‐nourished and malnourished participants were included. At our request, authors provided change scores for weight, fat‐free mass and body fat. Energy and protein intakes were only measured during 7 consecutive days in 10 randomly selected participants from each group during hospitalization; therefore results on nutritional intake are not presented in this review. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | The randomisation and assignment to group was performed by the senior researcher using a computer‐generated random number list (EPI INFO 6.0; Centers for Disease Control and Prevention, Atlanta). |
Allocation concealment (selection bias) | Low risk | The randomisation and assignment to group was performed by the senior researcher using a computer‐generated random number list (EPI INFO 6.0; Centers for Disease Control and Prevention, Atlanta). |
Blinding (performance bias and detection bias) Clinical outcomes | Unclear risk | No clinical outcomes reported. |
Blinding (performance bias and detection bias) Functional outcomes | High risk | The study was unblinded. Functional outcomes could have been influenced by lack of blinding. |
Blinding (performance bias and detection bias) Nutritional outcomes | High risk | The study was unblinded. Nutritional outcomes could have been influenced by lack of blinding. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not blinded and likely that researchers and participants were aware of group allocation as this was a nutritional intervention. It is possible that assessment of some outcomes was influenced by lack of blinding. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | The study was unblinded. Outcomes could have been influenced by lack of blinding. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | High drop‐out rates, but same numbers of dropouts across both groups (intervention group n = 12, control group n = 16). During hospitalisation, 6 participants died in the intervention group and 8 in the control group so 51 completed this stage (intervention group n = 26, control group n = 25). After 9 weeks of home monitoring, 6 participants dropped out of the intervention group (3 participants withdrew and 3 died) and 8 dropped out of the control group (4 participants lost to follow‐up and 4 died). Final analysis of 37 participants, 20 in intervention group and 17 in control group. |
Selective reporting (reporting bias) | Low risk | Study protocol identified; all outcomes reported. |
Other bias | Low risk | Trend towards less females, lower CD4 counts and lower Hb (all non‐significant) in the intervention group. Nutritional intake from the standard hospital diet was comparable between groups. |