| Changes to trial information |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Intervention |
Intervention List |
07/02/2020 |
The total number of participants is 70. However, since it is a crossover study design, each participant participated in both arms ( intervention and control). This ideally means that 70 participants per study arm, but not 140 participants in total. Please note, in a crossover study design, each crossover participant serves as their own control. |
Experimental Group, Common Bean Pumpkin Blend , 100 grams, once , One day, Children were offered Common Bean Pumpkin Blend (BPB) at least 1 hour after they were last fed. 100 grams of complementary food was offered to the child in a serving dish by the caregiver. The amount of food ingested was calculated by subtracting the left-over from the offered amount. Pre-weighed napkins were provided; any food that was regurgitated, vomited or spilled was swabbed, the napkin weighed and subtracted from the weight of the amount offered. Duration of feeding was measured as described elsewhere. Caregivers were asked to spoon feed their children the assigned CF until the child refused to eat. After a two-minute pause, the same food was offered a second time until s/he refused again. After a second two-minute pause, the food was offered a third time until refused again. After this third refusal, the feeding episode was considered terminated. The duration of the feeding (excluding the intervening ‘pause periods’) was recorded by stopwatch, and the total duration of the feeding was noted. The feeding episode took place under the direct supervision of a trained research assistant to ensure that feeding was not forced. Children were considered as refusing intake if they moved their head away from the food, cried, clamped the mouth shut or clenched the teeth, or became agitated, spat out the food or refused to swallow., 70, |
Experimental Group, Common Bean Pumpkin Blend , 100 grams, once , One day, 70 Children were offered Common Bean Pumpkin Blend (BPB) at least 1 hour after they were last fed. 100 grams of complementary food was offered to the child in a serving dish by the caregiver. The amount of food ingested was calculated by subtracting the left-over from the offered amount. Pre-weighed napkins were provided; any food that was regurgitated, vomited or spilled was swabbed, the napkin weighed and subtracted from the weight of the amount offered. Duration of feeding was measured as described elsewhere. Caregivers were asked to spoon feed their children the assigned CF until the child refused to eat. After a two-minute pause, the same food was offered a second time until s/he refused again. After a second two-minute pause, the food was offered a third time until refused again. After this third refusal, the feeding episode was considered terminated. The duration of the feeding (excluding the intervening ‘pause periods’) was recorded by stopwatch, and the total duration of the feeding was noted. The feeding episode took place under the direct supervision of a trained research assistant to ensure that feeding was not forced. Children were considered as refusing intake if they moved their head away from the food, cried, clamped the mouth shut or clenched the teeth, or became agitated, spat out the food or refused to swallow., 70, |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Intervention |
Intervention List |
24/02/2020 |
On day one, 35 children received the complementary food before crossing over to the control arm. |
Experimental Group, Common Bean Pumpkin Blend , 100 grams, once , One day, 70 Children were offered Common Bean Pumpkin Blend (BPB) at least 1 hour after they were last fed. 100 grams of complementary food was offered to the child in a serving dish by the caregiver. The amount of food ingested was calculated by subtracting the left-over from the offered amount. Pre-weighed napkins were provided; any food that was regurgitated, vomited or spilled was swabbed, the napkin weighed and subtracted from the weight of the amount offered. Duration of feeding was measured as described elsewhere. Caregivers were asked to spoon feed their children the assigned CF until the child refused to eat. After a two-minute pause, the same food was offered a second time until s/he refused again. After a second two-minute pause, the food was offered a third time until refused again. After this third refusal, the feeding episode was considered terminated. The duration of the feeding (excluding the intervening ‘pause periods’) was recorded by stopwatch, and the total duration of the feeding was noted. The feeding episode took place under the direct supervision of a trained research assistant to ensure that feeding was not forced. Children were considered as refusing intake if they moved their head away from the food, cried, clamped the mouth shut or clenched the teeth, or became agitated, spat out the food or refused to swallow., 70, |
Experimental Group, Common Bean Pumpkin Blend , 100 grams, once , One day, 70 Children were offered Common Bean Pumpkin Blend (BPB) at least 1 hour after they were last fed. 100 grams of complementary food was offered to the child in a serving dish by the caregiver. The amount of food ingested was calculated by subtracting the left-over from the offered amount. Pre-weighed napkins were provided; any food that was regurgitated, vomited or spilled was swabbed, the napkin weighed and subtracted from the weight of the amount offered. Duration of feeding was measured as described elsewhere. Caregivers were asked to spoon feed their children the assigned CF until the child refused to eat. After a two-minute pause, the same food was offered a second time until s/he refused again. After a second two-minute pause, the food was offered a third time until refused again. After this third refusal, the feeding episode was considered terminated. The duration of the feeding (excluding the intervening ‘pause periods’) was recorded by stopwatch, and the total duration of the feeding was noted. The feeding episode took place under the direct supervision of a trained research assistant to ensure that feeding was not forced. Children were considered as refusing intake if they moved their head away from the food, cried, clamped the mouth shut or clenched the teeth, or became agitated, spat out the food or refused to swallow., 35, |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Intervention |
Intervention List |
24/02/2020 |
To address reviewer query |
Experimental Group, Common Bean Pumpkin Blend , 100 grams, once , One day, 70 Children were offered Common Bean Pumpkin Blend (BPB) at least 1 hour after they were last fed. 100 grams of complementary food was offered to the child in a serving dish by the caregiver. The amount of food ingested was calculated by subtracting the left-over from the offered amount. Pre-weighed napkins were provided; any food that was regurgitated, vomited or spilled was swabbed, the napkin weighed and subtracted from the weight of the amount offered. Duration of feeding was measured as described elsewhere. Caregivers were asked to spoon feed their children the assigned CF until the child refused to eat. After a two-minute pause, the same food was offered a second time until s/he refused again. After a second two-minute pause, the food was offered a third time until refused again. After this third refusal, the feeding episode was considered terminated. The duration of the feeding (excluding the intervening ‘pause periods’) was recorded by stopwatch, and the total duration of the feeding was noted. The feeding episode took place under the direct supervision of a trained research assistant to ensure that feeding was not forced. Children were considered as refusing intake if they moved their head away from the food, cried, clamped the mouth shut or clenched the teeth, or became agitated, spat out the food or refused to swallow., 35, |
Experimental Group, Common Bean Pumpkin Blend , 100 grams, once , One day, 35 Children were offered Common Bean Pumpkin Blend (BPB) at least 1 hour after they were last fed before crossing over to control arm. 100 grams of complementary food was offered to the child in a serving dish by the caregiver. The amount of food ingested was calculated by subtracting the left-over from the offered amount. Pre-weighed napkins were provided; any food that was regurgitated, vomited or spilled was swabbed, the napkin weighed and subtracted from the weight of the amount offered. Duration of feeding was measured as described elsewhere. Caregivers were asked to spoon feed their children the assigned CF until the child refused to eat. After a two-minute pause, the same food was offered a second time until s/he refused again. After a second two-minute pause, the food was offered a third time until refused again. After this third refusal, the feeding episode was considered terminated. The duration of the feeding (excluding the intervening ‘pause periods’) was recorded by stopwatch, and the total duration of the feeding was noted. The feeding episode took place under the direct supervision of a trained research assistant to ensure that feeding was not forced. Children were considered as refusing intake if they moved their head away from the food, cried, clamped the mouth shut or clenched the teeth, or became agitated, spat out the food or refused to swallow., 35, |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Intervention |
Intervention List |
07/02/2020 |
The total number of participants is 70. However, since it is a crossover study design, each participant participated in both arms ( intervention and control). This ideally means that 70 participants per study arm, but not 140 participants in total. Please note, in a crossover study design, each crossover participant serves as their own control. |
Control Group, Pumpkin Blend, 100g given once, one day, Children were offered Pumpkin Blend (PB) at least 1 hour after they were last fed. 100 grams of BP was offered to the child in a serving dish by the caregiver. The amount of food ingested was calculated by subtracting the left-over from the offered amount. Pre-weighed napkins were provided; any food that was regurgitated, vomited or spilled was swabbed, the napkin weighed and subtracted from the weight of the amount offered. Duration of feeding was measured as described elsewhere. Caregivers were asked to spoon feed their children the assigned CF until the child refused to eat. After a two-minute pause, the same food was offered a second time until s/he refused again. After a second two-minute pause, the food was offered a third time until refused again. After this third refusal, the feeding episode was considered terminated. The duration of the feeding (excluding the intervening ‘pause periods’) was recorded by stopwatch, and the total duration of the feeding was noted. The feeding episode took place under the direct supervision of a trained research assistant to ensure that feeding was not forced. Children were considered as refusing intake if they moved their head away from the food, cried, clamped the mouth shut or clenched the teeth, or became agitated, spat out the food or refused to swallow., 70, Placebo |
Control Group, Pumpkin Blend, 100g given once, one day, 70 Children were offered Pumpkin Blend (PB) at least 1 hour after they were last fed. 100 grams of BP was offered to the child in a serving dish by the caregiver. The amount of food ingested was calculated by subtracting the left-over from the offered amount. Pre-weighed napkins were provided; any food that was regurgitated, vomited or spilled was swabbed, the napkin weighed and subtracted from the weight of the amount offered. Duration of feeding was measured as described elsewhere. Caregivers were asked to spoon feed their children the assigned CF until the child refused to eat. After a two-minute pause, the same food was offered a second time until s/he refused again. After a second two-minute pause, the food was offered a third time until refused again. After this third refusal, the feeding episode was considered terminated. The duration of the feeding (excluding the intervening ‘pause periods’) was recorded by stopwatch, and the total duration of the feeding was noted. The feeding episode took place under the direct supervision of a trained research assistant to ensure that feeding was not forced. Children were considered as refusing intake if they moved their head away from the food, cried, clamped the mouth shut or clenched the teeth, or became agitated, spat out the food or refused to swallow., 70, Placebo |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Intervention |
Intervention List |
24/02/2020 |
35 children were fed on complementary food before crossing over to the intervention arm |
Control Group, Pumpkin Blend, 100g given once, one day, 70 Children were offered Pumpkin Blend (PB) at least 1 hour after they were last fed. 100 grams of BP was offered to the child in a serving dish by the caregiver. The amount of food ingested was calculated by subtracting the left-over from the offered amount. Pre-weighed napkins were provided; any food that was regurgitated, vomited or spilled was swabbed, the napkin weighed and subtracted from the weight of the amount offered. Duration of feeding was measured as described elsewhere. Caregivers were asked to spoon feed their children the assigned CF until the child refused to eat. After a two-minute pause, the same food was offered a second time until s/he refused again. After a second two-minute pause, the food was offered a third time until refused again. After this third refusal, the feeding episode was considered terminated. The duration of the feeding (excluding the intervening ‘pause periods’) was recorded by stopwatch, and the total duration of the feeding was noted. The feeding episode took place under the direct supervision of a trained research assistant to ensure that feeding was not forced. Children were considered as refusing intake if they moved their head away from the food, cried, clamped the mouth shut or clenched the teeth, or became agitated, spat out the food or refused to swallow., 70, Placebo |
Control Group, Pumpkin Blend, 100g given once, one day, 70 Children were offered Pumpkin Blend (PB) at least 1 hour after they were last fed. 100 grams of BP was offered to the child in a serving dish by the caregiver. The amount of food ingested was calculated by subtracting the left-over from the offered amount. Pre-weighed napkins were provided; any food that was regurgitated, vomited or spilled was swabbed, the napkin weighed and subtracted from the weight of the amount offered. Duration of feeding was measured as described elsewhere. Caregivers were asked to spoon feed their children the assigned CF until the child refused to eat. After a two-minute pause, the same food was offered a second time until s/he refused again. After a second two-minute pause, the food was offered a third time until refused again. After this third refusal, the feeding episode was considered terminated. The duration of the feeding (excluding the intervening ‘pause periods’) was recorded by stopwatch, and the total duration of the feeding was noted. The feeding episode took place under the direct supervision of a trained research assistant to ensure that feeding was not forced. Children were considered as refusing intake if they moved their head away from the food, cried, clamped the mouth shut or clenched the teeth, or became agitated, spat out the food or refused to swallow., 35, Placebo |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Intervention |
Intervention List |
24/02/2020 |
To address reviewer query |
Control Group, Pumpkin Blend, 100g given once, one day, 70 Children were offered Pumpkin Blend (PB) at least 1 hour after they were last fed. 100 grams of BP was offered to the child in a serving dish by the caregiver. The amount of food ingested was calculated by subtracting the left-over from the offered amount. Pre-weighed napkins were provided; any food that was regurgitated, vomited or spilled was swabbed, the napkin weighed and subtracted from the weight of the amount offered. Duration of feeding was measured as described elsewhere. Caregivers were asked to spoon feed their children the assigned CF until the child refused to eat. After a two-minute pause, the same food was offered a second time until s/he refused again. After a second two-minute pause, the food was offered a third time until refused again. After this third refusal, the feeding episode was considered terminated. The duration of the feeding (excluding the intervening ‘pause periods’) was recorded by stopwatch, and the total duration of the feeding was noted. The feeding episode took place under the direct supervision of a trained research assistant to ensure that feeding was not forced. Children were considered as refusing intake if they moved their head away from the food, cried, clamped the mouth shut or clenched the teeth, or became agitated, spat out the food or refused to swallow., 35, Placebo |
Control Group, Pumpkin Blend, 100g given once, one day, 35 Children were offered Pumpkin Blend (PB) at least 1 hour after they were last fed before crossing over to intervention arm. 100 grams of BP was offered to the child in a serving dish by the caregiver. The amount of food ingested was calculated by subtracting the left-over from the offered amount. Pre-weighed napkins were provided; any food that was regurgitated, vomited or spilled was swabbed, the napkin weighed and subtracted from the weight of the amount offered. Duration of feeding was measured as described elsewhere. Caregivers were asked to spoon feed their children the assigned CF until the child refused to eat. After a two-minute pause, the same food was offered a second time until s/he refused again. After a second two-minute pause, the food was offered a third time until refused again. After this third refusal, the feeding episode was considered terminated. The duration of the feeding (excluding the intervening ‘pause periods’) was recorded by stopwatch, and the total duration of the feeding was noted. The feeding episode took place under the direct supervision of a trained research assistant to ensure that feeding was not forced. Children were considered as refusing intake if they moved their head away from the food, cried, clamped the mouth shut or clenched the teeth, or became agitated, spat out the food or refused to swallow., 35, Placebo |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Collaborators |
Collaborators List |
24/02/2020 |
Putting details of collaborator |
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Kirthee Pillay, University of Kwa-Zulu Natal Private Bag X01, Scottsville 3209, Pietermaritzburg 3201, Pietermaritzburg, , South Africa |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Reporting |
Plan to share IPD |
24/02/2020 |
To address reviewer query |
Undecided |
Yes |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Reporting |
IPD description |
24/02/2020 |
To address reviewer query |
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All of the individual data collected during the trial, after de-identification |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Reporting |
IPD-Sharing time frame |
24/02/2020 |
To address reviewer query |
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Between January and December 2020 |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Reporting |
Key access criteria |
24/02/2020 |
To address reviewer query |
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Any one who wishes to access the data |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Reporting |
IPD URL |
24/02/2020 |
To address reviewer query |
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No website |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Reporting |
Results summary |
24/02/2020 |
To address reviewer query |
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The mean consumption of BPB and PB was 53.9g and 54.4g, respectively. The mean duration for consumption of BPB and PB was 20.6 and 20.3 minutes, respectively. There was no significant difference in amounts consumed, and duration of consumption in BPB and PB (P>0.05). The mean intake of vitamin A was significantly higher (P<0.00001) in PB (152.5 µgRAE) compared to BPB (100.9 µgRAE). The mean iron intake was significantly higher in BPB (1.1mg) (P<0.00001) compared to BP (0.3mg). Furthermore, zinc intake was significantly higher (P<0.00001) in BPB (0.58mg) compared to BP (0.13mg). |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Reporting |
Date of results summaries |
24/02/2020 |
To be submitted to BMC pediatrics on on 31 march |
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31 Mar 2020 |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Reporting |
Date of the first journal publication |
24/02/2020 |
To be submitted to BMC pediatrics on on 31 march |
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31 Mar 2020 |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Reporting |
Results & Publication URL |
24/02/2020 |
To address reviewer query |
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Not applicable |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Reporting |
Baseline characteristics |
24/02/2020 |
To address reviewer query |
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Age, sex, nutrition status ( wasting , underweight and stunting), any acute illness. |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Reporting |
Participant flow |
24/02/2020 |
To address reviewer query |
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A total of 110 children from the growth monitoring and immunisation clinic at Ntwetwe Health Centre IV, Kyankwanzi district Uganda were identified for randomization (figure 2). Out of the 110 children, 70 were eligible and assigned to BPB (test CF) and PB (control CF) using simple random sampling according to computer-generated random numbers. Computer-generated numbers were given to participants by a research assistant who was located off site. On the first day, 35 children were assigned to each group (BPB and PB). A wash out period of one day was granted, and on the third day participants crossed over to the opposite CF group. Figure 2 shows the acceptability study profile. |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Reporting |
Adverse events |
24/02/2020 |
To address reviewer query |
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None reported by child caregivers |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Reporting |
Outcome measures description |
24/02/2020 |
To address reviewer query |
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Measurement of study outcomes
Child acceptability is assessed by feeding the novel CF to the child, followed by measuring the amount of CF consumed, and duration taken to complete the CF (Guinard, 2001; Adu-Afarwuah et al., 2008; Aaron et al., 2011; Ahmed et al., 2014). The primary outcome of the study was to measure the amount of CF consumed by children. The two secondary outcomes were to measure the time taken by the child to consume the served CF; and to analyse the PVAC, iron and zinc intake of each child based on the amount of CF consumed. Caregivers were also requested to report any discomfort or adverse effects experienced by the children after being fed the study CFs.
Amount of complementary food consumed by children
This study ensured that children were offered the assigned CF (BPB or PB) at least 1 hour after they were last fed. 100 grams of CF was offered to the child in a serving dish by the caregiver. The amount of food ingested was calculated by subtracting the left-over from the offered amount. Pre-weighed napkins were provided; any food that was regurgitated, vomited or spilled was swabbed, the napkin weighed and subtracted from the weight of the amount offered.
Duration of feeding
Duration of feeding was measured as described elsewhere (Ahmed et al., 2014). Caregivers were asked to spoon feed their children the assigned CF until the child refused to eat. After a two-minute pause, the same food was offered a second time until s/he refused again. After a second two-minute pause, the food was offered a third time until refused again. After this third refusal, the feeding episode was considered terminated. The duration of the feeding (excluding the intervening ‘pause periods’) was recorded by stopwatch, and the total duration of the feeding was noted. The feeding episode took place under the direct supervision of a trained research assistant to ensure that feeding was not forced. Children were considered as refusing intake if they moved their head away from the food, cried, clamped the mouth shut or clenched the teeth, or became agitated, spat out the food or refused to swallow as done elsewhere (Ahmed et al., 2014).
Micronutrient intake measurement
The micronutrient intake (MNI) for each child was calculated using the formula, MNI= A(g)xB/100, where A was the amount of CF (BPB or BP) consumed by the child and B was the nutrient composition in 100g of CF food served to the child (see table 2). For example, if the child consumed 50g of 100g of BPB served, then MNI for iron, zinc and vitamin A would be 50x1.99/100 (0.995mg), 50x1.08/100(0.54mg) and 50x187/100 (93.5µgRAE), respectively.
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Reporting |
Link to protocol |
24/02/2020 |
To address reviewer query |
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No link |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Reporting |
Link to protocol |
24/02/2020 |
To address reviewer query |
No link |
No link |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Reporting |
Study protocol document |
24/02/2020 |
To address reviewer query |
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Study Protocol |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Reporting |
Study protocol document |
24/02/2020 |
To address reviewer query |
Study Protocol |
Clinical Study Report |
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Section Name
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Field Name
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Date
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Reason
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Old Value
|
Updated Value
|
| Reporting |
Outcome measure document |
24/02/2020 |
To address reviewer query |
|
9701_7040_4738.pdf |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Reporting |
Participant flow document |
24/02/2020 |
To address reviewer query |
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9701_7040_4739.pdf |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Reporting |
Results Available |
24/02/2020 |
To address reviewer query |
No |
Yes |