Participants
We recruited 282 maternal/child dyads (140 from the intervention and 142 from SOC) to participate in this study. Two selected participants from the intervention arm were not able to participate due to the travel plans; otherwise, no mothers declined to participate. There were no significant differences in maternal, child or household characteristics by group (Table 1). The mean age of infants recruited was 11.7 months (range 11-13), with slightly more male infants in both arms. Almost 80% of mothers were married and 95.8% were above 18 years of age, with no differences by arms. Nearly all the participants (99.3% in intervention and 97.2% in SOC arm) were still breastfeeding.
Table 1: Characteristics of study sample of mother-infant dyads
|
Description
|
Intervention group (n=140)
|
SOC group (n=142)
|
P value
|
Age of infant (mos.)
|
Mean (SD, range)
|
11.7 (0.5, 11-13)
|
11.7(0.4,11-13)
|
0.97
|
Gender of infant
|
Males
|
75 (53.6%)
|
80 (56.3%)
|
0.64
|
|
Females
|
65 (46.4%)
|
62 (43.7%)
|
|
Breastfeeding status
|
Currently breast fed
|
139 (99.3%)
|
138 (97.2%)
|
0.25
|
|
No longer breastfed
|
1 (0.7%)
|
4 (2.8%)
|
|
Appetite of the child
|
Normal
|
95 (67.9%)
|
91 (64.1%)
|
0.81
|
|
Less than normal
|
43 (30.7%)
|
49 (34.5%)
|
|
|
More than normal
|
2 (1.4%)
|
2 (1.4%)
|
|
Age of the mother (years)
|
Mean (SD, range)
|
27.8(7.2, 16-47)
|
27.9(7.8,16-47)
|
0.89
|
Marital status
|
|
|
|
0.47
|
|
Married
|
111 (79.3%)
|
112 (78.9%)
|
|
|
Separated/Divorced
|
13 (9.3%)
|
9 (6.3%)
|
|
|
Single/Never married
|
16 (11.4%)
|
20 (14.1%)
|
|
|
Widowed
|
0 (0.0%)
|
1 (0.7%)
|
|
No of people in the house
|
Mean (SD, range)
|
5.3 (1.9, 1-11)
|
5.7 (1.9,1-11)
|
0.08
|
|
|
|
|
0.62
|
Type of toilet in use
|
Pit latrine
|
119 (85.0%)
|
98 (69.0%)
|
|
|
Ventilated improved pit
|
20 (14.3%)
|
37 (26.0%)
|
|
|
None, Bush
|
1 (0.7%)
|
5 (3.6%)
|
|
|
Others
|
0 (0.0%)
|
2 (1.4%)
|
|
|
|
|
|
0.62
|
Water source
|
Protected source
|
107 (76.4%)
|
108 (76.1%)
|
|
|
Unprotected source
|
33 (23.6%)
|
- (23.9%)
|
|
*P- value reported for categorical variables were calculated through chi-square and continuous variables were calculated by t-test.
Nutrient intake and adequacy
The mean intake of calories in the entire sample was 505 (range: 70-1573) and did not differ between arms (Table 2). Mean protein intake differed, being 13.7 g (range: 2.0- 45.0) in the intervention arm and 12.3g (range: 1.0- 46.0, p-value 0.03) in the SOC arm. Zinc and iron intakes were very low and did not differ in a clinically relevant way, although both differences approached statistical significance (Table 2).
Table 2: Daily macro- and micronutrient intake by group
Nutrient
|
Intervention group (n = 140) Mean (95% Confidence Interval)
|
SOC group (n=142) Mean (95% Confidence Interval)
|
Difference between groups (% of total sample mean)
|
p-value*
|
Energy (kcal)
|
519.7 (481.9, 556.3)
|
492.2 (455.3,529.1)
|
26.9 (5.3%)
|
0.32
|
Protein (gram)
|
12.3 (11.2,13.4)
|
10.7 (9.8,11.6)
|
1.6 (13.9%)
|
0.03*
|
Lipid (gram)
|
12.2 (11.0, 13.4)
|
11.0 (9.9, 12.1)
|
1.2 (10.3%)
|
0.19
|
Iron (g)
|
1.9 (1.7, 2.1)
|
1.7 (1.5,1.9)
|
0.2 (11.1%)
|
0.07
|
Zinc (mg)
|
1.5 (1.4,1.7)
|
1.4 (1.3,1.5)
|
0.1(6.7%)
|
0.06
|
Calcium (mg)
|
72.1 (59.3,84.9)
|
74.9 (61.7,88.1)
|
2.8 (3.8%)
|
0.72
|
Vitamin A (ug)
|
247.9 (190.6,305.1)
|
233.1 (179.6,286.6)
|
14.4 (5.9%)
|
0.79
|
*P values reported from mixed level models adjusting for age, gender and round with cluster as a random effect (Intervention and SOC)
The intake for all macro- and micronutrients that were evaluated in the study sample fell below the recommended nutrient intake (RNI) for breastfed infants. This was particularly true for lipids, iron and zinc; for these less than 10% of infant intakes met the recommended level (Table 3). For protein and vitamin, A, just over 50% of infants overall met the RNI. There were no differences in rates of adequacy between groups for any of these nutrients.
Table 3: Percent of infants who met Recommended Nutrient Intake (RNI) by arm.
Nutrient
|
RNI for 7-12 months of age
|
Intervention group % Met RNI (n = 140)
|
SOC group % Met RNI (n=142)
|
p-value
|
Energy(kcal) *
|
479 kcal
|
21.8%
|
22.9%
|
0.84
|
Protein(g)
|
10.5g
|
62.1%
|
52.8%
|
0.11
|
Lipid (g)
|
35% of caloric intake
|
7.1%
|
7.1%
|
0.97
|
Iron (g)
|
9.3g
|
1.4%
|
0.0%
|
0.15
|
Zinc (mg)
|
4.1g
|
1.4%
|
1.0%
|
0.55
|
Calcium (mg)
|
400mg
|
38.6%
|
32.4%
|
0.19
|
Vitamin A (ug)
|
400g
|
54.0%
|
46.0%
|
0.28
|
Notes: RNI for energy is for complementary foods only and assumes average breastmilk intake by age (9-11 mos and 12-23 mos) (28). For non-breastfed infants >12 mos old, we used 858 kcal per day for adequacy; Protein - WHO/FAO requirements we used the average by age and sex at 10.5 for 12 months and 11.9 >12 mos years according to Arimond, Zeilani (29), (30). The values shown are averages across age and sex; For iron and zinc, we assumed moderate bioavailability. There were 4 infants with13 months of age in this analysis, for energy, protein and lipids nutrients, the appropriate cutoff for 13-month-olds was used.”
Dietary composition
We also analyzed the food groups consumed by arm to understand the drivers of dietary differences between arms. There was a tendency toward higher consumption of grains and grain products, beans, nuts, seeds, cereals, and “lishe” porridge (the blended flour which was prepared by mixture of 4 parts of maize and 1 part of groundnut) in the intervention arm (Table 4). The higher protein intake in the intervention arm was coincident with higher groundnuts consumption in the intervention compared to the control arm (Table 2 & 3). Higher intake of groundnuts in the intervention arm may have been brought about by the provision of MMT groundnuts and blended flour. The consumption of roots and tubers, meat, poultry and insects, fish, and sea foods together with eggs were similar in both arms.
Table 4: Frequency of feeding episodes of protein foods by study arm
Ingredients
|
Group
|
n
|
Mean
|
SD
|
P-value
|
Blended flour (Lishe 4:1)
|
Intervention
|
133
|
7.78
|
5.31
|
0.49
|
SOC
|
107
|
7.32
|
5.26
|
Groundnuts
|
Intervention
|
94
|
8.09
|
5.71
|
0.05
|
SOC
|
62
|
6.31
|
5.57
|
Dairy
|
Intervention
|
17
|
12.18
|
7.29
|
0.36
|
SOC
|
35
|
10.31
|
6.57
|
Egg
|
Intervention
|
2
|
11
|
2.83
|
0.66
|
SOC
|
3
|
17.67
|
18.5
|
Beef
|
Intervention
|
9
|
7.33
|
3.12
|
0.70
|
SOC
|
8
|
8.13
|
5.11
|
Green peas, yellow beans and red beans
|
Intervention
|
46
|
10.43
|
6.67
|
0.18
|
SOC
|
39
|
8.41
|
7.15
|
Fish
|
Intervention
|
6
|
9.67
|
7.12
|
0.35
|
SOC
|
4
|
16.75
|
15.76
|
Note: The P-value for protein source was calculated by two-sample t test with equal variances
Table 5: Macronutrient intake by round of data collection
Nutrient
|
Round
|
Mean
|
Standard Deviation
|
P value
|
Energy (kcal)
|
Round 1
|
537.9
|
261.6
|
-
|
Round 2
|
522.1
|
206.3
|
0.82
|
Round 3
|
459
|
228.1
|
0.09
|
Protein (g)
|
Round 1
|
14
|
7.8
|
-
|
Round 2
|
13.3
|
5.9
|
0.79
|
Round 3
|
12.1
|
7.5
|
0.21
|
Lipid (g)
|
Round 1
|
14.5
|
8.2
|
-
|
Round 2
|
13.9
|
6.1
|
0.57
|
Round 3
|
11.4
|
5.2
|
0.13
|
Data were collected in three rounds (Table 5), rounds relate with the food harvest: July -September 2020, round one, months that were closer to the harvest; October -November 2020, round two, far from harvest months; and November -December 2020, round three, very far from the harvest months in Kongwa. The three rounds covered eight calendar months to capture potential differences in season. Babies consumed more nutrients during the harvest months as compared to other months far from the harvest, however the difference in nutrient intake between these three rounds was not significant. This difference was likely due to food accessibility depending on seasonality (21), and not due to a systematic change in assessment.