Stunting, Wasting
Conditions
Keywords
complementary food supplements, stunting, wasting, growth, Bangladesh, infant feeding
Brief summary
The purpose of this study is to test the impact on child growth of three specially formulated complementary food supplements vs. Plumpy'Doz, a previously tested, commercially available complementary food, and vs. a control group that receives no food. All groups will receive nutrition education related to infant and young child feeding. This will be a cluster-randomised trial in children 6-18 months old in rural Rangpur and Gaibandha in Bangladesh.
Detailed description
Childhood stunting and growth faltering is highly prevalent in South Asia. Among other strategies, adequate complementary feeding practices and provision of complementary foods that are appropriate and fill the nutrient gap by providing macro and micronutrients essential for growth are important means to reduce the global burden of undernutrition and related morbidity and mortality. We propose to evaluate the impact of three complementary food supplement products that are fortified with micronutrients in a rural, remote setting in Bangladesh, where high rates of childhood undernutrition persist on child growth, health, and development. The three foods being tested are an enhanced wheat-soy blend (WSB++) developed by WFP, and locally developed chickpea-based and a rice-based complementary food supplements. We will assess the impact of feeding these daily against the non-fed controls, hypothesizing that the children fed these foods show increased length for age Z scores (LAZ) and weight for length age Z scores (WLZ) of \>0.21 and decreased prevalence of stunting and wasting by \>10%. We expect that the impact of the three foods will be equivalent/ non-inferior to that of Plumpy'Doz.
Interventions
A wheat formulation containing protein from milk solids and soybeans, essential fats and sugar to provide optimal caloric density, and added vitamins and minerals.
A chickpea-based complementary food supplement with added milk powder, oil, sugar and added vitamins and minerals.
Locally developed rice based complementary food with and added vitamins and minerals.
Plumpy Doz is a prepackaged ready-to-use complementary food supplement enriched with added vitamins and minerals.
Sponsors
Study design
Eligibility
Inclusion criteria
* Infants 6 months of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stunting in Children at 18 mo | 18 months of age | Prevalence of stunting at 18 months of age. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Morbidity | weekly from 6 to 18 months of age | weekly morbidity will be assessed for a year and episodes of diarrhea, dysentery ALRI, and fever will be recorded. |
| Body Composition | At 6, 9 and 12 months of age | Bioelectrical impedance analysis will be used to look at body composition changes from baseline until 18 months of age |
| Developmental Milestones | At 6, 12, and 18 months of age | Age-specific developmental milestones will be assessed |
| Micronutrient Status | 18 months of age | Iron, vitamin A, zinc and other micronutrient status of children will be examined by intervention group. |
| Intestinal Function | At 24 months of age | Intestinal function using L:M and other biomarkers will be assessed by intervention group and its association with child growth |
| Cognitive and Motor Function | At 18 months of age | Using Bayley III |
Other
| Measure | Time frame | Description |
|---|---|---|
| Maternal Knowledge, Attitude and Practice Related to Infant and Young Child Feeding | At 6, 12 and 18 months of age | Maternal KAP |
Countries
Bangladesh
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| No Food A control in which mothers will receive nutrition education about continued breastfeeding and adequate complementary feeding throughout the period of 6-18 months of age. | 1,438 |
| Plumpy Doz In this control arm children will receive prepackaged, lipid-based Plumpy'Doz (Nutriset, Mulaunay, France) for daily consumption as a snack.
Plumpy Doz: Plumpy Doz is a prepackaged ready-to-use complementary food supplement enriched with added vitamins and minerals. | 1,492 |
| Wheat Soy Blend (WSB++) Children will receive a WFP-developed Wheat-Soy Blend (WSB++) snack to be consumed daily.
Wheat Soy Blend (WSB++): A wheat formulation containing protein from milk solids and soybeans, essential fats and sugar to provide optimal caloric density, and added vitamins and minerals. | 851 |
| Chickpea Based Complementary Food Supplement Children will receive a Chickpea based complementary food supplement to be consumed daily.
Chickpea based complementary food supplement: A chickpea-based complementary food supplement with added milk powder, oil, sugar and added vitamins and minerals. | 843 |
| Rice Based Complementary Food Supplement Children will receive a locally developed rice based complementary food supplement.
Rice based complementary food supplement: Locally developed rice based complementary food with and added vitamins and minerals. | 825 |
| Total | 5,449 |
Baseline characteristics
| Characteristic | No Food | Plumpy Doz | Wheat Soy Blend (WSB++) | Chickpea Based Complementary Food Supplement | Rice Based Complementary Food Supplement | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 6.13 months STANDARD_DEVIATION 0 | 6.26 months STANDARD_DEVIATION 0.26 | 6.26 months STANDARD_DEVIATION 0.27 | 6.24 months STANDARD_DEVIATION 0.25 | 6.25 months STANDARD_DEVIATION 0.25 | 6.23 months STANDARD_DEVIATION 0.21 |
| Region of Enrollment Bangladesh | 1438 participants | 1492 participants | 851 participants | 843 participants | 852 participants | 5476 participants |
| Sex: Female, Male Female | 752 Participants | 725 Participants | 432 Participants | 424 Participants | 425 Participants | 2758 Participants |
| Sex: Female, Male Male | 686 Participants | 767 Participants | 419 Participants | 419 Participants | 400 Participants | 2691 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 12 / 1,438 | 9 / 1,492 | 8 / 851 | 6 / 843 | 2 / 825 |
| other Total, other adverse events | 0 / 1,438 | 0 / 1,492 | 0 / 851 | 0 / 843 | 0 / 825 |
| serious Total, serious adverse events | 0 / 1,438 | 0 / 1,492 | 0 / 864 | 0 / 860 | 0 / 838 |
Outcome results
Stunting in Children at 18 mo
Prevalence of stunting at 18 months of age.
Time frame: 18 months of age
Population: Children followed after 1 year of supplementation from 6 months at 18 months of age
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| No Food | Stunting in Children at 18 mo | 559 Participants |
| Plumpy Doz | Stunting in Children at 18 mo | 542 Participants |
| Wheat Soy Blend (WSB++) | Stunting in Children at 18 mo | 341 Participants |
| Chickpea Based Complementary Food Supplement | Stunting in Children at 18 mo | 300 Participants |
| Rice Based Complementary Food Supplement | Stunting in Children at 18 mo | 330 Participants |
Body Composition
Bioelectrical impedance analysis will be used to look at body composition changes from baseline until 18 months of age
Time frame: At 6, 9 and 12 months of age
Cognitive and Motor Function
Using Bayley III
Time frame: At 18 months of age
Developmental Milestones
Age-specific developmental milestones will be assessed
Time frame: At 6, 12, and 18 months of age
Intestinal Function
Intestinal function using L:M and other biomarkers will be assessed by intervention group and its association with child growth
Time frame: At 24 months of age
Micronutrient Status
Iron, vitamin A, zinc and other micronutrient status of children will be examined by intervention group.
Time frame: 18 months of age
Morbidity
weekly morbidity will be assessed for a year and episodes of diarrhea, dysentery ALRI, and fever will be recorded.
Time frame: weekly from 6 to 18 months of age
Maternal Knowledge, Attitude and Practice Related to Infant and Young Child Feeding
Maternal KAP
Time frame: At 6, 12 and 18 months of age