The effect of prenatal food supplementation on child growth in northern Bangladesh

• Register: ISRCTN
• Last refreshed on: 8 May 2023
• Main ID: ISRCTN97447076
• Date of registration: 24/03/2015
• Prospective Registration: No
• Primary sponsor: James Cook University
• Public title: The effect of prenatal food supplementation on child growth in northern Bangladesh
• Scientific title: Effect of prenatal balanced protein energy supplementation on child physical growth in northern Bangladesh: a cluster randomised controlled trial
• Date of first enrolment: 21/03/2012
• Target sample size: 330
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN97447076
• Study type: Interventional
• Study design: Cluster randomised controlled trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

Bangladesh

Contacts

• Name: Briony Stevens

Key inclusion & exclusion criteria

Inclusion criteria: 1. Written informed consent
2. Confirmed to be pregnant
3. Undernourished as defined by a mid-upper-arm circumference (MUAC) =22.1 cm
4. Did not require medical referral
Exclusion criteria: Does not meet inclusion criteria

Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Maternal undernutrition (defined as Middle Upper Arm Circumference <22.1)
Nutritional, Metabolic, Endocrine

Intervention(s)

Balanced protein energy supplementation; where the protein provided less than 25% of the total energy content (Ota et al. 2012). No micronutrients were added to the mix.

The study consists of three phases.

Phase 1: Formative research (focus groups, photovoice, systematic literature review) exploring the dietary preferences and food security situation of pregnant women living in northern Bangladesh. This research informs which food items would be appropriate and acceptable for the development of a supplementary food. In addition, the research informs the development of IEC/BCC materials and tools.

Phase 2: Development of a balanced protein energy supplement using locally available foods, and 30-day acceptability trial. Acceptance of the supplement measured at two timepoints in its development (day 15 and day 30). An assessment and focus group at day 15 allowed for modifications to the initial supplement, and an assessment at day 30 allowed for testing acceptance of these modifications. The results of the 30-day trial will inform Phase 3 of this research. The composition of the supplement was influenced by the organoleptic preferences of women in the selected communities, and the local availability of foods that are accessible year-round. The production of the supplement involved the establishment of a local business enterprise, building on local capacity and providing an income generation opportunity to the community.

Phase 3: Cluster randomised controlled trial of the locally developed supplement in 12 villages in northern Bangladesh. All women in the selected villages are screened on a monthly basis. Undernourished pregnant women are invited to participate in the research project and written consent is obtained. In eight randomly selected intervention villages t

Primary Outcome(s)

1. Birth weight (salter scales) at birth.
2. Birth length (calibrated length board) at birth
3. Birth head circumference (measuring tape) at birth
4. Longer term growth (length/weight and head circumference) at 1, 3, 6 and 12 months of age

Secondary Outcome(s)

1. Maternal weight gain (salter scales) each month
2. Maternal dietary diversity (measured used the validated Womens Dietary Diversity Questionnaire developed by Food And Nutrition Technical Assistance FANTA)

Secondary ID(s)

N/A

Source(s) of Monetary Support

World Vision (New Zealand)

Ethics review

Status:
Approval date:
Contact:

1. Human Research Ethics Committee, James Cook University, ref: H4498 2. Bangladesh Medical Research Council (BMRC), ref: BMRC/NREC/2010-2013/58

Results

• Results available: Yes
• Date Completed: 21/03/2015