An interventional study of Experimental - Intensive nutrition counselling for pregnant, adolescent and under2 children in Gestational Weight Gain, Diet, Food, and Nutrition and Undernutrition, sponsored by International Centre for Diarrhoeal Disease Research, Bangladesh. Recruiting at 1 site in Bangladesh. Open to participants aged 1 Day to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-30.
Sponsored by International Centre for Diarrhoeal Disease Research, Bangladesh · Not applicable, Interventional, and Prevention
The objective of the research project is to establish an evidence-based sustainable nutrition service delivery platform for optimizing pregnancy weight gain, increasing dietary diversity of adolescent girls, and ensuring proper physical growth of under 2 children.
Hypothesis
Background
Methods
This study will be conducted in the Bauniabadh and the adjacent slum areas of Dhaka city. This study includes a community survey, formative study, community-based nutrition intervention, and an evaluation of the programmatic intervention using a quasi-experimental design.
Bauniabadh slum area has a population of \~150,000. It has five blocks: A, B, C, D, and E. Blocks B, C, and E will be the intervention area for programmatic intervention and A and D will be the control area where no intervention will be provided. Blocks A, and D is separated from other blocks by a road, a school, and a water body.
At first, a community survey will be conducted to identify the total number of beneficiaries in both the control and intervention areas: under 2 years old children, adolescent girls, and pregnant women at or before 16 weeks of gestation.
The formative research includes 24-h dietary recalls, in-depth interviews with purposively selected household heads, women, adolescent girls, and focus group discussions with women and adolescent girls to explore the locally available foods to prepare nutritious diets for pregnant women and adolescent girls. Moreover, this formative study will help in tailoring the messages for group counseling sessions on nutrition and WASH on the perspectives of the slum dwellers in Dhaka city. All counseling materials for the programmatic intervention will be developed from data generated from the formative research and using existing materials.
In the intervention area, nutrition intervention will be provided to all pregnant women, adolescent girls, and children under the age of 2 years. For pregnant women, intensive dietary counseling will be provided through household visits. The intervention also includes daily iron-folate and calcium supplementation to the pregnant women for the remaining pregnancy period till childbirth, and at least four antenatal visits to local ANC service providers will be ensured. For all adolescent girls, monthly two nutrition education sessions for six months will be organized to improve dietary diversity. Adolescent girls will also receive weekly iron and folate supplementation for 3 months and 10 mg of zinc sulfate tablet daily for 1 month. Training research staff will do monthly growth monitoring and promotion for all under 2-year-old children. All children suffering from acute malnutrition will be treated and severely stunted children will be supplemented with one egg daily for 3 consecutive months and multiple micronutrient powders for 2 months. Additionally, counseling on water sanitation and hygiene, and food safety will be provided to the mother of the child participants. This program will also ensure community participation to improve the garbage disposal system, water supply and cleaning of drains in the area.
The primary outcome measures will be total pregnancy weight gain (kg) and rate of weight gain (kg/week) for pregnant women. Change in dietary diversity scores in adolescent girls, change in maternal WASH practices, and change in length-for-age z-score for children under the age of 2 years.
Evaluation will be done using a quasi-experimental design. Data related to outcome indicators will be collected from target groups from both the intervention and the controls areas.
At the end of the intervention, based on calculated sample sizes to see the changes in outcome variables, at a 5% level of significance with 90% power, we will need to enroll at least 199 pregnant women, 572 adolescent girls, 420 children below 2years, 89 children below 2years (WASH group) in each group. Based on previous data, we assume that the total available sample sizes for the programmatic intervention will be 400 pregnant women, 1200 adolescent girls, 1500 for children below 2years, and 178 children below 2years for WASH group. Therefore, our sample size will have more than enough power to test our hypotheses.
134 studies on the registry are indexed under Gestational Weight Gain; 24 are open to participants now.
This study's planned enrollment of 3,278 is above the median of 104 across 108 interventional studies indexed under Gestational Weight Gain.
Browse Gestational Weight Gain studies →International Centre for Diarrhoeal Disease Research, Bangladesh is the lead sponsor of 206 studies on the registry; 31 are open to participants now.
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Pregnant women:
Adolescent girls:
Children:
Exclusion Criteria:
Pregnant women:
Adolescent girls:
Children:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
1. Pregnant women will receive monthly intensive dietary counseling, daily iron-folate, calcium supplementation, and at least four antenatal visits to local ANC service providers from enrollment before 16 weeks of gestation to delivery of the baby will be ensured. 2. Adolescent girls will receive twice-monthly nutrition education sessions to improve dietary diversity scores from enrolment to 6 months of enrollment. 3. Under 2y children will receive monthly growth monitoring and promotion, IYCF counseling 4. Under 2y children for WASH counseling group will receive twice-monthly nutrition education sessions for 6months to improve maternal WASH practices 5. Severely stunted children: Daily 1 egg for 3 consecutive months and 1 sachet of multiple micronutrient powder supplementation for 2 months.
Behavioral: Experimental - Intensive nutrition counselling for pregnant, adolescent and under2 children
Participants will receive the standard of care in the area
Pregnant women: Intensive dietary counseling using diet chart for locally available food, and to attend antenatal care services from local ANC providers, daily Iron, folic acid, and calcium supplementation. Adolescent girls: Group sessions in the nutrition centers with the adolescent girls will be conducted twice monthly for 6 months. Iron and folic acid (200 mg ferrous fumarate and 400 μg folic acid); once weekly for 3 months; zinc 10 mg daily for 1 month. Children \<2 years: Behavioral counseling sessions through monthly home visits on Infant and Young Child feeding, Growth monitoring and promotion, and water sanitation and hygiene, and food safety. Intensive WASH counselling: Intensive WASH counseling will be provided to separate group of child participants twice a month for 6 months. Severely stunted children: 1 egg supplementation for 3 months and 1 sachet of multiple micronutrient powder (1 RDA of vitamin A and C, iron-folic acid, and zinc) daily for 2 months.
Also known as: Iron, folic acid and calcium supplementation for pregnant women, Zinc and iron-folate supplementation to adolescent gilrs, Egg supplementation to severely stunted children daily for 3 months to
Gestational weight gain
Change in gestational weight gain and rate of weight gain in the pregnant woman
Time frame: From the 16th week of gestation to child birth
Dietary Diversity
Change in Dietary Diversity of Adolescent Girl
Time frame: 6 months
Improve linear growth
Change in length for age z-score of children less than 2 years
Time frame: 1 year
Improved maternal WASH practices
Improvement in maternal WASH practics will be assessed through use of safe water, handwashing practice during critical times, use of hygienic/ improved toilet using a structured questionnaire
Time frame: 6 months
Hemoglobin level of adolescent girl
A change in hemoglobin level Adolescent Girl
Time frame: 6 months
IYCF indicators
A change in WHO's core IYCF indicators for Children \<2 years
Time frame: 1 year
Hemoglobin level of Pregnant woman
A change in hemoglobin level of Pregnant woman
Time frame: 16 week of pregnancy to child birth
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