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Gestational Weight GainIMNiMNCT04868669

Improving Maternal Nutrition in Matlab

A study testing In-home, intensive nutrition counseling in people with Gestational Weight Gain, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background: Maternal undernutrition and inadequate gestational weight gain (GWG) are prevalent in rural communities of low- and middle-income countries (LMICs). In Matlab, Bangladesh, 54% of the women fail to gain adequate weight (>4 kg) in the third trimester. Read more about this study

Who is it for?
Ages 18 to 39 years, women onlyHealthy volunteers can take part
Conditions the study is for
Gestational Weight Gain
What is being tested?
In-home, intensive nutrition counseling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
285 participants
Where
1 siteBangladesh
Study dates
15 Jan 2020to 24 Oct 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 39 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • aged 18-39 years
  • in the first trimester of pregnancy (before 14 weeks of gestation)
  • BMI 16-24.99 kg/m^2 measured on enrollment
  • willing to participate in the study

Who cannot join

  • multiple pregnancy (carrying two or more fetuses)
  • threatened abortion, persistent pervaginal bleeding, or cervical incompetence
  • history of three or more consecutive abortions
  • history of gestational diabetes, macrosomia, gestational hypertension, preeclampsia/eclampsia in a prior pregnancy
  • chronic diseases, such as hypertension, heart disease, chronic obstructive pulmonary disease, chronic kidney disease, chronic liver disease, pancreatic diseases, Crohn's disease, ulcerative colitis, diabetes mellitus, thyroid dysfunction, immunological diseases, malignancy or any other diseases which could impede compliance with the study protocol
  • taking medications known to influence fetal growth, such as insulin, thyroid hormones, glucocorticoids
Show all 13Show fewer
  • known case of serious psychiatric or behavioral disorders, such as schizophrenia, bipolar disorder
  • scored as moderate or worse on enrollment on any one of the subscales of the Depression, Anxiety and Stress Scales-21 (DASS-21)
  • inability to read or write Bengali
  • belonging to moderately or severely food insecure households as measured by the Household Food Insecurity Access Scale (HFIAS)
  • having a plan to move or deliver outside the study area
  • women practicing some form of vegetarianism
  • women belonging to a household from which another woman is already enrolled in the study

Trial locations and contacts

1 site in 1 country.

Bangladesh1 site
  • International Centre for Diarrhoeal Disease Research, Bangladesh

    Chāndpur

Other trials in Bangladesh

About this study

Official title: In-home, Intensive Nutrition Counseling to Improve Gestational Weight Gain in Rural Bangladesh: A Cluster-Randomized Controlled Trial

Background: Maternal undernutrition and inadequate gestational weight gain (GWG) are prevalent in rural communities of low- and middle-income countries (LMICs). In Matlab, Bangladesh, 54% of the women fail to gain adequate weight (>4 kg) in the third trimester. Risks associated with inadequate GWG include giving birth to a small-for-gestational age (SGA) infant, low birth weight (LBW) infant, preterm birth (PTB), etc. Few contemporary studies examined the efficacy of nutrition counseling on GWG improvement in LMICs.

Objectives: The primary objective of this study is to assess whether in-home, intensive nutrition counseling during pregnancy, compared to standard antenatal care, could improve GWG among pregnant women in rural Bangladesh.

Read more

Methods: This prospective, two-arm, parallel group, equal allocation, open-label, community-based, cluster-randomized controlled trial will be conducted in the icddr,b service area of Matlab, a rural subdistrict of Bangladesh. Clusters will be randomly allocated 1:1 to the intervention arm in which pregnant women will receive monthly in-home, intensive nutrition counseling or the control arm in which pregnant women will receive standard antenatal care as offered by icddr,b and Govt. facilities. Fixed Site Clinics (FSCs) located at the homes of the community health research workers (CHRWs) will act as clusters. Of the 33 FSCs serving rural areas in the icddr,b service area, 20 will be selected randomly and listed. These 20 clinics will then be randomly allocated 1:1 to either an intervention or control group using a computer-generated random allocation sequence. To fulfil the required sample size, each selected CHRW will enroll 16 consecutive pregnancies. Required sample size is 16 women per cluster i.e. 160 women per arm. Eligible participants will be enrolled upon obtaining their consent by 13 and 6/7 weeks of gestation (first trimester) and followed up to 6 weeks postpartum. Trained health workers will visit the homes of the women in the intervention arm once a month and provide nutrition counseling to the women and her influential family members such as mothers, mothers-in-law and husbands. Both intention-to-treat and per-protocol analyses will be performed.

Outcome measures/variables: Proportion of women with inadequate rate of weight gain in the second and third trimester of pregnancy according to the US Institute of Medicine (IOM) 2009 guidelines is the primary outcome variable.

Being tested
In-home, intensive nutrition counseling
Keywords
nutrition counseling, gestational weight gain, cluster randomized controlled trial, birth weight
Medical subject headings
Gestational Weight Gain, Birth Weight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • In-home, intensive nutrition counselingBehavioural

    • Individualized sessions will be conducted by trained health workers following a standard document (counseling booklet)
    • The messages to be provided through the counseling will be contextualized
    • Sessions will start from the early second trimester and repeat monthly until 36 weeks of gestation
    • Counseling sessions will be conducted at the participant's place
    • Sessions will involve influential family members such as the husband, mother-in-law, mother, and the household head along with the pregnant women
    • Women will receive personalized feedback on their dietary intake pattern (dietary diversity) and the rate of weight gain in each session
    • Sessions will be tailored according to each participant's need and progress
Study groups in NCT04868669
Study groupRoleWhat they receive
InterventionExperimentalIn this arm, pregnant women, along with their influential family members such as mothers, mothers-in-law, and husbands, will receive monthly in-home, intensive nutrition counseling during the prenatal period.
Receives: Behavioral: In-home, intensive nutrition counseling
ControlNo interventionPregnant women in this arm will receive standard antenatal care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. proportion of women with inadequate rate of weight gain in the second and third trimester of pregnancy according to IOM 2009 guidelines

    Pregnancy trimesters are defined as follows: 1st trimester (0 weeks - 13+6 weeks), 2nd trimester (14 completed weeks - 27+6 weeks), and 3rd trimester (28 completed weeks - childbirth). Rate of weight gain between two time points (trimesters) will be calculated by subtracting the weight measured at the first time point from the weight measured at the second time point and dividing the derived value by the difference in weeks between the two time points.

    Measured: Pre-delivery

Secondary outcomes (30)
  1. total gestational weight gain (kg)

    Measured: pre-delivery

  2. rate of weight gain during the 2nd and 3rd trimester (kg/week)

    Measured: pre-delivery

  3. proportion of women with inadequate total GWG according to IOM criteria

    Measured: pre-delivery

  4. proportion of women with inadequate total GWG according to local criteria

    Measured: pre-delivery

  5. proportion of women with inadequate third trimester weight gain according to local criteria

    Measured: pre-delivery

  6. proportion of preterm births

    childbirth before 37 completed weeks

    Measured: at delivery

  7. maternal mid-upper arm circumference (MUAC) (mm)

    Measured: baseline, 36 weeks of gestation, at delivery and 6 weeks post-partum

  8. maternal weight (kg)

    Measured: baseline, 36 weeks of gestation, pre-delivery, at delivery and 6 weeks post-partum

  9. maternal body mass index (BMI) (kg/m^2)

    weight and height (at baseline) will be combined to report BMI

    Measured: baseline, 36 weeks of gestation, pre-delivery, at delivery and 6 weeks post-partum

  10. infant weight (g)

    Measured: at birth (delivery) and after 4 weeks

  11. infant length (cm)

    Measured: at birth (delivery) and after 4 weeks

  12. infant head circumference (cm)

    Measured: at birth (delivery) and after 4 weeks

  13. proportion of low birth weight (< 2500 g) infants

    Measured: at birth (delivery)

  14. proportion of small for gestational age (<10th percentile) infants according to Intergrowth-21st standards

    Measured: at birth (delivery)

  15. proportion of women with pregnancy complications e.g. anemia, preeclampsia

    Measured: at delivery

  16. proportion of women with obstetric complications e.g. induction of labor, caesarean section

    Measured: at delivery

  17. newborn Apgar score

    Measured: at birth (delivery)

  18. proportion of infants developing morbidity

    Measured: 4 weeks after birth

  19. proportion of infant mortality

    Measured: 4 weeks after birth

  20. dietary diversity score according to the "Guidelines for Measuring Household and Individual Dietary Diversity"

    score range: 0-9; higher scores indicate a better outcome

    Measured: baseline, 36 weeks of gestation and 6 weeks post-partum

  21. dietary diversity score according to the "Minimum Dietary Diversity for Women: A Guide to Measurement"

    score range: 0-10; higher scores indicate a better outcome

    Measured: baseline, 36 weeks of gestation and 6 weeks post-partum

  22. proportion of women with inadequate dietary diversity accroding to the "Minimum Dietary Diversity for Women: A Guide to Measurement"

    score range: 0-10; <5 indicates inadequate dietary diversity

    Measured: baseline, 36 weeks of gestation and 6 weeks post-partum

  23. energy consumption (kcal)

    Measured: baseline, 36 weeks of gestation and 6 weeks post-partum

  24. protein consumption (g)

    Measured: baseline, 36 weeks of gestation and 6 weeks post-partum

  25. proportion of women with symptoms of depression as measured by Depression, Anxiety, and Stress Scales-21 (DASS-21) scales

    DASS-21 is a validated, widely used, standardized self-report scale with 7 items in each subscale category of Depression, Anxiety, and Stress symptoms. Responses are scored on a 4-point Likert scale ranging from 0 (did not apply to me at all) to 3 (applied to me very much/most of the time), with higher scores indicating higher levels of depression, anxiety or stress.

    Measured: baseline, 36 weeks of gestation and 6 weeks post-partum

  26. proportion of women with symptoms of anxiety as measured by Depression, Anxiety, and Stress Scales-21 (DASS-21) scales

    DASS-21 is a validated, widely used, standardized self-report scale with 7 items in each subscale category of Depression, Anxiety, and Stress symptoms. Responses are scored on a 4-point Likert scale ranging from 0 (did not apply to me at all) to 3 (applied to me very much/most of the time), with higher scores indicating higher levels of depression, anxiety or stress.

    Measured: baseline, 36 weeks of gestation and 6 weeks post-partum

  27. proportion of women with symptoms of stress as measured by Depression, Anxiety, and Stress Scales-21 (DASS-21) scales

    DASS-21 is a validated, widely used, standardized self-report scale with 7 items in each subscale category of Depression, Anxiety, and Stress symptoms. Responses are scored on a 4-point Likert scale ranging from 0 (did not apply to me at all) to 3 (applied to me very much/most of the time), with higher scores indicating higher levels of depression, anxiety or stress.

    Measured: baseline, 36 weeks of gestation and 6 weeks post-partum

  28. healthcare seeking and services utilization e.g. number of prenatal visits

    Measured: at delivery

  29. components of gut microbiota/microbiome, proteome, and metabolome of women (subsample)

    Measured: at 24, 28, 32, 36 weeks of gestation and 6 weeks post-partum

  30. components of gut microbiota/microbiome of infants (subsample)

    Measured: 4 weeks after birth

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2021
  2. Study start15 Jan 2020
  3. Primary completion22 Aug 2021
  4. Study completion24 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
prospective, two-arm, parallel-group, equal allocation, open-label, community-based, cluster-randomized controlled trial
Masking
None (open label)
Enrolment
285 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04868669
Sponsor's protocol ID
PR-19109
Acronym
IMNiM
Status last verified
Oct 2026
First submitted
28 Dec 2019
Last updated
21 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing In-home, intensive nutrition counseling in people with Gestational Weight Gain, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

proportion of women with inadequate rate of weight gain in the second and third trimester of pregnancy according to IOM 2009 guidelines (time frame: Pre-delivery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.

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