Improving Maternal Nutrition in Matlab (IMNiM)
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.
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.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Chandpur、バングラデシュ
- International Centre for Diarrhoeal Disease Research, Bangladesh
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Pregnant women permanently residing in the icddr,b service area of Matlab fulfilling the following criteria:
Inclusion Criteria:
- 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
Exclusion criteria
- 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
- 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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ヘルスサービス研究
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：Intervention
In 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.
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介入なし：Control
Pregnant women in this arm will receive standard antenatal care.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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proportion of women with inadequate rate of weight gain in the second and third trimester of pregnancy according to IOM 2009 guidelines
時間枠：Pre-delivery
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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.
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Pre-delivery
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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total gestational weight gain (kg)
時間枠：pre-delivery
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pre-delivery
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rate of weight gain during the 2nd and 3rd trimester (kg/week)
時間枠：pre-delivery
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pre-delivery
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proportion of women with inadequate total GWG according to IOM criteria
時間枠：pre-delivery
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pre-delivery
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proportion of women with inadequate total GWG according to local criteria
時間枠：pre-delivery
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pre-delivery
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proportion of women with inadequate third trimester weight gain according to local criteria
時間枠：pre-delivery
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pre-delivery
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proportion of preterm births
時間枠：at delivery
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childbirth before 37 completed weeks
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at delivery
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maternal mid-upper arm circumference (MUAC) (mm)
時間枠：baseline, 36 weeks of gestation, at delivery and 6 weeks post-partum
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baseline, 36 weeks of gestation, at delivery and 6 weeks post-partum
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maternal weight (kg)
時間枠：baseline, 36 weeks of gestation, pre-delivery, at delivery and 6 weeks post-partum
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baseline, 36 weeks of gestation, pre-delivery, at delivery and 6 weeks post-partum
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maternal body mass index (BMI) (kg/m^2)
時間枠：baseline, 36 weeks of gestation, pre-delivery, at delivery and 6 weeks post-partum
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weight and height (at baseline) will be combined to report BMI
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baseline, 36 weeks of gestation, pre-delivery, at delivery and 6 weeks post-partum
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infant weight (g)
時間枠：at birth (delivery) and after 4 weeks
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at birth (delivery) and after 4 weeks
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infant length (cm)
時間枠：at birth (delivery) and after 4 weeks
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at birth (delivery) and after 4 weeks
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infant head circumference (cm)
時間枠：at birth (delivery) and after 4 weeks
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at birth (delivery) and after 4 weeks
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proportion of low birth weight (< 2500 g) infants
時間枠：at birth (delivery)
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at birth (delivery)
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proportion of small for gestational age (<10th percentile) infants according to Intergrowth-21st standards
時間枠：at birth (delivery)
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at birth (delivery)
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proportion of women with pregnancy complications e.g. anemia, preeclampsia
時間枠：at delivery
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at delivery
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proportion of women with obstetric complications e.g. induction of labor, caesarean section
時間枠：at delivery
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at delivery
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newborn Apgar score
時間枠：at birth (delivery)
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at birth (delivery)
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proportion of infants developing morbidity
時間枠：4 weeks after birth
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4 weeks after birth
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proportion of infant mortality
時間枠：4 weeks after birth
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4 weeks after birth
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dietary diversity score according to the "Guidelines for Measuring Household and Individual Dietary Diversity"
時間枠：baseline, 36 weeks of gestation and 6 weeks post-partum
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score range: 0-9; higher scores indicate a better outcome
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baseline, 36 weeks of gestation and 6 weeks post-partum
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dietary diversity score according to the "Minimum Dietary Diversity for Women: A Guide to Measurement"
時間枠：baseline, 36 weeks of gestation and 6 weeks post-partum
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score range: 0-10; higher scores indicate a better outcome
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baseline, 36 weeks of gestation and 6 weeks post-partum
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proportion of women with inadequate dietary diversity accroding to the "Minimum Dietary Diversity for Women: A Guide to Measurement"
時間枠：baseline, 36 weeks of gestation and 6 weeks post-partum
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score range: 0-10; <5 indicates inadequate dietary diversity
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baseline, 36 weeks of gestation and 6 weeks post-partum
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energy consumption (kcal)
時間枠：baseline, 36 weeks of gestation and 6 weeks post-partum
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baseline, 36 weeks of gestation and 6 weeks post-partum
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protein consumption (g)
時間枠：baseline, 36 weeks of gestation and 6 weeks post-partum
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baseline, 36 weeks of gestation and 6 weeks post-partum
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proportion of women with symptoms of depression as measured by Depression, Anxiety, and Stress Scales-21 (DASS-21) scales
時間枠：baseline, 36 weeks of gestation and 6 weeks post-partum
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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.
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baseline, 36 weeks of gestation and 6 weeks post-partum
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proportion of women with symptoms of anxiety as measured by Depression, Anxiety, and Stress Scales-21 (DASS-21) scales
時間枠：baseline, 36 weeks of gestation and 6 weeks post-partum
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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.
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baseline, 36 weeks of gestation and 6 weeks post-partum
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proportion of women with symptoms of stress as measured by Depression, Anxiety, and Stress Scales-21 (DASS-21) scales
時間枠：baseline, 36 weeks of gestation and 6 weeks post-partum
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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.
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baseline, 36 weeks of gestation and 6 weeks post-partum
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healthcare seeking and services utilization e.g. number of prenatal visits
時間枠：at delivery
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at delivery
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協力者と研究者
捜査官
- 主任研究者：S. M. Tafsir Hasan, MBBS, MS、Nutrition and Clinical Services Division, icddr,b
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
In-home, intensive nutrition counselingの臨床試験
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Centers for Disease Control and PreventionNorthwestern University; Emory University; Public Health Solutions完了
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University of North Carolina, Chapel HillNational Heart, Lung, and Blood Institute (NHLBI)積極的、募集していない
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The Hospital for Sick ChildrenCanadian Institutes of Health Research (CIHR); Unity Health Toronto; Mount Sinai Hospital, Canada と他の協力者完了