Maternal Nutrition Interventions in Uttar Pradesh, India
Primary Purpose
Anemia, Undernutrition, Underweight
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Maternal Nutrition Behavior change
Sponsored by
About this trial
This is an interventional prevention trial for Anemia
Eligibility Criteria
Inclusion Criteria:
- Recently delivered women with children <6 months of age
- Pregnant women in first, second and third trimester
- Husbands of these women
- Mothers or mother-in-law of these women
- Frontline health workers in the areas
Exclusion Criteria:
- Age <18
- Mental health problems that make it difficult for the respondent to answer the questions
Sites / Locations
- International Food Policy Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
A&T- intensive
A&T-non intensive
Arm Description
A&T-intensive arm receive standard MNCH services and intensified maternal nutrition behavior change intervention. Intervention includes provision of IFA and calcium supplements, interpersonal counseling on diet during pregnancy and consumption of IFA and calcium, community mobilization, and adequate weight-gain monitoring during pregnancy
A&T-non intensive arm only receives standard MNCH services
Outcomes
Primary Outcome Measures
Use of iron-folic acid and calcium supplements
Recall the total number of IFA and calcium tablets consumed throughout the last pregnancy
Dietary diversity during pregnancy
Number of food groups women consumed and proportion of women consumed at least 5 food groups
Secondary Outcome Measures
Coverage of maternal nutrition intervention
The proportion of pregnant and recently delivery women expose to and use of maternal nutrition intervention during the last 2 year
Micronutrient adequacy of the diet
Dietary intakes of 11 vitamins and micronutrients
Weight gain monitoring during pregnancy
proportion of women who are weighed and counselled about adequate weight gain and the numbers time women are weighed
Early initiation of breastfeeding
The proportion of newborns aged less than 6 months who were breastfed within 1 hour of birth
Exclusive breastfeeding
The proportion of infants aged less than 6 months who were exclusively breastfed on the day preceding the interview
Anemia (Hb levels)
The proportion of pregnant and recently delivered women diagnosed with moderate or severe anemia
Full Information
NCT ID
NCT03378141
First Posted
October 9, 2017
Last Updated
February 17, 2022
Sponsor
International Food Policy Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT03378141
Brief Title
Maternal Nutrition Interventions in Uttar Pradesh, India
Official Title
Evaluate a Feasibility Study of Integrating Maternal Nutrition Interventions in Existing Reproductive, Maternal, Newborn and Child Health Services in Uttar Pradesh, India
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
November 15, 2017 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
December 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
International Food Policy Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Maternal nutrition has been a long-standing concern of health authorities globally and in India. Despite the availability of proven, affordable interventions, and progressive policies and program platforms such as Maternal, Newborn and Child Health (MNCH) services, a streamlined package of proven maternal nutrition services is not reaching the majority of women during pregnancy.
Alive & Thrive India aims to test the feasibility of integrating a package of maternal nutrition interventions in routine Reproductive, Maternal, Newborn and Child Health (RMNCH) services.These include provision of IFA and calcium supplements, interpersonal counseling on diet during pregnancy and consumption of IFA and calcium, community mobilization, and adequate weight-gain monitoring during pregnancy.
This proposed evaluation aims to assess the feasibility of integrating maternal nutrition interventions into an existing RMNCH services in India, using a cluster-randomized evaluation design, complemented with a nested cohort study.
Detailed Description
Maternal nutrition has been a long-standing concern of health authorities globally and in India. Despite the availability of proven, affordable interventions, and progressive policies and program platforms such as Maternal, Newborn and Child Health (MNCH) services, a streamlined package of proven maternal nutrition services is not reaching the majority of women during pregnancy. This undermines national efforts to improve maternal and newborn survival; and reduce morbidity, malnutrition and disabilities in women and children.
Reducing maternal and child mortality are the most important goals of the National Health Mission with major strategic investments being made by Government of India to achieve these goals. The Maternal Mortality Ratio in India has shown a considerable decline from 424/100,000 live births in 1992-1993 to 167 in 2010-2013. These maternal deaths are exacerbated by the high burden of malnutrition and poor dietary intakes during and before pregnancy. The same nutritional deficits also contribute to low birth weight that in turn, is associated with higher infant mortality (which is at 37 per 1,000 live birth in 2015. Anemia remains a significant public health problem in India, affecting 53% women of reproductive age and 50% pregnant women, with a minimal decline during the last decade. Further more, nearly a third of women and 44.7% of girls aged 15 to 18 years have a low body mass index (BMI less than 18.5), thus entering pregnancy in a vulnerable state. During pregnancy, on average, women gained only 7 kg, much lower than the recommended weight gain of 10-12 kg.
In 2016, the World Health Organization (WHO) issued new guidelines on antenatal care (ANC) for a positive pregnancy experience to improve nutrition through dietary interventions and micronutrient supplements, along with health system interventions to improve the utilization and quality of ANC. Indian policy framework includes food supplementation, iron and folic acid (IFA) and calcium supplementation to improve maternal nutrition. In addition, with the advent of the National Health Mission in 2006, the Reproductive, Maternal, Newborn and Child Health (RMNCH) gained priority and investments were made to expand the quality and coverage of maternal health services, including ANC contacts.
Despite policy guidance, the nutrition content of ANC (e.g. IFA and calcium supplementation, monitoring and counseling on weight gain) remains to be prioritized. According to the National Family and Health Survey 2015-2016 (NFHS-4), nearly 90% of pregnancies in India were registered for health services, 51% received at least 4 ANC visits, but only 30% reported consuming 100 or more IFA tablets during their last pregnancy. In Uttar Pradesh, the proportion of women who received at least 4 ANC visits increased from 11% to 26% during the last decade. However, the proportion of women consuming IFA supplements more than doubled (6% to 13%) but is still very low. This suggests that there is a need to fully utilize the existing contacts to deliver maternal nutrition interventions within MNCH services.
Alive & Thrive (A&T) supports scaling up of nutrition interventions to save lives, prevent illnesses, and contributes to healthy growth and development through improved maternal nutrition, breastfeeding and complementary feeding in several countries. In India, A&T aims to test the feasibility of integrating a package of maternal nutrition interventions that align with the latest global evidence and the national policies and guidelines of Government of India within routine RMNCH services. These include provision of IFA and calcium supplements, interpersonal counseling on diet during pregnancy and consumption of IFA and calcium, community mobilization, and adequate weight-gain monitoring during pregnancy.
The primary objectives of the proposed evaluation are to answer the following questions using a cluster-randomized evaluation design:
Can the coverage and utilization of key maternal nutrition interventions be improved by integrating nutrition-focused social behavior change communication (SBC) and systems strengthening approaches into ANC services under RMNCH program?
What factors affect effective integration of maternal nutrition interventions into a well-established government ANC service delivery platform under RMNCH program?
What are the impacts of program on: 1) consumption of diversified foods and adequate intake of micronutrient, protein and energy compared to recommended intake; 2) intake of IFA and calcium supplements during pregnancy; 3) weight gain monitoring; and 4) early initiation of breastfeeding.
In addition, a nested cohort will be conducted to complement the overall impact evaluation with the following primary objectives:
To collect objective measures of maternal nutrition outcomes such as weight gain during pregnancy, anemia, IFA and calcium consumption, and diet diversity and adequate intake (including macro- and micro-nutrient intakes).
To understand the key barriers/facilitators which influence intentions and practices related to maternal nutrition.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Undernutrition, Underweight, Stunting, Maternal Malnutrition
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The impact evaluation follows a cluster randomized controlled trial design with repeated cross-sectional surveys at baseline and endline
The nested cohort study follows a prospective randomized controlled design (embedded in overall impact evaluation)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8000 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A&T- intensive
Arm Type
Experimental
Arm Description
A&T-intensive arm receive standard MNCH services and intensified maternal nutrition behavior change intervention. Intervention includes provision of IFA and calcium supplements, interpersonal counseling on diet during pregnancy and consumption of IFA and calcium, community mobilization, and adequate weight-gain monitoring during pregnancy
Arm Title
A&T-non intensive
Arm Type
No Intervention
Arm Description
A&T-non intensive arm only receives standard MNCH services
Intervention Type
Behavioral
Intervention Name(s)
Maternal Nutrition Behavior change
Intervention Description
Counseling and community mobilization
Primary Outcome Measure Information:
Title
Use of iron-folic acid and calcium supplements
Description
Recall the total number of IFA and calcium tablets consumed throughout the last pregnancy
Time Frame
During pregnancy (about 9 months) and up to 24 weeks postpartum
Title
Dietary diversity during pregnancy
Description
Number of food groups women consumed and proportion of women consumed at least 5 food groups
Time Frame
During pregnancy (about 9 months)
Secondary Outcome Measure Information:
Title
Coverage of maternal nutrition intervention
Description
The proportion of pregnant and recently delivery women expose to and use of maternal nutrition intervention during the last 2 year
Time Frame
During pregnancy (about 9 months) and up to 24 weeks postpartum
Title
Micronutrient adequacy of the diet
Description
Dietary intakes of 11 vitamins and micronutrients
Time Frame
During pregnancy (about 9 months)
Title
Weight gain monitoring during pregnancy
Description
proportion of women who are weighed and counselled about adequate weight gain and the numbers time women are weighed
Time Frame
During pregnancy (about 9 months)
Title
Early initiation of breastfeeding
Description
The proportion of newborns aged less than 6 months who were breastfed within 1 hour of birth
Time Frame
Infants up to 6 months
Title
Exclusive breastfeeding
Description
The proportion of infants aged less than 6 months who were exclusively breastfed on the day preceding the interview
Time Frame
Infants up to 6 months
Title
Anemia (Hb levels)
Description
The proportion of pregnant and recently delivered women diagnosed with moderate or severe anemia
Time Frame
During pregnancy (about 9 months) and up to 24 weeks postpartum
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Recently delivered women with children <6 months of age
Pregnant women in first, second and third trimester
Husbands of these women
Mothers or mother-in-law of these women
Frontline health workers in the areas
Exclusion Criteria:
Age <18
Mental health problems that make it difficult for the respondent to answer the questions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Phuong H Nguyen
Organizational Affiliation
International Food Policy Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
International Food Policy Research Institute
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20006
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34222761
Citation
Young MF, Bootwala A, Kachwaha S, Avula R, Ghosh S, Sharma PK, Shastri VD, Forissier T, Menon P, Nguyen PH. Understanding Implementation and Improving Nutrition Interventions: Barriers and Facilitators of Using Data Strategically to Inform the Implementation of Maternal Nutrition in Uttar Pradesh, India. Curr Dev Nutr. 2021 Jun 2;5(6):nzab081. doi: 10.1093/cdn/nzab081. eCollection 2021 Jun.
Results Reference
derived
PubMed Identifier
34038529
Citation
Nguyen PH, Kachwaha S, Tran LM, Avula R, Young MF, Ghosh S, Sharma PK, Escobar-Alegria J, Forissier T, Patil S, Frongillo EA, Menon P. Strengthening Nutrition Interventions in Antenatal Care Services Affects Dietary Intake, Micronutrient Intake, Gestational Weight Gain, and Breastfeeding in Uttar Pradesh, India: Results of a Cluster-Randomized Program Evaluation. J Nutr. 2021 Aug 7;151(8):2282-2295. doi: 10.1093/jn/nxab131.
Results Reference
derived
PubMed Identifier
32258987
Citation
Nguyen PH, Martin-Prevel Y, Moursi M, Tran LM, Menon P, Ruel MT, Arimond M. Assessing Dietary Diversity in Pregnant Women: Relative Validity of the List-Based and Open Recall Methods. Curr Dev Nutr. 2019 Nov 18;4(1):nzz134. doi: 10.1093/cdn/nzz134. eCollection 2020 Jan.
Results Reference
derived
Learn more about this trial
Maternal Nutrition Interventions in Uttar Pradesh, India
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