Maternal Nutrition Interventions in Uttar Pradesh, India

NCT03378141 | Completed

• 1 other identifier: 17-09-11
• Study Type: interventional
• Target: 8,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia; Undernutrition; Underweight; Stunting; Maternal Malnutrition

Outcome Measures

Primary Outcomes (2)

• Use of iron-folic acid and calcium supplements

  Recall the total number of IFA and calcium tablets consumed throughout the last pregnancy

  During pregnancy (about 9 months) and up to 24 weeks postpartum

• Dietary diversity during pregnancy

  Number of food groups women consumed and proportion of women consumed at least 5 food groups

  During pregnancy (about 9 months)

Secondary Outcomes (6)

• Coverage of maternal nutrition intervention

  During pregnancy (about 9 months) and up to 24 weeks postpartum

• Micronutrient adequacy of the diet

  During pregnancy (about 9 months)

• Weight gain monitoring during pregnancy

  During pregnancy (about 9 months)

• Early initiation of breastfeeding

  Infants up to 6 months

• Exclusive breastfeeding

  Infants up to 6 months

Study Arms (2)

A&T- intensive

EXPERIMENTAL

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

Behavioral: Maternal Nutrition Behavior change

A&T-non intensive

NO INTERVENTION

A\&T-non intensive arm only receives standard MNCH services

Interventions

Maternal Nutrition Behavior change BEHAVIORAL

Counseling and community mobilization

A&T- intensive

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Age \<18
• Mental health problems that make it difficult for the respondent to answer the questions

Sponsors & Collaborators

• International Food Policy Research Institute: lead

Study Sites (1)

International Food Policy Research Institute

Washington D.C., District of Columbia, 20006, United States

Location

Related Publications (3)

• 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.

  PMID: 34222761 DERIVED

• 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.

  PMID: 34038529 DERIVED

• 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.

  PMID: 32258987 DERIVED

MeSH Terms

Conditions

Anemia; Malnutrition; Thinness; Growth Disorders

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Phuong H Nguyen

  International Food Policy Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: * 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)

Study Record Dates

• First Submitted: October 9, 2017
• First Posted: December 19, 2017
• Study Start: November 15, 2017
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2020
• Last Updated: February 21, 2022

Record last verified: 2022-02

Locations

US (1)