Maternal Nutrition Interventions in Uttar Pradesh, India

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-15

Study Completion Date

2020-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Assessing the Feasibility of Integrating a Package of Maternal Nutrition Interventions Into Antenatal Care Services in Burkina Faso

NCT04155437

Maternal Dietary Diversity Iron-Folic Acid Supplementation Early Initiation of Breastfeeding

COMPLETED NA

A Feasibility Study of Integrating Maternal Nutrition Interventions Into Antenatal Care Services in Ethiopia

NCT04125368

Maternal Dietary Diversity Iron-Folic Acid Supplementation Early Initiation of Breastfeeding

COMPLETED NA

Impact of Food Insecurity on Utilization of Maternal Healthcare Services and Birth Outcomes in Slums in Pune, India

NCT06313112

Prenatal Care Food Insecurity Pregnancy Outcome

ACTIVE_NOT_RECRUITING

Assessing the Feasibility of Integrating Maternal Nutrition Interventions Into an Existing MNCH Platform in Bangladesh

NCT02745249

Poor Fetal Growth Small-for-gestational Age Premature Birth

COMPLETED NA

Evaluation Research of the Nutrition Interventions in the INHP II Areas of CARE India

NCT00198835

Underweight Stunting Wasting +1 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anemia Undernutrition Underweight Stunting Maternal Malnutrition

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

* 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)

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A&T- intensive

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

Group Type EXPERIMENTAL

Maternal Nutrition Behavior change

Intervention Type BEHAVIORAL

Counseling and community mobilization

A&T-non intensive

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Maternal Nutrition Behavior change

Counseling and community mobilization

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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