Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03378141 |
| Other study ID # |
17-09-11 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 15, 2017 |
| Est. completion date |
December 30, 2020 |
Study information
| Verified date |
February 2022 |
| Source |
International Food Policy Research Institute |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
