AnemiaNCT03378141
Maternal Nutrition Interventions in Uttar Pradesh, India
A study testing Maternal Nutrition Behavior change in people with Anemia and Undernutrition, run by International Food Policy Research Institute at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Anemia, Undernutrition, Underweight
- What is being tested?
- Maternal Nutrition Behavior change
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,000 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2017to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Age <18
- Mental health problems that make it difficult for the respondent to answer the questions
Trial locations and contacts
1 site in 1 country.
United States1 site
International Food Policy Research Institute
Washington D.C., District of Columbia, 20006
About this study
Official title: Evaluate a Feasibility Study of Integrating Maternal Nutrition Interventions in Existing Reproductive, Maternal, Newborn and Child Health Services in Uttar Pradesh, India
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.
Read the 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.
- Conditions
- Anemia, Undernutrition, Underweight, Stunting, Maternal Malnutrition
- Being tested
- Maternal Nutrition Behavior change
- Medical subject headings
- Anemia, Malnutrition, Thinness, Growth Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maternal Nutrition Behavior changeBehavioural
Counseling and community mobilization
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Maternal Nutrition Behavior change |
| A&T-non intensive | No intervention | A\&T-non intensive arm only receives standard MNCH services |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of iron-folic acid and calcium supplements
Recall the total number of IFA and calcium tablets consumed throughout the last pregnancy
Measured: 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
Measured: During pregnancy (about 9 months)
Secondary outcomes (6)
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
Measured: During pregnancy (about 9 months) and up to 24 weeks postpartum
Micronutrient adequacy of the diet
Dietary intakes of 11 vitamins and micronutrients
Measured: During pregnancy (about 9 months)
Weight gain monitoring during pregnancy
proportion of women who are weighed and counselled about adequate weight gain and the numbers time women are weighed
Measured: During pregnancy (about 9 months)
Early initiation of breastfeeding
The proportion of newborns aged less than 6 months who were breastfed within 1 hour of birth
Measured: Infants up to 6 months
Exclusive breastfeeding
The proportion of infants aged less than 6 months who were exclusively breastfed on the day preceding the interview
Measured: Infants up to 6 months
Anemia (Hb levels)
The proportion of pregnant and recently delivered women diagnosed with moderate or severe anemia
Measured: During pregnancy (about 9 months) and up to 24 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2017
- Study start15 Nov 2017
- Primary completion30 Dec 2019
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 8,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Food Policy Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Phuong H Nguyen, Principal investigator, International Food Policy Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03378141
- Sponsor's protocol ID
- 17-09-11
- Status last verified
- Feb 2022
- First submitted
- 9 Oct 2017
- Last updated
- 21 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34222761Nguyen 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.
PubMed 34038529Nguyen 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.
PubMed 32258987
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate a Feasibility Study of Integrating Maternal Nutrition Interventions in Existing Reproductive, Maternal, Newborn and Child Health Services in Uttar Pradesh, India
- ClinicalTrials.gov ID
- NCT03378141
- Acronym / sponsor ID
- 17-09-11
- Conditions
- Anemia, Undernutrition, Underweight, Stunting, Maternal Malnutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8,000 participants (actual)
- Lead sponsor
- International Food Policy Research InstituteUniversity, hospital or other
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 19 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| A&T- intensive | Experimental | Behavioral: Maternal Nutrition Behavior changeA\&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 | No intervention | –A\&T-non intensive arm only receives standard MNCH services |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Age <18
- Mental health problems that make it difficult for the respondent to answer the questions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maternal Nutrition Behavior changeCounseling and community mobilization | Behavioural | A&T- intensive |
Primary outcome
Use of iron-folic acid and calcium supplements
Time frame: During pregnancy (about 9 months) and up to 24 weeks postpartum
Recall the total number of IFA and calcium tablets consumed throughout the last pregnancy
Dietary diversity during pregnancy
Time frame: During pregnancy (about 9 months)
Number of food groups women consumed and proportion of women consumed at least 5 food groups
6 secondary outcomes
Coverage of maternal nutrition intervention
Time frame: During pregnancy (about 9 months) and up to 24 weeks postpartum
Micronutrient adequacy of the diet
Time frame: During pregnancy (about 9 months)
Weight gain monitoring during pregnancy
Time frame: During pregnancy (about 9 months)
Early initiation of breastfeeding
Time frame: Infants up to 6 months
Exclusive breastfeeding
Time frame: Infants up to 6 months
Anemia (Hb levels)
Time frame: During pregnancy (about 9 months) and up to 24 weeks postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2022.
- Derived from this study: PubMed 34222761Young 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.
- Derived from this study: PubMed 34038529Nguyen 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.
- Derived from this study: PubMed 32258987Nguyen 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Phuong H Nguyen principal investigator
International Food Policy Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maternal Nutrition Behavior change in people with Anemia and Undernutrition, run by International Food Policy Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use of iron-folic acid and calcium supplements (time frame: During pregnancy (about 9 months) and up to 24 weeks postpartum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03378141, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2022.