Maternal Dietary DiversityNCT04155437
Assessing the Feasibility of Integrating a Package of Maternal Nutrition Interventions Into Antenatal Care Services in Burkina Faso
A study testing Health Facility Level Interventions, Community Level Interventions and Health System Level Interventions in people with Maternal Dietary Diversity and Iron-Folic Acid Supplementation, run by International Food Policy Research Institute at 1 site in United States.
Trial summary
Alive \& Thrive (A\&T) is an initiative that supports the scaling up of nutrition interventions to save lives, prevent illnesses, and contribute to healthy growth and development through improved maternal nutrition, breastfeeding and complementary feeding practices. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Dietary Diversity, Iron-Folic Acid Supplementation, Early Initiation of Breastfeeding
- What is being tested?
- Health Facility Level Interventions, Community Level Interventions and Health System Level Interventions
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,110 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2019to 5 Mar 2021
- 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 15 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Currently pregnant or recently delivered with a child 0-5.9 months of age
- Residency in the health facility catchment area
- Informed consent
Who cannot join
- Age <15 years or >49 years
Trial locations and contacts
1 site in 1 country.
United States1 site
International Food Policy Research Institute
Washington D.C., District of Columbia, 20005
About this study
Official title: Assessing the Feasibility of Integrating a Package of Maternal Nutrition Interventions Into Antenatal Care Services in Burkina Faso: A Cluster-Randomized Evaluation
Alive \& Thrive (A\&T) is an initiative that supports the scaling up of nutrition interventions to save lives, prevent illnesses, and contribute to healthy growth and development through improved maternal nutrition, breastfeeding and complementary feeding practices. In Burkina Faso, A\&T developed an intensive package of maternal nutrition interventions to be integrated into existing ANC services delivered through government health facilities that align with the latest global evidence. These included intensified counseling and support on dietary diversity and quality during pregnancy, iron-folic acid (IFA) supplements consumption, importance of ANC and increasing the number of visits, adequate weight-gain monitoring, and early initiation of and exclusive breastfeeding. The evaluation used a two-arm cluster-randomized, non-masked trial design, consisting of two cross-sectional surveys of pregnant and recently delivered women (i.e. with a child under 6 months of age) in 2019 and 2021.
Read the detailed description
Routine antenatal care (ANC) offers opportunities to receive a broad range of health promotion and prevention services including support for adequate nutritional care for pregnant women and their newborns, and any required medical treatment. In 2016, World Health Organization (WHO) updated its guidelines on ANC with a high priority placed on nutrition interventions. These guidelines also recommended increasing the number of ANC from at least four to eight contacts to improve women's positive experience of care and to reduce perinatal morbidity and mortality. Following these new recommendations, the government of Burkina Faso is working with WHO and other partners to revise the national guidelines on ANC and test elements of the essential core package of routine ANC needed by women throughout pregnancy.
A\&T Burkina Faso, developed an intensive package of maternal nutrition interventions to be integrated into existing ANC services delivered through government health facilities that align with the latest global evidence. These included intensified counseling and support on dietary diversity and quality during pregnancy, iron-folic acid (IFA) supplements consumption, importance of ANC and increasing the number of visits, adequate weight-gain monitoring, and early initiation of and exclusive breastfeeding. IFPRI tested the feasibility of the behavior-change interventions and examined their impacts on pregnant women's health and nutrition practices and breastfeeding practices of recently delivered women, compared with standard antenatal care services provided in control areas.
The study was designed as a two-arm cluster-randomized, non-masked trial, consisting of two cross-sectional surveys at baseline and endline. The unit of randomization was the health and social promotion center (CSPS, Centre de Santé et de Promotion Social in French) catchment area. 40 CSPS in Boucle du Mouhoun and 40 CSPS in Hauts-Bassins were randomly assigned to intervention/control. A baseline cluster/facility-level and household survey took place in November-December 2019. Soon after the completion of the baseline survey, the interventions were implemented at the CSPS and villages within the intervention areas for approximately 10 months (less than 1 year, caused by brief service interruptions in March-April 2020 due to the COVID-19 pandemic). The endline survey took place in January-March 2021.
The overall study objective is to evaluate the feasibility of integrating locally relevant maternal nutrition interventions into ANC services provided by the government health system and their impact on diet quality and quantity and utilization of nutrition interventions during pregnancy.
The implementation research study addresses three research questions:
- What are the program impacts on maternal nutrition practices: (1) consumption of diversified foods and adequate intake of micronutrient, protein and energy compared to recommended intakes; (2) consumption of IFA supplements during pregnancy; and (3) early breastfeeding practices?
- Can the coverage and utilization of key nutrition interventions (maternal nutrition counseling, weight gain monitoring, distribution of and counseling on IFA supplementation, and breastfeeding counseling) and number of ANC contacts be improved through health system strengthening and nutrition-focused social and behavior change communication (SBCC; interpersonal communication and community mobilization) approaches?
- What factors influenced integration and strengthening of maternal nutrition interventions into the government ANC service delivery platform?
- Conditions
- Maternal Dietary Diversity, Iron-Folic Acid Supplementation, Early Initiation of Breastfeeding
- Being tested
- Health Facility Level Interventions, Community Level Interventions, Health System Level Interventions
- Keywords
- maternal nutrition, antenatal care, Burkina Faso
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Facility Level InterventionsBehavioural
- Intensified counseling on maternal dietary diversity and quality using job aids
- Counseling on purpose of IFA supplementation, managing side effects, and importance of adherence to daily consumption
- Distribution/prescription of IFA tablets at each ANC visit
- Use of pill card/reminders for pregnant women and their spouses
- Monthly IFA tablet stock monitoring to assure sufficient supplies
- Measurement of weight gain during each ANC visit and advise on healthy weight gain
- Checks for functioning scales and use of monitoring sheets
- Intensified counseling on early initiation of breastfeeding and exclusive breastfeeding using job aids
- Reminder on importance of early ANC attendance and 4+ visits
Community Level InterventionsBehavioural
- Advocacy among community leaders (traditional and religious leaders, local associations, etc.) about ANC
- Gatherings among grandmothers, husbands, and other influencers about ANC and their roles
- Promotion of ANC service utilisation and the importance of early ANC visit during the first trimester.
- Early identification of pregnant women
- Support women's group discussions
- 2-3 home visits per pregnant woman by community health workers (Agent de santé a base communautaire; ASBC) which will include counseling on diet quality, breastfeeding, importance on adherence to daily IFA consumption and side effect management, etc.
Health System Level InterventionsBehavioural
- Training on nutrition interventions during ANC for all ANC providers and community health workers
- Semi-annual supervision by the Regional Health Directorate (Direction Regionale de la Santé; DRS)
- Quarterly supportive supervision of health facility staff by the health district management team
- Monthly supportive supervision of ASBCs
- Monthly review between health facilities and ASBCs
- Training and use of data registers
- Training and use of mother's cards to record up to 8 ANC visits and nutrition services
- Training on data utilization to improve coverage and quality
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | A\&T intervention areas: intensified maternal nutrition behavior change interventions during antenatal care delivered through government health facilities. Receives: Behavioral: Health Facility Level Interventions; Behavioral: Community Level Interventions; Behavioral: Health System Level Interventions |
| Control | No intervention | Comparison areas: standard antenatal care services delivered at government health facilities. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dietary diversity during pregnancy
Mean number of food groups consumed by pregnant women on the day preceding the interview.
Measured: Approximately 16 months after baseline in a cross-sectional endline survey
Minimum dietary diversity during pregnancy
Proportion of pregnant women who consumed 5 or more food groups on the day preceding the interview.
Measured: Approximately 16 months after baseline in a cross-sectional endline survey
Consumption of iron-folic acid tablets during pregnancy
Mean number of IFA tablets consumed during last pregnancy by recently delivered women with a child 0-5.9 months of age.
Measured: Approximately 16 months after baseline in a cross-sectional endline survey
Consumption of 90+ iron-folic acid tablets during pregnancy
Proportion of women who consumed 90+ IFA tablets during last pregnancy by recently delivered women with a child 0-5.9 months of age.
Measured: Approximately 16 months after baseline in a cross-sectional endline survey
Secondary outcomes (7)
Micronutrient, protein and energy adequacy during pregnancy
Proportion of pregnant women whose micronutrient, protein and energy intakes are equal to or above the dietary reference intake.
Measured: Approximately 16 months after baseline in a cross-sectional endline survey
Early initiation of breastfeeding
Proportion of children aged 0-5.9 months who were breastfed within 1 hour of birth.
Measured: Approximately 16 months after baseline in a cross-sectional endline survey
Use of ANC services during pregnancy
Total number of ANC visits and month of first ANC first during last pregnancy reported by recently delivered women with a child age 0-5.9 months.
Measured: Approximately 16 months after baseline in a cross-sectional endline survey
Exposure to nutrition interventions during ANC
Proportion of recently delivered women with children 0-5.9 months of age who received nutrition interventions during their last pregnancy during ANC and in the community based on survey responses.
Measured: Approximately 16 months after baseline in a cross-sectional endline survey
Women's knowledge of maternal nutrition and breastfeeding
Proportion of recently delivered women with children 0-5.9 months of age with correct knowledge of maternal nutrition and appropriate breastfeeding practices based on survey responses.
Measured: Approximately 16 months after baseline in a cross-sectional endline survey
Health worker knowledge of IFA supplementation, dietary diversity, weight gain during pregnancy, and early and exclusive breastfeeding.
Proportion of Nurse-Midwives and community health workers (ASBCs) with correct knowledge of IFA supplementation, dietary diversity, weight gain during pregnancy and appropriate breastfeeding practices based on survey responses.
Measured: Approximately 16 months after baseline in a cross-sectional endline survey
Availability of ANC service supports
Proportion of health facilities with ANC materials and equipment based on enumerator observation.
Measured: Approximately 16 months after baseline in a cross-sectional endline survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start6 Nov 2019
- Primary completion5 Mar 2021
- Study completion5 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Maternal Dietary DiversityStudies 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
- Masking
- None (open label)
- Enrolment
- 8,110 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Food Policy Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- AFRICSanté, FHI 360
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04155437
- Sponsor's protocol ID
- PHND-19-1052
- Status last verified
- Feb 2022
- First submitted
- 5 Nov 2019
- Last updated
- 10 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In compliance with donor open access policy requirements, fully anonymized datasets will be made publicly available one year after the end of the project. Metadata and other documentation of data collection procedures (such as the codebook, data collection instruments and interviewer guides/protocols) will also be made publicly available.
Publications
Hanson MA, Bardsley A, De-Regil LM, Moore SE, Oken E, Poston L, Ma RC, McAuliffe FM, Maleta K, Purandare CN, Yajnik CS, Rushwan H, Morris JL. The International Federation of Gynecology and Obstetrics (FIGO) recommendations on adolescent, preconception, and maternal nutrition: "Think Nutrition First". Int J Gynaecol Obstet. 2015 Oct;131 Suppl 4:S213-53. doi: 10.1016/S0020-7292(15)30034-5. No abstract available.
PubMed 26433230Black RE, Allen LH, Bhutta ZA, Caulfield LE, de Onis M, Ezzati M, Mathers C, Rivera J; Maternal and Child Undernutrition Study Group. Maternal and child undernutrition: global and regional exposures and health consequences. Lancet. 2008 Jan 19;371(9608):243-60. doi: 10.1016/S0140-6736(07)61690-0. No abstract available.
PubMed 18207566WHO Recommendations on Antenatal Care for a Positive Pregnancy Experience. Geneva: World Health Organization; 2016. Available from http://www.ncbi.nlm.nih.gov/books/NBK409108/
PubMed 28079998Partnership for Maternal, Newborn and Child Health (PMNCH). 2006. Opportunities for Africa's newborns: Practical data, policy and programmatic support for newborn care in Africa. Edited by Joy Lawn and Kate Kerber. Cape Town: PMNCH.
United Nations Children's Fund (UNICEF). 2016. The state of the world's children 2016: A fair chance for every child. New York: UNICEF.
Alkema L, New JR, Pedersen J, You D; UN Inter-agency Group for Child Mortality Estimation; Technical Advisory Group. Child mortality estimation 2013: an overview of updates in estimation methods by the United Nations Inter-agency Group for Child Mortality Estimation. PLoS One. 2014 Jul 11;9(7):e101112. doi: 10.1371/journal.pone.0101112. eCollection 2014.
PubMed 25013954Kim SS, Zagre RR, Ouedraogo CT, Sununtnasuk C, Ganaba R, Zafimanjaka MG, Tharaney M, Sanghvi T, Menon P. Intensified Nutrition Interventions in Antenatal Care Services Increased Consumption of Iron and Folic Acid Supplements and Early Breastfeeding Practices in Burkina Faso: Results of a Cluster-Randomized Program Evaluation. J Nutr. 2023 Oct;153(10):3058-3067. doi: 10.1016/j.tjnut.2023.06.016. Epub 2023 Jun 17.
PubMed 37336320
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Feasibility of Integrating a Package of Maternal Nutrition Interventions Into Antenatal Care Services in Burkina Faso: A Cluster-Randomized Evaluation
- ClinicalTrials.gov ID
- NCT04155437
- Acronym / sponsor ID
- PHND-19-1052
- Conditions
- Maternal Dietary Diversity, Iron-Folic Acid Supplementation, Early Initiation of Breastfeeding
- Keywords
- maternal nutrition, antenatal care, Burkina Faso
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8,110 participants (actual)
- Lead sponsor
- International Food Policy Research InstituteUniversity, hospital or other
- Collaborators
- AFRICSanté, FHI 360
- Study start
- 6 Nov 2019 (actual)
- Primary completion
- 5 Mar 2021 (actual)
- Study completion
- 5 Mar 2021 (actual)
- First posted
- 7 Nov 2019 (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.
Alive \& Thrive (A\&T) is an initiative that supports the scaling up of nutrition interventions to save lives, prevent illnesses, and contribute to healthy growth and development through improved maternal nutrition, breastfeeding and complementary feeding practices. In Burkina Faso, A\&T developed an intensive package of maternal nutrition interventions to be integrated into existing ANC services delivered through government health facilities that align with the latest global evidence. These included intensified counseling and support on dietary diversity and quality during pregnancy, iron-folic acid (IFA) supplements consumption, importance of ANC and increasing the number of visits, adequate weight-gain monitoring, and early initiation of and exclusive breastfeeding. The evaluation used a two-arm cluster-randomized, non-masked trial design, consisting of two cross-sectional surveys of pregnant and recently delivered women (i.e. with a child under 6 months of age) in 2019 and 2021.
Detailed description
Routine antenatal care (ANC) offers opportunities to receive a broad range of health promotion and prevention services including support for adequate nutritional care for pregnant women and their newborns, and any required medical treatment. In 2016, World Health Organization (WHO) updated its guidelines on ANC with a high priority placed on nutrition interventions. These guidelines also recommended increasing the number of ANC from at least four to eight contacts to improve women's positive experience of care and to reduce perinatal morbidity and mortality. Following these new recommendations, the government of Burkina Faso is working with WHO and other partners to revise the national guidelines on ANC and test elements of the essential core package of routine ANC needed by women throughout pregnancy.
A\&T Burkina Faso, developed an intensive package of maternal nutrition interventions to be integrated into existing ANC services delivered through government health facilities that align with the latest global evidence. These included intensified counseling and support on dietary diversity and quality during pregnancy, iron-folic acid (IFA) supplements consumption, importance of ANC and increasing the number of visits, adequate weight-gain monitoring, and early initiation of and exclusive breastfeeding. IFPRI tested the feasibility of the behavior-change interventions and examined their impacts on pregnant women's health and nutrition practices and breastfeeding practices of recently delivered women, compared with standard antenatal care services provided in control areas.
The study was designed as a two-arm cluster-randomized, non-masked trial, consisting of two cross-sectional surveys at baseline and endline. The unit of randomization was the health and social promotion center (CSPS, Centre de Santé et de Promotion Social in French) catchment area. 40 CSPS in Boucle du Mouhoun and 40 CSPS in Hauts-Bassins were randomly assigned to intervention/control. A baseline cluster/facility-level and household survey took place in November-December 2019. Soon after the completion of the baseline survey, the interventions were implemented at the CSPS and villages within the intervention areas for approximately 10 months (less than 1 year, caused by brief service interruptions in March-April 2020 due to the COVID-19 pandemic). The endline survey took place in January-March 2021.
The overall study objective is to evaluate the feasibility of integrating locally relevant maternal nutrition interventions into ANC services provided by the government health system and their impact on diet quality and quantity and utilization of nutrition interventions during pregnancy.
The implementation research study addresses three research questions:
- What are the program impacts on maternal nutrition practices: (1) consumption of diversified foods and adequate intake of micronutrient, protein and energy compared to recommended intakes; (2) consumption of IFA supplements during pregnancy; and (3) early breastfeeding practices?
- Can the coverage and utilization of key nutrition interventions (maternal nutrition counseling, weight gain monitoring, distribution of and counseling on IFA supplementation, and breastfeeding counseling) and number of ANC contacts be improved through health system strengthening and nutrition-focused social and behavior change communication (SBCC; interpersonal communication and community mobilization) approaches?
- What factors influenced integration and strengthening of maternal nutrition interventions into the government ANC service delivery platform?
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Health Facility Level Interventions, Behavioral: Community Level Interventions, Behavioral: Health System Level InterventionsA\&T intervention areas: intensified maternal nutrition behavior change interventions during antenatal care delivered through government health facilities. |
| Control | No intervention | –Comparison areas: standard antenatal care services delivered at government health facilities. |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Currently pregnant or recently delivered with a child 0-5.9 months of age
- Residency in the health facility catchment area
- Informed consent
Key exclusion criteria (1 listed)
- Age <15 years or >49 years
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 |
|---|---|---|
| Health Facility Level Interventions* Intensified counseling on maternal dietary diversity and quality using job aids * Counseling on purpose of IFA supplementation, managing side effects, and importance of adherence to daily consumption * Distribution/prescription of IFA tablets at each ANC visit * Use of pill card/reminders for pregnant women and their spouses * Monthly IFA tablet stock monitoring to assure sufficient supplies * Measurement of weight gain during each ANC visit and advise on healthy weight gain * Checks for functioning scales and use of monitoring sheets * Intensified counseling on early initiation of breastfeeding and exclusive breastfeeding using job aids * Reminder on importance of early ANC attendance and 4+ visits | Behavioural | Intervention |
| Community Level Interventions* Advocacy among community leaders (traditional and religious leaders, local associations, etc.) about ANC * Gatherings among grandmothers, husbands, and other influencers about ANC and their roles * Promotion of ANC service utilisation and the importance of early ANC visit during the first trimester. * Early identification of pregnant women * Support women's group discussions * 2-3 home visits per pregnant woman by community health workers (Agent de santé a base communautaire; ASBC) which will include counseling on diet quality, breastfeeding, importance on adherence to daily IFA consumption and side effect management, etc. | Behavioural | Intervention |
| Health System Level Interventions* Training on nutrition interventions during ANC for all ANC providers and community health workers * Semi-annual supervision by the Regional Health Directorate (Direction Regionale de la Santé; DRS) * Quarterly supportive supervision of health facility staff by the health district management team * Monthly supportive supervision of ASBCs * Monthly review between health facilities and ASBCs * Training and use of data registers * Training and use of mother's cards to record up to 8 ANC visits and nutrition services * Training on data utilization to improve coverage and quality | Behavioural | Intervention |
Primary outcome
Dietary diversity during pregnancy
Time frame: Approximately 16 months after baseline in a cross-sectional endline survey
Mean number of food groups consumed by pregnant women on the day preceding the interview.
Minimum dietary diversity during pregnancy
Time frame: Approximately 16 months after baseline in a cross-sectional endline survey
Proportion of pregnant women who consumed 5 or more food groups on the day preceding the interview.
Consumption of iron-folic acid tablets during pregnancy
Time frame: Approximately 16 months after baseline in a cross-sectional endline survey
Mean number of IFA tablets consumed during last pregnancy by recently delivered women with a child 0-5.9 months of age.
Consumption of 90+ iron-folic acid tablets during pregnancy
Time frame: Approximately 16 months after baseline in a cross-sectional endline survey
Proportion of women who consumed 90+ IFA tablets during last pregnancy by recently delivered women with a child 0-5.9 months of age.
7 secondary outcomes
Micronutrient, protein and energy adequacy during pregnancy
Time frame: Approximately 16 months after baseline in a cross-sectional endline survey
Early initiation of breastfeeding
Time frame: Approximately 16 months after baseline in a cross-sectional endline survey
Use of ANC services during pregnancy
Time frame: Approximately 16 months after baseline in a cross-sectional endline survey
Exposure to nutrition interventions during ANC
Time frame: Approximately 16 months after baseline in a cross-sectional endline survey
Women's knowledge of maternal nutrition and breastfeeding
Time frame: Approximately 16 months after baseline in a cross-sectional endline survey
Health worker knowledge of IFA supplementation, dietary diversity, weight gain during pregnancy, and early and exclusive breastfeeding.
Time frame: Approximately 16 months after baseline in a cross-sectional endline survey
Availability of ANC service supports
Time frame: Approximately 16 months after baseline in a cross-sectional endline survey
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 10 Mar 2022.
- Background: PubMed 26433230Hanson MA, Bardsley A, De-Regil LM, Moore SE, Oken E, Poston L, Ma RC, McAuliffe FM, Maleta K, Purandare CN, Yajnik CS, Rushwan H, Morris JL. The International Federation of Gynecology and Obstetrics (FIGO) recommendations on adolescent, preconception, and maternal nutrition: "Think Nutrition First". Int J Gynaecol Obstet. 2015 Oct;131 Suppl 4:S213-53. doi: 10.1016/S0020-7292(15)30034-5. No abstract available.
- Background: PubMed 18207566Black RE, Allen LH, Bhutta ZA, Caulfield LE, de Onis M, Ezzati M, Mathers C, Rivera J; Maternal and Child Undernutrition Study Group. Maternal and child undernutrition: global and regional exposures and health consequences. Lancet. 2008 Jan 19;371(9608):243-60. doi: 10.1016/S0140-6736(07)61690-0. No abstract available.
- Background: PubMed 28079998WHO Recommendations on Antenatal Care for a Positive Pregnancy Experience. Geneva: World Health Organization; 2016. Available from http://www.ncbi.nlm.nih.gov/books/NBK409108/
- BackgroundPartnership for Maternal, Newborn and Child Health (PMNCH). 2006. Opportunities for Africa's newborns: Practical data, policy and programmatic support for newborn care in Africa. Edited by Joy Lawn and Kate Kerber. Cape Town: PMNCH.
- BackgroundUnited Nations Children's Fund (UNICEF). 2016. The state of the world's children 2016: A fair chance for every child. New York: UNICEF.
- Background: PubMed 25013954Alkema L, New JR, Pedersen J, You D; UN Inter-agency Group for Child Mortality Estimation; Technical Advisory Group. Child mortality estimation 2013: an overview of updates in estimation methods by the United Nations Inter-agency Group for Child Mortality Estimation. PLoS One. 2014 Jul 11;9(7):e101112. doi: 10.1371/journal.pone.0101112. eCollection 2014.
- Derived from this study: PubMed 37336320Kim SS, Zagre RR, Ouedraogo CT, Sununtnasuk C, Ganaba R, Zafimanjaka MG, Tharaney M, Sanghvi T, Menon P. Intensified Nutrition Interventions in Antenatal Care Services Increased Consumption of Iron and Folic Acid Supplements and Early Breastfeeding Practices in Burkina Faso: Results of a Cluster-Randomized Program Evaluation. J Nutr. 2023 Oct;153(10):3058-3067. doi: 10.1016/j.tjnut.2023.06.016. Epub 2023 Jun 17.
- Individual participant dataSharing planned: Yes. In compliance with donor open access policy requirements, fully anonymized datasets will be made publicly available one year after the end of the project. Metadata and other documentation of data collection procedures (such as the codebook, data collection instruments and interviewer guides/protocols) will also be made publicly available.
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Recruiting
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Facility Level Interventions, Community Level Interventions and Health System Level Interventions in people with Maternal Dietary Diversity and Iron-Folic Acid Supplementation, 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 3 inclusion and 1 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 10 Mar 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?
Dietary diversity during pregnancy (time frame: Approximately 16 months after baseline in a cross-sectional endline survey). The study lists 4 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 NCT04155437, which also lists 7 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 10 Mar 2022.