Maternal Dietary DiversityNCT04125368
A Feasibility Study of Integrating Maternal Nutrition Interventions Into Antenatal Care Services in Ethiopia
A study testing Health Facility Interventions, Community Interventions and Health System 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 Interventions, Community Interventions and Health System 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
- 4,256 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2019to 4 Sep 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
- Attended at least 1 ANC visit at a government health center or health post
- Resides in the same kebeles as the government health center catchment area
- Given informed consent
- Service providers and health facilities in the catchment areas
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: A Feasibility Study of Integrating Maternal Nutrition Interventions Into Antenatal Care Services in Ethiopia: 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 Ethiopia, A\&T integrated a package of maternal nutrition interventions into existing antenatal care (ANC) services delivered through government health facilities (counselling on diet quality during pregnancy, distribution and promotion of iron-folic acid (IFA) supplementation, weight gain monitoring, counselling on early breastfeeding practices, and systems strengthening through training and supportive supervision) and community platforms (home visits, Pregnant Women Conferences/Mother Support groups, and community gatherings). The evaluation used a two-arm cluster-randomized, non-masked trial design, consisting of two cross-sectional surveys in 2019 and 2021.
Read the detailed description
There is wide recognition of the importance of integrating maternal nutrition interventions in ANC to improve maternal and child health. In 2016, World Health Organization ANC guidelines were updated to place a high priority on nutrition interventions during pregnancy to improve perinatal outcomes and women's experience of care.
In Ethiopia, the government has adopted a package of maternal nutrition interventions into national guidelines (see Ethiopia's Federal Ministry of Health National Guideline on Adolescent, Maternal, Infant and Young Child Nutrition). Despite these efforts, the coverage and quality of maternal nutrition interventions remains low.
A\&T Ethiopia integrated a package of maternal nutrition interventions into existing ANC services delivered through government health facilities (counselling on diet quality during pregnancy, distribution and promotion of IFA supplementation, weight gain monitoring, counselling on early breastfeeding practices, and systems strengthening through training and supportive supervision) and community platforms (home visits, Pregnant Women Conferences/Mother Support groups, and community gatherings) that align with the latest global evidence. 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 evaluation used a two-arm cluster-randomized, non-masked trial design, consisting of two cross-sectional surveys of pregnant and recently delivered women who attended government ANC services. The unit of randomization is the health center and associated health posts in the catchment area. 18 health centers and 2 hospitals in SNNPR and 10 health centers in Somali were randomly assigned to intervention/control. The baseline survey was conducted in October-November 2019, and the endline survey took place in July-September 2021. In 2020, program activities were interrupted between April and July 2020 due to the COVID-19 pandemic. The endline survey was postponed to July-September 2021 to maximize implementation duration.
The overall study objective was to determine the feasibility and impact of integrating locally relevant maternal nutrition interventions into existing ANC services on diet quality and utilization of nutrition interventions during pregnancy.
Research questions include:
- What are the program impacts on maternal practices: (1) consumption of diversified foods during pregnancy; (2) consumption of IFA supplements during pregnancy; and (3) early breastfeeding practices?
- Can the coverage and utilization of key maternal nutrition interventions during ANC be improved through system strengthening approaches?
- What factors influenced the 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 Interventions, Community Interventions, Health System Interventions
- Keywords
- Maternal Nutrition, Antenatal Care, Ethiopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Facility InterventionsBehavioural
- Intensified counselling on dietary diversity and increased meal frequency during pregnancy.
- Strengthened government distribution of IFA supplies with counseling about its importance, managing side effects, and reminder about subsequent supplies.
- Weight-gain monitoring with messaging to mothers about healthy diet and adequate rest; excess weight gain as a danger sign.
- Intensified counseling on importance, benefits, and how-tos of early initiation of breastfeeding and exclusive breastfeeding.
Community InterventionsBehavioural
- Home visits to pregnant women by HEWs to discuss maternal nutrition (dietary diversity, adequate food intake, IFA supplementation, and weight gain), early breastfeeding practices, provide ANC and Pregnant Women Conference referrals, and engage husbands.
- HEWs use A\&T intervention tools (e.g. posters and maternal nutrition follow-up card) at Pregnant Women Conferences/ Mother Support Groups to reinforce maternal nutrition messages, encourage ANC attendance, distribute IFA tablets, measure and track weight gain, promote early breastfeeding practices, and encourage husband participation.
- HEWs and community volunteers (Women's Development Army (WDA), imams, etc.) deliver maternal nutrition messages and encourage ANC visits at kebele and community meetings.
Health System InterventionsBehavioural
- Trainings on the maternal nutrition interventions for health center heads, nurse-midwives, HEWs, community volunteers (WDA, imams, etc.), woreda health officers, and other key actors.
- Supportive supervision of maternal nutrition activities conducted by woreda nutrition officers, woreda health officers, TDA or A\&T.
| 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 and in the community Receives: Behavioral: Health Facility Interventions; Behavioral: Community Interventions; Behavioral: Health System Interventions |
| Control | No intervention | Comparison areas: standard antenatal care services delivered at government health facilities and in the community |
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 2 years 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 2 years 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 2 years after baseline in a cross-sectional endline survey
Consumption of 90+ iron-folic acid tablets during pregnancy
Proportion of women who consumed 90+ IFA supplements during pregnancy by recently delivered women with a child 0-5.9 months of age.
Measured: Approximately 2 years after baseline in a cross-sectional endline survey
Secondary outcomes (6)
Early initiation of breastfeeding
Proportion of children aged 0-5.9 months who were breastfed within 1 hour of birth.
Measured: Approximately 2 years after baseline in a cross-sectional endline survey
Use of ANC services during pregnancy
Total number of ANC visits and month of first ANC visit during last pregnancy reported by recently delivered women with a child age 0-5.9 months.
Measured: Approximately 2 years after baseline in a cross-sectional endline survey
Exposure to maternal nutrition interventions from ANC
Proportion of recently delivered women with children <6 months of age exposed to maternal nutrition interventions from ANC and other sources.
Measured: Approximately 2 years after baseline in a cross-sectional endline survey
Women's knowledge of maternal nutrition and breastfeeding
Proportion of recently delivered women with children <6 months of age with correct knowledge of maternal nutrition and appropriate breastfeeding practices based on survey responses.
Measured: Approximately 2 years after baseline in a cross-sectional endline survey
Health worker knowledge of IFA supplementation, dietary diversity, weight gain during pregnancy, and early initiation of and exclusive breastfeeding.
Proportion of nurse-midwives and health extension workers with correct knowledge of IFA supplementation, dietary diversity, weight gain during pregnancy and appropriate breastfeeding practices based on survey responses.
Measured: Approximately 2 years after baseline in a cross-sectional endline survey
Availability of ANC service supports
Proportion of health facilities with service supports (IFA supplies, records/registers and regular review of nutrition intervention coverage and IFA supply data, weight measurement equipment, counseling materials, and training and supervision for health workers) based on enumerator observation.
Measured: Approximately 2 years 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 posted14 Oct 2019
- Study start8 Oct 2019
- Primary completion4 Sep 2021
- Study completion4 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 4,256 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Food Policy Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Addis Continental Institute of Public Health, FHI 360
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04125368
- Sponsor's protocol ID
- PHND-19-0948
- Status last verified
- Feb 2022
- First submitted
- 8 Oct 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.
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
- A Feasibility Study of Integrating Maternal Nutrition Interventions Into Antenatal Care Services in Ethiopia: A Cluster-Randomized Evaluation
- ClinicalTrials.gov ID
- NCT04125368
- Acronym / sponsor ID
- PHND-19-0948
- Conditions
- Maternal Dietary Diversity, Iron-Folic Acid Supplementation, Early Initiation of Breastfeeding
- Keywords
- Maternal Nutrition, Antenatal Care, Ethiopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,256 participants (actual)
- Lead sponsor
- International Food Policy Research InstituteUniversity, hospital or other
- Collaborators
- Addis Continental Institute of Public Health, FHI 360
- Study start
- 8 Oct 2019 (actual)
- Primary completion
- 4 Sep 2021 (actual)
- Study completion
- 4 Sep 2021 (actual)
- First posted
- 14 Oct 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 Ethiopia, A\&T integrated a package of maternal nutrition interventions into existing antenatal care (ANC) services delivered through government health facilities (counselling on diet quality during pregnancy, distribution and promotion of iron-folic acid (IFA) supplementation, weight gain monitoring, counselling on early breastfeeding practices, and systems strengthening through training and supportive supervision) and community platforms (home visits, Pregnant Women Conferences/Mother Support groups, and community gatherings). The evaluation used a two-arm cluster-randomized, non-masked trial design, consisting of two cross-sectional surveys in 2019 and 2021.
Detailed description
There is wide recognition of the importance of integrating maternal nutrition interventions in ANC to improve maternal and child health. In 2016, World Health Organization ANC guidelines were updated to place a high priority on nutrition interventions during pregnancy to improve perinatal outcomes and women's experience of care.
In Ethiopia, the government has adopted a package of maternal nutrition interventions into national guidelines (see Ethiopia's Federal Ministry of Health National Guideline on Adolescent, Maternal, Infant and Young Child Nutrition). Despite these efforts, the coverage and quality of maternal nutrition interventions remains low.
A\&T Ethiopia integrated a package of maternal nutrition interventions into existing ANC services delivered through government health facilities (counselling on diet quality during pregnancy, distribution and promotion of IFA supplementation, weight gain monitoring, counselling on early breastfeeding practices, and systems strengthening through training and supportive supervision) and community platforms (home visits, Pregnant Women Conferences/Mother Support groups, and community gatherings) that align with the latest global evidence. 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 evaluation used a two-arm cluster-randomized, non-masked trial design, consisting of two cross-sectional surveys of pregnant and recently delivered women who attended government ANC services. The unit of randomization is the health center and associated health posts in the catchment area. 18 health centers and 2 hospitals in SNNPR and 10 health centers in Somali were randomly assigned to intervention/control. The baseline survey was conducted in October-November 2019, and the endline survey took place in July-September 2021. In 2020, program activities were interrupted between April and July 2020 due to the COVID-19 pandemic. The endline survey was postponed to July-September 2021 to maximize implementation duration.
The overall study objective was to determine the feasibility and impact of integrating locally relevant maternal nutrition interventions into existing ANC services on diet quality and utilization of nutrition interventions during pregnancy.
Research questions include:
- What are the program impacts on maternal practices: (1) consumption of diversified foods during pregnancy; (2) consumption of IFA supplements during pregnancy; and (3) early breastfeeding practices?
- Can the coverage and utilization of key maternal nutrition interventions during ANC be improved through system strengthening approaches?
- What factors influenced the 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 Interventions, Behavioral: Community Interventions, Behavioral: Health System InterventionsA\&T intervention areas: intensified maternal nutrition behavior change interventions during antenatal care delivered through government health facilities and in the community |
| Control | No intervention | –Comparison areas: standard antenatal care services delivered at government health facilities and in the community |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Currently pregnant or recently delivered with a child 0-5.9 months of age
- Attended at least 1 ANC visit at a government health center or health post
- Resides in the same kebeles as the government health center catchment area
- Given informed consent
- Service providers and health facilities in the catchment areas
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 Interventions1. Intensified counselling on dietary diversity and increased meal frequency during pregnancy. 2. Strengthened government distribution of IFA supplies with counseling about its importance, managing side effects, and reminder about subsequent supplies. 3. Weight-gain monitoring with messaging to mothers about healthy diet and adequate rest; excess weight gain as a danger sign. 4. Intensified counseling on importance, benefits, and how-tos of early initiation of breastfeeding and exclusive breastfeeding. | Behavioural | Intervention |
| Community Interventions1. Home visits to pregnant women by HEWs to discuss maternal nutrition (dietary diversity, adequate food intake, IFA supplementation, and weight gain), early breastfeeding practices, provide ANC and Pregnant Women Conference referrals, and engage husbands. 2. HEWs use A\&T intervention tools (e.g. posters and maternal nutrition follow-up card) at Pregnant Women Conferences/ Mother Support Groups to reinforce maternal nutrition messages, encourage ANC attendance, distribute IFA tablets, measure and track weight gain, promote early breastfeeding practices, and encourage husband participation. 3. HEWs and community volunteers (Women's Development Army (WDA), imams, etc.) deliver maternal nutrition messages and encourage ANC visits at kebele and community meetings. | Behavioural | Intervention |
| Health System Interventions1. Trainings on the maternal nutrition interventions for health center heads, nurse-midwives, HEWs, community volunteers (WDA, imams, etc.), woreda health officers, and other key actors. 2. Supportive supervision of maternal nutrition activities conducted by woreda nutrition officers, woreda health officers, TDA or A\&T. | Behavioural | Intervention |
Primary outcome
Dietary diversity during pregnancy
Time frame: Approximately 2 years 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 2 years 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 2 years 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 2 years after baseline in a cross-sectional endline survey
Proportion of women who consumed 90+ IFA supplements during pregnancy by recently delivered women with a child 0-5.9 months of age.
6 secondary outcomes
Early initiation of breastfeeding
Time frame: Approximately 2 years after baseline in a cross-sectional endline survey
Use of ANC services during pregnancy
Time frame: Approximately 2 years after baseline in a cross-sectional endline survey
Exposure to maternal nutrition interventions from ANC
Time frame: Approximately 2 years after baseline in a cross-sectional endline survey
Women's knowledge of maternal nutrition and breastfeeding
Time frame: Approximately 2 years after baseline in a cross-sectional endline survey
Health worker knowledge of IFA supplementation, dietary diversity, weight gain during pregnancy, and early initiation of and exclusive breastfeeding.
Time frame: Approximately 2 years after baseline in a cross-sectional endline survey
Availability of ANC service supports
Time frame: Approximately 2 years 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.
- 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
Ghana MHL Project, Tamale
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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 Interventions, Community Interventions and Health System 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 5 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 2 years 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?
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.