Small for Gestational Age at DeliveryBEPNCT06125860
BEP Targeting Strategies in Ethiopia
A study testing Targeted BEP based on baseline nutritional status, Targeted BEP based on baseline nutritional status and monthly GWG monitoring and Universal BEP in people with Small for Gestational Age at Delivery and Gestational Weight Gain, run by Harvard School of Public Health (HSPH) at 1 site in Ethiopia.
Trial summary
The goal of this randomized effectiveness study is to evaluate the different targeting strategies for the delivery of balanced energy and protein (BEP) supplements among pregnant women in Addis Ababa, Ethiopia. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Small for Gestational Age at Delivery, Gestational Weight Gain, Stillbirth
- What is being tested?
- Targeted BEP based on baseline nutritional status, Targeted BEP based on baseline nutritional status and monthly GWG monitoring and Universal BEP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,851 participants
- Where
- 1 siteEthiopia
- Study dates
- 7 Aug 2023to 7 Aug 2026
- 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 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- pregnant women aged 18 to 49;
- attending antenatal visits in one of the study health facilities;
- with a gestational age of 24 weeks or less;
- no known allergies to peanuts or soybeans;
- having resided in the current location for at least 6 months;
- intending to continue antenatal follow-up in the health facility;
- intending to give birth and remain in the study area until six weeks after delivery; and
- willing to take the BEP supplements for the entire duration of the pregnancy if eligible.
Who cannot join
- Not meeting all of the inclusion criteria above
Trial locations and contacts
1 site in 1 country.
Ethiopia1 site
Addis Continental Institute of Public Health (ACIPH)
Addis Ababa, Addis Ababa, Box 26751/1000
About this study
Official title: Targeting Strategies of Antenatal Balanced Energy and Protein Supplementation in Addis Ababa, Ethiopia
The goal of this randomized effectiveness study is to evaluate the different targeting strategies for the delivery of balanced energy and protein (BEP) supplements among pregnant women in Addis Ababa, Ethiopia. The main goals of the study are to: 1) determine the effectiveness of two individual-based antenatal BEP targeting strategies for preventing adverse pregnancy outcomes; 2) compare the cost-effectiveness of the universal BEP provision with two individual-based targeting strategies for preventing adverse pregnancy outcomes; and 3) generate implementation evidence regarding the feasibility and acceptability of different antenatal BEP targeting strategies. Pregnant women will be enrolled during pregnancy, assigned to different strategies of BEP supplementation, and followed from pregnancy through six weeks postpartum to evaluate the impacts of different BEP targeting strategies on pregnancy, maternal, and child outcomes.
- Conditions
- Small for Gestational Age at Delivery, Gestational Weight Gain, Stillbirth, Preterm Birth, Birth Weight, Maternal Anemia in Pregnancy, Before Birth
- Being tested
- Targeted BEP based on baseline nutritional status, Targeted BEP based on baseline nutritional status and monthly GWG monitoring, Universal BEP
- Keywords
- balanced energy and protein supplementation, food supplementation, antenatal nutrition, maternal nutrition, gestational weight gain, Ethiopia
- Medical subject headings
- Gestational Weight Gain, Stillbirth, Premature Birth, Birth Weight, Perinatal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted BEP based on baseline nutritional statusDietary supplement
In Arm 2 (targeted BEP based on baseline nutritional status), in addition to the standard of care, participants will receive BEP supplements if their baseline BMI is less than 18.5 or their baseline mid-upper arm circumference is less than 23 cm.
Targeted BEP based on baseline nutritional status and monthly GWG monitoringDietary supplement
In Arm 3 (targeted BEP based on baseline nutritional status and monthly GWG monitoring), in addition to the standard of care, participants will receive BEP supplements if their baseline BMI is less than 18.5 or their baseline mid-upper arm circumference is less than 23 cm; participants with an inadequate GWG at a monthly follow-up visit will receive additional BEP supplements.
Universal BEPDietary supplement
In Arm 4 (universal BEP), all participants will receive BEP supplements from baseline through the end of pregnancy.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (control arm) | No intervention | In Arm 1 (control arm), participants will receive the standard of antenatal care including iron and folic acid supplementation. |
| Arm 2 (Targeted BEP based on baseline nutritional status) | Experimental | Not described Receives: Dietary Supplement: Targeted BEP based on baseline nutritional status |
| Arm 3 (Targeted BEP by baseline nutritional status and monthly gestational weight gain monitoring) | Experimental | Not described Receives: Dietary Supplement: Targeted BEP based on baseline nutritional status and monthly GWG monitoring |
| Arm 4 (universal BEP) | Experimental | Not described Receives: Dietary Supplement: Universal BEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Small-for-gestational-age births
Live birth whose birthweight for sex and gestational age is < 10th percentile based on the INTERGROWTH-21st standards
Measured: Assessed within 72 hours of birth
Secondary outcomes (11)
Inadequate gestational weight gain
Gestational weight gain percent adequacy ratio less than 90% at the last weight measurement before delivery, based on the Institute of Medicine recommendations
Measured: At the last weight measurement before delivery, at around 36 weeks
Excessive gestational weight gain
Gestational weight gain percent adequacy ratio greater than 125% at the last weight measurement before delivery, based on the Institute of Medicine recommendations
Measured: At the last weight measurement before delivery, at around 36 weeks
Stillbirth
Fetal death between 28 weeks of gestation and delivery
Measured: Between 28 weeks of gestation and delivery
Preterm birth
Live birth < 37 completed weeks of gestation
Measured: Less than 37 completed weeks of gestation
Low birthweight
Live birth weighing < 2500 grams
Measured: Assessed within 72 hours of birth
Macrosomia
Live birth weighing > 4000 grams
Measured: Assessed within 72 hours of birth
Large-for-gestational-age births
Live birth whose birthweight for sex and gestational age is > 90th percentile based on the INTERGROWTH-21st standards
Measured: Assessed within 72 hours of birth
Third-trimester anemia
Hemoglobin concentration < 11 g/dL at 32 weeks of gestation
Measured: At 32 weeks of gestation
Neonatal death
Death of live newborn < 28 days of life
Measured: From birth through 28 days of life
Perinatal death
Fetal death between 28 weeks gestational age and delivery, or newborn death < 7 days of life
Measured: Between 28 weeks of gestation to 7 days after delivery
Pre-eclampsia
New onset hypertension (systolic blood pressure >= 140 or diastolic blood pressure >=90 mmhg) after 20 weeks of gestation with proteinuria.
Measured: After 20 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start7 Aug 2023
- Primary completion7 Aug 2026
- Study completion7 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Small for Gestational Age at DeliveryStudies 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
- 7,851 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- Addis Continental Institute of Public Health, George Mason University
- Responsible party
- Principal investigator, Wafaie Fawzi, Harvard School of Public Health (HSPH)
- Investigators
- Wafaie W Fawzi, DrPH, MBBS, Principal investigator, Harvard School of Public Health (HSPH)Yemane Berhane, MD, PhD, Principal investigator, Addis Continental Institute of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06125860
- Sponsor's protocol ID
- IRB22-1245
- Acronym
- BEP
- Status last verified
- Aug 2026
- First submitted
- 31 Oct 2023
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang D, Shifraw T, Costa JC, Abdelmenan S, Tsegaye S, Berhane Y, Gulema H, Berhane H, Fasil N, Workneh F, Tarekegn W, Wang M, Menzies NA, Worku A, Berhane Y, Fawzi WW. Targeting strategies of antenatal balanced energy and protein supplementation in Addis Ababa, Ethiopia: study protocol for a randomized effectiveness study. Trials. 2024 Apr 30;25(1):291. doi: 10.1186/s13063-024-08002-2.
PubMed 38689304
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Strategies of Antenatal Balanced Energy and Protein Supplementation in Addis Ababa, Ethiopia
- ClinicalTrials.gov ID
- NCT06125860
- Acronym / sponsor ID
- BEP / IRB22-1245
- Conditions
- Small for Gestational Age at Delivery, Gestational Weight Gain, Stillbirth, Preterm Birth, Birth Weight, Maternal Anemia in Pregnancy, Before Birth
- Keywords
- balanced energy and protein supplementation, food supplementation, antenatal nutrition, maternal nutrition, gestational weight gain, Ethiopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,851 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- Addis Continental Institute of Public Health, George Mason University
- Study start
- 7 Aug 2023 (actual)
- Primary completion
- 7 Aug 2026 (actual)
- Study completion
- 7 Aug 2026 (actual)
- First posted
- 9 Nov 2023 (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.
The goal of this randomized effectiveness study is to evaluate the different targeting strategies for the delivery of balanced energy and protein (BEP) supplements among pregnant women in Addis Ababa, Ethiopia. The main goals of the study are to: 1) determine the effectiveness of two individual-based antenatal BEP targeting strategies for preventing adverse pregnancy outcomes; 2) compare the cost-effectiveness of the universal BEP provision with two individual-based targeting strategies for preventing adverse pregnancy outcomes; and 3) generate implementation evidence regarding the feasibility and acceptability of different antenatal BEP targeting strategies. Pregnant women will be enrolled during pregnancy, assigned to different strategies of BEP supplementation, and followed from pregnancy through six weeks postpartum to evaluate the impacts of different BEP targeting strategies on pregnancy, maternal, and child outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (control arm) | No intervention | –In Arm 1 (control arm), participants will receive the standard of antenatal care including iron and folic acid supplementation. |
| Arm 2 (Targeted BEP based on baseline nutritional status) | Experimental | Dietary Supplement: Targeted BEP based on baseline nutritional status |
| Arm 3 (Targeted BEP by baseline nutritional status and monthly gestational weight gain monitoring) | Experimental | Dietary Supplement: Targeted BEP based on baseline nutritional status and monthly GWG monitoring |
| Arm 4 (universal BEP) | Experimental | Dietary Supplement: Universal BEP |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- pregnant women aged 18 to 49;
- attending antenatal visits in one of the study health facilities;
- with a gestational age of 24 weeks or less;
- no known allergies to peanuts or soybeans;
- having resided in the current location for at least 6 months;
Key exclusion criteria (1 listed)
- Not meeting all of the inclusion criteria above
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 |
|---|---|---|
| Targeted BEP based on baseline nutritional statusIn Arm 2 (targeted BEP based on baseline nutritional status), in addition to the standard of care, participants will receive BEP supplements if their baseline BMI is less than 18.5 or their baseline mid-upper arm circumference is less than 23 cm. | Dietary supplement | Arm 2 (Targeted BEP based on baseline nutritional status) |
| Targeted BEP based on baseline nutritional status and monthly GWG monitoringIn Arm 3 (targeted BEP based on baseline nutritional status and monthly GWG monitoring), in addition to the standard of care, participants will receive BEP supplements if their baseline BMI is less than 18.5 or their baseline mid-upper arm circumference is less than 23 cm; participants with an inadequate GWG at a monthly follow-up visit will receive additional BEP supplements. | Dietary supplement | Arm 3 (Targeted BEP by baseline nutritional status and monthly gestational weight gain monitoring) |
| Universal BEPIn Arm 4 (universal BEP), all participants will receive BEP supplements from baseline through the end of pregnancy. | Dietary supplement | Arm 4 (universal BEP) |
Primary outcome
Small-for-gestational-age births
Time frame: Assessed within 72 hours of birth
Live birth whose birthweight for sex and gestational age is < 10th percentile based on the INTERGROWTH-21st standards
11 secondary outcomes
Inadequate gestational weight gain
Time frame: At the last weight measurement before delivery, at around 36 weeks
Excessive gestational weight gain
Time frame: At the last weight measurement before delivery, at around 36 weeks
Stillbirth
Time frame: Between 28 weeks of gestation and delivery
Preterm birth
Time frame: Less than 37 completed weeks of gestation
Low birthweight
Time frame: Assessed within 72 hours of birth
Macrosomia
Time frame: Assessed within 72 hours of birth
Large-for-gestational-age births
Time frame: Assessed within 72 hours of birth
Third-trimester anemia
Time frame: At 32 weeks of gestation
Neonatal death
Time frame: From birth through 28 days of life
Perinatal death
Time frame: Between 28 weeks of gestation to 7 days after delivery
Pre-eclampsia
Time frame: After 20 weeks of gestation
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 14 Aug 2026.
- Derived from this study: PubMed 38689304Wang D, Shifraw T, Costa JC, Abdelmenan S, Tsegaye S, Berhane Y, Gulema H, Berhane H, Fasil N, Workneh F, Tarekegn W, Wang M, Menzies NA, Worku A, Berhane Y, Fawzi WW. Targeting strategies of antenatal balanced energy and protein supplementation in Addis Ababa, Ethiopia: study protocol for a randomized effectiveness study. Trials. 2024 Apr 30;25(1):291. doi: 10.1186/s13063-024-08002-2.
- Individual participant dataSharing planned: No
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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.
Wafaie W Fawzi, DrPH, MBBS principal investigator
Harvard School of Public Health (HSPH)
Yemane Berhane, MD, PhD principal investigator
Addis Continental Institute of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted BEP based on baseline nutritional status, Targeted BEP based on baseline nutritional status and monthly GWG monitoring and Universal BEP in people with Small for Gestational Age at Delivery and Gestational Weight Gain, run by Harvard School of Public Health (HSPH) at 1 site in Ethiopia.
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 8 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 14 Aug 2026. 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 Ethiopia. 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?
Small-for-gestational-age births (time frame: Assessed within 72 hours of birth). 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 NCT06125860, which also lists 1 linked publication.
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 14 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.