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IRB22-1245

Bep targeting strategies in ethiopia
Source : Import from center

clinicaltrials.gov reference: NCT06125860
balanced energy and protein supplementation
food supplementation
antenatal nutrition
maternal nutrition
gestational weight gain
Ethiopia
Source : Import from center
Recruiment open
Last modification : 2025/01/14
Study type

Interventional


Target population

Medical condition (targeted specialty)

Data not available

Participants profils

Participants gender(s)

FEMALE

Source : Import from center

Selection criterias

Inclusion criteria

Inclusion Criteria:

1. pregnant women aged 18 to 49;
2. attending antenatal visits in one of the study health facilities;
3. with a gestational age of 24 weeks or less;
4. no known allergies to peanuts or soybeans;
5. having resided in the current location for at least 6 months;
6. intending to continue antenatal follow-up in the health facility;
7. intending to give birth and remain in the study area until six weeks after delivery; and
8. willing to take the BEP supplements for the entire duration of the pregnancy if eligible.

Exclusion Criteria:

* Not meeting all of the inclusion criteria above

Source : Import from center

Proposed Therapy or Intervention

Cohorts
Name Medical condition Treatment Recruitment status
Arm 1 (control arm) In Arm 1 (control arm), participants will receive the standard of antenatal care including iron and folic acid supplementation. Data not available
  • Unknown
  • Arm 2 (Targeted BEP based on baseline nutritional status) Data not available Data not available
  • Unknown
  • Arm 3 (Targeted BEP by baseline nutritional status and monthly gestational weight gain monitoring) Data not available Data not available
  • Unknown
  • Arm 4 (universal BEP) Data not available Data not available
  • Unknown
  • Arm 1 (control arm)
    Recruitment status
    unknown
    Arm 2 (Targeted BEP based on baseline nutritional status)
    Recruitment status
    unknown
    Arm 3 (Targeted BEP by baseline nutritional status and monthly gestational weight gain monitoring)
    Recruitment status
    unknown
    Arm 4 (universal BEP)
    Recruitment status
    unknown
    Current data since : January 14, 2025 19:00

    Study description

    Study 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. 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.

    Source : Import from center

    Locations

    Participating centers


    Last modification : January 14, 2025
    Current data since : 16 Jan 00:54
    Data source : clinicaltrials.gov
    clinicaltrials.gov reference: NCT06125860