Increasing Access to Multiple Micronutrient Supplementation - A Pilot Intervention at up to 15 Clinics in Botswana

February 21, 2024 updated by: Ellen Caniglia, University of Pennsylvania
The purpose of this study is to pilot a clinic-level supplementation intervention at up to 15 antenatal clinics throughout Botswana. The overall objective of this study is to improve access to and uptake of MMS among pregnant women in Botswana. The investigators will evaluate both implementation outcomes (adoption, penetration, fidelity, and feasibility) and clinical outcomes (adverse birth outcomes, weight gain in pregnancy, and anemia) through linkage with the Tsepamo birth outcomes surveillance study.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Pregnant women attending interventional antenatal clinics during the 6-month study

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Multiple Micronutrient Supplement (MMS) supplied to clinic
Dietary supplement: Multiple Micronutrient Supplement
Multiple micronutrient supplementation (MMS) which includes iron, folic acid, and additional micronutrients,

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion with first supplement filled by MMS
Time Frame: 6-month intervention period
Among pregnant women presenting for their first antenatal visit during the 6-month intervention period at one of the intervention clinics who then deliver at one of the Tsepamo sites, the proportion for whom the first supplement filled during pregnancy is MMS. As comparators, we will use the 6-month pre-intervention period at the intervention clinics and the 6-month intervention period at non-intervention clinics (all non-intervention clinics as well as specific preselected control clinics).
6-month intervention period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implementation: Proportion for which MMS is filled
Time Frame: 6-month intervention period
This outcome will be evaluated using data from clinic logbooks and by subtracting the number of supplements remaining in the clinic at the end of the study from the number of supplements provided to the clinic
6-month intervention period
Implementation: Proportion for which first and second supplement filled by MMS
Time Frame: 6-month intervention period
Among pregnant women presenting for their first antenatal visit during the 6-month intervention period at one of the intervention clinics who then deliver at one of the Tsepamo sites, the proportion for whom MMS is filled at the first and second antenatal visit. This outcome will be evaluated through linkage with the Tsepamo Study. As comparators, we will use the 6-month pre-intervention period at the intervention clinics and the 6-month intervention period at non-intervention clinics (all non-intervention clinics as well as specific preselected control clinics).
6-month intervention period
Implementation: Feasibility
Time Frame: 8 months
Feasibility of the intervention will be measured via qualitative pre- and post- intervention surveys among staff at the intervention clinics. Questions will be asked using a Likert scale ranging from completely disagree to completely agree. We will report the mean/median response for each question as well as the mean/median change in score between the pre and post surveys. As this is a qualitative measure there is no predefined minimum or maximum value.
8 months
Clinical: Number of Pregnant Women with an Adverse Birth Outcome
Time Frame: 6-months
1) Any adverse birth outcome, consisting of stillbirth, preterm birth, SGA, neonatal death (as well as individual birth outcomes) among those who deliver at one of the Tsepamo sites. . As comparators, we will use the 6-month pre-intervention period at the intervention clinics and the 6-month intervention period at non-intervention clinics (all non-intervention clinics as well as specific preselected control clinics).
6-months
Clinical: Weight Gain in Pregnancy
Time Frame: 6-months
Weight gain in pregnancy among those who deliver at one of the Tsepamo sites. As comparators, we will use the 6-month pre-intervention period at the intervention clinics and the 6-month intervention period at non-intervention clinics (all non-intervention clinics as well as specific preselected control clinics).
6-months
Clinical: Number of mothers diagnosed with Maternal Anemia
Time Frame: 6-months
Number of mothers diagnosed with Anemia during the six month intervention or percentage of mothers diagnosed with anemia during 6 months of intervention compared to the percentage of mothers diagnosed with anemia in the 6 months prior to the intervention or 6 months after the interventions was completed.
6-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

December 22, 2022

First Submitted That Met QC Criteria

January 25, 2023

First Posted (Actual)

January 30, 2023

Study Record Updates

Last Update Posted (Estimated)

February 22, 2024

Last Update Submitted That Met QC Criteria

February 21, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 852412

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pregnancy Related

Clinical Trials on Multiple Micronutrient Supplement

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bosnia & Herzegovina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe