Mitigating Effect of Bicycles on Maternal and Child Health in Zambia

Last registered on May 23, 2022

Pre-Trial

Trial Information

General Information

Title
Mitigating Effect of Bicycles on Maternal and Child Health in Zambia
RCT ID
AEARCTR-0009468
Initial registration date
May 23, 2022

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
May 23, 2022, 7:24 PM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Locations

Region

Primary Investigator

Affiliation
Technical University of Munich

Other Primary Investigator(s)

PI Affiliation
Technical University of Munich

Additional Trial Information

Status
Completed
Start date
2017-08-07
End date
2018-12-14
Secondary IDs
Prior work
This trial does not extend or rely on any prior RCTs.
Abstract
Despite the reductions in maternal and child mortality ratios in Zambia, the current rates stand at 252 deaths per 100,000 live births for maternal mortality ratio (MMR) and 61.4 deaths per 1,000 live births for child mortality ratio (CMR). These rates are much higher than the global estimates of 152 deaths per 100,000 live births for MMR and 32 deaths per 1,000 live births for CMR. The key barriers to reductions in mortality in this region include poverty, malnutrition, inadequate infrastructure, access to services and gender inequality.

Gender inequality especially in access to education can have severe health impacts on girls and women including teen pregnancy, early marriages, HIV/AIDS, and poor sexual and reproductive health outcomes. The original randomized control trial (RCT) study “Wheels of Change: Transforming Girls’ Lives with Bicycles” studied if an intervention that provides a bicycle to an adolescent girl translates into higher measures of empowerment and increases her educational outcomes. Many researchers show that women’ empowerment is positively related to greater use of maternal and child health (MCH) services, ability to seek services, improve child nutrition, increase uptake of immunization and contraceptive use, and reduce fertility rates. Therefore, in the current study we want to examine whether receiving a bicycle can lead to positive maternal and child health outcomes among girls who were a part of the Wheels of Change study in 2017.

To examine the mitigating impact of the bicycle, we will conduct a quantitative survey with adolescent girls between 15 and 19 years old by comparing a group of girls that had received a bicycle with a group of girls that did not. We will collect data in communities around the 100 schools (3km or more) that were previously selected under the Wheels of Change RCT study. Under the original study 45 schools were assigned to the treatment group and 55 schools were assigned to the control group. This proposed study will be set up as an independent new study and will be conducted without drawing on any personally identifying information and data from the previous RCT study.
External Link(s)

Registration Citation

Citation
Shukla, Shruti and Janina Steinert. 2022. "Mitigating Effect of Bicycles on Maternal and Child Health in Zambia." AEA RCT Registry. May 23. https://doi.org/10.1257/rct.9468
Experimental Details

Interventions

Intervention(s)
The original study "Wheels of Change" which forms the basis of this study was a randomized controlled trial implemented in the Southern province of Zambia.The goal of this study was to examine the impact of providing bicycles to school-going adolescent girls on
education and empowerment outcomes.

The current study will be set up as an independent new study and will be conducted without drawing on any personally identifying information and data from the Wheels of Change (WoC) study. We aim to target the surrounding communities in 3 km or more distance from the same 100 schools that were part of the original WoC-study. From these communities, we will select a sample of girls (between 15 -19 years old) that is completely unrelated to the previous sample of the WoC-study to examine the effect of having received a bicycle on maternal and child health outcomes.
Intervention Start Date
2017-08-07
Intervention End Date
2018-12-14

Primary Outcomes

Primary Outcomes (end points)
1. Teen pregnancy
2. Antenatal care visits
3 Folic acid uptake
4. Mode of delivery
5. Exclusive breastfeeding
6. Birth weight of the child
Primary Outcomes (explanation)
The outcomes will cover some of the most important indicators of maternal and child health.

Secondary Outcomes

Secondary Outcomes (end points)
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
The original experiment "Wheels of Change" was designed as a multi-treatment design with two treatment arms and a control. For the current study we will select a completely unrelated group participants from the communities around the treatment and control schools from the previous WoC-study.
Experimental Design Details
Randomization Method
In the original study schools were randomly assigned to treatment or control group by a computer.
For the current study we will adopt a random walk procedure in the communities around the above mentioned schools in treatment and control groups. Enumerators will start from a central location in the community (i.e. a church or community hall), spin a pencil, and follow its direction. They will visit every 3rd household. They will screen each household for eligibility using the following criteria: 1) having a girls in the household that is aged between 15 and 19 years old, 2) girl having attended the school in the surrounding area (in 2017), and 3) girl having received a bicycle (only for communities of the initial 45 treatment schools). If the girl does not meet these criteria, the enumerator will continue to the next household according to the random walk rule until the target number of girls has been achieved.
Randomization Unit
School
Was the treatment clustered?
Yes

Experiment Characteristics

Sample size: planned number of clusters
100 schools
Sample size: planned number of observations
2000 girls
Sample size (or number of clusters) by treatment arms
45 treatment schools
55 control schools
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
The target sample size of girls for this study is 2,000 across 100 schools, with 50% in-school and 50% out-of-school-girls. We have performed power calculations with this sample size and research design, assuming a 0.08 intra cluster correlation (ICC), power of 80%, and alpha = 5%. The minimum detectable effect (MDE) that can be estimated with these assumptions is 0.2 standard deviations (SDs).
IRB

Institutional Review Boards (IRBs)

IRB Name
IRB Approval Date
IRB Approval Number

Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
No
Data Collection Complete
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials