Back to History Current Version

IODINE NUTRITION EDUCATION INTERVENTION AMONG WOMEN OF REPRODUCTIVE AGE IN CROSS RIVER STATE, NIGERIA

Last registered on June 23, 2023
View Trial History

Pre-Trial

Trial Information

General Information

Title
IODINE NUTRITION EDUCATION INTERVENTION AMONG WOMEN OF REPRODUCTIVE AGE IN CROSS RIVER STATE, NIGERIA
RCT ID
AEARCTR-0011621
Initial registration date
June 21, 2023

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
June 23, 2023, 5:23 PM EDT

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

Locations

Country
Nigeria
Region
Cross River State, Nigeria.

Primary Investigator

Name
Elizabeth Nji
Affiliation
University of Calabar
Contact Primary Investigator

Other Primary Investigator(s)

Additional Trial Information

Status
Completed
Start date
2021-07-12
End date
2021-11-19
Keywords
Education, Health
Additional Keywords
Iodine Nutrition, women
JEL code(s)
Secondary IDs
Prior work
This trial does not extend or rely on any prior RCTs.
Abstract
Approximately 2.2 billion people, reflecting 38% of the world's population, live in areas with iodine deficiency. Iodine deficiency disorders (IDDs) is the worlds’ leading cause of preventable brain damage and mental retardation. Knowledge about Iodine nutrition benefits and iodine deficiency disorders is an important tool in reducing the current indices of IDDs. This study thus assessed the effect of iodine nutrition education intervention among women of reproductive age in Obudu and Obanliku LGAs of Cross River State, Nigeria. Cluster-randomized controlled trial study design was employed for the study. Pocock’s formula was used to arrive at a sample size of 480. Iodized salt coverage at the household level and urinary iodine concentration (UIC) levels in a sub-set of the sample were also determined. Majority of participants 204(42.5%) were aged 25-34, most 332(69.2%) were married and while 181() had secondary education, 183() had tertiary level education. The characteristics of both groups were similar at baseline. Majority of respondents in the intervention group 134(55.8%) and the control group 125(52.1%) had marginally good knowledge score of iodine nutrition at Baseline. After the intervention there was a 42.9% increase in good knowledge in the intervention group while only a 1.6% increase was observed in the control group. Effect of nutrition intervention on knowledge of iodine nutrition benefits was statistically significant t (239) = 18.149, p < 0.001. Baseline Knowledge of iodine deficiency disorders was predominantly poor among both groups as only 25.8% in the control group and 21.3% in the intervention group had good knowledge scores. After the intervention, there was a 67.9% increase in the proportion of participants with good knowledge in the intervention group. The effect of the intervention was found to be statistically significant t (239) = 18.149, p < 0.001. At baseline also, the same proportion of participants across both groups 171(71.3%) had overall good practice scores regarding the use of iodized salt. After the nutrition education intervention, there was considerable increase in good practice score for participants in the intervention group by 22% while the control group saw a slight increase by 4.5%, the effect of the intervention on practice was however, statistically significant t (239) = 7.69, p < 0.001. Iodized salt coverage of the study area was 76.2% which is below the acceptable threshold of 90% and so poses a potential risk for iodine deficiency in the study area. Urinary Iodine concentration levels in the sub-set tested indicated that majority of the women 110(45.8%) had had mild deficiency and 15(6.3%) had moderate deficiency while 105(43.8%) had optimal UIC levels. In conclusion, this study demonstrated the effectiveness of nutrition education intervention on both outcome variables (knowledge and practice) and recommends that targeted iodine nutrition education should be carried out for women of reproductive age as well as health workers across various settings to reduce the incidence and future consequences of iodine deficiency disorders in Nigeria.
External Link(s)

Registration Citation

Citation
Nji, Elizabeth. 2023. "IODINE NUTRITION EDUCATION INTERVENTION AMONG WOMEN OF REPRODUCTIVE AGE IN CROSS RIVER STATE, NIGERIA." AEA RCT Registry. June 23. https://doi.org/10.1257/rct.11621-1.1
Sponsors & Partners
Experimental Details

Interventions

Intervention(s)
The intervention strategy was a nutrition education programme that was directed to groups of women in the intervention group. The nutrition education programme was in three (3) phases and were carried out in an interval of two weeks following a nutrition education guide for iodine nutrition, the participants were exposed to a nutrition class, and the session was repeated three times over a period of six weeks with each session lasting about one hour, thirty minutes. It is important to note that the control group did not benefit from any intervention. After the intervention, a period of one month was given for the participants to begin to practice all they had learnt after which end line data was collected from participants in both control and intervention clusters.
The content of the iodine nutrition education was consistent with guidelines developed by the WHO/UNICEF/IGN joint committee on iodine deficiency disorders. The sessions concentrated on education on iodine and its importance to health, iodine rich sources especially those that can be sourced locally, iodine storage practices and methods of food preparation. The sessions also covered the benefits of iodine nutrition and consequences of iodine deficiency as well as categories of iodine deficiency disorders. Demonstrations on iodized salt storage and how to identify iodized salts was carried out while sachets of iodized salts were distributed to all participants in the study (control and intervention). The sessions were very interactive and all concerns raised were treated accordingly. Available rich dietary sources of iodine was also brought to the training centres and shown to participants for easy recognition at the market place. Topics contents was made available to participants after each session and they were encouraged to practice all they have learnt from the sessions so as to imbibe the new habits with time.
Intervention Start Date
2021-09-13
Intervention End Date
2021-10-29

Primary Outcomes

Primary Outcomes (end points)
1) Increase in Knowledge level
2) Better practices
Primary Outcomes (explanation)

Secondary Outcomes

Secondary Outcomes (end points)
1) improved iodized salt coverage of the study area
2) Improved urinary iodine concentration
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
The experimental design is a randomized controlled trial
For this study, women of reproductive age in clusters were randomly allocated to the control group and the intervention group. Simple random sampling was employed in the allocation of two wards in each of the local governments to the intervention group, and two to the control group, making it a total of four wards for control and four wards for intervention for the entire study. Numbers were assigned to all the wards and was then written on pieces of paper and put in two containers according to their local government areas. The first ward drawn out on each side was assigned to the control group, the second was assigned to the intervention group, the third was assigned to the control group and finally the fourth was assigned to intervention group. This process was done by the principal investigator. The double-blind approach was used as both study participants and the field assistants were blinded to the intervention and the random assigning of the groups. Only the community health extension workers in clusters selected for intervention were aware of the intervention
Experimental Design Details
Randomization Method
The randomization method adopted was the lottery method
Randomization Unit
The randomization units were clusters
Was the treatment clustered?
Yes

Experiment Characteristics

Sample size: planned number of clusters
8 clusters were used in this study
Sample size: planned number of observations
480 women of reproductive age
Sample size (or number of clusters) by treatment arms
4 clusters control, 4 clusters intervention
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
80% chance of detecting as significant at the 5% level
Supporting Documents and Materials
IRB

Institutional Review Boards (IRBs)

IRB Name
IRB Approval Date
IRB Approval Number
Analysis Plan

Post-Trial

Post Trial Information

Study Withdrawal

There is information in this trial unavailable to the public. Use the button below to request access.

Request Information

Intervention

Is the intervention completed?
Yes
Intervention Completion Date
October 28, 2021, 12:00 +00:00
Data Collection Complete
Yes
Data Collection Completion Date
November 18, 2021, 12:00 +00:00
Final Sample Size: Number of Clusters (Unit of Randomization)
final sample size was 480 women of reproductive age, 8 clusters were used for the study and 4 clusters received intervention.
Was attrition correlated with treatment status?
Yes
Final Sample Size: Total Number of Observations
480 women of reproductive age
Final Sample Size (or Number of Clusters) by Treatment Arms
240 women of reproductive age in 4 clusters formed the control arm and 240 women of reproductive age in 4 clusters made up the intervention arm.
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials