The Effect of mHealth on Exclusive Breastfeeding and Its Associated Factors Among Women in South Ethiopia: A Cluster Randomized Controlled Trial
Abstract
1. Introduction
2. Methods and Materials
2.1. Study Design and Setting
2.2. Study Participants
2.2.1. Eligibility and Exclusion Criteria
2.2.2. Sampling and Recruitment Process
- P1 (proportion of fully vaccinated children among controls = 70.9%
- P2 (proportion of fully vaccinated children among intervention groups = 82.6%
- Delta, the difference in the proportion of fully vaccinated among groups = 12%
- α (level of significance) = 5%
- The standard normal curve or Z at 95% CI and 5% of α= 1.96 (two-tailed)
- Power of study = 80%
- Control to intervention ratio = 1:1
2.3. Randomization and Blinding
2.4. Intervention
2.5. Control
3. Study Variables
3.1. Outcome Variables
Data Collection and Follow-Up
3.2. Statistical Analysis
4. Results
4.1. Survival Probabilities over Time
4.1.1. Survival Curves for Time to EBF Cessation by Group
4.1.2. Interpretation of Key Findings
Random Effect
Fixed Effects
4.2. Secondary Outcomes
4.3. Model Evaluation
5. Discussion
Limitations and Strengths
6. Conclusions
7. Implications
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
Abbreviation
References
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| Variables | Intervention | Controls | |
|---|---|---|---|
| Number (%) | Number (%) | ||
| Mode of delivery | Spontaneous vaginal delivery | 279(92) | 298(95) |
| Cesarean Section | 23(8) | 17(5) | |
| Healthcare provider | Nurse | 40(12) | 70(21) |
| Mid-wife | 96(29) | 136(40) | |
| HO | 55(16) | 66(20) | |
| Doctor | 18(5) | 28(8) | |
| HEW | 128(38) | 38(11) | |
| Presence of diarrhea | No | 286(85) | 267(79) |
| Yes | 51(15) | 71(21) | |
| Exclusive breastfeeding | No | 91(27) | 165(49) |
| Yes | 246(73) | 173(51) | |
| Variables | Categories | Adjusted HR/AHR (95%CI) |
|---|---|---|
| Treatment group | Controls | 1 |
| Intervention | 0.40 (0.26–0.62) *** | |
| Antenatal care | 0.87(0.79–0.97) * | |
| Diarrhea | No | 1 |
| Yes | 1.47(1.07–2.02) * | |
| Family size | 2–3 | 1 |
| 4–5 | 0.85(0.61–1.18) | |
| 6–7 | 0.62(0.41–0.93) * | |
| 8+ | 0.77(0.42–1.42) | |
| Partner education | Read/write | 1 |
| Primary school (1–8 grade) | 1.83(0.78–4.31) | |
| Secondary school (9–12 grade) | 2.15(1.00–5.07) | |
| College and above | 2.41(1.01–5.78) * | |
| _cons | 0.13(0.05–0.38) *** | |
| /In_p | 0.62(0.50–0.72) *** | |
| Var(_cons) | 0.10(0.01–0.07) | |
| LL = −542 Wald chii2(17) = 52, p = 0.0002 | ||
| Variables | Model 0 | Model 1 | Model 2 | Model 3 | |
|---|---|---|---|---|---|
| Antenatal care | - | - | 1.25(1.10–1.43) *** | 1.23(3.10–7.16) *** | |
| Any complication | No | - | - | 1 | 1 |
| Yes | - | - | 0.32(0.10–1.00) * | 0.32(0.10–0.98) * | |
| Marriage | Married and live together | - | 1 | ||
| Married and live separately | - | 1.07(0.42–2.70) | |||
| Ethnicity | Gamo/Gofa | 1 | |||
| Kore | 0.68(0.34–1.26) | ||||
| Walaita | 1.07(0.42–2.69) | ||||
| Amhara | 2.39(0.73–7.76) | ||||
| Residences | Rural | - | 1 | - | |
| Urban | - | 1.20 (0.77–1.77) | - | ||
| Treatment | Control | - | 1 | - | 1 |
| Intervention | - | 5.20(3.41–7.87) *** | - | 4.71(3.10–7.16) *** | |
| Random Effect Model Comparison | Model 0 | Model 1 | Model 2 | Model 3 |
|---|---|---|---|---|
| Group-level Variance | 0.85 | 0.22 | 0.75 | 0.00 |
| Inter-cluster correlation (ICC) | 0.20 | 0.01 | 0.18 | 0.00 |
| Log likelihood ratio (LLR) | −375 | −359 | −364 | −350 |
| AIC BIC | 754 763 | 727 745 | 746 787 | 721 766 |
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Share and Cite
Gilano, G.; Dekker, A.; Fijten, R. The Effect of mHealth on Exclusive Breastfeeding and Its Associated Factors Among Women in South Ethiopia: A Cluster Randomized Controlled Trial. Nutrients 2025, 17, 3477. https://doi.org/10.3390/nu17213477
Gilano G, Dekker A, Fijten R. The Effect of mHealth on Exclusive Breastfeeding and Its Associated Factors Among Women in South Ethiopia: A Cluster Randomized Controlled Trial. Nutrients. 2025; 17(21):3477. https://doi.org/10.3390/nu17213477
Chicago/Turabian StyleGilano, Girma, Andre Dekker, and Rianne Fijten. 2025. "The Effect of mHealth on Exclusive Breastfeeding and Its Associated Factors Among Women in South Ethiopia: A Cluster Randomized Controlled Trial" Nutrients 17, no. 21: 3477. https://doi.org/10.3390/nu17213477
APA StyleGilano, G., Dekker, A., & Fijten, R. (2025). The Effect of mHealth on Exclusive Breastfeeding and Its Associated Factors Among Women in South Ethiopia: A Cluster Randomized Controlled Trial. Nutrients, 17(21), 3477. https://doi.org/10.3390/nu17213477

