Design of the study
This was a randomized parallel-group controlled trial study on 76 fathers who attended a health center in Karaj-Iran.
Inclusion criteria were assessed for 81 attendees to the health center using the criteria checklist. Five men were excluded as two of them had not the eligibility criteria, and 3 of them declined to participate. Seventy-six fathers were randomly assigned to the intervention (38 fathers) or control (38 fathers) groups. Samples were devoted to the control and intervention groups using the excel randomization option by the first author. They were recruited from attendees to a selected health center for receiving postpartum care services and had 3 to 5 days old neonates. The inclusion criteria were: men with a primiparous wife; with a healthy single neonate; lack of known medical condition and/or mental disorders (stated by the participant); and speaking in Persian. The exclusion criteria were: hospitalization of the neonate; posttraumatic stress disorder associated with the unexpected death of a loved one, or couple’s separation during the study period; taking medicine that prevents breastfeeding; using pacifier; and occurrence of unwanted pregnancy during the study period. The first author, Farideh Panahi (FP) assessed the eligibility criteria of the participants. Data collection was performed from June to December 2017.
The sample size was calculated by the rate of exclusive breastfeeding of 64 and 29% in the intervention and control groups in a similar study by Tavafian et al. , and considering 95% confidence interval and 80% power, using the following formula. The sample size was estimated at 30 and then considering 25% loss, 38 samples were devoted for each group.
After devoting the participants to two groups of intervention and control by the researcher (FP), the questionnaires were coded by her. The data of the completed questionnaires were entered into SPSS and analyzed by a blind statistician (MR).
Tools of the study
The tools for data collection were 4, including 1) a questionnaire to collect “Demographic and Maternal-Infant Information”; 2) a questionnaire to assess “Fathers’ support for Breastfeeding”, and 3) an observation checklist to assess “Mothers’ Breastfeeding Practice”; and 4) a questionnaire to assess “Exclusive Breastfeeding Status”. The questionnaires were filled up for the participants through an interview, by the first author (FP).
A questionnaire to collect “Demographic and Maternal-Infant Information”
This questionnaire consists of 14 questions to collect the participants’ demographic data and the maternal and infants’ information. The validity of the questionnaire was assessed and confirmed by 10 midwifery and reproductive health experts.
A questionnaire to assess “Fathers’ support for Breastfeeding”
The questionnaire consists of 12 items to measure fathers’ support for breastfeeding including items about mothers’ encouragement for breastfeeding; planning for nutrition and rest of mothers; the fathers’ involvement in housework and the infant-care. The items were assessed by a 5 point Likert scale from never to always (scoring 1 to five, respectively). The total scores were calculated and converted to percent, which indicated the level of Fathers’ support for breastfeeding. The validity of the questionnaire was assessed by 10 reproductive health experts. The validity was confirmed by S-CVI = 0.76 and S-CVR = 0.79, respectively. The reliability of the questionnaire was evaluated by assessing the internal consistency and the stability of the questionnaire. The internal consistency of the questionnaire was evaluated using Cronbach’s coefficient alpha. The coefficient of 0.93 for the entire questionnaire showed proper internal consistency. The stability of the questionnaire was evaluated using the test-retest stability assessment method. Fifteen men filled out the questionnaires within two-week intervals, and the Pearson correlation coefficient confirmed the stability of the questionnaire (r = 0.86; p < 0.05).
An observational checklist to assess “Mothers’ Breastfeeding Practice”
This checklist consists of 26 items to assess the breastfeeding practice of mothers; with “yes” or “no” responses (Scoring 1 and 0, respectively). The total score was calculated and converted to percent, which indicated the quality of mothers’ breastfeeding practice. The validity of the questionnaire was assessed by 10 reproductive health experts. The validity was confirmed by S-CVI = 0.78 and S-CVR = 0.83, respectively. The reliability of the checklist was confirmed by using the intra-rater stability assessment method. The breastfeeding practice of 15 mothers was rated by two researchers using the checklist, and then the average calculated ICC = 0.72 confirmed the stability of the checklist. Internal consistency assessment showed Cronbach’s α = 0.78 of the tool.
A questionnaire to assess “Exclusive Breastfeeding Status”
It contained 3 questions about exclusive breastfeeding.
The intervention process
Before the intervention, both groups completed the “Demographic and Maternal-Infant Information” and “Fathers’ support for Breastfeeding” questionnaires. Then, fathers (with the mothers) of the intervention group were educated using individual face-to-face education and counseling, in two sessions, with a duration of about 40 min and one-week interval. The intervention was arranged in the second week and third week of their infant’s life. The content of the education was as below:
Fathers (with mothers) of the intervention group were educated about the composition of breast milk; the importance and the benefits of exclusive breastfeeding for maternal and neonatal health; the correct positions for breastfeeding, in the first session. In the second session, the fathers were educated about their critical role in promoting and continuing breastfeeding; the ways for mothers’ encouragement, or planning for regular exclusive breastfeeding; involving in housework and infant-care, to free adequate time for mothers’ rest. The education of fathers with mothers (couples) was conducted by the first author Mrs. Farideh Pnahi in the childbirth preparation classes.
Fathers in the control group did not receive any education and only mothers were educated with the same instruction, about the composition of breast milk; the importance and the benefits of exclusive breastfeeding for maternal and neonatal health, and the correct positions for breastfeeding.
Four months later, all fathers in both groups completed the “Fathers’ support for Breastfeeding” and “Mothers’ Breastfeeding Practice” questionnaires, again; as well as the” Exclusive Breastfeeding Status” questionnaire. No harm was reported from the fathers’ education as the intervention. Therefore, only mothers were educated in the control group by the first author Mrs. Farideh Panahi in the childbirth preparation classes of the centers. The process of the study and data collection was performed from June to December 2017.
Data were analyzed using SPPS 23, and by statistical tests such as paired and t-test, Chi2. The Generalized Estimating Equation (GEE) test was used to evaluate the effects of time and groups on the outcomes of the study. The significance level was p-value lower than 0.05.
There were no changes to the method and outcome measures after trial commencement.