- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06781190
Promoting Mother-baby Bonding Through Sustainable Breastfeeding Practices
Promoting Mother-baby Bonding Through Sustainable Breastfeeding Practices: A Green Mom Approach
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This research aimed to identify sustainable breastfeeding practices and green mothers' initiatives to develop a strong mother-child bond.
The sample size was calculated using G*Power 3.1. 9.7 software (Faul et al., 2007), the effect size was determined to be Cohen's d=0.9780770. Statistical power analysis was performed according to A Priori: Calculate required sample size (Means: Difference between two independent means (two groups)), 95% power (1-β) and α=0.05, and given these parameters it was concluded that a sample size of at least 58 participants was required for the study in question. In the event of data loss, a 20% increase in the sample size was expected as a result of statistical advice. Accordingly, it was planned to conduct the study with a total of n=70 people, n=35 in the intervention group and n=35 in the control group.
It was carried out with the participation of two groups. The green mother education group received 4 training sessions of 60 minutes each. The control group received routine hospital care but no other intervention during this period.
Data for the study were collected by the researcher using face-to-face interviews, a personal information form with demographic questions, and the measurement tools used in the study. The training was completed after 4 weeks. After the training, the measurement tools were used for the woman's postpartum period.
The participants were given an explanation of the green motherhood education and told how, for how long, and where the training would take place. The face-to-face green motherhood education programme was completed by the participants in a specific way for each session (nutrition, breastfeeding, environmental awareness and bonding). The training was delivered using a poster.
Green motherhood education was delivered in this way in 4 sessions. The measurement tools were given to the participants again on the 1st day, 1st month, 3rd month and 6th month after birth.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Istanbul, Turkey (Türkiye), 34668
- University of Health Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Pregnant women 24 weeks gestation
- Must be between 18 and 35 years of age.
- Women must provide informed consent to participate in the study, indicating their willingness to participate in the educational intervention and assessments.
- Attend educational sessions
- Pregnant primiparous
Exclusion Criteria:
- Women with significant medical conditions that may affect breastfeeding or nutrition (e.g. serious mental illness, chronic disease) will be excluded.
- Multiple pregnancies
- Previous GREEN MOTHER training
- Substance abuse
- Women considered to be at high risk of non-compliance with the study protocol (e.g. those with unstable living conditions).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Green motherhood education
Pregnant women selected for the experimental group will receive 4 weeks of green motherhood training. The programme, which includes breastfeeding, bonding and carbon footprint training, is delivered 4 times by researchers. The training content has been prepared by the researchers by scanning the literature. The training will be delivered using posters. |
Pregnant women selected for the experimental group will receive 4 weeks of green motherhood training.
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No Intervention: Standard of care
Women in the control group receive routine care at the same hospital's polyclinics.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Sustainable and Healthy Eating Behaviors scale
Time Frame: Participants immediately after group assignment, 6 months after the birth
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The Sustainable and Healthy Eating Behaviours scale consists of 32 items and seven sub-dimensions. Quality labels (local and organic), seasonal food and avoiding food waste, animal health, reducing meat consumption, healthy and balanced diet, local food, low fat. Participants are asked to rate each item as 'never', 'very rarely', 'rarely', 'sometimes', 'often', 'very often' or 'always'. Never' is worth 1 point and 'always' is worth 7 points. Factor scores are calculated by taking the average of the scores given to the items in that factor (between 1 and 7 points). Cronbach's alpha was found to be 0.912. The lowest possible score is 32 and the highest is 224. This reflects high sustainability. |
Participants immediately after group assignment, 6 months after the birth
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Carbon Footprint Awareness Scale
Time Frame: Participants immediately after group assignment, 6 months after the birth
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The scale comprises 19 items measured on a 5-point Likert-type scale, focusing on five key areas: transportation, which includes 3 items; fuel consumption, also with 3 items; electricity use, featuring 5 items; food consumption, containing 5 items; and waste management, which has 3 items.
The scale demonstrates a strong factor structure, with a Cronbach's alpha of 0.86, indicating high reliability, and it explains 56.09% of the variance in the data.
The lowest score is 19 and the highest is 95.
High scores indicate sustainability.
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Participants immediately after group assignment, 6 months after the birth
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Depression Anxiety and Stress scales-21
Time Frame: Participants immediately after group assignment, 1st day after delivery, 3rd month after delivery, 6th month after delivery
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This 21-item scale consists of three dimensions, namely anxiety, depression, and stress.
Items are measured on a 4-point Likert-type scale ranging from 0 (Never) to 3 (Always).
A higher sum score indicates more severe symptoms of depression, anxiety, and stress.
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Participants immediately after group assignment, 1st day after delivery, 3rd month after delivery, 6th month after delivery
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Multidimensional Scale of Perceived Social Support
Time Frame: Participants were assigned to the group immediately after birth, 1 day after birth, 3 months after birth and 6 months after birth.
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Multidimensional Scale of Perceived Social Support is a psychometric tool designed by Zimet et al. 18 and adapted to Turkish by Eker et al. 19 to measure individuals' perceived social support from three sources: "family, friends, and a significant other."
This scale comprises 12 items, rated on a 5-point Likert-type scale from strongly disagree to strongly agree.
The internal consistency coefficients reported for the scale are within the range of 0.80 to 0.85, with a Cronbach's alpha coefficient of 0.92.
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Participants were assigned to the group immediately after birth, 1 day after birth, 3 months after birth and 6 months after birth.
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Scale Breast-feeding Self-efficacy Scale
Time Frame: 1st day after birth, 3rd month after birth, 6th month after birth
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Breastfeeding Self-Efficacy Scale: This is a 33-item scale developed by Dennis (1999).
It consists of two sub-dimensions to determine mothers' breastfeeding skills, beliefs and behaviours regarding breastfeeding.
The validity and reliability study of the Turkish form of the scale was conducted by Ekşioğlu and Çeber (2011).
Breastfeeding self-efficacy was assessed using a five-point Likert scale: (1) I never trust myself, (2) I do not trust myself very much, (3) I trust myself sometimes, (4) I trust myself often, (5) I always trust myself.
As the total score on the scale increases, so does breastfeeding self-efficacy.
The lowest score is 33 and the highest is 165.
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1st day after birth, 3rd month after birth, 6th month after birth
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Postpartum Attachment Scale
Time Frame: 1st day after birth, 3rd month after birth, 6th month after birth
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The Postpartum Attachment Scale is a mother-filled assessment tool that utilizes a six-point Likert scale defined as "always," "very often," "often," "sometimes," "rarely," and "never."
This scale consists of 25 items, with some items rated inversely, and scores range from 0 to 5. It is organized into four sub-dimensions: "attachment disorder" with 12 items, "rejection and irritability" with 7 items, "tension about care" with 4 items, and "risk of abuse" with 2 items.
The overall cut-off point for the scale is set at 26 points, with a score of 27 or above indicating a postpartum attachment problem.
In the original study, the total score had a Cronbach's alpha of 0.75, while the subscales showed varying reliability: 0.62 for attachment disorder, 0.53 for rejection and irritability, 0.40 for anxiety in babysitting, and 0.11 for risk of abuse.
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1st day after birth, 3rd month after birth, 6th month after birth
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Leyla Kaya, PhD, Saglik Bilimleri Universitesi
- Study Director: Esra Keles, PhD, Saglik Bilimleri Universitesi
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17.04.2024/43
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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