Nutrition and Physical Activity Intervention on Psychosocial Well-Being of Postpartum Mothers
NCT ID: NCT05444179
Last Updated: 2024-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
32 participants
INTERVENTIONAL
2022-08-01
2023-10-30
Brief Summary
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Detailed Description
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In intervention group, the participant will be provided an educational module entitled "Mommies can Eat and Exercise with No Stress" (MomEENS), in which the module will be delivered through a booklet and video. The MomEENS module incorporated achievement-based objectives for five key recommendations: 1. Eat healthy foods ;2. Eat foods rich in iron and folic acid; 3. Eat foods rich in omega-3 fatty acids; 4. Increase steps in a day and; 5. Increase body flexibility and strength. All the key recommendations will be explained in the booklet, while the video will provide full guidance on how to exercise during postpartum at home, explaining key recommendations 4 and 5.
Face-to-face consultation with the participants will be held at baseline and 4th week to enhance the participation and motivation of the participants towards the intervention. Besides, Whatsapp and Facebook page group is developed as a step to enhance the compliance of participants towards intervention. The group will be created soon after the participants undergo the baseline phase. Whatsapp group provides a medium for participant to ask, share, and communicate with other participants (only within the intervention group) regarding the intervention activities they commit. On the other hand, Facebook page group will provide a forum to support and additional related information. In addition to the continuity of the compliance, telephone follow-up calls will be at least administered once for every two weeks, lasting for about 5 to 10 minutes for each call. It is aimed to monitor the participant's progress while engaging in appropriating self-management behaviours.
The participants in the control group will be received advice on the standardised Malaysian food pyramid and be instructed to follow their usual standard care as suggested by their healthcare provider. Postpartum women in Malaysia typically attend postpartum healthcare visits with an exam on day 30 after childbirth but receive no other routine care following this appointment unless a specific health problem has been identified. Participants in the control group performed the same evaluations. They received the same incentives as those in the intervention group, but they did not receive any educational module and contact from the investigator during the 8 weeks follow-up.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Intervention group
The participant will be provided an educational module entitled "Mommies can Eat and Exercise with No Stress" (MomEENS), in which the module will be delivered through a booklet and video. The MomEENS module consist of five key recommendations: 1. Eat healthy foods ;2. Eat foods rich in iron and folic acid; 3. Eat foods rich in omega-3 fatty acids; 4. Increase steps in a day and; 5. Increase body flexibility and strength. All the key recommendations will be explained in the booklet, while the video will provide full guidance on how to exercise during postpartum at home, explaining key recommendations 4 and 5. Face-to-face consultation with the participants will be held during baseline and 4th week to enhance the participation. Besides, Whatsapp and Facebook page group is developed as a step to enhance the compliance of participants. All the participants will be contacted once for every two weeks, lasting for about 5 to 10 minutes for each call to monitor the participant's progress.
Mommies can Eat & Exercise with No Stress (MomEENS)
This intervention involving behaviour modification, incorporates nutrition and physical activity modification. The intervention encourages participants to consume a healthy diet and active lifestyle during postpartum period. For nutrition modification, a general advice on healthy nutrition were given and several nutrients are highlighted which evidenced can reduce postpartum depression. While for physical activity, the mothers are encouraged to do exercise, targeting aerobic, flexibility, and strength type of exercise. The exercise protocol is progressive. During the first month, the participants will be advised to conduct flexibility and strength exercises for 8 repetitions (1 set), at least 3 days per week for both aerobic and flexibility exercise. While during the second month, participants are asked to increase repetitions and frequency of exercises, up to 16 repetitions (2 set) for each flexibility exercise, and conduct exercise at least 5 days per week.
Control group
The participants in the control group will be received advice on the standardised Malaysian food pyramid and be instructed to follow their usual standard care as suggested by their healthcare provider. Postpartum women in Malaysia typically attend postpartum healthcare visits with an exam on day 30 after childbirth but receive no other routine care following this appointment unless a specific health problem has been identified. Participants in the control group performed the same evaluations. They received the same incentives as those in the intervention group, but they did not receive any educational module and contact from the investigator during the 8 weeks follow-up.
No interventions assigned to this group
Interventions
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Mommies can Eat & Exercise with No Stress (MomEENS)
This intervention involving behaviour modification, incorporates nutrition and physical activity modification. The intervention encourages participants to consume a healthy diet and active lifestyle during postpartum period. For nutrition modification, a general advice on healthy nutrition were given and several nutrients are highlighted which evidenced can reduce postpartum depression. While for physical activity, the mothers are encouraged to do exercise, targeting aerobic, flexibility, and strength type of exercise. The exercise protocol is progressive. During the first month, the participants will be advised to conduct flexibility and strength exercises for 8 repetitions (1 set), at least 3 days per week for both aerobic and flexibility exercise. While during the second month, participants are asked to increase repetitions and frequency of exercises, up to 16 repetitions (2 set) for each flexibility exercise, and conduct exercise at least 5 days per week.
Eligibility Criteria
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Inclusion Criteria
2. Mothers with an infant nearly graduated from NICU due to prematurity with minimum stays of 7 days (Gestational age: \< 37 weeks).
3. Postpartum mothers (within 4th to 8th weeks after childbirth).
4. Aged between 19 until 40 years old.
5. Mothers were from Malaysian citizen.
6. Mothers who only reside in Selangor, Klang Valley or Negeri Sembilan during their postpartum confinement.
7. Only Malay mothers will be selected (due to small number population on Chinese and Indian, following from Phase 1)
8. Mothers who undergo vaginal delivery for the current child.
9. Mothers who are fit to do exercise, based on the 10-item Physical Activity Readiness Questionnaire (PAR-Q).
Exclusion Criteria
2. Mothers who illiterate either in Malay or English
3. Mothers who are currently pregnant
4. Mothers whose infant has genetic or congenital anomaly or severe cardiorespiratory instability
5. Mothers who have chronic or terminal disease (such as cancer, renal failure, hypothyroid, exercised-induced asthma and uncontrolled hypertension and diabetes) or diseases that would limit to exercise.
6. Mothers who have any condition that would make exercise unsafe or unwise.
19 Years
40 Years
FEMALE
Yes
Sponsors
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Universiti Sains Islam Malaysia
OTHER
Universiti Teknologi Mara
OTHER
Responsible Party
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Assoc. Prof. Nur Islami Bt Mohd Fahmi Teng
Assoc. Prof/ Principle Investigator
Principal Investigators
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Nur Islami Bt Mohd Fahmi Teng, AP. Dr.
Role: PRINCIPAL_INVESTIGATOR
Universiti Teknologi Mara
Locations
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Universiti Teknologi MARA
Shah Alam, Selangor, Malaysia
Countries
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References
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Arifin, S. R. M., Ahmad, A., Rahman, R. A., Loh, H. S., & Ng, C. G. (2014). Postpartum depression in Malaysian women: The ssociation with the timing of pregnancy and sense of personal control during childbirth. International Journal of Academic Research, 6(3), 143-149. https://doi.org/10.7813/2075-4124.2014/6-3/b.20
Cohen, S., & Williamson, G. (1988). Perceived Stress in a Probability Sample of the United States. Sage.
Dennis CL. The breastfeeding self-efficacy scale: psychometric assessment of the short form. J Obstet Gynecol Neonatal Nurs. 2003 Nov-Dec;32(6):734-44. doi: 10.1177/0884217503258459.
Husin, H., Isa, Z. M., Ariffin, R., Rahman, S. A., & Ghazi, H. F. (2017). The Malay version of antenatal and postnatal breastfeeding self-efficacy scale-short form: Reliability and validity assessment. Malaysian Journal of Public Health Medicine, 17(2), 62-69.
Mahmud WM, Awang A, Mohamed MN. Revalidation of the Malay Version of the Edinburgh Postnatal Depression Scale (EPDS) Among Malay Postpartum Women Attending the Bakar Bata Health Center in Alor Setar, Kedah, North West Of Peninsular Malaysia. Malays J Med Sci. 2003 Jul;10(2):71-5.
Moriwaki SY. The affect balance scale: a validity study with aged samples. J Gerontol. 1974 Jan;29(1):73-8. doi: 10.1093/geronj/29.1.73. No abstract available.
Sandhu SS, Ismail NH, Rampal KG. The Malay Version of the Perceived Stress Scale (PSS)-10 is a Reliable and Valid Measure for Stress among Nurses in Malaysia. Malays J Med Sci. 2015 Nov;22(6):26-31.
Nightingale H, Walsh KJ, Olupot-Olupot P, Engoru C, Ssenyondo T, Nteziyaremye J, Amorut D, Nakuya M, Arimi M, Frost G, Maitland K. Validation of triple pass 24-hour dietary recall in Ugandan children by simultaneous weighed food assessment. BMC Nutr. 2016 Aug 24;2:56. doi: 10.1186/s40795-016-0092-4.
Yang CL, Chen CH. Effectiveness of aerobic gymnastic exercise on stress, fatigue, and sleep quality during postpartum: A pilot randomized controlled trial. Int J Nurs Stud. 2018 Jan;77:1-7. doi: 10.1016/j.ijnurstu.2017.09.009. Epub 2017 Sep 14.
Yang CL, Yu CH, Chen CH. Development and validation of the postpartum sleep quality scale. J Nurs Res. 2013 Jun;21(2):148-54. doi: 10.1097/jnr.0b013e3182921f80.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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MiChild Group
Identifier Type: -
Identifier Source: org_study_id
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