Postpartum DepressionNCT05444179
Nutrition and Physical Activity Intervention on Psychosocial Well-Being of Postpartum Mothers
A study testing Mommies can Eat & Exercise with No Stress (MomEENS) in people with Postpartum Depression and Lifestyle, Healthy, run by Universiti Teknologi Mara at 1 site in Malaysia.
Trial summary
This study aims to examine the effectiveness of nutrition and physical intervention to improve psychosocial well-being of postpartum mothers with preterm infants. The focus was highlighted towards the mothers of preterm infants who were cared in Neonatal Intensive Care Unit (NICU) as these parents might have a higher… Read more about this study
- Who is it for?
- Ages 19 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Depression, Lifestyle, Healthy
- What is being tested?
- Mommies can Eat & Exercise with No Stress (MomEENS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Aug 2022to 30 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants with EPDS score ≥ 12
- Mothers with an infant nearly graduated from NICU due to prematurity with minimum stays of 7 days (Gestational age: < 37 weeks).
- Postpartum mothers (within 4th to 8th weeks after childbirth).
- Aged between 19 until 40 years old.
- Mothers were from Malaysian citizen.
- Mothers who only reside in Selangor, Klang Valley or Negeri Sembilan during their postpartum confinement.
Show all 9Show fewer
- Only Malay mothers will be selected (due to small number population on Chinese and Indian, following from Phase 1)
- Mothers who undergo vaginal delivery for the current child.
- Mothers who are fit to do exercise, based on the 10-item Physical Activity Readiness Questionnaire (PAR-Q).
Who cannot join
- Mothers that is clinically diagnosed with mental illness or other known psychiatric disorders
- Mothers who illiterate either in Malay or English
- Mothers who are currently pregnant
- Mothers whose infant has genetic or congenital anomaly or severe cardiorespiratory instability
- 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.
- Mothers who have any condition that would make exercise unsafe or unwise.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Nutrition and Physical Activity Intervention on Psychosocial Well-Being of Mothers With Preterm Infants in Selangor
This study aims to examine the effectiveness of nutrition and physical intervention to improve psychosocial well-being of postpartum mothers with preterm infants. The focus was highlighted towards the mothers of preterm infants who were cared in Neonatal Intensive Care Unit (NICU) as these parents might have a higher stress level than the full-term infants. The intervention consisted of a module designed for postpartum mothers, incorporating nutrition and physical activity entitled Mommies can Eat \& Exercise with No Stress (MomEENS).
Read the detailed description
The intervention is aim to encourage the participant to have better nutrition intake and engage in low to moderate-intensity exercise on 3 to 5 days per week, for 8 weeks in order to improve their psychosocial well-being. After being informed about the study and potential risks, the participants will be screened according to their eligibility criteria. The participants who are eligible to participate in the study will be contacted again and asked for consent to join the study. After obtaining the consent, the participant will undergo a baseline assessment, and subsequently, the investigator will assign the participant to their respective groups, the intervention and control groups. All of the health assessments will be conducted at baseline, 4th week and 8th week.
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
- Postpartum Depression, Lifestyle, Healthy
- Being tested
- Mommies can Eat & Exercise with No Stress (MomEENS)
- Keywords
- postpartum depression, physical activity, intervention study, nutritional intake
- Medical subject headings
- Depression, Postpartum, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mommies can Eat & Exercise with No Stress (MomEENS)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | 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. Receives: Behavioral: Mommies can Eat & Exercise with No Stress (MomEENS) |
| Control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Edinburgh Postnatal Depression Scale
The presence of depressive symptoms will be assessed using the Edinburgh Postnatal Depression Scale (EPDS). The EPDS is a 10-item self-administered questionnaire designed specifically to measure postpartum depression. All items will be rated on a 4-point Likert-type scale, with a total score ranging from 0-30. Categories of response are scored 0,1,2, and 3 based on increased symptom severity. EPDS can only be used for screening but not for the clinical diagnosis of depression. The Malay version of the scale was validated in the local setting with the cut off 11/12 was used to determine a woman at risk of having depressive symptoms. Score of ≥12 indicates the presence of postpartum depression whereas <12 indicates absence of postpartum depression.
Measured: Change from Baseline Depression Screening Status at 8 weeks
Perceived Stress Scale (PSS)
The Perceived Stress Scale (PSS) was developed by Sheldon Cohen \& Williamson (1988), designed to measure the degree to which circumstances of an individual are considered stressful via their feelings and thoughts in the past month. The item asked regarding the current levels of stress, unpredictable, uncontrollable, and overloaded events, unexpectedly occur during their lives. The PSS consist of 10 items, derived from 5-point Likert scale (0= never, 1= almost never, 2= sometimes, 3= fairly often, 4= very often). Four items that are positively stated (item 4,5,7, and 8) are scored reversely (0= very often, 1= fairy often, 2= sometimes, 3= almost never, 4= never). The total score is calculated from the sum of 10 items, whereas higher scores indicate higher levels of perceived stress. In this study, Malay version of PSS-10 is used to enable participants to understand the questions asked and to make the assessment more culturally appropriate.
Measured: Change from Baseline Perceived Stress Status at 8 weeks
Postpartum Sleep Quality Scale (PSQS)
The Postpartum Sleep Quality Scale (PSQS) consists of 14 item scale, designed to assess subjective sleep quality during postpartum periods. Two domains were developed from the PSQS: "Factor 1: Infant night care-related daytime dysfunction", and "Factor 2: Physical symptoms related sleep inefficiency". Factor 1 explained how having care of infants at night impacted the quality of postpartum woman's sleep and the ability to handle daytime activities. Factor 2 described the physiological factors underlying sleep and sleep inefficiency symptoms of a woman. The PSQS found to be a valid and reliable tool, as previous study had demonstrated PSQS have adequate internal consistency between the item (Cronbach's α= 0.88; Factor I α =0.89, Factor II α= 0.82).
Measured: Change from Baseline Sleep Quality Status at 8 weeks
Positive Affect Balance Scale (PABS)
This scale consist of 10 item scales, which 5 items were developed for each positive and negative affect components, asking the psychological reactions of people respond to their daily lives, and individual's ability to cope with daily stresses. "Positive affect" questions are associate to social participation, satisfaction with social life, and engagement in activities. Three-point scale of "never", "sometimes", or "often" are answers made to the questions represents the past week's experiences. All calculations of positive affect score, a negative affect score and a total affect balance score can be made. The positive impact score (ranging from 5 to 15) with 15 being the highest (most positive result) will be used in this study. PABS has been proven to be a reliable tool for measuring psychosocial well-being, as reported by previous study.
Measured: Change from Baseline Psychosocial Well-being Status at 8 weeks
Secondary outcomes (7)
Multiple Pass 24-Hour Diet Recall
A multiple pass 24-hour diet recall will be performed to assess the dietary intake of the mother. Multiple pass 24-hour diet recall found to maximise recall accuracy for quantitation, with the used of the following algorithm: The first pass encourages the respondent to freely report all food and drink consumption for the previous 24 hours without any interruption. In second pass, the researcher probes for greater details on the exact time, type and quantity of food and drink consumed, and in the final pass, the researcher reviews all food reported in order, prompting for omissions and clarifying the ambiguities. Nutrient analysis software, the Nutritionist Pro Diet Analysis, will be used to calculate the average nutrients intake, which is based on the Nutrient Composition of Malaysian Foods database and the U.S. Department of Agriculture (USDA) Foods database.
Measured: Change from Baseline Dietary Intake at 8 weeks
International Physical Activity Questionnaire- Short Form
This is a self-report questionnaire that assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives. are considered to estimate total physical activity in MET-min/week and time spent sitting. There are 7 items asking for the number of days a week they participated in the activities and the average time for each session on each activity (hours and minutes) they spent during the past 7 days. The intensity score is then calculated based on the MET classification levels (low, moderate, high).
Measured: Change from Baseline Physical Activity Status at 8 weeks
Body weight measurement
Weight is measured to the nearest 0.1 kilogram (kg) with a portable standard scale using Seca 813 Electronic Flat (Birmingham, United Kingdom) weighing scale.
Measured: Change from Baseline Body Weight at 8 weeks
Height measurement
Height of the participant is measured to the nearest 0.1cm using Seca 217 Height Measure (Birmingham, United Kingdom).
Measured: Change from Baseline Height Measurement at 8 weeks
Waist circumference measurement
Waist circumference is measured to the nearest 0.1cm using Seca 201 Ergonomic circumference measuring tape (Birmingham, United Kingdom).
Measured: Change from Baseline Waist Circumference at 8 weeks
Blood Pressure Assessment
Systolic and diastolic blood pressure is measured using automated non-invasive blood pressure monitor device with cuff, Omron Blood Pressure Monitor HEM 7120 (Kyoto, Japan).
Measured: Change from Baseline Blood Pressure Assessment at 8 weeks
Breastfeeding Self-Efficacy -Short Form (BSES-SF)
The Breastfeeding Self-Efficacy Scale- Short Form (BSES-SF) is a self-report instrument developed to measure breastfeeding confidence. BSES-SF consist of 14 items, with each item is followed by the phrase "I can always". The answer option is assisted with a 5-point Likert-type scale where 1 indicates not at all confident and 5 indicates always confident. The sum of all items will be in the range of 14 for the minimum score, and 70 is the maximum score, which indicates the data as continuous. BSES-SF is a very excellent measure of breastfeeding efficacy as it has shown a high reliability (with Chronbach's Alpha value is 0.97) and validity score (BSES-SF is significantly correlated (p< 0.05) with other theoretically related concepts (self-esteem, postpartum depression and perceived stress).
Measured: Change from Baseline Breastfeeding Self-Efficacy at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start1 Aug 2022
- Primary completion1 Oct 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Postpartum DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a parallel-group study design, which employed block randomization via a computer-generated randomisation list for allocation of the participants, with the block size of 8, and equal randomization ratio (1:1) between intervention and control groups. The block randomization process is conducted by an investigator that had no clinical involvement in the trial, in which the allocation sequence was concealed from the principal investigator who are enrolling and assessing the eligible participants. Due to nature of intervention, blinding of principal investigator and participants are not possible. Measurement of the outcome will commence at the baseline, at week 4 and week 8 of the randomised controlled trial.
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Teknologi Mara
- Sponsor type
- University, hospital or other
- Collaborators
- Universiti Sains Islam Malaysia
- Responsible party
- Principal investigator, Assoc. Prof. Nur Islami Bt Mohd Fahmi Teng, Universiti Teknologi Mara
- Investigators
- Nur Islami Bt Mohd Fahmi Teng, AP. Dr., Principal investigator, Universiti Teknologi Mara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05444179
- Sponsor's protocol ID
- MiChild Group
- Status last verified
- Jul 2024
- First submitted
- 13 Apr 2022
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 14649593Husin, 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.
PubMed 23386800Moriwaki 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.
PubMed 4809667Sandhu 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.
PubMed 28223882Nightingale 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.
PubMed 27795836Yang 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.
PubMed 28950158Yang 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.
PubMed 23681351
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Nutrition and Physical Activity Intervention on Psychosocial Well-Being of Mothers With Preterm Infants in Selangor
- ClinicalTrials.gov ID
- NCT05444179
- Acronym / sponsor ID
- MiChild Group
- Conditions
- Postpartum Depression, Lifestyle, Healthy
- Keywords
- postpartum depression, physical activity, intervention study, nutritional intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Universiti Teknologi MaraUniversity, hospital or other
- Collaborators
- Universiti Sains Islam Malaysia
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 5 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to examine the effectiveness of nutrition and physical intervention to improve psychosocial well-being of postpartum mothers with preterm infants. The focus was highlighted towards the mothers of preterm infants who were cared in Neonatal Intensive Care Unit (NICU) as these parents might have a higher stress level than the full-term infants. The intervention consisted of a module designed for postpartum mothers, incorporating nutrition and physical activity entitled Mommies can Eat \& Exercise with No Stress (MomEENS).
Detailed description
The intervention is aim to encourage the participant to have better nutrition intake and engage in low to moderate-intensity exercise on 3 to 5 days per week, for 8 weeks in order to improve their psychosocial well-being. After being informed about the study and potential risks, the participants will be screened according to their eligibility criteria. The participants who are eligible to participate in the study will be contacted again and asked for consent to join the study. After obtaining the consent, the participant will undergo a baseline assessment, and subsequently, the investigator will assign the participant to their respective groups, the intervention and control groups. All of the health assessments will be conducted at baseline, 4th week and 8th week.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a parallel-group study design, which employed block randomization via a computer-generated randomisation list for allocation of the participants, with the block size of 8, and equal randomization ratio (1:1) between intervention and control groups. The block randomization process is conducted by an investigator that had no clinical involvement in the trial, in which the allocation sequence was concealed from the principal investigator who are enrolling and assessing the eligible participants. Due to nature of intervention, blinding of principal investigator and participants are not possible. Measurement of the outcome will commence at the baseline, at week 4 and week 8 of the randomised controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Behavioral: Mommies can Eat & Exercise with No Stress (MomEENS)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. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Participants with EPDS score ≥ 12
- Mothers with an infant nearly graduated from NICU due to prematurity with minimum stays of 7 days (Gestational age: < 37 weeks).
- Postpartum mothers (within 4th to 8th weeks after childbirth).
- Aged between 19 until 40 years old.
- Mothers were from Malaysian citizen.
Key exclusion criteria (6 listed)
- Mothers that is clinically diagnosed with mental illness or other known psychiatric disorders
- Mothers who illiterate either in Malay or English
- Mothers who are currently pregnant
- Mothers whose infant has genetic or congenital anomaly or severe cardiorespiratory instability
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Intervention group |
Primary outcome
Edinburgh Postnatal Depression Scale
Time frame: Change from Baseline Depression Screening Status at 8 weeks
The presence of depressive symptoms will be assessed using the Edinburgh Postnatal Depression Scale (EPDS). The EPDS is a 10-item self-administered questionnaire designed specifically to measure postpartum depression. All items will be rated on a 4-point Likert-type scale, with a total score ranging from 0-30. Categories of response are scored 0,1,2, and 3 based on increased symptom severity. EPDS can only be used for screening but not for the clinical diagnosis of depression. The Malay version of the scale was validated in the local setting with the cut off 11/12 was used to determine a woman at risk of having depressive symptoms. Score of ≥12 indicates the presence of postpartum depression whereas <12 indicates absence of postpartum depression.
Perceived Stress Scale (PSS)
Time frame: Change from Baseline Perceived Stress Status at 8 weeks
The Perceived Stress Scale (PSS) was developed by Sheldon Cohen \& Williamson (1988), designed to measure the degree to which circumstances of an individual are considered stressful via their feelings and thoughts in the past month. The item asked regarding the current levels of stress, unpredictable, uncontrollable, and overloaded events, unexpectedly occur during their lives. The PSS consist of 10 items, derived from 5-point Likert scale (0= never, 1= almost never, 2= sometimes, 3= fairly often, 4= very often). Four items that are positively stated (item 4,5,7, and 8) are scored reversely (0= very often, 1= fairy often, 2= sometimes, 3= almost never, 4= never). The total score is calculated from the sum of 10 items, whereas higher scores indicate higher levels of perceived stress. In this study, Malay version of PSS-10 is used to enable participants to understand the questions asked and to make the assessment more culturally appropriate.
Postpartum Sleep Quality Scale (PSQS)
Time frame: Change from Baseline Sleep Quality Status at 8 weeks
The Postpartum Sleep Quality Scale (PSQS) consists of 14 item scale, designed to assess subjective sleep quality during postpartum periods. Two domains were developed from the PSQS: "Factor 1: Infant night care-related daytime dysfunction", and "Factor 2: Physical symptoms related sleep inefficiency". Factor 1 explained how having care of infants at night impacted the quality of postpartum woman's sleep and the ability to handle daytime activities. Factor 2 described the physiological factors underlying sleep and sleep inefficiency symptoms of a woman. The PSQS found to be a valid and reliable tool, as previous study had demonstrated PSQS have adequate internal consistency between the item (Cronbach's α= 0.88; Factor I α =0.89, Factor II α= 0.82).
Positive Affect Balance Scale (PABS)
Time frame: Change from Baseline Psychosocial Well-being Status at 8 weeks
This scale consist of 10 item scales, which 5 items were developed for each positive and negative affect components, asking the psychological reactions of people respond to their daily lives, and individual's ability to cope with daily stresses. "Positive affect" questions are associate to social participation, satisfaction with social life, and engagement in activities. Three-point scale of "never", "sometimes", or "often" are answers made to the questions represents the past week's experiences. All calculations of positive affect score, a negative affect score and a total affect balance score can be made. The positive impact score (ranging from 5 to 15) with 15 being the highest (most positive result) will be used in this study. PABS has been proven to be a reliable tool for measuring psychosocial well-being, as reported by previous study.
7 secondary outcomes
Multiple Pass 24-Hour Diet Recall
Time frame: Change from Baseline Dietary Intake at 8 weeks
International Physical Activity Questionnaire- Short Form
Time frame: Change from Baseline Physical Activity Status at 8 weeks
Body weight measurement
Time frame: Change from Baseline Body Weight at 8 weeks
Height measurement
Time frame: Change from Baseline Height Measurement at 8 weeks
Waist circumference measurement
Time frame: Change from Baseline Waist Circumference at 8 weeks
Blood Pressure Assessment
Time frame: Change from Baseline Blood Pressure Assessment at 8 weeks
Breastfeeding Self-Efficacy -Short Form (BSES-SF)
Time frame: Change from Baseline Breastfeeding Self-Efficacy at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- BackgroundArifin, 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
- BackgroundCohen, S., & Williamson, G. (1988). Perceived Stress in a Probability Sample of the United States. Sage.
- Background: PubMed 14649593Dennis 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.
- BackgroundHusin, 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.
- Background: PubMed 23386800Mahmud 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.
- Background: PubMed 4809667Moriwaki 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.
- Background: PubMed 28223882Sandhu 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.
- Background: PubMed 27795836Nightingale 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.
- Background: PubMed 28950158Yang 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.
- Background: PubMed 23681351Yang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nur Islami Bt Mohd Fahmi Teng, AP. Dr. principal investigator
Universiti Teknologi Mara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mommies can Eat & Exercise with No Stress (MomEENS) in people with Postpartum Depression and Lifestyle, Healthy, run by Universiti Teknologi Mara at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Edinburgh Postnatal Depression Scale (time frame: Change from Baseline Depression Screening Status at 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05444179, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2024; AzTrials last refreshed its copy on 7 Nov 2026.