Nutrition and Physical Activity Intervention on Psychosocial Well-Being of Postpartum Mothers

NCT05444179 | Completed

• 1 other identifier: MiChild Group
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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 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).

Conditions

Postpartum Depression; Lifestyle, Healthy

Keywords

postpartum depression; physical activity; intervention study; nutritional intake

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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).

  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.

  Change from Baseline Psychosocial Well-being Status at 8 weeks

Secondary Outcomes (7)

• Multiple Pass 24-Hour Diet Recall

  Change from Baseline Dietary Intake at 8 weeks

• International Physical Activity Questionnaire- Short Form

  Change from Baseline Physical Activity Status at 8 weeks

• Body weight measurement

  Change from Baseline Body Weight at 8 weeks

• Height measurement

  Change from Baseline Height Measurement at 8 weeks

• Waist circumference measurement

  Change from Baseline Waist Circumference at 8 weeks

Study Arms (2)

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.

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.

Interventions

Mommies can Eat & Exercise with No Stress (MomEENS) BEHAVIORAL

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.

Intervention group

Eligibility Criteria

• Age: 19 Years - 40 Years
• Gender Eligibility Details: Only postpartum female is eligible in this study
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universiti Teknologi Mara: lead
• Universiti Sains Islam Malaysia: collaborator

Study Sites (1)

Universiti Teknologi MARA

Shah Alam, Selangor, 42300, Malaysia

Location

Related Publications (10)

• 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

  BACKGROUND

• Cohen, S., & Williamson, G. (1988). Perceived Stress in a Probability Sample of the United States. Sage.

  BACKGROUND

• 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.

  PMID: 14649593 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 23386800 BACKGROUND

• 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.

  PMID: 4809667 BACKGROUND

• 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.

  PMID: 28223882 BACKGROUND

• 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.

  PMID: 27795836 BACKGROUND

• 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.

  PMID: 28950158 BACKGROUND

• 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.

  PMID: 23681351 BACKGROUND

MeSH Terms

Conditions

Depression, Postpartum; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Nur Islami Bt Mohd Fahmi Teng, AP. Dr.

  Universiti Teknologi Mara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof/ Principle Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: July 5, 2022
• Study Start: August 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: October 30, 2023
• Last Updated: July 25, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)