Clinical trial NCT05444179: Nutrition and Physical Activity Intervention on Psychosocial Well-Being of Postpartum Mothers
Official title: The Effectiveness of Nutrition and Physical Activity Intervention on Psychosocial Well-Being of Mothers With Preterm Infants in Selangor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Depression
Lifestyle, Healthy
Keywords: postpartum depression
physical activity
intervention study
nutritional intake
Lead sponsor: Universiti Teknologi Mara
Sponsor class: OTHER
Collaborators: name: Universiti Sains Islam Malaysia
First posted: 2022-07-05
Enrollment: 32
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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).

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.

Eligibility criteria: Inclusion Criteria:

1. Participants with EPDS score ≥ 12
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:

1. Mothers that is clinically diagnosed with mental illness or other known psychiatric disorders
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.

Primary outcomes:
measure: Edinburgh Postnatal Depression Scale
timeFrame: Change from Baseline Depression Screening Status at 8 weeks
measure: Perceived Stress Scale (PSS)
timeFrame: Change from Baseline Perceived Stress Status at 8 weeks
measure: Postpartum Sleep Quality Scale (PSQS)
timeFrame: Change from Baseline Sleep Quality Status at 8 weeks
measure: Positive Affect Balance Scale (PABS)
timeFrame: Change from Baseline Psychosocial Well-being Status at 8 weeks
Secondary outcomes:
measure: Multiple Pass 24-Hour Diet Recall
timeFrame: Change from Baseline Dietary Intake at 8 weeks
measure: International Physical Activity Questionnaire- Short Form
timeFrame: Change from Baseline Physical Activity Status at 8 weeks
measure: Body weight measurement
timeFrame: Change from Baseline Body Weight at 8 weeks
measure: Height measurement
timeFrame: Change from Baseline Height Measurement at 8 weeks
measure: Waist circumference measurement
timeFrame: Change from Baseline Waist Circumference at 8 weeks
measure: Blood Pressure Assessment
timeFrame: Change from Baseline Blood Pressure Assessment at 8 weeks
measure: Breastfeeding Self-Efficacy -Short Form (BSES-SF)
timeFrame: Change from Baseline Breastfeeding Self-Efficacy at 8 weeks
Other outcomes:
Locations:
city: Shah Alam
country: Malaysia
facility: Universiti Teknologi MARA
state: Selangor
Study officials:
affiliation: Universiti Teknologi Mara
name: Nur Islami Bt Mohd Fahmi Teng, AP. Dr.
role: PRINCIPAL_INVESTIGATOR
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