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

Universiti Teknologi Mara

Status: Completed

Conditions: Lifestyle, Healthy; Postpartum Depression

Treatments: Behavioral: Mommies can Eat & Exercise with No Stress (MomEENS)

Study type: Interventional

Funder types: Other

Identifiers

NCT05444179

MiChild Group

Details and patient eligibility

About

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).

Full 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.

Enrollment: 32 patients

Sex: Female

Ages: 19 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Intervention group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Mommies can Eat & Exercise with No Stress (MomEENS)

Control group

No Intervention group

Description:

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.