Maternal-Infant Exercise Program on Body Composition, Stress, Fatigue, and Attachment in Postpartum Women

• ClinicalTrials.gov Identifier: NCT04546100
• Recruitment Status: Recruiting
• First Posted: September 11, 2020
• Last Update Posted: September 11, 2020
• Sponsor: National Defense Medical Center, Taiwan
• Information provided by (Responsible Party): Hsiang-Yun Lan, National Defense Medical Center, Taiwan

Study Description

Brief Summary:

The aim of this study is to explore the effectiveness of the intervention measures of the "Maternal-Infant Exercise Program" to improve the postpartum women's body composition, stress, fatigue and parent-child attachment.

Condition or disease	Intervention/treatment	Phase
Postpartum; Body Composition; Stress; Fatigue; Attachment	Other: Maternal-Infant Exercise Program	Not Applicable

Detailed Description:

Background:

In Taiwan, more than 50% of maternal women will encounter obesity problems, because they have to take care of newborns, lack of proper exercise, and the traditional concept of confinement leads to excessive dietary supplementation, basal metabolic rate decline, and insufficient exercise. In addition to the physical changes after birth, women also face the change of the role of mothers. Caring for newborns is almost 24 hours on standby, gradually forming stress and fatigue. Stress may make postpartum women unable to perform the tasks of mothers. Makes postpartum women feel physiologically and psychologically uncomfortable. Both stress and fatigue have an adverse effect on their health, and are not conducive to parent-child attachment. However, early postpartum mothers and infants are almost inseparable. This period of attachment often affects infants' interpersonal relationships and emotions, if the relationship is not harmonious, may cause deviations in the baby's future behavior. Many studies have pointed out that moderate exercise can not only reduce the fatigue of postpartum women but also help to restore physical strength, help the recovery of organs and body, maintain physical health and weight management. However, busy with baby care and lack of continuous exercise often lead to postpartum women unable to reduce body weight. Therefore, this study hopes to develop a "Maternal-Infant Exercise Program" to improve the postpartum women's body composition, stress and fatigue, and to improve the attachment relationship between parents and their infants.

Purposes:

Explore the effectiveness of the intervention measures of the "Maternal-Infant Exercise Program" to improve the postpartum women's body composition, stress, fatigue and parent-child attachment.

Method:

In this study, a longitudinal and long-term follow-up randomized controlled trial study was adopted. The case was collected in a postpartum ward and an obstetrics and gynecology clinic of a medical center in the north Taiwan. The mothers who met the conditions for sample selection were selected as the research object. There are two different intervention modes (intervention group and control group), the intervention group is a Maternal-Infant Exercise Program, and the control group receives routine postpartum exercise nursing guidance. There are 50 people in each group. It is estimated that 100 healthy women with vagina postpartum will be collected. The questionnaires and physiological measurements are used to collect and aggregate the data. The main research variables are the Maternal-Infant Exercise Program, and the dependent variables are the postpartum women's body composition, stress, fatigue and parent-child attachment. The body composition of postpartum women is measured using a body fat meter, postpartum stress is measured using a Perceived Stress Scale(PSS), postpartum fatigue is measured using a Modified Fatigue Symptoms Checklist(MFSC), and the parent-child attachment relationship is measured using the Maternal Attachment Inventory(MAI). The two groups will collect data at one month, two months and three months after delivery, including body composition measurement and filling in each scale. The analysis method of the research data will use SPSS version 22.0 software, using chi-square test, independent sample t test , Pearson correlation, generalized estimation equations for discussion of results.

Result:

This study expects to understand the current status of postpartum women's body composition, stress, fatigue, and parent-child attachment. It is expected that parent-child exercise programs will improve postpartum women's body composition, as well as improve stress, fatigue, and enhance parent-child attachment.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Effects of a Maternal-Infant Exercise Program on Body Composition, Stress, Fatigue, and Attachment in Postpartum Women：A Randomized Control Trial
• Actual Study Start Date: August 4, 2020
• Estimated Primary Completion Date: July 30, 2021
• Estimated Study Completion Date: December 31, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Maternal-Infant Exercise Program; In the postpartum period, give the intervention group "Maternal-Infant Exercise Program" and encourage them to do exercise. The "Parent-Child Exercise Program" can be divided into three stages. Videos will be provided in each stage. As time progresses during the three months, the parent-child exercise videos provided will have stronger intensity. The content includes general post-natal exercises (e.g., baby Lying on the mother's bed, raising legs or back of hands exercises, breast exercises; neck exercises; pelvic swinging exercises), aerobic exercises (e.g. walking with strollers, walking with baby on back), core exercises (e.g. kneeling balance, kneeling Push ups, stick exercises, modified side stick exercises) and hip and leg exercises (such as donkey kicks, side lifts), etc., with relaxing music during exercise.	Other: Maternal-Infant Exercise Program; "Maternal-Infant Exercise Program" can be divided into three videos stages. As time progresses during the three months, the parent-child exercise videos provided will have stronger intensity. The content includes general post-natal exercises (e.g., baby Lying on the mother's bed, raising legs or back of hands exercises, breast exercises; neck exercises; pelvic swinging exercises), aerobic exercises (e.g. walking with strollers, walking with baby on back), core exercises (e.g. kneeling balance, kneeling Push ups, stick exercises, modified side stick exercises) and hip and leg exercises (such as donkey kicks, side lifts), etc., with relaxing music during exercise.
Placebo Comparator: Regular postpartum exercise guidance; Another group will receive "Regular postpartum exercise guidance". The guidance includes chest exercises, neck exercises, leg exercises, hip exercises, abdominal exercises, vagina contraction exercises, and uterine contraction exercises, starting from the third day after delivery to one month after delivery. The detail information will refer to the General Hospital of Tri-Services Provided the postpartum health education manual-postpartum exercise (p.8-10)	Other: Maternal-Infant Exercise Program; "Maternal-Infant Exercise Program" can be divided into three videos stages. As time progresses during the three months, the parent-child exercise videos provided will have stronger intensity. The content includes general post-natal exercises (e.g., baby Lying on the mother's bed, raising legs or back of hands exercises, breast exercises; neck exercises; pelvic swinging exercises), aerobic exercises (e.g. walking with strollers, walking with baby on back), core exercises (e.g. kneeling balance, kneeling Push ups, stick exercises, modified side stick exercises) and hip and leg exercises (such as donkey kicks, side lifts), etc., with relaxing music during exercise.

Outcome Measures

Primary Outcome Measures :

1. Body Composition- weight-T1 [ Time Frame: T1-baseline ]
   This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data: weight(kg).
2. Body Composition- weight-T2 [ Time Frame: T2-one month later ]
   This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data: weight(kg).
3. Body Composition- weight-T3 [ Time Frame: T3-two months later ]
   This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data: weight(kg).
4. Body Composition- weight-T4 [ Time Frame: T4-three months later ]
   This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data: weight(kg).
5. Body Composition- body mass index-T1 [ Time Frame: T1-baseline ]
   This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data: body mass index(kg/m2).
6. Body Composition- body mass index-T2 [ Time Frame: T2-one month later ]
   This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data: body mass index(kg/m2).
7. Body Composition- body mass index-T3 [ Time Frame: T3-two months later ]
   This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data: body mass index(kg/m2).
8. Body Composition- body mass index-T4 [ Time Frame: T4-three months later ]
   This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data: body mass index(kg/m2).
9. Body Composition- body fat-T1 [ Time Frame: T1-baseline ]
   This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data: body fat percentage(%).
10. Body Composition- body fat-T2 [ Time Frame: T2-one month later ]
    This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data: body fat percentage(%).
11. Body Composition- body fat-T3 [ Time Frame: T3-two months later ]
    This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data: body fat percentage(%).
12. Body Composition- body fat-T4 [ Time Frame: T4-three months later ]
    This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:body fat percentage(%).
13. Body Composition- body water-T1 [ Time Frame: T1-baseline ]
    This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:body water(%).
14. Body Composition- body water-T2 [ Time Frame: T2-one month later ]
    This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:body water(%).
15. Body Composition- body water-T3 [ Time Frame: T3-two months later ]
    This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:body water(%).
16. Body Composition- body water-T4 [ Time Frame: T4-three months later ]
    This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:body water(%).
17. Body Composition- muscle mass-T1 [ Time Frame: T1-baseline ]
    This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:muscle mass(kg).
18. Body Composition- muscle mass-T2 [ Time Frame: T2-one month later ]
    This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:muscle mass(kg).
19. Body Composition- muscle mass-T3 [ Time Frame: T3-two months later ]
    This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:muscle mass(kg).
20. Body Composition- muscle mass-T4 [ Time Frame: T4-three months later ]
    This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:muscle mass(kg).
21. Body Composition- bone mass-T1 [ Time Frame: T1-baseline ]
    This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:bone mass(kg).
22. Body Composition- bone mass-T2 [ Time Frame: T2-one month later ]
    This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:bone mass(kg).
23. Body Composition- bone mass-T3 [ Time Frame: T3-two months later ]
    This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:bone mass(kg).
24. Body Composition- bone mass-T4 [ Time Frame: T4-three months later ]
    This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:bone mass(kg).
25. Body Composition- basal metabolic rate(BMR)-T1 [ Time Frame: T1-baseline ]
    This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:basal metabolic rate(kcal).
26. Body Composition- basal metabolic rate(BMR)-T2 [ Time Frame: T2-one month later ]
    This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:basal metabolic rate(kcal).
27. Body Composition- basal metabolic rate(BMR)-T3 [ Time Frame: T3-two months later ]
    This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:basal metabolic rate(kcal).
28. Body Composition- basal metabolic rate(BMR)-T4 [ Time Frame: T4-three months later ]
    This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:basal metabolic rate(kcal).
29. Body Composition- body age-T1 [ Time Frame: T1-baseline ]
    This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:body age(age).
30. Body Composition- body age-T2 [ Time Frame: T2-one month later ]
    This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:body age(age).
31. Body Composition- body age-T3 [ Time Frame: T3-two months later ]
    This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:body age(age).
32. Body Composition- body age-T4 [ Time Frame: T4-three months later ]
    This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:body age(age).
33. Body Composition- Visceral fat-T1 [ Time Frame: T1-baseline ]
    This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:visceral fat (level).
34. Body Composition- Visceral fat-T2 [ Time Frame: T2-one month later ]
    This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:visceral fat (level).
35. Body Composition- Visceral fat-T3 [ Time Frame: T3-two months later ]
    This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:visceral fat (level).
36. Body Composition- Visceral fat-T4 [ Time Frame: T4-three months later ]
    This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:visceral fat (level).

Secondary Outcome Measures :

1. Postpartum stress-T1 [ Time Frame: T1-baseline ]
   The Perceived Stress Scale(PSS) has 14 questions on the scale. The questions use a response level of 0 to 4. The 0 point means never, 1 point means occasionally, 2 points means sometimes, 3 points means often,and 4 points means always. The higher the total score, the greater the postpartum stress.
2. Postpartum stress-T2 [ Time Frame: T2-one month later ]
   The Perceived Stress Scale(PSS) has 14 questions on the scale. The questions use a response level of 0 to 4. The 0 point means never, 1 point means occasionally, 2 points means sometimes, 3 points means often,and 4 points means always. The higher the total score, the greater the postpartum stress.
3. Postpartum stress-T3 [ Time Frame: T3-two months later ]
   The Perceived Stress Scale(PSS) has 14 questions on the scale. The questions use a response level of 0 to 4. The 0 point means never, 1 point means occasionally, 2 points means sometimes, 3 points means often,and 4 points means always. The higher the total score, the greater the postpartum stress.
4. Postpartum stress-T4 [ Time Frame: T4-three months later ]
   The Perceived Stress Scale(PSS) has 14 questions on the scale. The questions use a response level of 0 to 4. The 0 point means never, 1 point means occasionally, 2 points means sometimes, 3 points means often,and 4 points means always. The higher the total score, the greater the postpartum stress.
5. Postpartum fatigue-T1 [ Time Frame: T1-baseline ]
   The Modified Fatigue Symptoms Checklist(MFSC) has 10 questions on the scale. The questions use a response level of 0 to 4. The 0 point means never, 1 point means occasionally, 2 points means sometimes, 3 points means often,and 4 points means always. The higher the total score, the greater the postpartum fatigue.
6. Postpartum fatigue-T2 [ Time Frame: T2-one month later ]
   The Modified Fatigue Symptoms Checklist(MFSC) has 10 questions on the scale. The questions use a response level of 0 to 4. The 0 point means never, 1 point means occasionally, 2 points means sometimes, 3 points means often,and 4 points means always. The higher the total score, the greater the postpartum fatigue.
7. Postpartum fatigue-T3 [ Time Frame: T3-two months later ]
   The Modified Fatigue Symptoms Checklist(MFSC) has 10 questions on the scale. The questions use a response level of 0 to 4. The 0 point means never, 1 point means occasionally, 2 points means sometimes, 3 points means often,and 4 points means always. The higher the total score, the greater the postpartum fatigue.
8. Postpartum fatigue-T4 [ Time Frame: T4-three months later ]
   The Modified Fatigue Symptoms Checklist(MFSC) has 10 questions on the scale. The questions use a response level of 0 to 4. The 0 point means never, 1 point means occasionally, 2 points means sometimes, 3 points means often,and 4 points means always. The higher the total score, the greater the postpartum fatigue.
9. Attachment-T1 [ Time Frame: T1-baseline ]
   The Maternal Attachment Inventory(MAI) has 26 questions on the scale. The questions use a response level of 1 to 4. The 1 point means almost none, 2 points means occasionally, 3 points means often, and 4 points means almost often. The higher the total score, the closer the maternal-infant attachment.
10. Attachment-T2 [ Time Frame: T2-one month later ]
    The Maternal Attachment Inventory(MAI) has 26 questions on the scale. The questions use a response level of 1 to 4. The 1 point means almost none, 2 points means occasionally, 3 points means often, and 4 points means almost often. The higher the total score, the closer the maternal-infant attachment.
11. Attachment-T3 [ Time Frame: T3-two months later ]
    The Maternal Attachment Inventory(MAI) has 26 questions on the scale. The questions use a response level of 1 to 4. The 1 point means almost none, 2 points means occasionally, 3 points means often, and 4 points means almost often. The higher the total score, the closer the maternal-infant attachment.
12. Attachment-T4 [ Time Frame: T4-three months later ]
    The Maternal Attachment Inventory(MAI) has 26 questions on the scale. The questions use a response level of 1 to 4. The 1 point means almost none, 2 points means occasionally, 3 points means often, and 4 points means almost often. The higher the total score, the closer the maternal-infant attachment.

Eligibility Criteria

• Ages Eligible for Study: 20 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Postpartum healthy women with vaginal delivery
2. No obstetric complications
3. Taiwanese, understand Chinese
4. Agreed to participate in the research after the explanation, and agreed to receive four questionnaire surveys
5. The baby's gestational weeks are more than 37 weeks and the birth weight is more than 2500 grams
6. The baby has no complications or no congenital abnormalities

Exclusion Criteria:

1. Four-degree laceration of the perineal wound
2. A history of serious medical and surgical diseases cannot perform exercise
3. Those who cannot cooperate with the implementation of the parent-child exercise program at least three days a week, 20-30 minutes each time
4. The infant must be hospitalized for observation after being evaluated by a doctor and cannot be discharged

Contacts and Locations

Contacts

Contact: Hsiang-Yun Lan, Asst. Prof.; 87923311 ext 18781; shinnylan@msn.com

Locations

Taiwan

TSGH; Recruiting

Taipei city, Taiwan

Contact: Hsiang-Yun Lan, Asst. Prof. 87923311 ext 18781 shinnylan@msn.com

Sponsors and Collaborators

National Defense Medical Center, Taiwan

More Information

• Responsible Party: Hsiang-Yun Lan, Assistant Professor, National Defense Medical Center, Taiwan
• ClinicalTrials.gov Identifier: NCT04546100
• Other Study ID Numbers: 1-2020-07-16
• First Posted: September 11, 2020
• Last Update Posted: September 11, 2020
• Last Verified: September 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hsiang-Yun Lan, National Defense Medical Center, Taiwan:

postpartum; maternal-infant exercise program; body composition; stress; fatigue; attachment

Additional relevant MeSH terms:

Fatigue