Clinical trial NCT04546100: Maternal-Infant Exercise Program on Body Composition, Stress, Fatigue, and Attachment in Postpartum Women
Official title: Effects of a Maternal-Infant Exercise Program on Body Composition, Stress, Fatigue, and Attachment in Postpartum Women：A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postpartum
Body Composition
Stress
Fatigue
Attachment
Keywords: postpartum
maternal-infant exercise program
body composition
stress
fatigue
attachment
Lead sponsor: National Defense Medical Center, Taiwan
Sponsor class: OTHER
First posted: 2020-09-11
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility 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

Primary outcomes:
measure: Body Composition- weight-T1
timeFrame: T1-baseline
measure: Body Composition- weight-T2
timeFrame: T2-one month later
measure: Body Composition- weight-T3
timeFrame: T3-two months later
measure: Body Composition- weight-T4
timeFrame: T4-three months later
measure: Body Composition- body mass index-T1
timeFrame: T1-baseline
measure: Body Composition- body mass index-T2
timeFrame: T2-one month later
measure: Body Composition- body mass index-T3
timeFrame: T3-two months later
measure: Body Composition- body mass index-T4
timeFrame: T4-three months later
measure: Body Composition- body fat-T1
timeFrame: T1-baseline
measure: Body Composition- body fat-T2
timeFrame: T2-one month later
measure: Body Composition- body fat-T3
timeFrame: T3-two months later
measure: Body Composition- body fat-T4
timeFrame: T4-three months later
measure: Body Composition- body water-T1
timeFrame: T1-baseline
measure: Body Composition- body water-T2
timeFrame: T2-one month later
measure: Body Composition- body water-T3
timeFrame: T3-two months later
measure: Body Composition- body water-T4
timeFrame: T4-three months later
measure: Body Composition- muscle mass-T1
timeFrame: T1-baseline
measure: Body Composition- muscle mass-T2
timeFrame: T2-one month later
measure: Body Composition- muscle mass-T3
timeFrame: T3-two months later
measure: Body Composition- muscle mass-T4
timeFrame: T4-three months later
measure: Body Composition- bone mass-T1
timeFrame: T1-baseline
measure: Body Composition- bone mass-T2
timeFrame: T2-one month later
measure: Body Composition- bone mass-T3
timeFrame: T3-two months later
measure: Body Composition- bone mass-T4
timeFrame: T4-three months later
measure: Body Composition- basal metabolic rate(BMR)-T1
timeFrame: T1-baseline
measure: Body Composition- basal metabolic rate(BMR)-T2
timeFrame: T2-one month later
measure: Body Composition- basal metabolic rate(BMR)-T3
timeFrame: T3-two months later
measure: Body Composition- basal metabolic rate(BMR)-T4
timeFrame: T4-three months later
measure: Body Composition- body age-T1
timeFrame: T1-baseline
measure: Body Composition- body age-T2
timeFrame: T2-one month later
measure: Body Composition- body age-T3
timeFrame: T3-two months later
measure: Body Composition- body age-T4
timeFrame: T4-three months later
measure: Body Composition- Visceral fat-T1
timeFrame: T1-baseline
measure: Body Composition- Visceral fat-T2
timeFrame: T2-one month later
measure: Body Composition- Visceral fat-T3
timeFrame: T3-two months later
measure: Body Composition- Visceral fat-T4
timeFrame: T4-three months later
Secondary outcomes:
measure: Postpartum stress-T1
timeFrame: T1-baseline
measure: Postpartum stress-T2
timeFrame: T2-one month later
measure: Postpartum stress-T3
timeFrame: T3-two months later
measure: Postpartum stress-T4
timeFrame: T4-three months later
measure: Postpartum fatigue-T1
timeFrame: T1-baseline
measure: Postpartum fatigue-T2
timeFrame: T2-one month later
measure: Postpartum fatigue-T3
timeFrame: T3-two months later
measure: Postpartum fatigue-T4
timeFrame: T4-three months later
measure: Attachment-T1
timeFrame: T1-baseline
measure: Attachment-T2
timeFrame: T2-one month later
measure: Attachment-T3
timeFrame: T3-two months later
measure: Attachment-T4
timeFrame: T4-three months later
Other outcomes:
Locations:
city: Taipei city
country: Taiwan
facility: TSGH
Study officials:
References: