Unique ID issued by UMIN | UMIN000015644 |
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Receipt number | R000018148 |
Scientific Title | Development and impact of a physical exercise and nutritional guidance program during pregnancy and postpartum |
Date of disclosure of the study information | 2014/11/13 |
Last modified on | 2017/05/17 14:55:16 |
Development and impact of a physical exercise and nutritional guidance program during pregnancy and postpartum
Impact of a exercise and nutrition program during pregnancy and postpartum
Development and impact of a physical exercise and nutritional guidance program during pregnancy and postpartum
Impact of a exercise and nutrition program during pregnancy and postpartum
Japan |
Healthy pregnant women
Obstetrics and Gynecology | Nursing | Adult |
Others
NO
To investigate the effects of integrated yoga exercise and nutritional guidance on pregnancy, birth and postpartum outcomes including mental stress and minor disturbance symptoms.
Others
To clear stress reduction effects of exercise during pregnancy by using physiological and psychological measures.
Exploratory
Pragmatic
Not applicable
Weight gain during pregnancy (baseline: 20 gestational weeks, endpoint 1: 28 gestational weeks, endpoint 2: 36 gestational weeks, endpoint 3: within 3 days after childbirth, endpoint 4: one month postpartum and endpoint 5: 18 months after child birth)
Comparison between baseline (20 gestational weeks) and endpoints (endpoint 1: 28 gestational weeks, endpoint 2: 36 gestational weeks);
1. Salivary cortisol concentrations measured by using saliva collected 4 times a day for two days among yoga exercise group and control group
2. Scores of psychological scales between control and nutrition group vs yoga group and yoga & nutrition group, additionally comparison between these four groups.
1) Scores measured by Hospital anxiety and depression scale and Edinburgh Postnatal Depression Scale
2) Fatigue scores measured by jikakusho shirabe
3) Scores measured by pregnancy self-evaluation questionnaire
4) Self-esteem scores
5) General Health Questionnaire
6) Health related QOL(SF8)
7) Scores of minor disturbance symptoms
8)Birth satisfaction (within 3days after childbirth)
9) Cost-effectiveness for maternal and family health from childbirth to 18 months after childbirth.
3. Comparison nutrient outcomes between control and yoga group vs nutrition group and yoga & nutrition group, additionally comparison between these four groups
1. Nutrient intakes
2. Serum and plasma micro nutrients
Comparison of salivary cortisol collected at 14:00 and 15:00
1. Control group: collection at their home
2. Yoga exercise group: collection before and after yoga class
Comparisons of lower leg condition before and after exercise program participation among yoga and yoga & nutrition group;
1. Circumference length of legs
2. Blood flow and vessel diameter measured by ultrasonic echo
3. Surface temperature measured by thermography
4. Subjective symptoms
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
No treatment
YES
NO
Institution is not considered as adjustment factor.
NO
Central registration
4
Treatment
Behavior,custom |
Control group: they are received usual care from 20 gestational weeks until child birth
Yoga Exercise intervention group: they perform yoga exercise 3 times a week at classes and their home
Nutrition intervention group: they are individually instructed about their diet intakes during pregnancy
Yoga Exercise and Nutrition intervention group: they receive both exercise and nutrition intervention
20 | years-old | <= |
Not applicable |
Female
1) Healthy pregnant women who are permitted to participate the study by their obstetricians
2) with singleton pregnancies
1) less than 20 years old
2) abnormality with their fetus
3) with inadequate Japanese literacy
4) with serious disease or obstetric complications
400
1st name | |
Middle name | |
Last name | Masayo Matsuzaki |
The University of Tokyo
Division of Health Sciences and Nursing, Graduate school of Medicine
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, JAPAN
03-5841-3396
msumi-tky@umin.ac.jp
1st name | |
Middle name | |
Last name | Masayo Matsuzaki |
The University of Tokyo
Division of Health Sciences and Nursing, Graduate school of Medicine
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, JAPAN
03-5841-3396
msumi-tky@umin.ac.jp
Graduate School of Medicine, The University of Tokyo
Japan Society for the Promotion of Science
Japanese Governmental office
Japan
NO
東京大学医学部附属病院
2014 | Year | 11 | Month | 13 | Day |
Unpublished
Completed
2014 | Year | 11 | Month | 01 | Day |
2014 | Year | 11 | Month | 13 | Day |
2016 | Year | 09 | Month | 30 | Day |
2016 | Year | 10 | Month | 31 | Day |
2016 | Year | 10 | Month | 31 | Day |
2017 | Year | 07 | Month | 31 | Day |
2014 | Year | 11 | Month | 10 | Day |
2017 | Year | 05 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018148
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