UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015644
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

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Basic information

Public title

Development and impact of a physical exercise and nutritional guidance program during pregnancy and postpartum

Acronym

Impact of a exercise and nutrition program during pregnancy and postpartum

Scientific Title

Development and impact of a physical exercise and nutritional guidance program during pregnancy and postpartum

Scientific Title:Acronym

Impact of a exercise and nutrition program during pregnancy and postpartum

Region

Japan


Condition

Condition

Healthy pregnant women

Classification by specialty

Obstetrics and Gynecology Nursing Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effects of integrated yoga exercise and nutritional guidance on pregnancy, birth and postpartum outcomes including mental stress and minor disturbance symptoms.

Basic objectives2

Others

Basic objectives -Others

To clear stress reduction effects of exercise during pregnancy by using physiological and psychological measures.

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

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)

Key secondary outcomes

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



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

4

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

Control group: they are received usual care from 20 gestational weeks until child birth

Interventions/Control_2

Yoga Exercise intervention group: they perform yoga exercise 3 times a week at classes and their home

Interventions/Control_3

Nutrition intervention group: they are individually instructed about their diet intakes during pregnancy

Interventions/Control_4

Yoga Exercise and Nutrition intervention group: they receive both exercise and nutrition intervention

Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

1) Healthy pregnant women who are permitted to participate the study by their obstetricians

2) with singleton pregnancies

Key exclusion criteria

1) less than 20 years old
2) abnormality with their fetus
3) with inadequate Japanese literacy
4) with serious disease or obstetric complications

Target sample size

400


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masayo Matsuzaki

Organization

The University of Tokyo

Division name

Division of Health Sciences and Nursing, Graduate school of Medicine

Zip code


Address

7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, JAPAN

TEL

03-5841-3396

Email

msumi-tky@umin.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masayo Matsuzaki

Organization

The University of Tokyo

Division name

Division of Health Sciences and Nursing, Graduate school of Medicine

Zip code


Address

7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, JAPAN

TEL

03-5841-3396

Homepage URL


Email

msumi-tky@umin.ac.jp


Sponsor or person

Institute

Graduate School of Medicine, The University of Tokyo

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

東京大学医学部附属病院  


Other administrative information

Date of disclosure of the study information

2014 Year 11 Month 13 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2014 Year 11 Month 01 Day

Date of IRB


Anticipated trial start date

2014 Year 11 Month 13 Day

Last follow-up date

2016 Year 09 Month 30 Day

Date of closure to data entry

2016 Year 10 Month 31 Day

Date trial data considered complete

2016 Year 10 Month 31 Day

Date analysis concluded

2017 Year 07 Month 31 Day


Other

Other related information



Management information

Registered date

2014 Year 11 Month 10 Day

Last modified on

2017 Year 05 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018148


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name