UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development and impact of a physical exercise and nutritional guidance program during pregnancy and postpartum
Title of the study (Brief title)	Impact of a exercise and nutrition program during pregnancy and postpartum
Region	Japan

Condition
Condition	Healthy pregnant women
Classification by specialty	Obsterics 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	Masayo Matsuzaki
Organization	The University of Tokyo
Division name	Division of Health Sciences and Nursing, Graduate school of Medicine
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	Masayo Matsuzaki
Organization	The University of Tokyo
Division name	Division of Health Sciences and Nursing, Graduate school of Medicine
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, JAPAN
TEL	03-5841-3396
Homepage URL
Email	msumi-tky@umin.ac.jp

Sponsor
Institute	Graduate School of Medicine, The University of Tokyo
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 11 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018148