UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008573 |
|---|---|
| Receipt number | R000010072 |
| Scientific Title | Effectiveness of dietary counseling for pregnant women: A quasi-experimental study. |
| Date of disclosure of the study information | 2012/07/30 |
| Last modified on | 2024/08/08 14:50:05 |
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Basic information
Public title
Effectiveness of dietary counseling for pregnant women: A quasi-experimental study.
Acronym
Effectiveness of dietary counseling for pregnant women.
Scientific Title
Effectiveness of dietary counseling for pregnant women: A quasi-experimental study.
Scientific Title:Acronym
Effectiveness of dietary counseling for pregnant women.
Region
| Japan |
Condition
Condition
Healthy pregnant women
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Aims: To evaluate the effectiveness of one-to-one dietary counseling program on adequate nutrient intakes and healthy eating habits during pregnancy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Nutrient intakes
Key secondary outcomes
Healthy eating habits
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
One-to-one dietary counseling
Interventions/Control_2
Usual care
Interventions/Control_3
Interventions/Control_4
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
Healthy singleton pregnant women with no major complications.
Key exclusion criteria
Women are illiterate in Japanese.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Megumi |
| Middle name | |
| Last name | Haruna |
Organization
The University of Tokyo
Division name
Division of Health Sciences & Nursing, Graduate School of Medicine
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, JAPAN
TEL
03-5841-3396
mharuna-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Megumi |
| Middle name | |
| Last name | Haruna |
Organization
The University of Tokyo
Division name
Division of Health Sciences & Nursing, Graduate School of Medicine
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, JAPAN
TEL
03-5841-3396
Homepage URL
mharuna-tky@umin.ac.jp
Sponsor or person
Institute
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
Graduate School of Medicine, The University of Tokyo, Japan
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
Tel
03-5841-3396
mharuna-tky@umin.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 07 | Month | 30 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/10.1111/mcn.12391
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1111/mcn.12391
Number of participants that the trial has enrolled
378
Results
Of 378 eligible women, follow-up data were obtained from 309, and blood samples from 202. Dietary intake did not improve, but plasma levels of polyunsaturated fatty acids and maternal weight gain were significantly higher in the intervention group. Serum folate levels were significantly lower, while 25-hydroxyvitamin D levels, blood cell counts, mean birth weight, and the percentage of low birth weight infants showed no significant differences between groups.
Results date posted
| 2024 | Year | 08 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The study included healthy pregnant women over 20 years of age who visited a maternity health clinic at a university hospital in Tokyo. The exclusion criteria were multiple pregnancies, diabetes, hypertension, psychiatric diseases, and inability to speak Japanese.
Participant flow
The recruitment occurred in two phases over 2 years. The control group was recruited between May 2010 and November 2010 and received usual care, including provision of general information by midwives about a healthy diet, exercise, and appropriate weight gain during pregnancy. The data for the controls were collected a year prior to the intervention group. The intervention group was recruited between June 2011 and June 2012 and received tailored dietary guidance by the researchers based on baseline dietary assessments in addition to usual care.
Ultrasonography was performed for all pregnant women to determine accurate gestational dating at 8-12 weeks gestation. Baseline data were collected at 19-26 weeks gestation, and the outcome variables were collected at 34-37 weeks gestation.
Adverse events
No adverse events
Outcome measures
The primary outcome measures: maternal dietary nutrient intake, collected using the BDHQ, serum or plasma nutrient concentrations: arachidonic acid, dihomo-gamma-linolenic acid, docosahexaenoic acid, eicosapentaenoic, high-density lipoprotein (HDL), low-density lipoprotein (LDL), 25-hydroxy vitamin D. Blood count including hemoglobin (Hb), mean corpuscular hemoglobin (MCH), mean corpuscular volume (MCV).
The secondary outcomes: maternal dietary intention and self-reported supplementation, as collected from the questionnaire, and prescribed iron preparation to treat iron deficiency anemia (based on Hb levels), gestational weight gain, infant birth weight, and rate of LBW (birth weight less than 2,500g), as collected from hospital medical records.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2010 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2010 | Year | 04 | Month | 26 | Day |
Anticipated trial start date
| 2010 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 30 | Day |
Last modified on
| 2024 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010072
