UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052753 |
|---|---|
| Receipt number | R000060194 |
| Scientific Title | Intensive nutrition counseling with multiple nutrient supplementation in pregnant women with obesity to prevent gestational diabetes, adverse perinatal outcomes and promote optimal infant nutritional status and neurodevelopment in the first six months of life. |
| Date of disclosure of the study information | 2023/12/30 |
| Last modified on | 2024/11/13 04:10:24 |
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Basic information
Public title
Intensive nutrition counseling with multiple nutrient supplementation in pregnant women with obesity to prevent gestational diabetes, adverse perinatal outcomes and promote optimal infant nutritional status and neurodevelopment in the first six months of life.
Acronym
Intensive nutrition intervention in pregnant women with obesity to prevent gestational diabetes and adverse maternal, neonatal and infant outcomes.
Scientific Title
Intensive nutrition counseling with multiple nutrient supplementation in pregnant women with obesity to prevent gestational diabetes, adverse perinatal outcomes and promote optimal infant nutritional status and neurodevelopment in the first six months of life.
Scientific Title:Acronym
Intensive nutrition intervention in pregnant women with obesity to prevent gestational diabetes and adverse maternal, neonatal and infant outcomes.
Region
| North America |
Condition
Condition
Gestational diabetes, adverse perinatal outcomes (preeclampsia, preterm birth, fetal growth impairment), alterations in newborn and infant nutritional status, excessive adiposity and neurodevelopmental disorders.
Classification by specialty
| Endocrinology and Metabolism | Obstetrics and Gynecology | Pediatrics |
| Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the effect of intensive nutrition counseling and multiple nutrient supplementation in pregnant women with obesity on gestational diabetes risk and other perinatal outcomes, maternal and newborn nutritional status, and infant growth, adiposity and neurodevelpment.
Basic objectives2
Others
Basic objectives -Others
1. Assess the frequency of gestational diabetes in both study groups and determine whether intensive nutritional care with supplementation lowers the risk of developing the disease.
2. Describe maternal gestational weight gain and metabolic status at the end of pregnancy and evaluate differences between groups.
3. Describe infant nutritional status, growth, adiposity and neurodevelopment at 1 and 6 months of age and evaluate differences between groups.
4. Assess the frequency of other adverse perinatal outcomes and alterations in infant nutritional status, adiposity and neurodevelopment in both study groups and determine the crude and adjusted risk according to receiving the intensive nutrition intervention with supplementation.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Gestational diabetes mellitus (GDM).
The primary outcome is to compare GDM incidence in both groups. For this, a 75g 2h oral glucose tolerance test (OGTT) will be performed at 24 to 28 weeks of gestation. GDM will be stablished if at least one glucose value is altered: fasting equal or more than 92 mg/dL, 1h equal or more than 180 mg/dL and 2h equal or more than 153 mg/dL, according to the International Association of Diabetes and Pregnancy Study Groups criteria.
All women (in both groups) who develop GDM will be referred to the Institutional Diabetes in Pregnancy Program for multidisciplinary care, including endocrinology treatment and intensive MNT.
Key secondary outcomes
Adverse perinatal outcomes:
- Preeclampsia
- Preterm birth
- Fetal and neonatal death
- Mode of delivery
- Fetal growth alterations (intrauterine growth restriction(IUGR), small for gestational age(SGA), large for gestational age(LGA))
Maternal nutrition and metabolic variables:
- Gestational weight and postpartum weight retention
- Metabolic markers and inflammation (lipid profile, glucose, insulin, HOMA-IR, leptin, adiponectin, resistin, high sensitive C-reactive protein, lipopolysacharide)
Neonatal and infant outcomes:
- Newborn and infant nutritional status (low birth weight, macrosomia, SGA, LGA, weight/age, lenght/age, weight/lenght, body mass index(BMI)/age, head circumference/age)
- Infant body composition (body density, fat mass (in kg))
- Neurodevelopment outcomes (Brazelton Neonatal Behavioral Assessment Scale (NBAS), Bayley Scales of Infant Development, third edition (BSID III))
Control variables:
- Dietary intake
- Adherence to the intervention
- Adherence to supplementation
- Pharmacological treatment
- Physical activity (International Physical Activity Questionnaire-Short version)
- Sleep quality (Pittsburgh Sleep Quality Index scale)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food | Behavior,custom | Other |
Interventions/Control_1
Group 1 (intervention group):
Women in this group will receive medical prenatal care by an assigned attending obstetrician who will follow institutional guidelines and intensive medical nutrition therapy (MNT) by a clinical nutritionist and multiple nutrient supplementation.
MNT and supplementation
Intensive MNT will be offered every 4 weeks. According to nutrition assessment, a healthy dietary pattern (low ultraprocessed, traditional) will be promoted to achieve adequate nutrient intakes, promote optimal metabolic control and fetal growth. Barriers and motivators will be explored; a goal setting approach and problem-solving strategies will be implemented in each visit. MNT will be delivered in the context of intensive counseling, with a strong education component. Breastfeeding education and promotion will be done. During each visit, women will report their overall dietary adherence to intensive MNT recommendations on a scale of 0 to 100.
The supplementation scheme represents taking 4 capsules daily: 1 multivitamin, 1 folic acid and iron and 2 myo-inositol-folic acid. Two capsules of vitamin D3 will be taken weekly.
Daily total nutrient doses and contribution to daily intake recommendations, are presented:
- Folic acid 1000 ug (166%), iron 29 mg (107%), zinc 10 mg (91%), vitamin D3 11,200 IU/week (1600 IU/day) (400%), vitamin C 40 mg (47%), vitamin E 12 mg (80%), tiamine B1 1.1 mg (79%), riboflavin B2 1.4 mg (100%), niacin B3 16 mg (89%), pantothenic acid B5 6 mg (100%), piridoxin B6 1.4 mg (74%), biotin B8 50 ug (166%), cianocobalamine B12 2.5 ug (96%), omega 3 (DHA) 250 mg (approx. 100%), omega 3 (EPA) 50 mg (approx. 100%), manganese 1 mg (50%), copper 1 mg (100%), iodine (0.15 mg (68%), selenium 55 ug (92%), myo-inositol 1200 mg (600 mg 2x day) (NA).
Interventions/Control_2
Group 2: Control Group (Usual care): Participants within this group will be provided with identical medical prenatal care as the intervention group, offered by the same obstetrician, following institutional guidelines. Nutrient supplementation in this group will consist in a multivitamin containing folic acid (400 mcg/d), iron (equeal or less than 30 mg/d), vitamin D (equeal or less than 400UI/d), and other micronutrients (meeting equeal or less than 100% of recommended intake). In this group omega 3 fatty acids and myo-inositol will not be supplemented. Calcium supplementation (1-2 g/d) will be recommended in some women (as in the intervention group). The attending obstetrician will prescribe this supplementation scheme.
Prenatal Medical Care (both groups)
The schedule for prenatal care appointments will include monthly visits from the first visit (11-13.6 weeks) until the 32nd week of pregnancy, bi-weekly visits from the 33rd to the 36th week, and weekly appointments from the 36th to the 40th week of gestation. During pregnancy, the risk, and the presence of fetal malformations, chromosomopathies, preeclampsia, premature labor, intrauterine growth restriction (IUGR) and fetal growth will be evaluated according to maternal fetal medicine ultrasound assessments in each trimester. Complete blood count, blood chemistry, urine tests and vaginal swabs will be performed in each trimester or at a higher frequency based on clinical necessity. Blood pressure will be measured in the morning in each visit with an ambulatory device (Spacelabs Healthcare, USA). If the obstetrician in charge considers that a patient has a high risk of preeclampsia, 100mg of aspirin will be indicated. If a patient is detected with a high risk of preterm birth, 200 mg/d of progesterone will be indicated. The obstetrician will determine the delivery method based on the clinical obstetric background of participants.
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
| 18 | years-old | <= |
Age-upper limit
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
Adult women without previous diseases, pregnancies with only one fetus (no congenital malformations), and pregestational BMI (pBMI) equal or more than 30 (using pregestational weight self reported and height measured with a digital stadiometer).
Key exclusion criteria
Women will be excluded if they have pregestational diabetes mellitus, chronic hypertension, heart, kidney, liver or autoimmune disease, uncontrolled hypothyroidism, history of bariatric surgery, or if take medications influencing the metabolism of the endocrine system (insulin, metformin, and/or corticosteroids). All women will have an oral glucose tolerance test (OGTT) at the first prenatal care visit, according to Institutional GDM screening procedures. Women with 2 or more altered values or those classified with pregestational diabetes mellitus will be excluded.
Target sample size
136
Research contact person
Name of lead principal investigator
| 1st name | Otilia |
| Middle name | |
| Last name | Perichart Perera |
Organization
Instituto Nacional de Perinatologia (National Institute of Perinatology)
Division name
Coordinacion de Nutricion y Bioprogramacion (Nutrition and Bioprogramming Coordination)
Zip code
11000
Address
C. Montes Urales 800, Lomas-Virreyes, Lomas de Chapultepec IV Secc, Miguel Hidalgo, Ciudad de Mexico
TEL
(+52)5555209900
otiliaperichart@inper.gob.mx
Public contact
Name of contact person
| 1st name | Otilia |
| Middle name | |
| Last name | Perichart Perera |
Organization
Instituto Nacional de Perinatologia (National Institute of Perinatology)
Division name
Coordinacion de Nutricion y Bioprogramacion (Nutrition and Bioprogramming Coordination)
Zip code
11000
Address
C. Montes Urales 800, Lomas-Virreyes, Lomas de Chapultepec IV Secc, Miguel Hidalgo, Ciudad de Mexico
TEL
(+52)5555209900
Homepage URL
otiliaperichart@inper.gob.mx
Sponsor or person
Institute
Instituto Nacional de Perinatologia
Institute
Department
Personal name
Funding Source
Organization
Instituto Nacional de Perinatologia (Mexico City)
Supplements will be donated by Exeltis Pharma Mexico
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Mexico
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
General Direction of Health Research Policies, Ministry of Health (Mexico)-(project #FPIS2023-INPER-4257)
Instituto Nacional de Perinatologia (Mexico City) (project #INPer: 2023-1-5)
IRB Contact (For public release)
Organization
Instituto Nacional de Perinatologia (National Institute of Perinatology)
Address
C. Montes Urales 800, Lomas-Virreyes, Lomas de Chapultepec IV Secc, Miguel Hidalgo. 11000, Ciudad de Mexico
Tel
(+52)5255 5520 9900
comision_inv@yahoo.com.mx
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
Instituto Nacional de Perinatologia (Mexico City)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 30 | Day |
Related information
URL releasing protocol
https://www.frontiersin.org/journals/medicine/articles/10.3389/fmed.2024.1339428/full
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
3
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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 09 | Month | 04 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 22 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2027 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2027 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2028 | Year | 01 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 11 | Month | 10 | Day |
Last modified on
| 2024 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060194
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