UMIN-ICDS Clinical Trial

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

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

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

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)

Study type

Interventional

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

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

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

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

Email

otiliaperichart@inper.gob.mx

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

Email

otiliaperichart@inper.gob.mx

Institute

Instituto Nacional de Perinatologia

Institute

Department

Personal name

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

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: 2023-1-31)

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

Email

comision_inv@yahoo.com.mx

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Instituto Nacional de Perinatologia (Mexico City)

Date of disclosure of the study information

2023

Year

12

Month

30

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2023

Year

09

Month

04

Day

Date of IRB

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 related information

Registered date

2023

Year

11

Month

10

Day

Last modified on

2024

Year

03

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060194