Nutrition and Pregnancy Intervention Study

Obesity Clinical Trial

Official title:

Placebo-controlled Intervention Study for Maternal and Child Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01922791
• Other study ID #: T166/2012
• Status: Completed
• Phase: N/A
• Start date: October 2013
• Est. completion date: March 2023

Study information

• Verified date: April 2023
• Source: Turku University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A randomized double-blind placebo controlled intervention study with pregnant obese women (n=440) will be conducted. The intervention will involve consumption of fish oil and/or probiotic capsules from early pregnancy until 6 months after delivery.

The aim of the study is firstly to investigate the effects of the supplements on the risk of gestational diabetes mellitus and obesity in the women and secondly to modify the risk markers of allergy and obesity in children of the women. Also the underlying metabolic mechanisms will be investigated.

Follow up visits at child's age of 5 to 6 years will be conducted to evalute long-term effects on maternal and child health. The aim is to investigate the impact of dietary intervention, diet, maternal overweight/obesity and gestational diabetes status as well as gut microbiota and metabolism during pregnancy on maternal and child's health, allergy and child neuropsychological development.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 439
• Est. completion date: March 2023
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• pregnant, less than 17 gestational weeks

• overweight

• healthy

Exclusion Criteria:

• Diabetes (type 1 or 2)

• Coeliac disease

• Increased bleeding tendency

Related Conditions & MeSH terms

• Adiposity
• Cardiovascular Risk Factor
• Cognitive Developmental Disorders
• Developmental Disabilities
• Diabetes Mellitus
• Diabetes, Gestational
• Disease
• Eating Behavior
• Gestational Diabetes Mellitus
• Liver Diseases
• Neurodevelopmental Disorders
• Obesity
• Pregnancy
• Type2 Diabetes

Intervention

Dietary Supplement:
• Comparison of probiotics, fish oil and their combination to placebo
Double-blind randomized placebo controlled intervention

Locations

Country	Name	City	State
Finland	Turku University Hospital	Turku
Finland	University of Turku	Turku

Sponsors (2)

Lead Sponsor	Collaborator
Turku University Hospital	University of Turku

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Body composition, growth, development and metabolic markers of the child		0 to 24 months of age
Primary	Prevalence of gestational diabetes mellitus, GDM		Assessed at gestational weeks 24-28
Primary	Fasting glucose levels		assessed at the third trimester of pregnancy
Primary	Prevalence of allergy in child		assessed at 12 and 24 months of age
Secondary	Need for medication for management of gestational diabetes mellitus GDM (insulin or metformin)		During pregnancy
Secondary	Body composition of mother		During and after pregnancy
Secondary	Immunologic and metabolic markers		During and after pregnancy
Secondary	Fecal microbiota		Before, during and after intervention
Secondary	Fasting serum glucose (mmol/l) (mother/ child)		Assessed at 5-6 years postpartum
Secondary	Fasting serum insulin (mU/l) (mother/child)		Assessed at 5-6 years postpartum
Secondary	Number of women with prediabetes using criteria defined by American Diabetes Association		Assessed at 5-6 years postpartum
Secondary	Number of women with metabolic syndrome using criteria defined by The International Diabetes Federation		Assessed at 5-6 yrs postpartum
Secondary	Risk for Type 2 diabetes using questionnaire (mother)		Assessed at 5-6 yrs postpartum
Secondary	Serum high sensitive C-reactive protein (mg/l) (mother/child)		Assessed at 5-6 yrs postpartum
Secondary	Lipid metabolism (fasting cholesterol (mmol/l), fasting triglycerides (mmol/l), fasting HDL-cholesterol (mmol/l), fasting LDL-cholesterol (mmol/l) (mother/child)		Assessed at 5-6 yrs postpartum
Secondary	Serum metabolomics by NMR (mother/child)		assessed at 5-6 yrs postpartum
Secondary	Obesity by body mass index (mother/child) and body fat percentage by air displacement plethysmography (mother/child)		Assessed at 5-6 yrs postpartum
Secondary	Carotid intima media thickness by ultra sound (mother/child)		Assessed at 5-6 yrs postpartum
Secondary	Retinal microvasculature by digital retinal imaging (mother)		Assessed at 5-6 yrs postpartum
Secondary	Liver fat by ultra sound (mother)		Assessed at 5-6 yrs postpartum
Secondary	Liver health by ALAT (child/mother)		Assessed at 5-6 yrs postpartum
Secondary	Fecal microbiota composition (mother/child)		Assessed at 5-6 yrs postpartum
Secondary	Dietary intake of foods and nutrients and diet pattern calculated from food diaries, dietary quality index and food frequencies (assessed by questionnaires)/mother and child		Assessed at 5-6 yrs postpartum
Secondary	Eating behavior by Three Factor Eating Questionnaire, Neofobia and Comprehensive Feeding Practices Questionnaire, Child Feeding Questionnaire, Child Eating Behaviour Questionnaire (child)		Assessed at 5-6 yrs postpartum
Secondary	Motor development by Movement Assessment Battery for Children and by Developmental Coordination Disorder Questionnaire 2007 (DCDQ'07) (Child)		Assessed at 5-6 yrs postpartum
Secondary	Cognitive development by Cantab test and Wechsler Preschool and Primary Scale of Intelligence (child)		Assessed at 5-6 yrs postpartum
Secondary	Child effortful/emotionally-driven inhibition by the Forbidden Toy task and by Delay of gratification test (child)		Assessed at 5-6 yrs postpartum
Secondary	Social emotional assessment by Behavior Rating Inventory of Executive Functions (child)		Assessed at 5-6 yrs postpartum
Secondary	The child's social competence by Multisource Assessment of Children's Social Competence questionnaire and children's behavioral, social, and attention problems by the Child Behavior Checklist. (child)		Assessed at 5-6 yrs postpartum
Secondary	Infant temperament, Child Behavior Questionnaire (child)		Assessed at 5-6 yrs postpartum
Secondary	Child growth measured from weight (kg) and length (cm)		Assessed at 5-6 yrs postpartum
Secondary	Atopy by serum antigens and asthma by spirometry (child)		Assessed at 5-6 yrs postpartum
Secondary	Immunological cells from blood (child)		Assessed at 5-6 yrs postpartum
Secondary	Physical activity by questionnaires and activity monitor		Assessed at 5-6 yrs postpartum

External Links

•   Research group www-pages
•   Turku University Hospital
•   University of Turku