Long-term Effects of Lifestyle Intervention During Pregnancy in High Risk Women and in Their Offspring - Role of Environmental, Genetic and Epigenetic Factors
Condition: Type 2 Diabetes; Obesity; Metabolic Syndrome
MeSH terms: Metabolic Syndrome
Study type: Observational

Summary: 
      SUBJECTS:

      All participants in the RADIEL-study (2008-2011) who delivered (n=535), will be invited to
      this follow-up study, with their children (age 3-5 years) and the father. The investigations
      are carried out during two separate visits. The father receives mail questionnaires

      OVERALL OBJECTIVES:

        1. To determine the long-term effectiveness of a lifestyle intervention in high risk women
           and their offspring a in reducing the incidence of T2DM and cardiovascular disease and
           their risk factors b in preventing obesity c on biomarkers d on genetic and epigenetics
           markers .

        2. To study the association between maternal diet during pregnancy and metabolic markers in
           the offspring at age 3-5 years.

        3. To study the association between maternal exercise habits during pregnancy and metabolic
           markers in the offspring at age 3-5 years.

        4. To study the association between maternal a) glucose-insulin metabolism b) lipid
           metabolism c) adipoinsulinar axis and d) inflammatory markers and birth size and later
           health outcomes in the mothers and their offspring.

        5. To study the association between gut microbiota and markers of offspring health

        6. To study associations between offspring cardiovascular morphology/function, offspring
           body size/composition, and maternal cardiovascular risk

        7. To study the cost effectiveness of the intervention.

      METHODS:

      Maternal measurements

        1. Height, weight, waist and hip circumference

        2. Blood pressure, pulse

        3. Body fat percentage

        4. Blood tests e.g. markers of glucose metabolism and lipids, vitamin D, Calcium and bone
           markers, DNA sample and inflammation markers

        5. Fecal and hair samples

        6. Diurnal salivary cortisol assessment

        7. Background questionnaire: socioeconomic and health-related background

        8. Health-related quality of life (15-D).

        9. 3-day food diary and exercise diary

       10. ArmBand (acceleration sensor), assessment of physical activity and sleep for 7 days

       11. Psychological questionnaires

       12. Pulse wave velocity (PWV) will be assessed

       13. Advanced glycation endproducts - a marker of cardiovascular health will be assessed

       14. Dental and oral health

       15. Bone health

       16. VHRU of arterial structure

      Paternal measurements

        1. Background questionnaire (incl. height, weight, age)

        2. DNA-sample (buccal)

        3. 3-day food diary

        4. Psychological questionnaires

        5. Physical activity questionnaire (12 months)

      Measurements of children

        1. Body weight, height, blood pressure, pulse

        2. Body fat percentage

        3. Psychological questionnaires

        4. Food and physical activities diaries

        5. ActiGraph, assessment of physical activity and sleep for 7 days

        6. Blood samples e.g. glucose- and insulin metabolism, lipids, vitamin D and calcium
           metabolism, DNA-sample and samples for inflammation markers

        7. Fecal, urine and hair samples

        8. A copy of child welfare center card (e.g. data on growth, immunizations, health)

        9. Endothelial function and pulse wave velocity (PWV)

       10. Bone health with peripheral CT

       11. Heart structure and function

       12. VHRU of arterial structure

      TIMETABLE

      Follow up starts in January 2014, and will continue until 2018. Data analysis starts in 2017
      and results will be reported from 2018 onwards in international peer-reviewed journals.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women who participated the Radiel intervention study, and were originally randomly assigned
        to either active lifestyle intervention group or control group. They were all high risk
        women with BMI >30 or prior gestational GDM. To this follow up-study we invite also the
        children born during the intervention.
      
Biospecimen description: 
      Blood, saliva, hair, urine and fecal samples