An Optimized Programming of Healthy Children (APPROACH)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Copenhagen University Hospital at Herlev
Sponsor:
Collaborators:
The Danish Dairy Research Foundation, Denmark
Nordea-Fonden, Denmark
LEGO Charity, Denmark
Pharma Nord
Information provided by (Responsible Party):
Christian Bitz, Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier:
NCT01894139
First received: July 3, 2013
Last updated: January 14, 2014
Last verified: January 2014
  Purpose

The Nutrition Research Unit at Copenhagen University Hospital Herlev will during the fall 2013 initiate a randomized and controlled intervention study engaging 390 obese pregnant women. The overall aim of APPROACH is to investigate how an optimal diet during pregnancy influences the programming of the offspring. The children will after birth be included in a prospective cohort according to maternal randomization and examined six times from delivery until the age of nine years.


Condition Intervention
Pregnancy
Obesity
Gestational Age and Weight Conditions
Maternal Care for Excessive Fetal Growth
Metabolic Disorders
Other: High-Protein/Low-GI Diet
Other: Low-protein/High-GI Diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: An Optimized Programming of Healthy Children (APPROACH) - The Most Favourable Dietary Protein:Carbohydrate Ratio During Pregnancy in the Context of New Nordic Diet

Resource links provided by NLM:


Further study details as provided by Copenhagen University Hospital at Herlev:

Primary Outcome Measures:
  • Gestational weight gain [ Time Frame: Gestational week 14, 15, 17, 21, 25, 28, 36, 39 ] [ Designated as safety issue: No ]
    Changes in bodyweight, body composition (Magnetic Resonance Imaging) and measurements of body fat by means of skinfold thickness and mid-upper arm circumference.


Secondary Outcome Measures:
  • Growth and development of fetus and child [ Time Frame: Gestational week 11+2, 14+0, 28, 32, 36 and month 0, 6, 18, 36 and year 5, 9 ] [ Designated as safety issue: No ]
    Fetus: Nuchal Translucency Scan (once gw 11+3 - 14+0) and ultrasound scan (gw 28, 32, 36); child: Height, weight, body composition (Bioimpedance (month 6,18)and Dual-energy X-ray absorptiometry, DXA (month 0, 36, year 5, 9)), skin fold thickness and mid-upper arm circumference, IGF-1.

  • Fetal programming of obesity and metabolic disorders [ Time Frame: Month 0, 6,18, 36 and year 5, 9 ] [ Designated as safety issue: No ]
    Fasting blod samples (month 0 from umbilical cord), not at 6 months; dietary intake, physical activity, growth and development


Estimated Enrollment: 390
Study Start Date: November 2013
Estimated Study Completion Date: December 2024
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High-protein/Low-GI Diet
High-protein (25-28 E%), especially marine- and dairy-protein (8-10 E%) and low-GI (GI<55) ad libitum Diet in accordance with the principles of palatability and sustainability of the New Nordic Diet.
Other: High-Protein/Low-GI Diet
Active Comparator: Low-protein/High-GI Diet
Ad libitum diet based on the Danish National Guidelines (NNR) (protein 10-20 E%; no information on restricting glycaemic load (GI ~ 60)) and in accordance with the principles of palatability and sustainability of the New Nordic Diet.
Other: Low-protein/High-GI Diet

Detailed Description:

Overweight and excessive gestational weight gain (GWG) is associated with increased risk of high birth weight; furthermore there is increased risk of the child developing overweight, diabetes and other metabolic diseases in childhood or adulthood. The effect of reducing gestational weight gain while supplying optimized amount and sources of nutrients is not well investigated. Increased knowledge to the possibility and efficacy of preventing overweight and related diseases is necessary. Modification of protein source and increase in ratio of protein in relation to amount of carbohydrate and reduction of glycaemic index (GI) has in observational studies individually been linked to improved fetal body composition, metabolism and weight control later in life, and less weight gain and weight retention for the mother. The overall aim of APPROACH is to investigate how an optimal diet during pregnancy influences the programming of the offspring. This study will increase the knowledge of the effect of a specific nutrient composition and weight retention during pregnancy on growth and development during the foetal stage and until nine years off age, risk markers later metabolic diseases, especially diabetes and metabolic syndrome. APPROACH will be a dietary intervention investigating differences in responds to a high-protein, especially marine and dairy protein and low-GI diet versus a diet according to the Nordic Nutritional Recommendations. All visits and assessment will be performed by trained staff at Copenhagen University Hospital Herlev. Subjects will be women with expected delivery at Department of Gynaecology and Obstetrics and all examinations of gestational development and foetal growth will take place her; assessment of the children will be performed at the Department of Paediatrics. A total of 390 obese (body mass index (BMI) ≥ 30 kg/m2) pregnant women will be randomized to intervention or control and engage in the program from late first trimester or early second trimester to birth. After birth the children will be included in a prospective cohort according to maternal randomization and examined six times from delivery until the age of nine years. APPROACH will increase the knowledge of the effect of a nutrient composition with high protein for carbohydrate ratio and weight retention during pregnancy on growth and development during the foetal stage and until nine years off age, risk markers later metabolic diseases, especially diabetes and metabolic syndrome. Plasma lipids, markers of metabolic diseases, epigenetics and vitamin D status will be assessed at baseline and several times during pregnancy; and in both intervention and control group these data will increase the knowledge of the effect of supplementing with marine oils and vitamin D in pregnant women. Results from the intervention will be communicated to the general population and published in peer-relieved journals.

  Eligibility

Ages Eligible for Study:   18 Years to 42 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Birth planed at Copenhagen University Hospital Herlev
  • Pre-pregnancy BMI 30-45
  • Age 18-42 years
  • Speak and understand oral and written Danish
  • Singleton pregnancy

Exclusion Criteria:

  • Multiple pregnancy
  • History of spontaneous abortions or gestational diabetes or preeclampsia or spontaneous preterm birth
  • Dairy product intolerant or allergic
  • > 5 kg weight loss during the past year
  • Abuse of alcohol or drugs (>14 units of alcohol per week)
  • Critical or chronic disease: diabetes, kidney disease, medically treated heart diseases or arthritis, sarcoidosis, tuberculosis, cancer, liver disease, inflammatory gastrointestinal or lung disease, known active metabolic disease.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01894139

Contacts
Contact: Nina RW Geiker, Post Doc +45 38689393 nina.rica.wium.geiker@regionh.dk
Contact: Annette Vedelspang, Dietician RD +45 38689393 annette.vedelspang@regionh.dk

Locations
Denmark
Copenhagen University Hospital at Herlev (EFFECT) Recruiting
Herlev, Denmark, 2730
Contact: Nina RW Geiker, Post doc    38689393    nina.rica.wium.geiker@regionh.dk   
Principal Investigator: Arne V Astrup, Professor         
Sponsors and Collaborators
Copenhagen University Hospital at Herlev
The Danish Dairy Research Foundation, Denmark
Nordea-Fonden, Denmark
LEGO Charity, Denmark
Pharma Nord
Investigators
Principal Investigator: Arne V Astrup, Professor Copenhagen University Hospital at Herlev (EFFECT)
  More Information

Additional Information:
No publications provided

Responsible Party: Christian Bitz, Head of Research, Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier: NCT01894139     History of Changes
Other Study ID Numbers: EFFECT.C02.2012
Study First Received: July 3, 2013
Last Updated: January 14, 2014
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by Copenhagen University Hospital at Herlev:
Gestational weight gain
Obese women
Fetal programming
Metabolic disorders
Development of obesity
Development og overweight
Complications during pregnancy and birth

Additional relevant MeSH terms:
Metabolic Diseases
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014