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An Optimized Programming of Healthy Children (APPROACH)

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ClinicalTrials.gov Identifier: NCT01894139
Recruitment Status : Active, not recruiting
First Posted : July 10, 2013
Last Update Posted : August 20, 2020
Sponsor:
Collaborators:
The Danish Dairy Research Foundation, Denmark
Nordea-Fonden, Denmark
LEGO Charity, Denmark
Pharma Nord
Danish Agriculture and Food Council
Svineafgiftsfonden
Information provided by (Responsible Party):
Arne Astrup, University of Copenhagen

Tracking Information
First Submitted Date  ICMJE July 3, 2013
First Posted Date  ICMJE July 10, 2013
Last Update Posted Date August 20, 2020
Study Start Date  ICMJE November 2013
Actual Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2013)
Gestational weight gain [ Time Frame: Gestational week 14, 15, 17, 21, 25, 28, 36, 39 ]
Changes in bodyweight, body composition (Magnetic Resonance Imaging) and measurements of body fat by means of skinfold thickness and mid-upper arm circumference.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2013)
  • 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 ]
    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 ]
    Fasting blod samples (month 0 from umbilical cord), not at 6 months; dietary intake, physical activity, growth and development
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Optimized Programming of Healthy Children (APPROACH)
Official Title  ICMJE An Optimized Programming of Healthy Children (APPROACH) - The Most Favourable Dietary Protein:Carbohydrate Ratio During Pregnancy in the Context of New Nordic Diet
Brief Summary 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Pregnancy
  • Obesity
  • Gestational Age and Weight Conditions
  • Maternal Care for Excessive Fetal Growth
  • Metabolic Disorders
Intervention  ICMJE
  • Other: High-Protein/Low-GI Diet
  • Other: Low-protein/High-GI Diet
Study Arms  ICMJE
  • 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.
    Intervention: 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.
    Intervention: Other: Low-protein/High-GI Diet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 10, 2019)
280
Original Estimated Enrollment  ICMJE
 (submitted: July 3, 2013)
390
Estimated Study Completion Date  ICMJE December 2027
Actual Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 42 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01894139
Other Study ID Numbers  ICMJE EFFECT.C02.2012
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Arne Astrup, University of Copenhagen
Study Sponsor  ICMJE University of Copenhagen
Collaborators  ICMJE
  • The Danish Dairy Research Foundation, Denmark
  • Nordea-Fonden, Denmark
  • LEGO Charity, Denmark
  • Pharma Nord
  • Danish Agriculture and Food Council
  • Svineafgiftsfonden
Investigators  ICMJE
Principal Investigator: Arne V Astrup, Professor Department of Nutrition, Exercise and sports, University of Copenhagen
PRS Account University of Copenhagen
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP