- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01894139
An Optimized Programming of Healthy Children (APPROACH)
September 29, 2021 updated by: Arne Astrup, University of Copenhagen
An Optimized Programming of Healthy Children (APPROACH) - The Most Favourable Dietary Protein:Carbohydrate Ratio During Pregnancy in the Context of New Nordic Diet
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
280
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Frederiksberg
-
Copenhagen, Frederiksberg, Denmark, 1958
- University of Copenhagen, Faculty of Sceience, NEXS
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 42 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Birth planed at Copenhagen University Hospital Herlev
- Pre-pregnancy BMI 28-45
- 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
- > 10 kg weight change 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Gestational week 14, 15, 17, 21, 25, 28, 36, 39
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Gestational week 11+2, 14+0, 28, 32, 36 and month 0, 6, 18, 36 and year 5, 9
|
Fetal programming of obesity and metabolic disorders
Time Frame: Month 0, 6,18, 36 and year 5, 9
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Fasting blod samples (month 0 from umbilical cord), not at 6 months; dietary intake, physical activity, growth and development
|
Month 0, 6,18, 36 and year 5, 9
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Arne V Astrup, Professor, Department of Nutrition, Exercise and Sports, University of Copenhagen
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 4, 2014
Primary Completion (Actual)
January 1, 2018
Study Completion (Anticipated)
December 1, 2027
Study Registration Dates
First Submitted
July 3, 2013
First Submitted That Met QC Criteria
July 3, 2013
First Posted (Estimate)
July 10, 2013
Study Record Updates
Last Update Posted (Actual)
September 30, 2021
Last Update Submitted That Met QC Criteria
September 29, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EFFECT.C02.2012
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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