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Active, not recruitingNCT01894139Updated Sep 19, 2024

An Optimized Programming of Healthy Children (APPROACH)

An interventional study of High-Protein/Low-GI Diet and Low-protein/High-GI Diet in Pregnancy, Obesity and Gestational Age and Weight Conditions, sponsored by University of Copenhagen. Active, not recruiting at 1 site in Denmark. Open to female participants aged 18 Years to 42 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by University of Copenhagen · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
280
Allocation
Randomized
Ages
18 Years to 42 Years
Sex
Female
01

Study 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.

Read the 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) ≥ 28 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.

02

Conditions studied

  • Pregnancy
  • Obesity
  • Gestational Age and Weight Conditions
  • Maternal Care for Excessive Fetal Growth
  • Metabolic Disorders

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Keywords

  • Gestational weight gain
  • Obese women
  • Fetal programming
  • Metabolic disorders
  • Development of obesity
  • Development og overweight
  • Complications during pregnancy and birth
03

In context

Metabolic Diseases

997 studies on the registry are indexed under Metabolic Diseases; 234 are open to participants now.

This study's enrollment of 280 is above the median of 48 across 670 interventional studies indexed under Metabolic Diseases.

Browse Metabolic Diseases studies →

Lead sponsor

University of Copenhagen is the lead sponsor of 450 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 42 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
280 participants (actual)

Study arms

  • 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

Interventions

  • OtherHigh-Protein/Low-GI Diet
  • OtherLow-protein/High-GI Diet
06

What researchers measure

Primary outcomes

  1. Gestational weight gain

    Changes in bodyweight, body composition (Magnetic Resonance Imaging) and measurements of body fat by means of skinfold thickness and mid-upper arm circumference.

    Time frame: Gestational week 14, 15, 17, 21, 25, 28, 36, 39

Secondary outcomes

  1. Growth and development of fetus and child

    Fetus: Nuchal Translucency Scan (once gw 11+3 - 14+0) and ultrasound scan (gw 28, 32, 36); child: Height in meter, weight in kilograms, body composition (Bioimpedance (month 6,18) and Dual-energy X-ray absorptiometry, DXA (month 0, 36, year 5, 9) , and Magnetic Resonance Imaging (year 9)), skin fold thickness and mid-upper arm circumference, IGF-1.

    Time frame: Gestational week 11+2, 14+0, 28, 32, 36 and month 0, 6, 18, 36 and year 5, 9

  2. Fetal programming of obesity and metabolic disorders

    Fasting blood samples (month 0 from umbilical cord), not at 6 months and 18 months; continuous glucose monitoring (year 9) in mmol/L; dietary intake, physical activity, growth and development.

    Time frame: Month 0, 6,18, 36 and year 5, 9

07

Study locations

1 site
  • University of Copenhagen, Faculty of Sceience, NEXS
    Copenhagen, Frederiksberg 1958, Denmark
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01894139
Lead sponsor
University of Copenhagen
Collaborators
The Danish Dairy Research Foundation, Denmark, Nordea-Fonden, Denmark, LEGO Charity, Denmark, Pharma Nord, Danish Agriculture and Food Council, Danish Pork Levy Foundation, The Novo Nordic Foundation
Responsible party
Christian Mølgaard (Professor, University of Copenhagen) — Principal investigator
First posted
Jul 10, 2013
Start date
Jan 4, 2014
Primary completion
Jan 2018
Completion
Dec 31, 2027 (estimated)
Last update
Sep 19, 2024

Study contacts

Christian Mølgaard, Professor
principal investigator · Department of Nutrition, Exercise and sports, University of Copenhagen

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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