PregnancyNCT01894139
An Optimized Programming of Healthy Children (APPROACH)
A study testing High-Protein/Low-GI Diet and Low-protein/High-GI Diet in people with Pregnancy and Obesity, run by University of Copenhagen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Obesity, Gestational Age and Weight Conditions
- What is being tested?
- High-Protein/Low-GI Diet and Low-protein/High-GI Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteDenmark
- Study dates
- 4 Jan 2014to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
University of Copenhagen, Faculty of Sceience, NEXS
Copenhagen, Frederiksberg, 1958
About this study
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
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.
- Conditions
- Pregnancy, Obesity, Gestational Age and Weight Conditions, Maternal Care for Excessive Fetal Growth, Metabolic Disorders
- Being tested
- High-Protein/Low-GI Diet, Low-protein/High-GI Diet
- Keywords
- Gestational weight gain, Obese women, Fetal programming, Metabolic disorders, Development of obesity, Development og overweight, Complications during pregnancy and birth
- Medical subject headings
- Obesity, Metabolic Diseases, Gestational Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Protein/Low-GI DietOther
Low-protein/High-GI DietOther
| Study group | Role | What they receive |
|---|---|---|
| High-protein/Low-GI Diet | Experimental | 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. Receives: Other: High-Protein/Low-GI Diet |
| Low-protein/High-GI Diet | Active comparator | 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. Receives: Other: Low-protein/High-GI Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Gestational week 14, 15, 17, 21, 25, 28, 36, 39
Secondary outcomes (2)
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.
Measured: 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
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.
Measured: Month 0, 6,18, 36 and year 5, 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study start4 Jan 2014
- Primary completionJan 2018
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- The Danish Dairy Research Foundation, Denmark, Nordea-Fonden, Denmark, LEGO Foundation, Pharma Nord, Danish Agriculture and Food Council, Danish Pork Levy Foundation, The Novo Nordic Foundation
- Responsible party
- Principal investigator, Christian Mølgaard, University of Copenhagen
- Investigators
- Christian Mølgaard, Professor, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01894139
- Sponsor's protocol ID
- EFFECT.C02.2012
- Status last verified
- Sep 2024
- First submitted
- 3 Jul 2013
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Larson EA, Magkos F, Zingenberg H, Svare J, Astrup A, Geiker NRW. A high protein low glycemic index diet has no adverse effect on blood pressure in pregnant women with overweight or obesity: a secondary data analysis of a randomized clinical trial. Front Nutr. 2023 Nov 21;10:1289395. doi: 10.3389/fnut.2023.1289395. eCollection 2023.
PubMed 38075210
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01894139
- Acronym / sponsor ID
- EFFECT.C02.2012
- Conditions
- Pregnancy, Obesity, Gestational Age and Weight Conditions, Maternal Care for Excessive Fetal Growth, Metabolic Disorders
- Keywords
- Gestational weight gain, Obese women, Fetal programming, Metabolic disorders, Development of obesity, Development og overweight, Complications during pregnancy and birth
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 280 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- The Danish Dairy Research Foundation, Denmark, Nordea-Fonden, Denmark, LEGO Foundation, Pharma Nord, Danish Agriculture and Food Council, Danish Pork Levy Foundation, The Novo Nordic Foundation
- Study start
- 4 Jan 2014 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 10 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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) ≥ 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-protein/Low-GI Diet | Experimental | Other: High-Protein/Low-GI DietHigh-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. |
| Low-protein/High-GI Diet | Active comparator | Other: Low-protein/High-GI DietAd 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. |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-Protein/Low-GI Diet | Other | High-protein/Low-GI Diet |
| Low-protein/High-GI Diet | Other | Low-protein/High-GI Diet |
Primary outcome
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.
2 secondary outcomes
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
Fetal programming of obesity and metabolic disorders
Time frame: Month 0, 6,18, 36 and year 5, 9
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 38075210Larson EA, Magkos F, Zingenberg H, Svare J, Astrup A, Geiker NRW. A high protein low glycemic index diet has no adverse effect on blood pressure in pregnant women with overweight or obesity: a secondary data analysis of a randomized clinical trial. Front Nutr. 2023 Nov 21;10:1289395. doi: 10.3389/fnut.2023.1289395. eCollection 2023.
- Homepage of Department of Nutrition, Exercise and Sports, University of CopenhagenLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Mølgaard, Professor principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Protein/Low-GI Diet and Low-protein/High-GI Diet in people with Pregnancy and Obesity, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gestational weight gain (time frame: Gestational week 14, 15, 17, 21, 25, 28, 36, 39). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01894139, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.