NCT01894139

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P50-P75 for not_applicable pregnancy

Timeline
20mo left

Started Jan 2014

Longer than P75 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Jan 2014Dec 2027

First Submitted

Initial submission to the registry

July 3, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 10, 2013

Completed
6 months until next milestone

Study Start

First participant enrolled

January 4, 2014

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Expected
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

4 years

First QC Date

July 3, 2013

Last Update Submit

September 4, 2024

Conditions

PregnancyObesityGestational Age and Weight ConditionsMaternal Care for Excessive Fetal GrowthMetabolic Disorders

Keywords

Gestational weight gainObese womenFetal programmingMetabolic disordersDevelopment of obesityDevelopment og overweightComplications during pregnancy and birth

Outcome Measures

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.

    Gestational week 14, 15, 17, 21, 25, 28, 36, 39

Secondary Outcomes (2)

  • Growth and development of fetus and child

    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

    Month 0, 6,18, 36 and year 5, 9

Study Arms (2)

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.

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.

Other: Low-protein/High-GI Diet

Interventions

High-Protein/Low-GI DietOTHER
High-protein/Low-GI Diet
Low-protein/High-GI DietOTHER
Low-protein/High-GI Diet

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Copenhagen, Faculty of Sceience, NEXS

Copenhagen, Frederiksberg, 1958, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 38075210DERIVED

Related Links

MeSH Terms

Conditions

ObesityMetabolic DiseasesGestational Weight Gain

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsWeight GainBody Weight Changes

Study Officials

  • Christian Mølgaard, Professor

    University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 3, 2013

First Posted

July 10, 2013

Study Start

January 4, 2014

Primary Completion

January 1, 2018

Study Completion (Estimated)

December 31, 2027

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations

DK(1)