An Optimized Programming of Healthy Children (APPROACH)

NCT01894139 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2024-09-19

No results posted yet for this 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.

Conditions

Interventions

OTHER

High-Protein/Low-GI Diet

OTHER

Low-protein/High-GI Diet

Sponsors & Collaborators

  • The Danish Dairy Research Foundation, Denmark

    collaborator OTHER
  • Nordea-Fonden, Denmark

    collaborator UNKNOWN
  • LEGO Charity, Denmark

    collaborator UNKNOWN
  • Pharma Nord

    collaborator INDUSTRY
  • Danish Agriculture and Food Council

    collaborator OTHER
  • Danish Pork Levy Foundation

    collaborator UNKNOWN
  • The Novo Nordic Foundation

    collaborator OTHER
  • University of Copenhagen

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
42 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-01-04
Primary Completion
2018-01-31
Completion
2027-12-31

Countries

  • Denmark

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01894139 on ClinicalTrials.gov