NCT01235676

Brief Summary

0-hypothesis: the tissue composition of newborn infants is not modified by lifestyle intervention during pregnancy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
270

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Feb 2010

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

February 1, 2010

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 5, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

March 20, 2013

Status Verified

March 1, 2013

Enrollment Period

2.4 years

First QC Date

November 4, 2010

Last Update Submit

March 18, 2013

Conditions

Obesity

Keywords

obesitylifestylepregnancynewborn infant

Outcome Measures

Primary Outcomes (1)

  • amount of fat tissue

    at birth

Secondary Outcomes (1)

  • birth weight

    at birth

Study Arms (2)

Diet

EXPERIMENTAL

Calorie restriction to reduce weight gain

Behavioral: diet

Exercise

EXPERIMENTAL

Exercise to reduce weight gain

Behavioral: Exercise

Interventions

dietBEHAVIORAL

calorie restriction to reduce weight gain

Diet
ExerciseBEHAVIORAL

Exercise to reduce weight gain

Exercise

Eligibility Criteria

AgeUp to 3 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy term neonates Informed and written consent from both parents -

You may not qualify if:

  • Sick or preterm infants No consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hvidovre University Hospital

Hvidovre, 2650, Denmark

Location

MeSH Terms

Conditions

Obesity

Interventions

DietExercise

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

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
MD

Study Record Dates

First Submitted

November 4, 2010

First Posted

November 5, 2010

Study Start

February 1, 2010

Primary Completion

July 1, 2012

Study Completion

October 1, 2012

Last Updated

March 20, 2013

Record last verified: 2013-03

Locations

DK(1)