NCT01345149

Brief Summary

Purpose: To evaluate if lifestyle intervention (diet and exercise) can reduce maternal weight gain, the incidence of pregnancy complications and minimize the number of macrosomic infants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
420

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Apr 2009

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

April 1, 2009

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

April 27, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 29, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

September 6, 2012

Status Verified

September 1, 2012

Enrollment Period

3.2 years

First QC Date

April 27, 2011

Last Update Submit

September 5, 2012

Conditions

Obesity

Keywords

ObesityPregnancyInterventionDietPhysical activity

Outcome Measures

Primary Outcomes (1)

  • Maternal weight gain

    At delivery, avarage 27 weeks after inclusion. For the last participant this will be aproximately April 2012

Secondary Outcomes (3)

  • Pregnancy complications

    At delivery, avarage 27 weeks after inclusion. For the last participant this will be aproximately April 2012

  • Glucose tolerance in pregnancy

    At delivery, avarage 27 weeks after inclusion. For the last participant this will be aproximately April 2012

  • Birth weight

    At delivery, avarage 27 weeks after inclusion. For the last participant this will be aproximately April 2012

Study Arms (3)

Diet + Exercise

EXPERIMENTAL

Diet: Intensive counselling about calorie restriction to reduce weight gain by dietician. Exercise: Individual counselling

Behavioral: Diet + Exercise

Exercise

EXPERIMENTAL

Exercise: Individual counselling

Behavioral: Diet + Exercise

Control

NO INTERVENTION

Standard treatment without intervention.

Interventions

Diet + ExerciseBEHAVIORAL

Diet: Intensive counselling about calorie restriction to reduce weight gain by dietician. Exercise: Individual counselling

Also known as: Lifestyle intervention.
Diet + ExerciseExercise

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18 years
  • BMI \> 30
  • Singleton pregnancy
  • Must speak and understand Danish

You may not qualify if:

  • Alcohol or drug abuse
  • Diabetes type I or other critical medical disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology, Hvidovre University Hospital

Copenhagen, DK-2650, Denmark

Location

Related Publications (2)

  • Renault KM, Carlsen EM, Norgaard K, Nilas L, Pryds O, Secher NJ, Cortes D, Jensen JE, Olsen SF, Halldorsson TI. Intake of carbohydrates during pregnancy in obese women is associated with fat mass in the newborn offspring. Am J Clin Nutr. 2015 Dec;102(6):1475-81. doi: 10.3945/ajcn.115.110551. Epub 2015 Nov 11.

    PMID: 26561621DERIVED

  • Renault KM, Carlsen EM, Norgaard K, Nilas L, Pryds O, Secher NJ, Olsen SF, Halldorsson TI. Intake of Sweets, Snacks and Soft Drinks Predicts Weight Gain in Obese Pregnant Women: Detailed Analysis of the Results of a Randomised Controlled Trial. PLoS One. 2015 Jul 20;10(7):e0133041. doi: 10.1371/journal.pone.0133041. eCollection 2015.

    PMID: 26192183DERIVED

MeSH Terms

Conditions

ObesityMotor Activity

Interventions

DietExercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Niels Jørgen Secher, Professor

    Department of Obstetrics and Gynecology, Hvidovre University Hospital

    STUDY CHAIR

  • Lisbeth Nilas, Prof. DMSc

    Department of Obstetrics and Gynecology, Hvidovre University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 27, 2011

First Posted

April 29, 2011

Study Start

April 1, 2009

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

September 6, 2012

Record last verified: 2012-09

Locations

DK(1)