Clinical trial NCT01345149: Effect of Intervention With Diet and Physical Activity in Obese Pregnant Women
Official title: Effect of Lifestyleintervention With Diet and Physical Activity in Obese Pregnant Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Pregnancy
Intervention
Diet
Physical activity
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2011-04-29
Enrollment: 420
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: Obese pregnant women with a BMI\>30 are randomized to Diet + Exercise, Exercise or control (1:1:1) in order to reduce maternal weight gain to less than 5 kg during pregnancy.

The effect on the children of mothers in this study is evaluated in the study: Is it possible to reduce the Number of Macrosomic Infants With Abundant Fat Tissue by Lifestyle Intervention during Pregnancy (NCT01235676)

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Maternal weight gain
timeFrame: At delivery, avarage 27 weeks after inclusion. For the last participant this will be aproximately April 2012
Secondary outcomes:
measure: Pregnancy complications
timeFrame: At delivery, avarage 27 weeks after inclusion. For the last participant this will be aproximately April 2012
measure: Glucose tolerance in pregnancy
timeFrame: At delivery, avarage 27 weeks after inclusion. For the last participant this will be aproximately April 2012
measure: Birth weight
timeFrame: At delivery, avarage 27 weeks after inclusion. For the last participant this will be aproximately April 2012
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Obstetrics and Gynecology, Hvidovre University Hospital
Study officials:
affiliation: Department of Obstetrics and Gynecology, Hvidovre University Hospital
name: Niels Jørgen Secher, Professor
role: STUDY_CHAIR
affiliation: Department of Obstetrics and Gynecology, Hvidovre University Hospital
name: Lisbeth Nilas, Prof. DMSc
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.