Trial Outcomes & Findings for Lifestyle and Pregnancy: The Clinical Effect of Lifestyle Intervention During Pregnancy in Obese Women (NCT NCT00530439)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

360 participants

Primary outcome timeframe

At delivery

Results posted on

2011-07-22

Participant Flow

Participant milestones

Participant milestones
Measure	Lifestyle Intervention physical activity, dietetic counselling	Control
Overall Study STARTED	180	180
Overall Study COMPLETED	150	154
Overall Study NOT COMPLETED	30	26

Reasons for withdrawal

Reasons for withdrawal
Measure	Lifestyle Intervention physical activity, dietetic counselling	Control
Overall Study GDM	9	3
Overall Study Withdraw	18	14
Overall Study Missed abortion	1	4
Overall Study Misclassification	2	0
Overall Study Twin pregnancy	0	2
Overall Study Severe malformation/abortion	0	3

Baseline Characteristics

Lifestyle and Pregnancy: The Clinical Effect of Lifestyle Intervention During Pregnancy in Obese Women

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lifestyle Intervention n=180 Participants physical activity, dietetic counselling	Control n=180 Participants	Total n=360 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	180 Participants n=5 Participants	180 Participants n=7 Participants	360 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	29 Years n=5 Participants	29 Years n=7 Participants	29 Years n=5 Participants
Sex: Female, Male Female	180 Participants n=5 Participants	180 Participants n=7 Participants	360 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Denmark	180 participants n=5 Participants	180 participants n=7 Participants	360 participants n=5 Participants

PRIMARY outcome

Timeframe: At delivery

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Delivery

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Delivery

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Delivery

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Within 1 month postpartum

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Gestational week 35

Weight at gestational week 35 - weight by inclusion

Outcome measures

Outcome measures
Measure	Lifestyle Intervention n=144 Participants physical activity, dietetic counselling	Control n=148 Participants
Gestational Weight Gain	7.0 kg Interval 4.7 to 10.6	8.6 kg Interval 5.7 to 11.5

SECONDARY outcome

Timeframe: Until 6 months post partum

Outcome measures

Outcome data not reported

Adverse Events

Lifestyle Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Christina Vinter

Odense University Hospital

Phone: +45 21782118

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place