Gestational Weight Gain, Maternal Obesity, Obstetric Complications
Conditions
Brief summary
Obesity is a serious and increasing health problem in the Western World with about one third of all pregnant women in Denmark being overweight. Among these are more than 11% severe obese. Obesity in pregnancy is related to higher maternal morbidity and perinatal morbidity and mortality. Observational studies indicate that the rate of pregnancy complications among obese pregnant women can be limited if weight gain during pregnancy is restricted. Aims of the trial is to study the effects of diet and physical training during pregnancy among Danish obese women. Also to describe the metabolic effects of lifestyle intervention during pregnancy. 360 obese pregnant women with Body Mass Index (BMI) \> 30 are randomized to lifestyle intervention group or control group. The intervention is composed of individual dietician counselling and physical training. The physical training includes weekly aerobic exercises in a fitness center and lifestyle coaching in small groups. Both groups will be examined during pregnancy with extra ultrasound scanning of the fetus, blood pressure, and metabolic markers. All women receive vitamin supplementation to assure sufficient intake.
Interventions
OTHERLifestyle intervention
Dietician counselling and physical training
OTHERControl
Repeated measuring of maternal weight gain, blood samples and ultrasound
BEHAVIORALPhysical activity, dietetic counselling
The active intervention consisted of two major components: dietary counseling and physical activity. Dietary counseling was performed by trained dieticians on four separate occasions at 15, 20, 28 and 35 weeks gestation. Energy requirements for each participant were individually estimated according to weight and level of activity during pregnancy. Women in the active intervention group were encouraged to be moderately physically active 30-60 minutes a day.Women in this group also had free full time membership in a fitness center for six months. In the fitness centers they had closed training classes with trained physiotherapists for one hour each week.
Sponsors
Aarhus University Hospital
Odense University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* singleton pregnant * BMI \>/= 30 and \</= 45
Exclusion criteria
* Chronic diseases * Not Danish speaking * Abuse of alcohol or drugs * Preterm delivery in earlier pregnancies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gestational Diabetes Mellitus | Delivery | — |
| Cesarean Section | At delivery | — |
| Preeclampsia/Pregnancy Induced Hypertension | Delivery | — |
| Gestational Weight Gain | Gestational week 35 | Weight at gestational week 35 - weight by inclusion |
| Large for Gestational Age | Delivery | — |
| Neonatal Intensive Care Unit | Within 1 month postpartum | — |
Secondary
| Measure | Time frame |
|---|---|
| Metabolic Markers | Until 6 months post partum |
Countries
Denmark
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lifestyle Intervention physical activity, dietetic counselling | 180 |
| Control | 180 |
| Total | 360 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | GDM | 9 | 3 |
| Overall Study | Misclassification | 2 | 0 |
| Overall Study | Missed abortion | 1 | 4 |
| Overall Study | Severe malformation/abortion | 0 | 3 |
| Overall Study | Twin pregnancy | 0 | 2 |
| Overall Study | Withdraw | 18 | 14 |
Baseline characteristics
| Characteristic | Lifestyle Intervention | Total | Control |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 180 Participants | 360 Participants | 180 Participants |
| Age Continuous | 29.6 years STANDARD_DEVIATION 4.35 | 29 Years | 29 Years |
| Region of Enrollment Denmark | 180 participants | 360 participants | 180 participants |
| Sex: Female, Male Female | 180 Participants | 360 Participants | 180 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 180 | 0 / 180 |
| serious Total, serious adverse events | 0 / 180 | 0 / 180 |
Outcome results
Primary
Cesarean Section
Time frame: At delivery
Primary
Gestational Diabetes Mellitus
Time frame: Delivery
Primary
Gestational Weight Gain
Weight at gestational week 35 - weight by inclusion
Time frame: Gestational week 35
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lifestyle Intervention | Gestational Weight Gain | 7.0 kg |
| Control | Gestational Weight Gain | 8.6 kg |
p-value: 0.014Wilcoxon (Mann-Whitney)
Primary
Large for Gestational Age
Time frame: Delivery
Primary
Neonatal Intensive Care Unit
Time frame: Within 1 month postpartum
Primary
Preeclampsia/Pregnancy Induced Hypertension
Time frame: Delivery
Secondary
Metabolic Markers
Time frame: Until 6 months post partum