Pregnancy, Weight Gain
Conditions
Keywords
Pregnancy, Weight gain, Obesity, Pregnancy and weight gain
Brief summary
The prevalence of maternal overweight and obesity has nearly doubled in the United States since 1976. In 2004-2005, 42% of pregnant women had body mass index (BMI) above 25 versus 23% in 1993. Most American women are overweight/ obese (OW/OB) at conception, especially within certain racial, ethnic, and lower socioeconomic groups leading to increased adverse maternal and birth outcomes. This study will recruit, randomize and test in 300 ethnically diverse OW/OB pregnant women a behavioral intervention aimed at controlling gestational weight gain (GWG) through recommended diet, activity and lifestyle changes that are to be maintained postpartum. Outcomes include anthropometric (height, weight, percent body fat) metabolic (blood pressure, fasting glucose, insulin, HbA1c, lipids and C-reactive protein) and behavioral measures (diet. physical activity, sleep and stress). In addition, babies will be measured for length, weight and percent body fat. The goal is to limit excessive gestational weight gain through improved maternal lifestyle that can be maintained and modelled for the family post partum and beyond.
Detailed description
A Randomized Control Trial is planned among ethnically diverse OW/OB pregnant women ages 18-45 years to be randomly assigned to the MOMFIT Active Intervention Group (AIG) or the Educational Control Group (ECG) plus standard obstetrical care. The Dietary Approaches to Stop Hypertension (DASH) diet, along with moderate physical activity and group intervention as utilized in the Diabetes Prevention Program (DPP), will be adapted for pregnant and postpartum women through individual visits to tailor calorie/nutrient/activity goals, plus group coaching sessions and electronic self-monitoring behavior. Evidence based motivational interviewing and state of the art self-monitoring tools involving the LoseIt app will be adapted for pregnant/postpartum women via smartphone or Internet access, along with tailored feedback and encouragement from the Lifestyle Coach. Prevention of excessive GWG and achievement of the Institute Of Medicine (IOM) weight gain goals will be compared between groups, whether ongoing adherence to the lifestyle interventions can be sustained through postpartum intervention. Approximately one third of the participants are expected to be minorities and/or from low income backgrounds. The primary outcome is gestational weight gain from baseline (self-reported prepregnancy weight) to near delivery (36 weeks) compared with IOM goals in both groups and postpartum weight retention between 6 weeks and 12 months postpartum. Additional outcome variables include changes in maternal Body Mass Index (BMI) and adiposity postpartum, blood pressure, blood glucose, insulin, Hemoglobin A1c (HbA1c), C-reactive Protein (CRP), and lipids, diet quality, and physical activity levels, offspring adiposity and anthropometrics, and glucose and C-peptide in cord blood
Interventions
BEHAVIORALLifestyle Intervention Group
Moms will meet individually with their Lifestyle Coach (LC)at least 3 times(more as needed, attend six sessions during pregnancy and one session after delivery. In addition moms will participate in monthly phone counseling sessions with Lifestyle Coach and complete daily tracking of diet & activity and use of pedometer
BEHAVIORALUsual Care Group
Mom and family continue their typical eating, activity and other lifestyle habits for 24 months. They are invited to attend quarterly classes addressing prenatal wellness and family topics.
Sponsors
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-45 years * Singleton viable pregnancy. A twin pregnancy reduced to singleton before 14 weeks by project gestational age. An ultrasound must be conducted before randomization that shows a fetal heartbeat; there should be no evidence of more than one fetus on the most recent pre-randomization ultrasound. * Gestational age at randomization no earlier than 9 weeks 0 days and no later than 15 weeks 6 days based on an algorithm (see Section 3.4.3 below) that compares the last menstrual period (LMP) date and data from the earliest ultrasound * Body mass index between 25-35 kg/m2 based on first trimester measured weight and on measured height. The earliest weight measurement before randomization, measured specifically for the study will be used.
Exclusion criteria
* In vitro fertilization (IVF) conception/ovulation induction w/ gonadotropins * Weight gain of \>15 pounds from reported prepregnancy weight to Baseline visit * Current smoker * Prior bariatric surgery * In weight loss program w/in 3 months of conception * History of alcohol or drug abuse within 5 years * No access to internet and/or smartphone * Unable to attend intervention/follow-up visits * Unwilling/unable to commit to self-monitoring data collection * Unable to complete intervention program * Presence of any condition that limits walking or following diet recommendations * Not fluent in English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gestational Weight Gain (GWG) | 14-37 weeks | The primary outcome is GWG as assessed continuously by the difference between the maternal weight measured at the baseline and at the 35-37 week visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Gestational Diabetes | 24-26 weeks | Oral Glucose Tolerance Test (OGTT) will be administered at 24-26wks, as part of routine obstetric visit. Difference in incidence of Gestational diabetes between study groups will be documented. |
| Fasting Glucose | 14-37 wks | Blood will be collected at Baseline and 35-37 weeks. |
| High-density Lipoprotein (HDL) | 14-37 wks | Blood will be collected at Baseline and 35-37 weeks. |
| Low-density Lipoprotein (LDL) | 14-37 weeks | Blood will be collected at Baseline and 35-37 weeks. |
| Total Cholesterol | 14-37 Weeks | Blood will be collected at Baseline and 35-37 weeks. |
| Triglycerides | 14-37 Weeks | Blood will be collected at Baseline and 35-37 weeks. |
| Leptin | 14-37 weeks | Blood will be collected at Baseline and 35-37 weeks. |
| Steady State Beta Cell Function | baseline (14 weeks) and 35-37 weeks | Insulin resistance will be measured with the assistance of a computer program (HOMA Calculator v2.2.3, Diabetic Trial Unit, University of Oxford) which uses blood Glucose and Insulin measures to yield the Homeostatic Model Assessment (HOMA) Steady State beta cell function (%B). 100% is set at normal reference. Should not be interpreted alone, but in combination with Insulin Sensitivity (%S). |
| Insulin Sensitivity | baseline(14 weeks) and 35-37 weeks | Insulin resistance will be measured with the assistance of a computer program which will yield the Homeostatic Model Assessment (HOMA) Insulin Sensitivity (%S). 100% is equivalent to the normal reference, but needs to be interpreted in context of %B. |
| Insulin Resistance (IR) | Baseline (14 weeks) and 35 weeks | Insulin resistance will be measured with the assistance of a computer program (HOMA Calculator v2.2.3, Diabetic Trial Unit, University of Oxford) which uses blood Glucose and Insulin measures to yield the Homeostatic Model Assessment (HOMA) Insulin Resistance. HOMA IR (insulin resistance) is the reciprocal of insulin sensitivity (%S), as a percentage of a normal reference population (100/%S); Lower IR is better. Note: estimates are model-derived, and not linear approximations. |
| Birth Weight | Delivery | Neonatal Body measurements |
| Birth Length | Delivery | Neonate birth measures |
| Head Circumference | Delivery | Neonate birth measures |
| Neonate Percent Body Fat | Delivery | Neonate percent body fat as measured by PeaPod, and air displacement plethysmography system. |
| Infant Weight | 1 year | Infant Body measurements |
| Infant Length | 1 year | Infant body measurement |
Countries
United States
Participant flow
Recruitment details
Women were screened from multiple practices at the Prentice Women's Hospital of Northwestern Memorial Hospital. Screening took place between Feb 2013-Dec 2015.
Pre-assignment details
Women completed baseline clinic visit and two 24 hour recalls prior to randomization.
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Group Mom and family continue their typical eating, activity and other lifestyle habits for 24 months. They are invited to attend quarterly classes addressing prenatal wellness and family topics.
Usual Care Group: Mom and family continue their typical eating, activity and other lifestyle habits for 24 months. They are invited to attend quarterly classes addressing prenatal wellness and family topics. | 141 |
| Lifestyle Intervention Group Moms will meet individually with their Lifestyle Coach (LC)at least 3 times(more as needed, attend six sessions during pregnancy and one session after delivery. In addition moms will participate in monthly phone counseling sessions with Lifestyle Coach and complete daily tracking of diet & activity and use of pedometer
Lifestyle Intervention Group: Women in the Intervention group will participate in a lifestyle program based on Moms'adopting a healthier diet and becoming more active for 24 months. Implementation is at approximately 15 weeks.Moms will meet individually with their Lifestyle Coach (LC)at least 3 times(more as needed, attend six sessions during pregnancy and one session after delivery. In addition moms will participate in monthly phone counseling sessions with Lifestyle Coach and complete daily tracking of diet & activity and use of pedometer | 140 |
| Total | 281 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Live Birth | MIscarriage | 2 | 0 |
| Live Birth | Pregnancy Termination | 1 | 0 |
| Live Birth | Stillbirth | 1 | 1 |
| One Year Infant Outcomes | Patient Refused | 13 | 9 |
| Randomization Through End of Pregnancy | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | Lifestyle Intervention Group | Total | Usual Care Group |
|---|---|---|---|
| Age, Continuous | 33 years STANDARD_DEVIATION 4 | 33 years STANDARD_DEVIATION 4 | 34 years STANDARD_DEVIATION 4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 30 Participants | 60 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 110 Participants | 221 Participants | 111 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Gestational Age at Randomization | 13 weeks STANDARD_DEVIATION 1 | 13 weeks STANDARD_DEVIATION 1 | 13 weeks STANDARD_DEVIATION 1 |
| Pre-pregnancy BMI | 31 kg per meters-squared STANDARD_DEVIATION 4 | 31 kg per meters-squared STANDARD_DEVIATION 4 | 31 kg per meters-squared STANDARD_DEVIATION 4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 10 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 34 Participants | 54 Participants | 20 Participants |
| Race (NIH/OMB) More than one race | 9 Participants | 14 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 12 Participants | 22 Participants | 10 Participants |
| Race (NIH/OMB) White | 79 Participants | 178 Participants | 99 Participants |
| Region of Enrollment United States | 140 participants | 281 participants | 141 participants |
| Sex: Female, Male Female | 140 Participants | 281 Participants | 141 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 | 0 / 141 | 0 / 140 |
| other Total, other adverse events | 5 / 141 | 3 / 140 |
| serious Total, serious adverse events | 29 / 141 | 18 / 140 |
Outcome results
Primary
Gestational Weight Gain (GWG)
The primary outcome is GWG as assessed continuously by the difference between the maternal weight measured at the baseline and at the 35-37 week visit.
Time frame: 14-37 weeks
Population: Women who had at least one follow-up weight in addition to baseline clinic weight.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care Group | Gestational Weight Gain (GWG) | 12 kg | Standard Deviation 6 |
| Lifestyle Intervention Group | Gestational Weight Gain (GWG) | 10 kg | Standard Deviation 6 |
Comparison: Sample size was based on an independent 2-sample t-test using a two-sided type 1 error rate of 0.05, and 80% power. Assuming a standard deviation (SD) of 15lbs (6.8kg), a clinically meaningful difference of 5lbs (2.4kg) between groups, and 10% attrition, a sample size of 150/group was required.p-value: 0.01t-test, 2 sided
p-value: 0.02Regression, Linear
Secondary
Birth Length
Neonate birth measures
Time frame: Delivery
Population: participants with live births
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care Group | Birth Length | 51 cm | Standard Deviation 3 |
| Lifestyle Intervention Group | Birth Length | 51 cm | Standard Deviation 2 |
p-value: 0.61t-test, 2 sided
Secondary
Birth Weight
Neonatal Body measurements
Time frame: Delivery
Population: Participants with live births
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care Group | Birth Weight | 3213 g | Standard Deviation 524 |
| Lifestyle Intervention Group | Birth Weight | 3244 g | Standard Deviation 489 |
p-value: 0.62t-test, 2 sided
Secondary
Fasting Glucose
Blood will be collected at Baseline and 35-37 weeks.
Time frame: 14-37 wks
Population: Participants with valid glucose measures
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Usual Care Group | Fasting Glucose | Baseline | 87 mg/dL |
| Usual Care Group | Fasting Glucose | 35-37 Weeks | 85 mg/dL |
| Lifestyle Intervention Group | Fasting Glucose | Baseline | 86 mg/dL |
| Lifestyle Intervention Group | Fasting Glucose | 35-37 Weeks | 84 mg/dL |
p-value: 0.89t-test, 2 sided
Secondary
Head Circumference
Neonate birth measures
Time frame: Delivery
Population: Live births
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care Group | Head Circumference | 34 cm | Standard Deviation 2 |
| Lifestyle Intervention Group | Head Circumference | 34 cm | Standard Deviation 2 |
p-value: 0.42t-test, 2 sided
Secondary
High-density Lipoprotein (HDL)
Blood will be collected at Baseline and 35-37 weeks.
Time frame: 14-37 wks
Population: Participants with phlebotomy
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Usual Care Group | High-density Lipoprotein (HDL) | Baseline | 66 mg/dL |
| Usual Care Group | High-density Lipoprotein (HDL) | 35-37 Weeks | 68 mg/dL |
| Lifestyle Intervention Group | High-density Lipoprotein (HDL) | Baseline | 71 mg/dL |
| Lifestyle Intervention Group | High-density Lipoprotein (HDL) | 35-37 Weeks | 70 mg/dL |
p-value: 0.3t-test, 2 sided
Secondary
Infant Length
Infant body measurement
Time frame: 1 year
Population: Participants with one year infant body measures
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care Group | Infant Length | 76.3 cm | Standard Deviation 3.6 |
| Lifestyle Intervention Group | Infant Length | 76.2 cm | Standard Deviation 3.5 |
p-value: 0.94t-test, 2 sided
Secondary
Infant Weight
Infant Body measurements
Time frame: 1 year
Population: Participants with measured or reported 1 year infant weight
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care Group | Infant Weight | 9.9 kg | Standard Deviation 1.2 |
| Lifestyle Intervention Group | Infant Weight | 9.9 kg | Standard Deviation 1.3 |
p-value: 0.66t-test, 2 sided
Secondary
Insulin Resistance (IR)
Insulin resistance will be measured with the assistance of a computer program (HOMA Calculator v2.2.3, Diabetic Trial Unit, University of Oxford) which uses blood Glucose and Insulin measures to yield the Homeostatic Model Assessment (HOMA) Insulin Resistance. HOMA IR (insulin resistance) is the reciprocal of insulin sensitivity (%S), as a percentage of a normal reference population (100/%S); Lower IR is better. Note: estimates are model-derived, and not linear approximations.
Time frame: Baseline (14 weeks) and 35 weeks
Population: Participants with valid glucose levels.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Usual Care Group | Insulin Resistance (IR) | Baseline | 1.3 inverse proportion of normal reference |
| Usual Care Group | Insulin Resistance (IR) | 35-37 Weeks | 2.0 inverse proportion of normal reference |
| Lifestyle Intervention Group | Insulin Resistance (IR) | 35-37 Weeks | 1.6 inverse proportion of normal reference |
| Lifestyle Intervention Group | Insulin Resistance (IR) | Baseline | 1.2 inverse proportion of normal reference |
p-value: 0.26t-test, 2 sided
Secondary
Insulin Sensitivity
Insulin resistance will be measured with the assistance of a computer program which will yield the Homeostatic Model Assessment (HOMA) Insulin Sensitivity (%S). 100% is equivalent to the normal reference, but needs to be interpreted in context of %B.
Time frame: baseline(14 weeks) and 35-37 weeks
Population: Participants with valid glucose measures
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Usual Care Group | Insulin Sensitivity | Baseline | 78 percentage of normal reference |
| Usual Care Group | Insulin Sensitivity | 35-37 Weeks | 51 percentage of normal reference |
| Lifestyle Intervention Group | Insulin Sensitivity | Baseline | 87 percentage of normal reference |
| Lifestyle Intervention Group | Insulin Sensitivity | 35-37 Weeks | 62 percentage of normal reference |
p-value: 0.32t-test, 2 sided
Secondary
Leptin
Blood will be collected at Baseline and 35-37 weeks.
Time frame: 14-37 weeks
Population: Participants with phlebotomy at week 35
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Usual Care Group | Leptin | 35-37 Weeks | 59 ug/L |
| Usual Care Group | Leptin | Baseline | 49 ug/L |
| Lifestyle Intervention Group | Leptin | 35-37 Weeks | 54 ug/L |
| Lifestyle Intervention Group | Leptin | Baseline | 50 ug/L |
p-value: 0.003t-test, 2 sided
Secondary
Low-density Lipoprotein (LDL)
Blood will be collected at Baseline and 35-37 weeks.
Time frame: 14-37 weeks
Population: Participants with valid LDL measures
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Usual Care Group | Low-density Lipoprotein (LDL) | Baseline | 95 mg/dL |
| Usual Care Group | Low-density Lipoprotein (LDL) | 35-37 Weeks | 146 mg/dL |
| Lifestyle Intervention Group | Low-density Lipoprotein (LDL) | Baseline | 94 mg/dL |
| Lifestyle Intervention Group | Low-density Lipoprotein (LDL) | 35-37 Weeks | 130 mg/dL |
p-value: 0.69t-test, 2 sided
Secondary
Neonate Percent Body Fat
Neonate percent body fat as measured by PeaPod, and air displacement plethysmography system.
Time frame: Delivery
Population: Participants with PeaPod measurements
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care Group | Neonate Percent Body Fat | 11.9 percentage of weight | Standard Deviation 4.2 |
| Lifestyle Intervention Group | Neonate Percent Body Fat | 11.2 percentage of weight | Standard Deviation 4.4 |
p-value: 0.25t-test, 2 sided
Secondary
Percentage of Participants With Gestational Diabetes
Oral Glucose Tolerance Test (OGTT) will be administered at 24-26wks, as part of routine obstetric visit. Difference in incidence of Gestational diabetes between study groups will be documented.
Time frame: 24-26 weeks
Population: Inadequate testing was done for several participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care Group | Percentage of Participants With Gestational Diabetes | 9 Participants |
| Lifestyle Intervention Group | Percentage of Participants With Gestational Diabetes | 7 Participants |
p-value: 0.54Chi-squared
Secondary
Steady State Beta Cell Function
Insulin resistance will be measured with the assistance of a computer program (HOMA Calculator v2.2.3, Diabetic Trial Unit, University of Oxford) which uses blood Glucose and Insulin measures to yield the Homeostatic Model Assessment (HOMA) Steady State beta cell function (%B). 100% is set at normal reference. Should not be interpreted alone, but in combination with Insulin Sensitivity (%S).
Time frame: baseline (14 weeks) and 35-37 weeks
Population: Participants with valid glucose measures
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Usual Care Group | Steady State Beta Cell Function | Baseline | 120 percentage of normal reference |
| Usual Care Group | Steady State Beta Cell Function | 35-37 Weeks | 174 percentage of normal reference |
| Lifestyle Intervention Group | Steady State Beta Cell Function | Baseline | 121 percentage of normal reference |
| Lifestyle Intervention Group | Steady State Beta Cell Function | 35-37 Weeks | 159 percentage of normal reference |
p-value: 0.24t-test, 2 sided
Secondary
Total Cholesterol
Blood will be collected at Baseline and 35-37 weeks.
Time frame: 14-37 Weeks
Population: participants with Phlebotomy at week 35
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Usual Care Group | Total Cholesterol | Baseline | 188 mg/dL |
| Usual Care Group | Total Cholesterol | 35-37 Weeks | 255 mg/dL |
| Lifestyle Intervention Group | Total Cholesterol | Baseline | 185 mg/dL |
| Lifestyle Intervention Group | Total Cholesterol | 35-37 Weeks | 252 mg/dL |
p-value: 0.19t-test, 2 sided
Secondary
Triglycerides
Blood will be collected at Baseline and 35-37 weeks.
Time frame: 14-37 Weeks
Population: Participants with phlebotomy at 35 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Usual Care Group | Triglycerides | Baseline | 108 mg/dL |
| Usual Care Group | Triglycerides | 35-37 Weeks | 235 mg/dL |
| Lifestyle Intervention Group | Triglycerides | Baseline | 109 mg/dL |
| Lifestyle Intervention Group | Triglycerides | 35-37 Weeks | 223 mg/dL |
p-value: 0.27t-test, 2 sided