MOMFIT: Maternal-Offspring Metabolics:Family Intervention Trial

• Sponsor: Northwestern University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01631747
• Collaborator: National Institutes of Health (NIH) (NIH), National Heart, Lung, and Blood Institute (NHLBI) (NIH)
• Enrollment: 281
• Locations: 2
• Arms: 2
• Duration (Months): 56.9
• Patients Per Site: 140.5
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy; Weight Gain	Behavioral: Lifestyle Intervention Group; Behavioral: Usual Care Group	N/A

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 281 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Maternal-Offspring Metabolics:Family Intervention Trial (MOMFIT)
• Study Start Date: Nov 1, 2012
• Actual Primary Completion Date: Jul 31, 2017
• Actual Study Completion Date: Jul 31, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Behavioral: 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.
Experimental: 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	Behavioral: 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

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. Fasting Glucose [14-37 wks]

   Blood will be collected at Baseline and 35-37 weeks.

3. High-density Lipoprotein (HDL) [14-37 wks]

   Blood will be collected at Baseline and 35-37 weeks.

4. Low-density Lipoprotein (LDL) [14-37 weeks]

   Blood will be collected at Baseline and 35-37 weeks.

5. Total Cholesterol [14-37 Weeks]

   Blood will be collected at Baseline and 35-37 weeks.

6. Triglycerides [14-37 Weeks]

   Blood will be collected at Baseline and 35-37 weeks.

7. Leptin [14-37 weeks]

   Blood will be collected at Baseline and 35-37 weeks.

8. 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).

9. 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.

10. 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.

11. Birth Weight [Delivery]

    Neonatal Body measurements

12. Birth Length [Delivery]

    Neonate birth measures

13. Head Circumference [Delivery]

    Neonate birth measures

14. Neonate Percent Body Fat [Delivery]

    Neonate percent body fat as measured by PeaPod, and air displacement plethysmography system.

15. Infant Weight [1 year]

    Infant Body measurements

16. Infant Length [1 year]

    Infant body measurement

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern Memorial Hospital; Prentice Women's	Chicago	Illinois	United States	60611
2	Northwestern University: Dept of Preventive Medicine	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University
• National Institutes of Health (NIH)
• National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Linda V Van Horn, PhD, Northwestern University
• Principal Investigator: Alan Peaceman, MD, Northwestern Memorial Hospital

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 28, 2016

More Information

Publications

None provided.

• Responsible Party: Linda Van Horn, Professor, Preventive Medicine, Northwestern University
• ClinicalTrials.gov Identifier: NCT01631747
• Other Study ID Numbers: DK10-014; 1U01HL114344-01
• First Posted: Jun 29, 2012
• Last Update Posted: Nov 6, 2018
• Last Verified: Oct 1, 2018

• Keywords provided by Linda Van Horn, Professor, Preventive Medicine, Northwestern University: Pregnancy; Weight gain; Obesity; Pregnancy and weight gain
• Additional relevant MeSH terms: Weight Gain

Study Results

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 Detail	Women completed baseline clinic visit and two 24 hour recalls prior to randomization.

Arm/Group Title	Usual Care Group	Lifestyle Intervention Group
Arm/Group Description	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.	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
Period Title: Randomization Through End of Pregnancy
STARTED	141	140
COMPLETED	140	140
NOT COMPLETED	1	0
Period Title: Randomization Through End of Pregnancy
STARTED	140	140
COMPLETED	136	139
NOT COMPLETED	4	1
Period Title: Randomization Through End of Pregnancy
STARTED	136	139
COMPLETED	123	130
NOT COMPLETED	13	9

Baseline Characteristics

Arm/Group Title	Usual Care Group	Lifestyle Intervention Group	Total
Arm/Group Description	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.	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	Total of all reporting groups
Overall Participants	141	140	281
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	34 (4)	33 (4)	33 (4)
Sex: Female, Male (Count of Participants)
Female	141 100%	140 100%	281 100%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	30 21.3%	30 21.4%	60 21.4%
Not Hispanic or Latino	111 78.7%	110 78.6%	221 78.6%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	2 1.4%	0 0%	2 0.7%
Asian	4 2.8%	6 4.3%	10 3.6%
Native Hawaiian or Other Pacific Islander	1 0.7%	0 0%	1 0.4%
Black or African American	20 14.2%	34 24.3%	54 19.2%
White	99 70.2%	79 56.4%	178 63.3%
More than one race	5 3.5%	9 6.4%	14 5%
Unknown or Not Reported	10 7.1%	12 8.6%	22 7.8%
Region of Enrollment (participants) [Number]
United States	141 100%	140 100%	281 100%
Gestational Age at Randomization (weeks) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [weeks]	13 (1)	13 (1)	13 (1)
Pre-pregnancy BMI (kg per meters-squared) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg per meters-squared]	31 (4)	31 (4)	31 (4)

Outcome Measures

1. Primary Outcome

Title	Gestational Weight Gain (GWG)
Description	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

Outcome Measure Data

Analysis Population Description

Women who had at least one follow-up weight in addition to baseline clinic weight.

Arm/Group Title	Usual Care Group	Lifestyle Intervention Group
Arm/Group Description	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.	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
Measure Participants	140	140
Mean (Standard Deviation) [kg]	12 (6)	10 (6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care Group, Lifestyle Intervention Group
	Comments	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.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.01
	Comments	p-value is not adjusted for multiple comparisons, and tested at an a priori type I error rate of 0.05.
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Usual Care Group, Lifestyle Intervention Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.02
	Comments
	Method	Regression, Linear
	Comments	adjusted for actual gestational age of 36 week weight, gestational age, bmi, and maternal age at randomization, maternal race and paternal race.

2. Secondary Outcome

Title	Percentage of Participants With Gestational Diabetes
Description	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

Outcome Measure Data

Analysis Population Description

Inadequate testing was done for several participants.

Arm/Group Title	Usual Care Group	Lifestyle Intervention Group
Arm/Group Description	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.	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
Measure Participants	127	133
Count of Participants [Participants]	9 6.4%	7 5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care Group, Lifestyle Intervention Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.54
	Comments
	Method	Chi-squared
	Comments

3. Secondary Outcome

Title	Fasting Glucose
Description	Blood will be collected at Baseline and 35-37 weeks.
Time Frame	14-37 wks

Outcome Measure Data

Analysis Population Description

Participants with valid glucose measures

Arm/Group Title	Usual Care Group	Lifestyle Intervention Group
Arm/Group Description	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.	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 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
Measure Participants	92	102
Baseline	87	86
35-37 Weeks	85	84

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care Group, Lifestyle Intervention Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.89
	Comments
	Method	t-test, 2 sided
	Comments	T-test performed on change in glucose (log scale), but presented as Median and inter-quartile range for interpretability

4. Secondary Outcome

Title	High-density Lipoprotein (HDL)
Description	Blood will be collected at Baseline and 35-37 weeks.
Time Frame	14-37 wks

Outcome Measure Data

Analysis Population Description

Participants with phlebotomy

Arm/Group Title	Usual Care Group	Lifestyle Intervention Group
Arm/Group Description	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.	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
Measure Participants	94	106
Baseline	66	71
35-37 Weeks	68	70

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care Group, Lifestyle Intervention Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.30
	Comments
	Method	t-test, 2 sided
	Comments	t-test performed on changes in HDL, but presented as median and IQR for ease of interpretation

5. Secondary Outcome

Title	Low-density Lipoprotein (LDL)
Description	Blood will be collected at Baseline and 35-37 weeks.
Time Frame	14-37 weeks

Outcome Measure Data

Analysis Population Description

Participants with valid LDL measures

Arm/Group Title	Usual Care Group	Lifestyle Intervention Group
Arm/Group Description	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.	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 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
Measure Participants	90	104
Baseline	95	94
35-37 Weeks	146	130

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care Group, Lifestyle Intervention Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.69
	Comments
	Method	t-test, 2 sided
	Comments	t-test run on changes between groups. Data presented as median and IQR for ease of interpretation

6. Secondary Outcome

Title	Total Cholesterol
Description	Blood will be collected at Baseline and 35-37 weeks.
Time Frame	14-37 Weeks

Outcome Measure Data

Analysis Population Description

participants with Phlebotomy at week 35

Arm/Group Title	Usual Care Group	Lifestyle Intervention Group
Arm/Group Description	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.	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 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
Measure Participants	94	106
Baseline	188	185
35-37 Weeks	255	252

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care Group, Lifestyle Intervention Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.19
	Comments
	Method	t-test, 2 sided
	Comments	t-test run on change between groups (log scale), but presented as median and IQR for ease of interpretation

7. Secondary Outcome

Title	Triglycerides
Description	Blood will be collected at Baseline and 35-37 weeks.
Time Frame	14-37 Weeks

Outcome Measure Data

Analysis Population Description

Participants with phlebotomy at 35 weeks

Arm/Group Title	Usual Care Group	Lifestyle Intervention Group
Arm/Group Description	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.	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 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
Measure Participants	94	106
Baseline	108	109
35-37 Weeks	235	223

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care Group, Lifestyle Intervention Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.27
	Comments
	Method	t-test, 2 sided
	Comments	t-test used to compare changes between groups (log scale). Median and IQR are presented for ease of interpretation.

8. Secondary Outcome

Title	Leptin
Description	Blood will be collected at Baseline and 35-37 weeks.
Time Frame	14-37 weeks

Outcome Measure Data

Analysis Population Description

Participants with phlebotomy at week 35

Arm/Group Title	Usual Care Group	Lifestyle Intervention Group
Arm/Group Description	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.	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 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
Measure Participants	94	106
Baseline	49	50
35-37 Weeks	59	54

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care Group, Lifestyle Intervention Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.003
	Comments
	Method	t-test, 2 sided
	Comments	t-test performed on changes between groups (log scale). Median and IQR are presented for ease of interpretation

9. Secondary Outcome

Title	Steady State Beta Cell Function
Description	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

Outcome Measure Data

Analysis Population Description

Participants with valid glucose measures

Arm/Group Title	Usual Care Group	Lifestyle Intervention Group
Arm/Group Description	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.	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 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
Measure Participants	92	102
Baseline	120	121
35-37 Weeks	174	159

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.24
	Comments
	Method	t-test, 2 sided
	Comments	t-test run on change between groups (log scale), but presented as median and IQR for ease of interpretation

10. Secondary Outcome

Title	Insulin Sensitivity
Description	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

Outcome Measure Data

Analysis Population Description

Participants with valid glucose measures

Arm/Group Title	Usual Care Group	Lifestyle Intervention Group
Arm/Group Description	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.	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 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
Measure Participants	92	102
Baseline	78	87
35-37 Weeks	51	62

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care Group, Lifestyle Intervention Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.32
	Comments
	Method	t-test, 2 sided
	Comments	t-test run on change between groups (log scale), but presented as median and IQR for ease of interpretation

11. Secondary Outcome

Title	Insulin Resistance (IR)
Description	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

Outcome Measure Data

Analysis Population Description

Participants with valid glucose levels.

Arm/Group Title	Usual Care Group	Lifestyle Intervention Group
Arm/Group Description	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.	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 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
Measure Participants	92	102
Baseline	1.3	1.2
35-37 Weeks	2.0	1.6

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care Group, Lifestyle Intervention Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.26
	Comments
	Method	t-test, 2 sided
	Comments	T-test performed on change between groups (log scale). Median and IQR are presented for ease of interpretation

12. Secondary Outcome

Title	Birth Weight
Description	Neonatal Body measurements
Time Frame	Delivery

Outcome Measure Data

Analysis Population Description

Participants with live births

Arm/Group Title	Usual Care Group	Lifestyle Intervention Group
Arm/Group Description	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.	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
Measure Participants	121	130
Mean (Standard Deviation) [g]	3213 (524)	3244 (489)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care Group, Lifestyle Intervention Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.62
	Comments
	Method	t-test, 2 sided
	Comments

13. Secondary Outcome

Title	Birth Length
Description	Neonate birth measures
Time Frame	Delivery

Outcome Measure Data

Analysis Population Description

participants with live births

Arm/Group Title	Usual Care Group	Lifestyle Intervention Group
Arm/Group Description	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.	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
Measure Participants	121	130
Mean (Standard Deviation) [cm]	51 (3)	51 (2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care Group, Lifestyle Intervention Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.61
	Comments
	Method	t-test, 2 sided
	Comments

14. Secondary Outcome

Title	Head Circumference
Description	Neonate birth measures
Time Frame	Delivery

Outcome Measure Data

Analysis Population Description

Live births

Arm/Group Title	Usual Care Group	Lifestyle Intervention Group
Arm/Group Description	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.	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
Measure Participants	121	130
Mean (Standard Deviation) [cm]	34 (2)	34 (2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care Group, Lifestyle Intervention Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.42
	Comments
	Method	t-test, 2 sided
	Comments

15. Secondary Outcome

Title	Neonate Percent Body Fat
Description	Neonate percent body fat as measured by PeaPod, and air displacement plethysmography system.
Time Frame	Delivery

Outcome Measure Data

Analysis Population Description

Participants with PeaPod measurements

Arm/Group Title	Usual Care Group	Lifestyle Intervention Group
Arm/Group Description	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.	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
Measure Participants	92	106
Mean (Standard Deviation) [percentage of weight]	11.9 (4.2)	11.2 (4.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care Group, Lifestyle Intervention Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.25
	Comments
	Method	t-test, 2 sided
	Comments

16. Secondary Outcome

Title	Infant Weight
Description	Infant Body measurements
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Participants with measured or reported 1 year infant weight

Arm/Group Title	Usual Care Group	Lifestyle Intervention Group
Arm/Group Description	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.	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
Measure Participants	123	130
Mean (Standard Deviation) [kg]	9.9 (1.2)	9.9 (1.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care Group, Lifestyle Intervention Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.66
	Comments
	Method	t-test, 2 sided
	Comments

17. Secondary Outcome

Title	Infant Length
Description	Infant body measurement
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Participants with one year infant body measures

Arm/Group Title	Usual Care Group	Lifestyle Intervention Group
Arm/Group Description	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.	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
Measure Participants	118	125
Mean (Standard Deviation) [cm]	76.3 (3.6)	76.2 (3.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care Group, Lifestyle Intervention Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.94
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Time Frame	Each participant was followed from initial contact through delivery for adverse events (approximately 7 months).
Arm/Group Title	Usual Care Group		Lifestyle Intervention Group
Arm/Group Description	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.		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
All Cause Mortality
	Usual Care Group		Lifestyle Intervention Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/141 (0%)		0/140 (0%)
Serious Adverse Events
	Usual Care Group		Lifestyle Intervention Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	29/141 (20.6%)		18/140 (12.9%)
Cardiac disorders
Tachycardia	1/141 (0.7%)	1	0/140 (0%)	0
Congenital, familial and genetic disorders
Congenital anomaly	7/141 (5%)	7	2/140 (1.4%)	2
General disorders
NICU admission	18/141 (12.8%)	18	12/140 (8.6%)	12
Hepatobiliary disorders
Cholestasis	1/141 (0.7%)	1	1/140 (0.7%)	1
Infections and infestations
Chorioamnionitis	1/141 (0.7%)	1	0/140 (0%)	0
Pregnancy, puerperium and perinatal conditions
Pregnancy Loss/Termination	4/141 (2.8%)	4	1/140 (0.7%)	1
Abruption	1/141 (0.7%)	1	0/140 (0%)	1
Preeclampsia	6/141 (4.3%)	6	6/140 (4.3%)	6
Preterm labor	1/141 (0.7%)	1	1/140 (0.7%)	1
Vasa Previa	0/141 (0%)	0	1/140 (0.7%)	1
Respiratory, thoracic and mediastinal disorders
Respiratory	0/141 (0%)	0	1/140 (0.7%)	1
Surgical and medical procedures
Postpartum maternal infection	1/141 (0.7%)	1	0/140 (0%)	0
Other (Not Including Serious) Adverse Events
	Usual Care Group		Lifestyle Intervention Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/141 (3.5%)		3/140 (2.1%)
Endocrine disorders
Small for gestational age	5/141 (3.5%)	5	3/140 (2.1%)	3

Limitations/Caveats

The study recruited 281 participants, fewer than the target sample size of 300; this did not impact power for the primary outcome (higher retention rates), but requires attention when considering translational implications to a clinic setting.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.