Trial Outcomes & Findings for Maternal-Offspring Metabolics:Family Intervention Trial (NCT NCT01631747)

NCT ID: NCT01631747

Last Updated: 2018-11-06

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 281 participants
• Primary outcome timeframe: 14-37 weeks
• Results posted on: 2018-11-06

Participant Flow

Women were screened from multiple practices at the Prentice Women's Hospital of Northwestern Memorial Hospital. Screening took place between Feb 2013-Dec 2015.

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

Participant milestones

Measure	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.	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
Randomization Through End of Pregnancy STARTED	141	140
Randomization Through End of Pregnancy COMPLETED	140	140
Randomization Through End of Pregnancy NOT COMPLETED	1	0
Live Birth STARTED	140	140
Live Birth COMPLETED	136	139
Live Birth NOT COMPLETED	4	1
One Year Infant Outcomes STARTED	136	139
One Year Infant Outcomes COMPLETED	123	130
One Year Infant Outcomes NOT COMPLETED	13	9

Reasons for withdrawal

Measure	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.	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
Randomization Through End of Pregnancy Lost to Follow-up	1	0
Live Birth Pregnancy Termination	1	0
Live Birth MIscarriage	2	0
Live Birth Stillbirth	1	1
One Year Infant Outcomes Patient Refused	13	9

Baseline Characteristics

Maternal-Offspring Metabolics:Family Intervention Trial

Baseline characteristics by cohort

Measure	Usual Care Group n=141 Participants 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.	Lifestyle Intervention Group n=140 Participants 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 n=281 Participants Total of all reporting groups
Age, Continuous	34 years STANDARD_DEVIATION 4 • n=5 Participants	33 years STANDARD_DEVIATION 4 • n=7 Participants	33 years STANDARD_DEVIATION 4 • n=5 Participants
Sex: Female, Male Female	141 Participants n=5 Participants	140 Participants n=7 Participants	281 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	111 Participants n=5 Participants	110 Participants n=7 Participants	221 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	20 Participants n=5 Participants	34 Participants n=7 Participants	54 Participants n=5 Participants
Race (NIH/OMB) White	99 Participants n=5 Participants	79 Participants n=7 Participants	178 Participants n=5 Participants
Race (NIH/OMB) More than one race	5 Participants n=5 Participants	9 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants
Region of Enrollment United States	141 participants n=5 Participants	140 participants n=7 Participants	281 participants n=5 Participants
Gestational Age at Randomization	13 weeks STANDARD_DEVIATION 1 • n=5 Participants	13 weeks STANDARD_DEVIATION 1 • n=7 Participants	13 weeks STANDARD_DEVIATION 1 • n=5 Participants
Pre-pregnancy BMI	31 kg per meters-squared STANDARD_DEVIATION 4 • n=5 Participants	31 kg per meters-squared STANDARD_DEVIATION 4 • n=7 Participants	31 kg per meters-squared STANDARD_DEVIATION 4 • n=5 Participants

PRIMARY outcome

Timeframe: 14-37 weeks

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

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.

Outcome measures

Measure	Usual Care Group n=140 Participants 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.	Lifestyle Intervention Group n=140 Participants 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
Gestational Weight Gain (GWG)	12 kg Standard Deviation 6	10 kg Standard Deviation 6

SECONDARY outcome

Timeframe: 24-26 weeks

Population: Inadequate testing was done for several participants.

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.

Outcome measures

Measure	Usual Care Group n=127 Participants 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.	Lifestyle Intervention Group n=133 Participants 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
Percentage of Participants With Gestational Diabetes	9 Participants	7 Participants

SECONDARY outcome

Timeframe: 14-37 wks

Population: Participants with valid glucose measures

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

Outcome measures

Measure	Usual Care Group n=92 Participants 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.	Lifestyle Intervention Group n=102 Participants 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
Fasting Glucose Baseline	87 mg/dL Interval 83.0 to 91.0	86 mg/dL Interval 82.0 to 90.0
Fasting Glucose 35-37 Weeks	85 mg/dL Interval 81.0 to 89.0	84 mg/dL Interval 80.0 to 89.0

SECONDARY outcome

Timeframe: 14-37 wks

Population: Participants with phlebotomy

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

Outcome measures

Measure	Usual Care Group n=94 Participants 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.	Lifestyle Intervention Group n=106 Participants 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
High-density Lipoprotein (HDL) Baseline	66 mg/dL Interval 58.0 to 78.0	71 mg/dL Interval 60.0 to 80.0
High-density Lipoprotein (HDL) 35-37 Weeks	68 mg/dL Interval 57.0 to 79.0	70 mg/dL Interval 56.0 to 82.0

SECONDARY outcome

Timeframe: 14-37 weeks

Population: Participants with valid LDL measures

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

Outcome measures

Measure	Usual Care Group n=90 Participants 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.	Lifestyle Intervention Group n=104 Participants 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
Low-density Lipoprotein (LDL) Baseline	95 mg/dL Interval 79.0 to 112.0	94 mg/dL Interval 78.0 to 117.0
Low-density Lipoprotein (LDL) 35-37 Weeks	146 mg/dL Interval 103.0 to 164.0	130 mg/dL Interval 106.0 to 163.0

SECONDARY outcome

Timeframe: 14-37 Weeks

Population: participants with Phlebotomy at week 35

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

Outcome measures

Measure	Usual Care Group n=94 Participants 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.	Lifestyle Intervention Group n=106 Participants 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 Cholesterol Baseline	188 mg/dL Interval 167.0 to 205.0	185 mg/dL Interval 164.0 to 208.0
Total Cholesterol 35-37 Weeks	255 mg/dL Interval 219.0 to 290.0	252 mg/dL Interval 222.0 to 281.0

SECONDARY outcome

Timeframe: 14-37 Weeks

Population: Participants with phlebotomy at 35 weeks

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

Outcome measures

Measure	Usual Care Group n=94 Participants 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.	Lifestyle Intervention Group n=106 Participants 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
Triglycerides Baseline	108 mg/dL Interval 86.0 to 138.0	109 mg/dL Interval 81.0 to 131.0
Triglycerides 35-37 Weeks	235 mg/dL Interval 187.0 to 300.0	223 mg/dL Interval 180.0 to 271.0

SECONDARY outcome

Timeframe: 14-37 weeks

Population: Participants with phlebotomy at week 35

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

Outcome measures

Measure	Usual Care Group n=94 Participants 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.	Lifestyle Intervention Group n=106 Participants 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
Leptin Baseline	49 ug/L Interval 40.0 to 58.0	50 ug/L Interval 40.0 to 61.0
Leptin 35-37 Weeks	59 ug/L Interval 49.0 to 68.0	54 ug/L Interval 44.0 to 67.0

SECONDARY outcome

Timeframe: baseline (14 weeks) and 35-37 weeks

Population: Participants with valid glucose measures

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).

Outcome measures

Measure	Usual Care Group n=92 Participants 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.	Lifestyle Intervention Group n=102 Participants 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
Steady State Beta Cell Function Baseline	120 percentage of normal reference Interval 99.0 to 150.0	121 percentage of normal reference Interval 98.0 to 145.0
Steady State Beta Cell Function 35-37 Weeks	174 percentage of normal reference Interval 137.0 to 205.0	159 percentage of normal reference Interval 133.0 to 195.0

SECONDARY outcome

Timeframe: baseline(14 weeks) and 35-37 weeks

Population: Participants with valid glucose measures

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.

Outcome measures

Measure	Usual Care Group n=92 Participants 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.	Lifestyle Intervention Group n=102 Participants 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
Insulin Sensitivity Baseline	78 percentage of normal reference Interval 56.0 to 107.0	87 percentage of normal reference Interval 59.0 to 112.0
Insulin Sensitivity 35-37 Weeks	51 percentage of normal reference Interval 39.0 to 74.0	62 percentage of normal reference Interval 41.0 to 80.0

SECONDARY outcome

Timeframe: Baseline (14 weeks) and 35 weeks

Population: Participants with valid glucose levels.

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.

Outcome measures

Measure	Usual Care Group n=92 Participants 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.	Lifestyle Intervention Group n=102 Participants 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
Insulin Resistance (IR) Baseline	1.3 inverse proportion of normal reference Interval 0.9 to 1.8	1.2 inverse proportion of normal reference Interval 0.9 to 1.7
Insulin Resistance (IR) 35-37 Weeks	2.0 inverse proportion of normal reference Interval 1.4 to 2.6	1.6 inverse proportion of normal reference Interval 1.3 to 2.4

SECONDARY outcome

Timeframe: Delivery

Population: Participants with live births

Neonatal Body measurements

Outcome measures

Measure	Usual Care Group n=121 Participants 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.	Lifestyle Intervention Group n=130 Participants 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
Birth Weight	3213 g Standard Deviation 524	3244 g Standard Deviation 489

SECONDARY outcome

Timeframe: Delivery

Population: participants with live births

Neonate birth measures

Outcome measures

Measure	Usual Care Group n=121 Participants 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.	Lifestyle Intervention Group n=130 Participants 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
Birth Length	51 cm Standard Deviation 3	51 cm Standard Deviation 2

SECONDARY outcome

Timeframe: Delivery

Population: Live births

Neonate birth measures

Outcome measures

Measure	Usual Care Group n=121 Participants 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.	Lifestyle Intervention Group n=130 Participants 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
Head Circumference	34 cm Standard Deviation 2	34 cm Standard Deviation 2

SECONDARY outcome

Timeframe: Delivery

Population: Participants with PeaPod measurements

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

Outcome measures

Measure	Usual Care Group n=92 Participants 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.	Lifestyle Intervention Group n=106 Participants 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
Neonate Percent Body Fat	11.9 percentage of weight Standard Deviation 4.2	11.2 percentage of weight Standard Deviation 4.4

SECONDARY outcome

Timeframe: 1 year

Population: Participants with measured or reported 1 year infant weight

Infant Body measurements

Outcome measures

Measure	Usual Care Group n=123 Participants 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.	Lifestyle Intervention Group n=130 Participants 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
Infant Weight	9.9 kg Standard Deviation 1.2	9.9 kg Standard Deviation 1.3

SECONDARY outcome

Timeframe: 1 year

Population: Participants with one year infant body measures

Infant body measurement

Outcome measures

Measure	Usual Care Group n=118 Participants 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.	Lifestyle Intervention Group n=125 Participants 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
Infant Length	76.3 cm Standard Deviation 3.6	76.2 cm Standard Deviation 3.5

Adverse Events

Usual Care Group

Serious events: 29 serious events

Other events: 5 other events

Deaths: 0 deaths

Lifestyle Intervention Group

Serious events: 18 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Usual Care Group n=141 participants at risk 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.	Lifestyle Intervention Group n=140 participants at risk 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
Pregnancy, puerperium and perinatal conditions Pregnancy Loss/Termination	2.8% 4/141 • Number of events 4 • Each participant was followed from initial contact through delivery for adverse events (approximately 7 months).	0.71% 1/140 • Number of events 1 • Each participant was followed from initial contact through delivery for adverse events (approximately 7 months).
Pregnancy, puerperium and perinatal conditions Abruption	0.71% 1/141 • Number of events 1 • Each participant was followed from initial contact through delivery for adverse events (approximately 7 months).	0.00% 0/140 • Each participant was followed from initial contact through delivery for adverse events (approximately 7 months).
Pregnancy, puerperium and perinatal conditions Preeclampsia	4.3% 6/141 • Number of events 6 • Each participant was followed from initial contact through delivery for adverse events (approximately 7 months).	4.3% 6/140 • Number of events 6 • Each participant was followed from initial contact through delivery for adverse events (approximately 7 months).
Hepatobiliary disorders Cholestasis	0.71% 1/141 • Number of events 1 • Each participant was followed from initial contact through delivery for adverse events (approximately 7 months).	0.71% 1/140 • Number of events 1 • Each participant was followed from initial contact through delivery for adverse events (approximately 7 months).
Pregnancy, puerperium and perinatal conditions Preterm labor	0.71% 1/141 • Number of events 1 • Each participant was followed from initial contact through delivery for adverse events (approximately 7 months).	0.71% 1/140 • Number of events 1 • Each participant was followed from initial contact through delivery for adverse events (approximately 7 months).
Cardiac disorders Tachycardia	0.71% 1/141 • Number of events 1 • Each participant was followed from initial contact through delivery for adverse events (approximately 7 months).	0.00% 0/140 • Each participant was followed from initial contact through delivery for adverse events (approximately 7 months).
Infections and infestations Chorioamnionitis	0.71% 1/141 • Number of events 1 • Each participant was followed from initial contact through delivery for adverse events (approximately 7 months).	0.00% 0/140 • Each participant was followed from initial contact through delivery for adverse events (approximately 7 months).
Pregnancy, puerperium and perinatal conditions Vasa Previa	0.00% 0/141 • Each participant was followed from initial contact through delivery for adverse events (approximately 7 months).	0.71% 1/140 • Number of events 1 • Each participant was followed from initial contact through delivery for adverse events (approximately 7 months).
Surgical and medical procedures Postpartum maternal infection	0.71% 1/141 • Number of events 1 • Each participant was followed from initial contact through delivery for adverse events (approximately 7 months).	0.00% 0/140 • Each participant was followed from initial contact through delivery for adverse events (approximately 7 months).
Respiratory, thoracic and mediastinal disorders Respiratory	0.00% 0/141 • Each participant was followed from initial contact through delivery for adverse events (approximately 7 months).	0.71% 1/140 • Number of events 1 • Each participant was followed from initial contact through delivery for adverse events (approximately 7 months).
Congenital, familial and genetic disorders Congenital anomaly	5.0% 7/141 • Number of events 7 • Each participant was followed from initial contact through delivery for adverse events (approximately 7 months).	1.4% 2/140 • Number of events 2 • Each participant was followed from initial contact through delivery for adverse events (approximately 7 months).
General disorders NICU admission	12.8% 18/141 • Number of events 18 • Each participant was followed from initial contact through delivery for adverse events (approximately 7 months).	8.6% 12/140 • Number of events 12 • Each participant was followed from initial contact through delivery for adverse events (approximately 7 months).

Other adverse events

Measure	Usual Care Group n=141 participants at risk 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.	Lifestyle Intervention Group n=140 participants at risk 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
Endocrine disorders Small for gestational age	3.5% 5/141 • Number of events 5 • Each participant was followed from initial contact through delivery for adverse events (approximately 7 months).	2.1% 3/140 • Number of events 3 • Each participant was followed from initial contact through delivery for adverse events (approximately 7 months).

Additional Information

Mary J. Kwasny

Northwestern University

Phone: 312-503-2294

Email: m-kwasny@northwestern.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place