Trial Outcomes & Findings for Gestational Weight Gain and Postpartum Weight Loss in Active Duty Women (Moms Fit 2 Fight) (NCT NCT03057808)
NCT ID: NCT03057808
Last Updated: 2022-12-23
Results Overview
At all measurement visits, weight will be recorded in kilograms. Weight will be measured on a calibrated digital scale in duplicate, with the participant wearing light clothing and no shoes. While Investigators obtain the mother's weight at baseline, there will also be a self reported pregravid weight (before the last menstrual period).
COMPLETED
NA
430 participants
Baseline to 6 months postpartum
2022-12-23
Participant Flow
Initially, participants were required to receive obstetric care at either San Antonio Military Medical Center or Wilford Hall Ambulatory Surgical Center. With the obstetric clinic closure at Wilford Hall Ambulatory Surgical Center in October 2019 and the coronavirus pandemic, recruitment was expanded to include obstetric clinics at Andrews and Wright Patterson Air Force Bases in July 2020. Interested individuals were recruited between February 2017 to October 2020.
Potentially eligible participants presented for a screening visit where full eligibility was assessed, informed consent was obtained, and study measures were collected. Participants were then asked to track their diet and exercise for one week and obtain their obstetrician's clearance for participation. Active duty personnel were also required to submit their fitness test scores for the year prior to study enrollment, to facilitate comparisons with their postpartum fitness test scores.
Participant milestones
| Measure |
Gestational Weight Gain Intervention (GWG-only)
The GWG intervention will begin upon randomization to the GWG-only or the GWG+PPWL arm, and continue until the birth of the participant's child.
Gestational weight gain intervention: This intervention will provide individual, telephone-based sessions (20-30 minutes each) by trained interventionists. The intervention will focus on self-monitoring, clear goals (i.e., GWG, caloric intake exercise), and problem solving.
|
Postpartum Weight Loss Intervention (PPWL-only)
The PPWL intervention will begin at 6-weeks postpartum (when most women will be approved for weight loss and exercise by their obstetrician) for those participants randomized to the PPWL only or the GWG+PPWL arms, and will continue until 6-months postpartum.
Postpartum weight loss intervention: The PPWL intervention will provide individual, telephone-based sessions (20-30 minutes each) by trained interventionists. (The number of possible telephone sessions will depend on the level of support needed by each participant to meet her weight loss goals). The PPWL intervention will focus on self-monitoring; weight, dietary intake and exercise goals; and problem solving.
|
Combined
During the gestational phase participants will receive the same intervention as the GWG only group. During the postpartum phase participants will receive the the same intervention as the PPWL group.
Gestational weight gain intervention: This intervention will provide individual, telephone-based sessions (20-30 minutes each) by trained interventionists. The intervention will focus on self-monitoring, clear goals (i.e., GWG, caloric intake exercise), and problem solving.
Postpartum weight loss intervention: The PPWL intervention will provide individual, telephone-based sessions (20-30 minutes each) by trained interventionists. (The number of possible telephone sessions will depend on the level of support needed by each participant to meet her weight loss goals). The PPWL intervention will focus on self-monitoring; weight, dietary intake and exercise goals; and problem solving.
|
|---|---|---|---|
|
Overall Study
STARTED
|
144
|
142
|
144
|
|
Overall Study
32-36 Weeks Gestation
|
129
|
129
|
120
|
|
Overall Study
COMPLETED
|
132
|
121
|
127
|
|
Overall Study
NOT COMPLETED
|
12
|
21
|
17
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gestational Weight Gain and Postpartum Weight Loss in Active Duty Women (Moms Fit 2 Fight)
Baseline characteristics by cohort
| Measure |
Gestational Weight Gain Intervention (GWG-only)
n=144 Participants
The GWG intervention will begin upon randomization to the GWG-only or the GWG+PPWL arm, and continue until the birth of the participant's child.
Gestational weight gain intervention: This intervention will provide individual, telephone-based sessions (20-30 minutes each) by trained interventionists. The intervention will focus on self-monitoring, clear goals (i.e., GWG, caloric intake exercise), and problem solving.
|
Postpartum Weight Loss Intervention (PPWL-only)
n=142 Participants
The PPWL intervention will begin at 6-weeks postpartum (when most women will be approved for weight loss and exercise by their obstetrician) for those participants randomized to the PPWL only or the GWG+PPWL arms, and will continue until 6-months postpartum.
Postpartum weight loss intervention: The PPWL intervention will provide individual, telephone-based sessions (20-30 minutes each) by trained interventionists. (The number of possible telephone sessions will depend on the level of support needed by each participant to meet her weight loss goals). The PPWL intervention will focus on self-monitoring; weight, dietary intake and exercise goals; and problem solving.
|
Combined
n=144 Participants
During the gestational phase participants will receive the same intervention as the GWG only group. During the postpartum phase participants will receive the the same intervention as the PPWL group.
Gestational weight gain intervention: This intervention will provide individual, telephone-based sessions (20-30 minutes each) by trained interventionists. The intervention will focus on self-monitoring, clear goals (i.e., GWG, caloric intake exercise), and problem solving.
Postpartum weight loss intervention: The PPWL intervention will provide individual, telephone-based sessions (20-30 minutes each) by trained interventionists. (The number of possible telephone sessions will depend on the level of support needed by each participant to meet her weight loss goals). The PPWL intervention will focus on self-monitoring; weight, dietary intake and exercise goals; and problem solving.
|
Total
n=430 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
30.9 years
STANDARD_DEVIATION 4.9 • n=93 Participants
|
30.4 years
STANDARD_DEVIATION 4.8 • n=4 Participants
|
30.6 years
STANDARD_DEVIATION 4.8 • n=27 Participants
|
30.6 years
STANDARD_DEVIATION 4.9 • n=483 Participants
|
|
Sex: Female, Male
Female
|
144 Participants
n=93 Participants
|
142 Participants
n=4 Participants
|
144 Participants
n=27 Participants
|
430 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
22 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
29 Participants
n=27 Participants
|
72 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
122 Participants
n=93 Participants
|
121 Participants
n=4 Participants
|
115 Participants
n=27 Participants
|
358 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
13 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
20 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
64 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
101 Participants
n=93 Participants
|
99 Participants
n=4 Participants
|
92 Participants
n=27 Participants
|
292 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
21 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
14 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
33 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
144 participants
n=93 Participants
|
142 participants
n=4 Participants
|
144 participants
n=27 Participants
|
430 participants
n=483 Participants
|
|
Body mass index
|
27.6 Kg/m^2
STANDARD_DEVIATION 5.3 • n=93 Participants
|
27.7 Kg/m^2
STANDARD_DEVIATION 5.5 • n=4 Participants
|
27.6 Kg/m^2
STANDARD_DEVIATION 5.0 • n=27 Participants
|
27.6 Kg/m^2
STANDARD_DEVIATION 5.2 • n=483 Participants
|
|
Gestational week at screening
|
11.8 weeks
STANDARD_DEVIATION 1.1 • n=93 Participants
|
11.6 weeks
STANDARD_DEVIATION 1.2 • n=4 Participants
|
11.8 weeks
STANDARD_DEVIATION 1.0 • n=27 Participants
|
11.7 weeks
STANDARD_DEVIATION 1.1 • n=483 Participants
|
|
Active duty
|
70 Participants
n=93 Participants
|
64 Participants
n=4 Participants
|
70 Participants
n=27 Participants
|
204 Participants
n=483 Participants
|
|
Previous live birth
|
80 Participants
n=93 Participants
|
80 Participants
n=4 Participants
|
80 Participants
n=27 Participants
|
240 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Baseline to 6 months postpartumPopulation: Those who completed the 6 month postpartum visit
At all measurement visits, weight will be recorded in kilograms. Weight will be measured on a calibrated digital scale in duplicate, with the participant wearing light clothing and no shoes. While Investigators obtain the mother's weight at baseline, there will also be a self reported pregravid weight (before the last menstrual period).
Outcome measures
| Measure |
Gestational Weight Gain Intervention (GWG-only)
n=132 Participants
The GWG intervention will begin upon randomization to the GWG-only or the GWG+PPWL arm, and continue until the birth of the participant's child.
Gestational weight gain intervention: This intervention will provide individual, telephone-based sessions (20-30 minutes each) by trained interventionists. The intervention will focus on self-monitoring, clear goals (i.e., GWG, caloric intake exercise), and problem solving.
|
Postpartum Weight Loss Intervention (PPWL-only)
n=121 Participants
The PPWL intervention will begin at 6-weeks postpartum (when most women will be approved for weight loss and exercise by their obstetrician) for those participants randomized to the PPWL only or the GWG+PPWL arms, and will continue until 6-months postpartum.
Postpartum weight loss intervention: The PPWL intervention will provide individual, telephone-based sessions (20-30 minutes each) by trained interventionists. (The number of possible telephone sessions will depend on the level of support needed by each participant to meet her weight loss goals). The PPWL intervention will focus on self-monitoring; weight, dietary intake and exercise goals; and problem solving.
|
Combined
n=127 Participants
During the gestational phase participants will receive the same intervention as the GWG only group. During the postpartum phase participants will receive the the same intervention as the PPWL group.
Gestational weight gain intervention: This intervention will provide individual, telephone-based sessions (20-30 minutes each) by trained interventionists. The intervention will focus on self-monitoring, clear goals (i.e., GWG, caloric intake exercise), and problem solving.
Postpartum weight loss intervention: The PPWL intervention will provide individual, telephone-based sessions (20-30 minutes each) by trained interventionists. (The number of possible telephone sessions will depend on the level of support needed by each participant to meet her weight loss goals). The PPWL intervention will focus on self-monitoring; weight, dietary intake and exercise goals; and problem solving.
|
|---|---|---|---|
|
Changes in the Mother's Body Weight Pre and Post Pregnancy
|
2.39 kilograms
Standard Deviation 5.36
|
1.25 kilograms
Standard Deviation 5.40
|
1.37 kilograms
Standard Deviation 5.76
|
SECONDARY outcome
Timeframe: Baseline (13 weeks gestational to delivery)Population: Those who delivered in military hospitals, with some missing data for some of the variables. The two conditions that received the same intervention during the gestational period (GWG-only, Combined) were combined for analyses and compared to the PPWL-only condition.
Pregnancy-related medical outcomes will be obtained from the participant's medical record and will include: maternal (e.g., gestational diabetes, preeclampsia) and fetal conditions.
Outcome measures
| Measure |
Gestational Weight Gain Intervention (GWG-only)
n=233 Participants
The GWG intervention will begin upon randomization to the GWG-only or the GWG+PPWL arm, and continue until the birth of the participant's child.
Gestational weight gain intervention: This intervention will provide individual, telephone-based sessions (20-30 minutes each) by trained interventionists. The intervention will focus on self-monitoring, clear goals (i.e., GWG, caloric intake exercise), and problem solving.
|
Postpartum Weight Loss Intervention (PPWL-only)
n=115 Participants
The PPWL intervention will begin at 6-weeks postpartum (when most women will be approved for weight loss and exercise by their obstetrician) for those participants randomized to the PPWL only or the GWG+PPWL arms, and will continue until 6-months postpartum.
Postpartum weight loss intervention: The PPWL intervention will provide individual, telephone-based sessions (20-30 minutes each) by trained interventionists. (The number of possible telephone sessions will depend on the level of support needed by each participant to meet her weight loss goals). The PPWL intervention will focus on self-monitoring; weight, dietary intake and exercise goals; and problem solving.
|
Combined
During the gestational phase participants will receive the same intervention as the GWG only group. During the postpartum phase participants will receive the the same intervention as the PPWL group.
Gestational weight gain intervention: This intervention will provide individual, telephone-based sessions (20-30 minutes each) by trained interventionists. The intervention will focus on self-monitoring, clear goals (i.e., GWG, caloric intake exercise), and problem solving.
Postpartum weight loss intervention: The PPWL intervention will provide individual, telephone-based sessions (20-30 minutes each) by trained interventionists. (The number of possible telephone sessions will depend on the level of support needed by each participant to meet her weight loss goals). The PPWL intervention will focus on self-monitoring; weight, dietary intake and exercise goals; and problem solving.
|
|---|---|---|---|
|
Maternal and Fetal Conditions During Pregnancy
Cesarean delivery (emergency)
|
39 Participants
|
14 Participants
|
—
|
|
Maternal and Fetal Conditions During Pregnancy
Preeclampsia
|
22 Participants
|
13 Participants
|
—
|
|
Maternal and Fetal Conditions During Pregnancy
Pregancy inducaed hypertension
|
35 Participants
|
26 Participants
|
—
|
|
Maternal and Fetal Conditions During Pregnancy
Gestational diabetes
|
17 Participants
|
13 Participants
|
—
|
|
Maternal and Fetal Conditions During Pregnancy
Cesarean delivery (elective)
|
36 Participants
|
18 Participants
|
—
|
|
Maternal and Fetal Conditions During Pregnancy
Preterm delivery (<37 weeks)
|
14 Participants
|
7 Participants
|
—
|
|
Maternal and Fetal Conditions During Pregnancy
Small-for-gestational age (<10th percentile)
|
15 Participants
|
7 Participants
|
—
|
|
Maternal and Fetal Conditions During Pregnancy
Large-for-gestational age (> 90th percentile)
|
19 Participants
|
9 Participants
|
—
|
|
Maternal and Fetal Conditions During Pregnancy
Neonatal Intensive Care Unit admission)
|
19 Participants
|
12 Participants
|
—
|
SECONDARY outcome
Timeframe: DeliveryPopulation: For participants who delivered at a military hospital. The two conditions that received the same intervention during the gestational period (GWG-only, Combined) were combined for analyses and compared to the PPWL-only condition.
Birth weight of the infant will be recorded in grams.
Outcome measures
| Measure |
Gestational Weight Gain Intervention (GWG-only)
n=225 Participants
The GWG intervention will begin upon randomization to the GWG-only or the GWG+PPWL arm, and continue until the birth of the participant's child.
Gestational weight gain intervention: This intervention will provide individual, telephone-based sessions (20-30 minutes each) by trained interventionists. The intervention will focus on self-monitoring, clear goals (i.e., GWG, caloric intake exercise), and problem solving.
|
Postpartum Weight Loss Intervention (PPWL-only)
n=106 Participants
The PPWL intervention will begin at 6-weeks postpartum (when most women will be approved for weight loss and exercise by their obstetrician) for those participants randomized to the PPWL only or the GWG+PPWL arms, and will continue until 6-months postpartum.
Postpartum weight loss intervention: The PPWL intervention will provide individual, telephone-based sessions (20-30 minutes each) by trained interventionists. (The number of possible telephone sessions will depend on the level of support needed by each participant to meet her weight loss goals). The PPWL intervention will focus on self-monitoring; weight, dietary intake and exercise goals; and problem solving.
|
Combined
During the gestational phase participants will receive the same intervention as the GWG only group. During the postpartum phase participants will receive the the same intervention as the PPWL group.
Gestational weight gain intervention: This intervention will provide individual, telephone-based sessions (20-30 minutes each) by trained interventionists. The intervention will focus on self-monitoring, clear goals (i.e., GWG, caloric intake exercise), and problem solving.
Postpartum weight loss intervention: The PPWL intervention will provide individual, telephone-based sessions (20-30 minutes each) by trained interventionists. (The number of possible telephone sessions will depend on the level of support needed by each participant to meet her weight loss goals). The PPWL intervention will focus on self-monitoring; weight, dietary intake and exercise goals; and problem solving.
|
|---|---|---|---|
|
Birth Weight of Infant
|
3363.5 grams
Standard Deviation 529.1
|
3365.3 grams
Standard Deviation 545.8
|
—
|
SECONDARY outcome
Timeframe: DeliveryPopulation: For participants who delivered at a military hospital. The two conditions that received the same intervention during the gestational period (GWG-only, Combined) were combined for analyses and compared to the PPWL-only condition.
Birth height of the infant will be recorded in centimeters.
Outcome measures
| Measure |
Gestational Weight Gain Intervention (GWG-only)
n=209 Participants
The GWG intervention will begin upon randomization to the GWG-only or the GWG+PPWL arm, and continue until the birth of the participant's child.
Gestational weight gain intervention: This intervention will provide individual, telephone-based sessions (20-30 minutes each) by trained interventionists. The intervention will focus on self-monitoring, clear goals (i.e., GWG, caloric intake exercise), and problem solving.
|
Postpartum Weight Loss Intervention (PPWL-only)
n=100 Participants
The PPWL intervention will begin at 6-weeks postpartum (when most women will be approved for weight loss and exercise by their obstetrician) for those participants randomized to the PPWL only or the GWG+PPWL arms, and will continue until 6-months postpartum.
Postpartum weight loss intervention: The PPWL intervention will provide individual, telephone-based sessions (20-30 minutes each) by trained interventionists. (The number of possible telephone sessions will depend on the level of support needed by each participant to meet her weight loss goals). The PPWL intervention will focus on self-monitoring; weight, dietary intake and exercise goals; and problem solving.
|
Combined
During the gestational phase participants will receive the same intervention as the GWG only group. During the postpartum phase participants will receive the the same intervention as the PPWL group.
Gestational weight gain intervention: This intervention will provide individual, telephone-based sessions (20-30 minutes each) by trained interventionists. The intervention will focus on self-monitoring, clear goals (i.e., GWG, caloric intake exercise), and problem solving.
Postpartum weight loss intervention: The PPWL intervention will provide individual, telephone-based sessions (20-30 minutes each) by trained interventionists. (The number of possible telephone sessions will depend on the level of support needed by each participant to meet her weight loss goals). The PPWL intervention will focus on self-monitoring; weight, dietary intake and exercise goals; and problem solving.
|
|---|---|---|---|
|
Length of Infant
|
51.3 centimeters
Standard Deviation 2.8
|
50.8 centimeters
Standard Deviation 4.0
|
—
|
SECONDARY outcome
Timeframe: Baseline and 12 months postpartumPopulation: Due to the coronavirus pandemic, military fitness tests were suspended for approximately 18 months, which did not allow for postpartum fitness tests to be conducted at the designated time.
Waist circumference will be recorded in centimeters.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 12 months postpartumPopulation: Due to the COVID-19 pandemic, military fitness tests were suspended for approximately 18 months, which did not allow for postpartum fitness tests to be conducted at the designated time.
Number of push ups completed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 12 months postpartumPopulation: Due to the COVID-19 pandemic, military fitness tests were suspended for approximately 18 months, which did not allow for postpartum fitness tests to be conducted at the designated time.
Number of sit ups completed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 12 months postpartumPopulation: Due to the COVID-19 pandemic, military fitness tests were suspended for approximately 18 months, which did not allow for postpartum fitness tests to be conducted at the designated time.
The amount of time it took to complete 1.5 miles.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 months postpartumPopulation: Includes participants who completed the 12 month program satisfaction measure and did not indicate "don't know"
Program satisfaction will be assessed using the Investigators program evaluation form to offer insight into program acceptability as well as barriers and facilitators to participation in each intervention arm. Participants will be given 10 statements to rate their experience using a 5 point scale.
Outcome measures
| Measure |
Gestational Weight Gain Intervention (GWG-only)
n=111 Participants
The GWG intervention will begin upon randomization to the GWG-only or the GWG+PPWL arm, and continue until the birth of the participant's child.
Gestational weight gain intervention: This intervention will provide individual, telephone-based sessions (20-30 minutes each) by trained interventionists. The intervention will focus on self-monitoring, clear goals (i.e., GWG, caloric intake exercise), and problem solving.
|
Postpartum Weight Loss Intervention (PPWL-only)
n=103 Participants
The PPWL intervention will begin at 6-weeks postpartum (when most women will be approved for weight loss and exercise by their obstetrician) for those participants randomized to the PPWL only or the GWG+PPWL arms, and will continue until 6-months postpartum.
Postpartum weight loss intervention: The PPWL intervention will provide individual, telephone-based sessions (20-30 minutes each) by trained interventionists. (The number of possible telephone sessions will depend on the level of support needed by each participant to meet her weight loss goals). The PPWL intervention will focus on self-monitoring; weight, dietary intake and exercise goals; and problem solving.
|
Combined
n=109 Participants
During the gestational phase participants will receive the same intervention as the GWG only group. During the postpartum phase participants will receive the the same intervention as the PPWL group.
Gestational weight gain intervention: This intervention will provide individual, telephone-based sessions (20-30 minutes each) by trained interventionists. The intervention will focus on self-monitoring, clear goals (i.e., GWG, caloric intake exercise), and problem solving.
Postpartum weight loss intervention: The PPWL intervention will provide individual, telephone-based sessions (20-30 minutes each) by trained interventionists. (The number of possible telephone sessions will depend on the level of support needed by each participant to meet her weight loss goals). The PPWL intervention will focus on self-monitoring; weight, dietary intake and exercise goals; and problem solving.
|
|---|---|---|---|
|
Moms Fit 2 Fight Program Evaluation Form
Appropriate length of sessions
|
100 Participants
|
92 Participants
|
92 Participants
|
|
Moms Fit 2 Fight Program Evaluation Form
Appropriate number of sessions
|
90 Participants
|
85 Participants
|
93 Participants
|
|
Moms Fit 2 Fight Program Evaluation Form
Lesson materials were helpful
|
82 Participants
|
75 Participants
|
71 Participants
|
|
Moms Fit 2 Fight Program Evaluation Form
Diet/Exercise monitoring was helpful
|
95 Participants
|
86 Participants
|
90 Participants
|
|
Moms Fit 2 Fight Program Evaluation Form
Electronic scale was helpful
|
104 Participants
|
98 Participants
|
109 Participants
|
|
Moms Fit 2 Fight Program Evaluation Form
Meal replacements were helpful
|
29 Participants
|
31 Participants
|
32 Participants
|
|
Moms Fit 2 Fight Program Evaluation Form
Meal plans were helpful
|
31 Participants
|
29 Participants
|
27 Participants
|
|
Moms Fit 2 Fight Program Evaluation Form
Would recommend the program
|
104 Participants
|
99 Participants
|
96 Participants
|
|
Moms Fit 2 Fight Program Evaluation Form
Found the program useful
|
96 Participants
|
88 Participants
|
93 Participants
|
|
Moms Fit 2 Fight Program Evaluation Form
Enjoyed the program
|
95 Participants
|
87 Participants
|
96 Participants
|
Adverse Events
Gestational Weight Gain Intervention (GWG-only)
Postpartum Weight Loss Intervention (PPWL-only)
Combined
Serious adverse events
| Measure |
Gestational Weight Gain Intervention (GWG-only)
n=144 participants at risk
The GWG intervention will begin upon randomization to the GWG-only or the GWG+PPWL arm, and continue until the birth of the participant's child.
Gestational weight gain intervention: This intervention will provide individual, telephone-based sessions (20-30 minutes each) by trained interventionists. The intervention will focus on self-monitoring, clear goals (i.e., GWG, caloric intake exercise), and problem solving.
|
Postpartum Weight Loss Intervention (PPWL-only)
n=142 participants at risk
The PPWL intervention will begin at 6-weeks postpartum (when most women will be approved for weight loss and exercise by their obstetrician) for those participants randomized to the PPWL only or the GWG+PPWL arms, and will continue until 6-months postpartum.
Postpartum weight loss intervention: The PPWL intervention will provide individual, telephone-based sessions (20-30 minutes each) by trained interventionists. (The number of possible telephone sessions will depend on the level of support needed by each participant to meet her weight loss goals). The PPWL intervention will focus on self-monitoring; weight, dietary intake and exercise goals; and problem solving.
|
Combined
n=144 participants at risk
During the gestational phase participants will receive the same intervention as the GWG only group. During the postpartum phase participants will receive the the same intervention as the PPWL group.
Gestational weight gain intervention: This intervention will provide individual, telephone-based sessions (20-30 minutes each) by trained interventionists. The intervention will focus on self-monitoring, clear goals (i.e., GWG, caloric intake exercise), and problem solving.
Postpartum weight loss intervention: The PPWL intervention will provide individual, telephone-based sessions (20-30 minutes each) by trained interventionists. (The number of possible telephone sessions will depend on the level of support needed by each participant to meet her weight loss goals). The PPWL intervention will focus on self-monitoring; weight, dietary intake and exercise goals; and problem solving.
|
|---|---|---|---|
|
Gastrointestinal disorders
Appendectomy
|
0.00%
0/144 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
0.70%
1/142 • Number of events 1 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
0.69%
1/144 • Number of events 1 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
|
Reproductive system and breast disorders
Tubal ligation
|
0.00%
0/144 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
0.70%
1/142 • Number of events 1 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
0.69%
1/144 • Number of events 1 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
|
Pregnancy, puerperium and perinatal conditions
Preterm labor/delivery
|
4.9%
7/144 • Number of events 7 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
0.70%
1/142 • Number of events 1 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
2.1%
3/144 • Number of events 3 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
|
Reproductive system and breast disorders
Caesarean section
|
4.2%
6/144 • Number of events 6 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
0.70%
1/142 • Number of events 1 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
2.1%
3/144 • Number of events 3 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
|
Pregnancy, puerperium and perinatal conditions
Miscarriage
|
0.00%
0/144 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
2.8%
4/142 • Number of events 4 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
2.1%
3/144 • Number of events 3 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
|
Pregnancy, puerperium and perinatal conditions
Preeclampsia
|
3.5%
5/144 • Number of events 5 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
2.1%
3/142 • Number of events 3 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
0.69%
1/144 • Number of events 1 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
|
Renal and urinary disorders
Kidney infection
|
0.69%
1/144 • Number of events 1 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
0.70%
1/142 • Number of events 1 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
0.00%
0/144 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
|
General disorders
Syncope
|
0.69%
1/144 • Number of events 1 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
0.00%
0/142 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
0.00%
0/144 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
|
General disorders
NICU admission
|
0.69%
1/144 • Number of events 1 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
0.00%
0/142 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
0.69%
1/144 • Number of events 1 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
|
Blood and lymphatic system disorders
Low white blood count
|
0.69%
1/144 • Number of events 1 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
0.00%
0/142 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
0.00%
0/144 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
|
Cardiac disorders
Heart rate issues
|
0.69%
1/144 • Number of events 1 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
0.00%
0/142 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
0.00%
0/144 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
|
Gastrointestinal disorders
Gallbladder removal
|
0.69%
1/144 • Number of events 1 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
0.00%
0/142 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
0.00%
0/144 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
|
Infections and infestations
Hospitalization due to viral illness
|
0.69%
1/144 • Number of events 1 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
0.00%
0/142 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
0.00%
0/144 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
|
Renal and urinary disorders
Kidney stones
|
0.69%
1/144 • Number of events 1 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
0.00%
0/142 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
0.00%
0/144 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
|
Pregnancy, puerperium and perinatal conditions
Uterine bleeding
|
1.4%
2/144 • Number of events 2 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
0.00%
0/142 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
0.00%
0/144 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
|
General disorders
Elevated blood pressure with amniotic fluid leak
|
0.69%
1/144 • Number of events 1 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
0.00%
0/142 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
0.00%
0/144 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
|
General disorders
Chest pains, shortness of breath, syncope
|
0.69%
1/144 • Number of events 1 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
0.00%
0/142 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
0.00%
0/144 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
|
Pregnancy, puerperium and perinatal conditions
Placenta previa
|
0.69%
1/144 • Number of events 1 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
0.70%
1/142 • Number of events 1 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
0.00%
0/144 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
|
Gastrointestinal disorders
Ruptured rectum
|
0.00%
0/144 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
0.00%
0/142 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
0.69%
1/144 • Number of events 1 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
|
Renal and urinary disorders
Fetal Single Umbilical Artery
|
0.00%
0/144 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
0.00%
0/142 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
0.00%
0/144 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
|
Nervous system disorders
Epileptic event
|
0.00%
0/144 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
0.70%
1/142 • Number of events 1 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
0.69%
1/144 • Number of events 1 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
|
Pregnancy, puerperium and perinatal conditions
Retained placenta
|
0.00%
0/144 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
0.00%
0/142 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
0.69%
1/144 • Number of events 1 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
|
Injury, poisoning and procedural complications
Car accident
|
0.00%
0/144 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
0.00%
0/142 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
0.69%
1/144 • Number of events 1 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
|
Pregnancy, puerperium and perinatal conditions
Mastitis
|
0.00%
0/144 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
0.00%
0/142 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
0.69%
1/144 • Number of events 1 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
|
Gastrointestinal disorders
Nausea and vomiting
|
0.00%
0/144 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
0.00%
0/142 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
0.69%
1/144 • Number of events 1 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
|
Gastrointestinal disorders
Gallbladder stone
|
0.00%
0/144 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
0.70%
1/142 • Number of events 1 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
0.69%
1/144 • Number of events 1 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
|
Skin and subcutaneous tissue disorders
Dermoid cyst
|
0.00%
0/144 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
0.00%
0/142 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
0.69%
1/144 • Number of events 1 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
|
Pregnancy, puerperium and perinatal conditions
Fetal termination due to anomalies
|
0.00%
0/144 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
0.00%
0/142 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
0.69%
1/144 • Number of events 1 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
|
Pregnancy, puerperium and perinatal conditions
Neonatal death
|
0.00%
0/144 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
0.70%
1/142 • Number of events 1 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
0.00%
0/144 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/144 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
0.70%
1/142 • Number of events 1 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
0.00%
0/144 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
|
Skin and subcutaneous tissue disorders
Cellulitis infection
|
0.00%
0/144 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
0.70%
1/142 • Number of events 1 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
0.00%
0/144 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
Other adverse events
| Measure |
Gestational Weight Gain Intervention (GWG-only)
n=144 participants at risk
The GWG intervention will begin upon randomization to the GWG-only or the GWG+PPWL arm, and continue until the birth of the participant's child.
Gestational weight gain intervention: This intervention will provide individual, telephone-based sessions (20-30 minutes each) by trained interventionists. The intervention will focus on self-monitoring, clear goals (i.e., GWG, caloric intake exercise), and problem solving.
|
Postpartum Weight Loss Intervention (PPWL-only)
n=142 participants at risk
The PPWL intervention will begin at 6-weeks postpartum (when most women will be approved for weight loss and exercise by their obstetrician) for those participants randomized to the PPWL only or the GWG+PPWL arms, and will continue until 6-months postpartum.
Postpartum weight loss intervention: The PPWL intervention will provide individual, telephone-based sessions (20-30 minutes each) by trained interventionists. (The number of possible telephone sessions will depend on the level of support needed by each participant to meet her weight loss goals). The PPWL intervention will focus on self-monitoring; weight, dietary intake and exercise goals; and problem solving.
|
Combined
n=144 participants at risk
During the gestational phase participants will receive the same intervention as the GWG only group. During the postpartum phase participants will receive the the same intervention as the PPWL group.
Gestational weight gain intervention: This intervention will provide individual, telephone-based sessions (20-30 minutes each) by trained interventionists. The intervention will focus on self-monitoring, clear goals (i.e., GWG, caloric intake exercise), and problem solving.
Postpartum weight loss intervention: The PPWL intervention will provide individual, telephone-based sessions (20-30 minutes each) by trained interventionists. (The number of possible telephone sessions will depend on the level of support needed by each participant to meet her weight loss goals). The PPWL intervention will focus on self-monitoring; weight, dietary intake and exercise goals; and problem solving.
|
|---|---|---|---|
|
Infections and infestations
Common cold
|
6.2%
9/144 • Number of events 9 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
8.5%
12/142 • Number of events 12 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
13.9%
20/144 • Number of events 20 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
|
Psychiatric disorders
Depressive symptoms
|
8.3%
12/144 • Number of events 12 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
9.9%
14/142 • Number of events 14 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
11.8%
17/144 • Number of events 17 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
|
Pregnancy, puerperium and perinatal conditions
Gestational diabetes
|
7.6%
11/144 • Number of events 11 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
4.2%
6/142 • Number of events 6 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
9.0%
13/144 • Number of events 13 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.8%
4/144 • Number of events 4 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
2.1%
3/142 • Number of events 3 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
6.9%
10/144 • Number of events 10 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
|
Infections and infestations
COVID-19
|
1.4%
2/144 • Number of events 2 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
5.6%
8/142 • Number of events 8 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
1.4%
2/144 • Number of events 2 • From study enrollment/consent to 12 months postpartum (approximately 20 months)
At each data collection visit, the participants were asked if they experienced any changes in their health since the last visit
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place