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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

430 participants

Primary outcome timeframe

Baseline to 6 months postpartum

Results posted on

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

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

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 postpartum

Population: 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

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

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: Delivery

Population: 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

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: Delivery

Population: 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

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 postpartum

Population: 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 postpartum

Population: 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 postpartum

Population: 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 postpartum

Population: 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 postpartum

Population: 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

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)

Serious events: 23 serious events
Other events: 30 other events
Deaths: 0 deaths

Postpartum Weight Loss Intervention (PPWL-only)

Serious events: 13 serious events
Other events: 38 other events
Deaths: 0 deaths

Combined

Serious events: 22 serious events
Other events: 46 other events
Deaths: 0 deaths

Serious adverse events

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

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

Dr. Rebecca Krukowski

University of Virginia

Phone: 4349245303

Results disclosure agreements

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