Weight Gain, Weight Loss
Conditions
Keywords
Pregnancy, Postpartum
Brief summary
The purpose of this study is to enroll approximately 450 subjects to see if a behavioral weight management program is successful in helping TRICARE beneficiaries who are pregnant or post-partum to manage their weight during and after their pregnancy.
Detailed description
Investigators will randomize 450 consented participants to 1 of 3 interventions: a) a gestational weight gain intervention (GWG-only); b) a postpartum weight loss intervention (PPWL-only), or c) a combined gestational weight gain and postpartum weight loss intervention (GWG+PPWL) to determine the efficacy of the interventions on GWG as well as PPWL. Procedures: Interested individuals will be directed to call the study telephone number to learn more and determine whether eligibility criteria is met. Individuals who meet the telephone screening eligibility criteria will be invited to schedule a Screening Visit, during which written informed consent will be obtained. At this visit, eligibility will be assessed and measures will be administrated. The potential participant will also be asked to complete a one-week dietary and exercise self-monitoring run-in and receive medical clearance from their obstetrician to participate. Should she continue to be interested, she will return for a Baseline Visit and will be randomized. Randomized participants will have 5 in person scheduled visits after their Screening Visit and Baseline Visit to the Wilford Hall Ambulatory Surgical Center (WHASC) or San Antonio Military Medical Center (SAMMC) Obstetrics (OB) clinic. These visits will be scheduled at gestational week 32, 36, as well as at 6- weeks, 6-months, and 12- month postpartum. At these visits, physical measurements will be collected and participants will complete various questionnaires.
Interventions
BEHAVIORALGestational 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.
BEHAVIORALPostpartum 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.
Sponsors
59th Medical Wing
San Antonio Military Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Tennessee
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Participants will be active duty military, dependents or retired with TRICARE benefits * Participants must be less than 12 weeks gestation upon recruitment (based on the date of their last menstrual period and then confirmed by their physician at their first prenatal visit, which typically occurs at 6-8 weeks gestation at WHASC and SAMMC) * Participants also must be within the normal, overweight, or obese BMI ranges * Are generally in good health * Currently not smoking more than 5 cigarettes per day at the time of conception
Exclusion criteria
* Expecting multiple babies (e.g. twins) * Diabetic * Not interested in participating in a program for 21 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the Mother's Body Weight Pre and Post Pregnancy | Baseline to 6 months postpartum | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Birth Weight of Infant | Delivery | Birth weight of the infant will be recorded in grams. |
| Length of Infant | Delivery | Birth height of the infant will be recorded in centimeters. |
| Waist Circumference on Fitness Test Scores | Baseline and 12 months postpartum | Waist circumference will be recorded in centimeters. |
| Maternal and Fetal Conditions During Pregnancy | Baseline (13 weeks gestational to delivery) | 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. |
| Number of Sit Ups on Fitness Test Scores | Baseline and 12 months postpartum | Number of sit ups completed. |
| 1.5 Mile Run on Fitness Test Scores | Baseline and 12 months postpartum | The amount of time it took to complete 1.5 miles. |
| Moms Fit 2 Fight Program Evaluation Form | 12 months postpartum | 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. |
| Number of Push Ups on Fitness Test Scores | Baseline and 12 months postpartum | Number of push ups completed. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 144 |
| 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. | 142 |
| 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. | 144 |
| Total | 430 |
Baseline characteristics
| Characteristic | Gestational Weight Gain Intervention (GWG-only) | Total | Combined | Postpartum Weight Loss Intervention (PPWL-only) |
|---|---|---|---|---|
| Active duty | 70 Participants | 204 Participants | 70 Participants | 64 Participants |
| Age, Continuous | 30.9 years STANDARD_DEVIATION 4.9 | 30.6 years STANDARD_DEVIATION 4.9 | 30.6 years STANDARD_DEVIATION 4.8 | 30.4 years STANDARD_DEVIATION 4.8 |
| Body mass index | 27.6 Kg/m^2 STANDARD_DEVIATION 5.3 | 27.6 Kg/m^2 STANDARD_DEVIATION 5.2 | 27.6 Kg/m^2 STANDARD_DEVIATION 5 | 27.7 Kg/m^2 STANDARD_DEVIATION 5.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 22 Participants | 72 Participants | 29 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 122 Participants | 358 Participants | 115 Participants | 121 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Gestational week at screening | 11.8 weeks STANDARD_DEVIATION 1.1 | 11.7 weeks STANDARD_DEVIATION 1.1 | 11.8 weeks STANDARD_DEVIATION 1 | 11.6 weeks STANDARD_DEVIATION 1.2 |
| Previous live birth | 80 Participants | 240 Participants | 80 Participants | 80 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 13 Participants | 6 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 20 Participants | 64 Participants | 22 Participants | 22 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 21 Participants | 13 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 5 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 14 Participants | 33 Participants | 6 Participants | 13 Participants |
| Race (NIH/OMB) White | 101 Participants | 292 Participants | 92 Participants | 99 Participants |
| Region of Enrollment United States | 144 participants | 430 participants | 144 participants | 142 participants |
| Sex: Female, Male Female | 144 Participants | 430 Participants | 144 Participants | 142 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 144 | 0 / 142 | 0 / 144 |
| other Total, other adverse events | 30 / 144 | 38 / 142 | 46 / 144 |
| serious Total, serious adverse events | 23 / 144 | 13 / 142 | 22 / 144 |
Outcome results
Primary
Changes in the Mother's Body Weight Pre and Post Pregnancy
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).
Time frame: Baseline to 6 months postpartum
Population: Those who completed the 6 month postpartum visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gestational Weight Gain Intervention (GWG-only) | Changes in the Mother's Body Weight Pre and Post Pregnancy | 2.39 kilograms | Standard Deviation 5.36 |
| Postpartum Weight Loss Intervention (PPWL-only) | Changes in the Mother's Body Weight Pre and Post Pregnancy | 1.25 kilograms | Standard Deviation 5.4 |
| Combined | Changes in the Mother's Body Weight Pre and Post Pregnancy | 1.37 kilograms | Standard Deviation 5.76 |
Secondary
1.5 Mile Run on Fitness Test Scores
The amount of time it took to complete 1.5 miles.
Time frame: 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.
Secondary
Birth Weight of Infant
Birth weight of the infant will be recorded in grams.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gestational Weight Gain Intervention (GWG-only) | Birth Weight of Infant | 3363.5 grams | Standard Deviation 529.1 |
| Postpartum Weight Loss Intervention (PPWL-only) | Birth Weight of Infant | 3365.3 grams | Standard Deviation 545.8 |
Secondary
Length of Infant
Birth height of the infant will be recorded in centimeters.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gestational Weight Gain Intervention (GWG-only) | Length of Infant | 51.3 centimeters | Standard Deviation 2.8 |
| Postpartum Weight Loss Intervention (PPWL-only) | Length of Infant | 50.8 centimeters | Standard Deviation 4 |
Secondary
Maternal and Fetal Conditions During Pregnancy
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gestational Weight Gain Intervention (GWG-only) | Maternal and Fetal Conditions During Pregnancy | Pregancy inducaed hypertension | 35 Participants |
| Gestational Weight Gain Intervention (GWG-only) | Maternal and Fetal Conditions During Pregnancy | Preterm delivery (<37 weeks) | 14 Participants |
| Gestational Weight Gain Intervention (GWG-only) | Maternal and Fetal Conditions During Pregnancy | Cesarean delivery (elective) | 36 Participants |
| Gestational Weight Gain Intervention (GWG-only) | Maternal and Fetal Conditions During Pregnancy | Small-for-gestational age (<10th percentile) | 15 Participants |
| Gestational Weight Gain Intervention (GWG-only) | Maternal and Fetal Conditions During Pregnancy | Gestational diabetes | 17 Participants |
| Gestational Weight Gain Intervention (GWG-only) | Maternal and Fetal Conditions During Pregnancy | Large-for-gestational age (> 90th percentile) | 19 Participants |
| Gestational Weight Gain Intervention (GWG-only) | Maternal and Fetal Conditions During Pregnancy | Cesarean delivery (emergency) | 39 Participants |
| Gestational Weight Gain Intervention (GWG-only) | Maternal and Fetal Conditions During Pregnancy | Neonatal Intensive Care Unit admission) | 19 Participants |
| Gestational Weight Gain Intervention (GWG-only) | Maternal and Fetal Conditions During Pregnancy | Preeclampsia | 22 Participants |
| Postpartum Weight Loss Intervention (PPWL-only) | Maternal and Fetal Conditions During Pregnancy | Neonatal Intensive Care Unit admission) | 12 Participants |
| Postpartum Weight Loss Intervention (PPWL-only) | Maternal and Fetal Conditions During Pregnancy | Preeclampsia | 13 Participants |
| Postpartum Weight Loss Intervention (PPWL-only) | Maternal and Fetal Conditions During Pregnancy | Pregancy inducaed hypertension | 26 Participants |
| Postpartum Weight Loss Intervention (PPWL-only) | Maternal and Fetal Conditions During Pregnancy | Gestational diabetes | 13 Participants |
| Postpartum Weight Loss Intervention (PPWL-only) | Maternal and Fetal Conditions During Pregnancy | Cesarean delivery (elective) | 18 Participants |
| Postpartum Weight Loss Intervention (PPWL-only) | Maternal and Fetal Conditions During Pregnancy | Cesarean delivery (emergency) | 14 Participants |
| Postpartum Weight Loss Intervention (PPWL-only) | Maternal and Fetal Conditions During Pregnancy | Preterm delivery (<37 weeks) | 7 Participants |
| Postpartum Weight Loss Intervention (PPWL-only) | Maternal and Fetal Conditions During Pregnancy | Small-for-gestational age (<10th percentile) | 7 Participants |
| Postpartum Weight Loss Intervention (PPWL-only) | Maternal and Fetal Conditions During Pregnancy | Large-for-gestational age (> 90th percentile) | 9 Participants |
Secondary
Moms Fit 2 Fight Program Evaluation Form
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.
Time frame: 12 months postpartum
Population: Includes participants who completed the 12 month program satisfaction measure and did not indicate don't know
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gestational Weight Gain Intervention (GWG-only) | Moms Fit 2 Fight Program Evaluation Form | Diet/Exercise monitoring was helpful | 95 Participants |
| Gestational Weight Gain Intervention (GWG-only) | Moms Fit 2 Fight Program Evaluation Form | Would recommend the program | 104 Participants |
| Gestational Weight Gain Intervention (GWG-only) | Moms Fit 2 Fight Program Evaluation Form | Electronic scale was helpful | 104 Participants |
| Gestational Weight Gain Intervention (GWG-only) | Moms Fit 2 Fight Program Evaluation Form | Meal replacements were helpful | 29 Participants |
| Gestational Weight Gain Intervention (GWG-only) | Moms Fit 2 Fight Program Evaluation Form | Meal plans were helpful | 31 Participants |
| Gestational Weight Gain Intervention (GWG-only) | Moms Fit 2 Fight Program Evaluation Form | Found the program useful | 96 Participants |
| Gestational Weight Gain Intervention (GWG-only) | Moms Fit 2 Fight Program Evaluation Form | Appropriate number of sessions | 90 Participants |
| Gestational Weight Gain Intervention (GWG-only) | Moms Fit 2 Fight Program Evaluation Form | Enjoyed the program | 95 Participants |
| Gestational Weight Gain Intervention (GWG-only) | Moms Fit 2 Fight Program Evaluation Form | Appropriate length of sessions | 100 Participants |
| Gestational Weight Gain Intervention (GWG-only) | Moms Fit 2 Fight Program Evaluation Form | Lesson materials were helpful | 82 Participants |
| Postpartum Weight Loss Intervention (PPWL-only) | Moms Fit 2 Fight Program Evaluation Form | Diet/Exercise monitoring was helpful | 86 Participants |
| Postpartum Weight Loss Intervention (PPWL-only) | Moms Fit 2 Fight Program Evaluation Form | Appropriate number of sessions | 85 Participants |
| Postpartum Weight Loss Intervention (PPWL-only) | Moms Fit 2 Fight Program Evaluation Form | Lesson materials were helpful | 75 Participants |
| Postpartum Weight Loss Intervention (PPWL-only) | Moms Fit 2 Fight Program Evaluation Form | Electronic scale was helpful | 98 Participants |
| Postpartum Weight Loss Intervention (PPWL-only) | Moms Fit 2 Fight Program Evaluation Form | Would recommend the program | 99 Participants |
| Postpartum Weight Loss Intervention (PPWL-only) | Moms Fit 2 Fight Program Evaluation Form | Found the program useful | 88 Participants |
| Postpartum Weight Loss Intervention (PPWL-only) | Moms Fit 2 Fight Program Evaluation Form | Meal replacements were helpful | 31 Participants |
| Postpartum Weight Loss Intervention (PPWL-only) | Moms Fit 2 Fight Program Evaluation Form | Appropriate length of sessions | 92 Participants |
| Postpartum Weight Loss Intervention (PPWL-only) | Moms Fit 2 Fight Program Evaluation Form | Meal plans were helpful | 29 Participants |
| Postpartum Weight Loss Intervention (PPWL-only) | Moms Fit 2 Fight Program Evaluation Form | Enjoyed the program | 87 Participants |
| Combined | Moms Fit 2 Fight Program Evaluation Form | Meal plans were helpful | 27 Participants |
| Combined | Moms Fit 2 Fight Program Evaluation Form | Found the program useful | 93 Participants |
| Combined | Moms Fit 2 Fight Program Evaluation Form | Enjoyed the program | 96 Participants |
| Combined | Moms Fit 2 Fight Program Evaluation Form | Would recommend the program | 96 Participants |
| Combined | Moms Fit 2 Fight Program Evaluation Form | Appropriate number of sessions | 93 Participants |
| Combined | Moms Fit 2 Fight Program Evaluation Form | Appropriate length of sessions | 92 Participants |
| Combined | Moms Fit 2 Fight Program Evaluation Form | Lesson materials were helpful | 71 Participants |
| Combined | Moms Fit 2 Fight Program Evaluation Form | Diet/Exercise monitoring was helpful | 90 Participants |
| Combined | Moms Fit 2 Fight Program Evaluation Form | Electronic scale was helpful | 109 Participants |
| Combined | Moms Fit 2 Fight Program Evaluation Form | Meal replacements were helpful | 32 Participants |
Secondary
Number of Push Ups on Fitness Test Scores
Number of push ups completed.
Time frame: 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.
Secondary
Number of Sit Ups on Fitness Test Scores
Number of sit ups completed.
Time frame: 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.
Secondary
Waist Circumference on Fitness Test Scores
Waist circumference will be recorded in centimeters.
Time frame: 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.