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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK104872-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| 59th Medical Wing | FED |
| San Antonio Military Medical Center | FED |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gestational weight gain intervention (GWG-only) | Experimental | 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. |
|
| Postpartum weight loss intervention (PPWL-only) | Experimental | 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. |
|
| Combined | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gestational weight gain intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline to 6 months postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (13 weeks gestational to delivery) |
| Birth Weight of Infant |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca Krukowski, PhD | University of Tennessee | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Antonio Military Medical Center Obstetrics Clinic (SAMMC) | San Antonio | Texas | 78219 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39587506 | Derived | Solomon E, McPhail A, Bursac Z, Little MA, Talcott GW, Krukowski RA. Provider advice, pregnant persons' expectations, and actual gestational weight gain among United States military health care beneficiaries: a secondary analysis of a randomized controlled trial. BMC Pregnancy Childbirth. 2024 Nov 25;24(1):785. doi: 10.1186/s12884-024-06987-x. | |
| 37061829 | Derived | Perez-Munoz A, Hare ME, Andres A, Klesges RC, Wayne Talcott G, Little MA, Waters TM, Harvey JR, Bursac Z, Krukowski RA. A Postpartum Weight Loss-focused Stepped-care Intervention in a Military Population: A Randomized Controlled Trial. Ann Behav Med. 2023 Sep 13;57(10):836-845. doi: 10.1093/abm/kaad014. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Those who completed the 6 month postpartum visit | Posted | Mean | Standard Deviation | kilograms | Baseline to 6 months postpartum |
|
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
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendectomy | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Common cold | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rebecca Krukowski | University of Virginia | 4349245303 | wae4mq@virginia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 3, 2019 | Aug 10, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015430 | Weight Gain |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
|
| Postpartum weight loss intervention | Behavioral | 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 the infant will be recorded in grams. |
| Delivery |
| Length of Infant | Birth height of the infant will be recorded in centimeters. | Delivery |
| Waist Circumference on Fitness Test Scores | Waist circumference will be recorded in centimeters. | Baseline and 12 months postpartum |
| Number of Push Ups on Fitness Test Scores | Number of push ups completed. | Baseline and 12 months postpartum |
| Number of Sit Ups on Fitness Test Scores | Number of sit ups completed. | Baseline and 12 months postpartum |
| 1.5 Mile Run on Fitness Test Scores | The amount of time it took to complete 1.5 miles. | Baseline and 12 months postpartum |
| 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. | 12 months postpartum |
| Wilford Hall Ambulatory Surgical Center |
| San Antonio |
| Texas |
| 78236 |
| United States |
| 36336697 | Derived | Pebley K, Farage G, Hare ME, Bursac Z, Andres A, Chowdhury SMR, Talcott GW, Krukowski RA. Changes in self-reported and accelerometer-measured physical activity among pregnant TRICARE Beneficiaries. BMC Public Health. 2022 Nov 7;22(1):2029. doi: 10.1186/s12889-022-14457-2. |
| 36041980 | Derived | Estevez Burns R, Hare ME, Andres A, Klesges RC, Talcott GW, LeRoy K, Little MA, Hyrshko-Mullen A, Waters TM, Harvey JR, Bursac Z, Krukowski RA. An interim analysis of a gestational weight gain intervention in military personnel and other TRICARE beneficiaries. Obesity (Silver Spring). 2022 Oct;30(10):1951-1962. doi: 10.1002/oby.23523. Epub 2022 Aug 30. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body mass index | Mean | Standard Deviation | Kg/m^2 |
|
| Gestational week at screening | Mean | Standard Deviation | weeks |
|
| Active duty | Count of Participants | Participants |
|
| Previous live birth | Count of Participants | Participants |
|
| OG001 | 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. |
| OG002 | 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. |
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Baseline (13 weeks gestational to delivery) |
|
|
|
| Secondary | Birth Weight of Infant | Birth weight of the infant will be recorded in grams. | 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. | Posted | Mean | Standard Deviation | grams | Delivery |
|
|
|
| Secondary | Length of Infant | Birth height of the infant will be recorded in centimeters. | 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. | Posted | Mean | Standard Deviation | centimeters | Delivery |
|
|
|
| Secondary | Waist Circumference on Fitness Test Scores | Waist circumference will be recorded in centimeters. | 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. | Posted | Baseline and 12 months postpartum |
|
|
| Secondary | Number of Push Ups on Fitness Test Scores | Number of push ups completed. | 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. | Posted | Baseline and 12 months postpartum |
|
|
| Secondary | Number of Sit Ups on Fitness Test Scores | Number of sit ups completed. | 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. | Posted | Baseline and 12 months postpartum |
|
|
| Secondary | 1.5 Mile Run on Fitness Test Scores | The amount of time it took to complete 1.5 miles. | 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. | Posted | Baseline and 12 months postpartum |
|
|
| 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. | Includes participants who completed the 12 month program satisfaction measure and did not indicate "don't know" | Posted | Count of Participants | Participants | 12 months postpartum |
|
|
|
| 0 |
| 144 |
| 23 |
| 144 |
| 30 |
| 144 |
| EG001 | 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. | 0 | 142 | 13 | 142 | 38 | 142 |
| EG002 | 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. | 0 | 144 | 22 | 144 | 46 | 144 |
| Tubal ligation | Reproductive system and breast disorders | Systematic Assessment |
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| Preterm labor/delivery | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Caesarean section | Reproductive system and breast disorders | Systematic Assessment |
|
| Miscarriage | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Preeclampsia | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Kidney infection | Renal and urinary disorders | Systematic Assessment |
|
| Syncope | General disorders | Systematic Assessment |
|
| NICU admission | General disorders | Systematic Assessment |
|
| Low white blood count | Blood and lymphatic system disorders | Systematic Assessment |
|
| Heart rate issues | Cardiac disorders | Systematic Assessment |
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| Gallbladder removal | Gastrointestinal disorders | Systematic Assessment |
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| Hospitalization due to viral illness | Infections and infestations | Systematic Assessment |
|
| Kidney stones | Renal and urinary disorders | Systematic Assessment |
|
| Uterine bleeding | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Elevated blood pressure with amniotic fluid leak | General disorders | Systematic Assessment |
|
| Chest pains, shortness of breath, syncope | General disorders | Systematic Assessment |
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| Placenta previa | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Ruptured rectum | Gastrointestinal disorders | Systematic Assessment |
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| Fetal Single Umbilical Artery | Renal and urinary disorders | Systematic Assessment |
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| Epileptic event | Nervous system disorders | Systematic Assessment |
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| Retained placenta | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Car accident | Injury, poisoning and procedural complications | Systematic Assessment |
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| Mastitis | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Nausea and vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Gallbladder stone | Gastrointestinal disorders | Systematic Assessment |
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| Dermoid cyst | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Fetal termination due to anomalies | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Neonatal death | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Suicide attempt | Psychiatric disorders | Systematic Assessment |
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| Cellulitis infection | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Depressive symptoms | Psychiatric disorders | Systematic Assessment |
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| Gestational diabetes | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| COVID-19 | Infections and infestations | Systematic Assessment |
|
Not provided
Not provided
| Gestational diabetes |
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| Cesarean delivery (elective) |
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| Cesarean delivery (emergency) |
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| Preterm delivery (<37 weeks) |
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| Small-for-gestational age (<10th percentile) |
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| Large-for-gestational age (> 90th percentile) |
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| Neonatal Intensive Care Unit admission) |
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| Enjoyed the program |
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| Would recommend the program |
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| Appropriate number of sessions |
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| Appropriate length of sessions |
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| Lesson materials were helpful |
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| Diet/Exercise monitoring was helpful |
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| Electronic scale was helpful |
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| Meal replacements were helpful |
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| Meal plans were helpful |
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