- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT03249324
Preventing Obesity in Military Communities: Mother-Baby
torstai 10. elokuuta 2017 päivittänyt: Henry M. Jackson Foundation for the Advancement of Military Medicine
Women with pre-pregnancy obesity, women who exceed recommended weight gain during pregnancy, and children who experience rapid and excess growth during the first year of life are all at risk for subsequent obesity.
The purpose of this study is to examine creative cognitive strategies to promote healthy weight gain during pregnancy, creating a sound substrate of metabolic programming for the critical first six months of life.
A trans-disciplinary approach utilizing a patient- and family-centered intervention and active patient engagement with counseling for positive gain will work with women to shape lifestyle during pregnancy and postpartum, and when feeding their infants in the first 6 months of life.
It is hypothesized patient engagement with counseling for positive gains will successfully mitigate excess weight gain in both pregnancy and infancy compared to usual care.
Moreover, data will be examined to assess whether psychological variables, work and school climate, and social support factors influence body weight gain trajectories and/or weight loss during and after pregnancy.
Tutkimuksen yleiskatsaus
Tila
Tuntematon
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
Obesity is increasingly common among reproductive aged women and women presenting for their first pregnancy.
Women with overweight and obesity are more likely to exceed recommended weight gain during pregnancy and retain excess weight after delivery.
Women with pre-pregnancy obesity, women who exceed recommended weight gain during pregnancy, and children who experience rapid and excess growth during the first year of life are all at risk for subsequent obesity.
Additionally, maternal obesity is a significant risk factor for pregnancy complications (i.e., hypertensive disorders of pregnancy, gestational diabetes) and is associated with adverse pregnancy outcomes, including excess fetal weight at birth.
The goal of this study is to test the effectiveness of active patient engagement with counseling for positive gain to mitigate excess weight gain in women during pregnancy and postpartum, and in the first six months of life.
Pregnant women eligible to receive care in the Military Health System (MHS) will be randomized to receive either the positive-gain counseling (PGC) prevention program or usual care (UC).
PGC is designed to empower women to examine food choices and activity patterns during pregnancy to help them adhere to the Institute of Medicine (IOM) recommended weight gain standards.
PGC patients will be paired with counselors who follow their pregnancy from start to finish, as well as providing neonatal and infant support in a continuous fashion as part of team-based care.
Women in the usual care (UC) group will receive prenatal care in accordance with the VA/DoD Guideline for the Management of Pregnancy.
Both groups will receive routine well-child care in accordance with established guidelines from the American Academy of Pediatrics and the American Academy of Family Physicians.
Routine well-child care appointments (UC) take place at 2-3 days after birth, 2 weeks of life, 2 months of life, 4 months, 6 months, 9 months and 12 months.
Participants' weight status, food intake, and mood will be assessed once during each trimester and at 2 weeks, 2 months, 4 months, and 6 months postpartum.
Individuals enrolled in the PGC group will receive specific counseling once during each trimester and at 2 weeks, 2 months, 4 months and 6 months postpartum.
Well-child sessions will focus on positive-gain-based cognitive strategies to promote breastfeeding, recognition of satiety cues and other healthy food choices.
It is hypothesized that participants who receive the positive-gains counseling program will show significantly less weight gain in both pregnancy and infancy relative to those randomized to usual care.
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
58
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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North Carolina
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Camp Lejeune, North Carolina, Yhdysvallat, 28547
- Naval Hospital Camp Lejeune
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
18 vuotta - 35 vuotta (Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Joo
Sukupuolet, jotka voivat opiskella
Nainen
Kuvaus
Inclusion Criteria:
- Age between 18 and 35 years
- Absence of underlying medical conditions that would place the pregnancy in the high-risk category (e.g., hypertension, pre-existing diabetes mellitus, thyroid disease, multiple gestations)
- Baseline BMI (on determination of pregnancy) >18 kg/m2 and ≤29.9 kg/m2
- Plan to reside in the study area (Jacksonville, NC area) for at least 18 months
- Eligible for care within the Military Health System (MHS)
- No planned surgeries, medical interventions, or other procedures that would place participants in the high-risk pregnancy category
- No involvement in a commercial or military weight management program in the past 3 months
- Fluent command of the English language
Exclusion Criteria:
- Current involvement in a structured weight loss program
- BMI of ≤18 kg/m2 or ≥30 kg/m2
- Potential participants with high-risk pregnancies. Participants will be placed in the high risk pregnancy category if they have any underlying medical conditions (e.g. hypertension, diabetes, thyroid disease, multiple gestations) placing the subject into a high-risk category by American College of Obstetrics and Gynecology (ACOG) standards
- Planned surgeries or other procedures that would place participants in the high-risk pregnancy category
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Ennaltaehkäisy
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: Positive-Gain Counseling (PGC)
Positive-gain-based health promotion interventions capitalize on the basic human desire to maintain consistency between one's words and actions for beneficial outcomes.
Participants will discuss potential costs of unhealthy behaviors and the benefits of healthier lifestyle choices, and how they apply not only to adults, but also to developing children.
Theoretically, discussing these perspectives will make the mothers more likely to make healthier lifestyle choices in the future.
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Positive-gain-based health promotion interventions capitalize on the basic human desire to maintain consistency between one's words and actions for beneficial outcomes.
Participants will be asked to discuss potential adverse effects of obesity, an unhealthy diet, and sedentary behavior, as well as the benefits of maintaining a physically fit body, eating a healthy diet, and regular physical activity.
They will also discuss the costs and benefits as they apply to developing children.
Theoretically, discussing and reviewing these perspectives will make the mothers more apt to make healthier lifestyle choices in the future.
Women randomized to the positive-gains counseling (PGC) group will have PGC sessions once during each trimester and at 2 weeks, 2 months, 4 months and 6 months postpartum.
PGC participants will also receive prenatal care in accordance with the VA/DoD Guideline for the Management of Pregnancy.
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Active Comparator: Usual Care (UC)
UC includes regular clinic visits, routine blood and urine screening tests, and anticipatory guidance from a primary care provider in accordance with the VA/DoD Guideline for the Management of Pregnancy.
After delivery, participants receive routine well-child care in accordance with established guidelines from the American Academy of Pediatrics and the American Academy of Family Physicians.
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Women in the usual care (UC) group will receive prenatal care in accordance with the VA/DoD Guideline for the Management of Pregnancy.
This entails regular clinic visits, routine blood and urine screening tests, and anticipatory guidance.
Routine well-child care appointments will take place at 2-3 days, 2 weeks, 2 months, 4 months, 6 months, 9 months and 12 months after birth.
During routine well-child visits, height, weight, and vital signs are measured, developmental milestones are reviewed, and a thorough physical examination is performed.
Age-appropriate immunizations are provided as is parental anticipatory guidance, including the importance of breastfeeding.
Participants enrolled in the UC group will receive anticipatory guidance from their primary care provider in the usual fashion.
Providers will deliver this anticipatory guidance with no external cues or counseling provided by the research team.
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
|---|---|
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Maternal weight gain
Aikaikkuna: Pre-pregnancy to delivery
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Pre-pregnancy to delivery
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Infant birth weight
Aikaikkuna: Birth
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Data will be collected from the participant's inpatient medical records (Essentris) at Naval Hospital Camp Lejeune
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Birth
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Development of gestational diabetes
Aikaikkuna: Gestation
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Data will be collected for all participants from the outpatient electronic medical records (AHLTA) at Naval Hospital Camp Lejeune
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Gestation
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Need for induction of labor and methods of labor induction used
Aikaikkuna: Labor and delivery
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Data will be collected from the participant's inpatient medical records (Essentris) at Naval Hospital Camp Lejeune
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Labor and delivery
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Mode of Delivery
Aikaikkuna: Birth
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Mode of delivery (e.g., vaginal or Caesarean section) will be collected from the participant's inpatient medical records (Essentris) at Naval Hospital Camp Lejeune
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Birth
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Length of Labor
Aikaikkuna: Onset of latent phase of labor to delivery of the placenta and fetal membranes
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The length of labor will be collected from the participant's inpatient medical records (Essentris) at Naval Hospital Camp Lejeune
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Onset of latent phase of labor to delivery of the placenta and fetal membranes
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Need for anesthesia or analgesics and forms of anesthesia or analgesics used during labor
Aikaikkuna: Labor and delivery
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Data will be collected from the participant's inpatient medical records (Essentris) at Naval Hospital Camp Lejeune
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Labor and delivery
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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Yhteistyökumppanit
Tutkijat
- Päätutkija: Mark Stephens, MD, Uniformed Services University of the Health Sciences
- Päätutkija: Linda Chan, MD, Naval Hospital Camp Lejeune
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Lauantai 1. marraskuuta 2014
Ensisijainen valmistuminen (Odotettu)
Perjantai 1. syyskuuta 2017
Opintojen valmistuminen (Odotettu)
Perjantai 1. syyskuuta 2017
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Tiistai 20. kesäkuuta 2017
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Torstai 10. elokuuta 2017
Ensimmäinen Lähetetty (Todellinen)
Tiistai 15. elokuuta 2017
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Tiistai 15. elokuuta 2017
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Torstai 10. elokuuta 2017
Viimeksi vahvistettu
Tiistai 1. elokuuta 2017
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- NHCL.2012.0011
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
EI
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