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Preventing Obesity in Military Communities: Mother-Baby

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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

58

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • North Carolina
      • Camp Lejeune, North Carolina, Stati Uniti, 28547
        • Naval Hospital Camp Lejeune

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 35 anni (Adulto)

Accetta volontari sani

Sessi ammissibili allo studio

Femmina

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
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.
Comparatore attivo: 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.
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Maternal weight gain
Lasso di tempo: Pre-pregnancy to delivery
Pre-pregnancy to delivery

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Infant birth weight
Lasso di tempo: Birth
Data will be collected from the participant's inpatient medical records (Essentris) at Naval Hospital Camp Lejeune
Birth
Development of gestational diabetes
Lasso di tempo: Gestation
Data will be collected for all participants from the outpatient electronic medical records (AHLTA) at Naval Hospital Camp Lejeune
Gestation
Need for induction of labor and methods of labor induction used
Lasso di tempo: Labor and delivery
Data will be collected from the participant's inpatient medical records (Essentris) at Naval Hospital Camp Lejeune
Labor and delivery
Mode of Delivery
Lasso di tempo: Birth
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
Birth
Length of Labor
Lasso di tempo: Onset of latent phase of labor to delivery of the placenta and fetal membranes
The length of labor will be collected from the participant's inpatient medical records (Essentris) at Naval Hospital Camp Lejeune
Onset of latent phase of labor to delivery of the placenta and fetal membranes
Need for anesthesia or analgesics and forms of anesthesia or analgesics used during labor
Lasso di tempo: Labor and delivery
Data will be collected from the participant's inpatient medical records (Essentris) at Naval Hospital Camp Lejeune
Labor and delivery

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Mark Stephens, MD, Uniformed Services University of the Health Sciences
  • Investigatore principale: Linda Chan, MD, Naval Hospital Camp Lejeune

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 novembre 2014

Completamento primario (Anticipato)

1 settembre 2017

Completamento dello studio (Anticipato)

1 settembre 2017

Date di iscrizione allo studio

Primo inviato

20 giugno 2017

Primo inviato che soddisfa i criteri di controllo qualità

10 agosto 2017

Primo Inserito (Effettivo)

15 agosto 2017

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

15 agosto 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 agosto 2017

Ultimo verificato

1 agosto 2017

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • NHCL.2012.0011

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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