Clinical trial NCT03249324: Preventing Obesity in Military Communities: Mother-Baby
Official title: Preventing Obesity in Military Communities: Mother-Baby
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnancy
Overweight
Obesity
Keywords: Pregnancy
Overweight
Obesity
Prevention
Positive-gain counseling
Lead sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine
Sponsor class: OTHER
Collaborators: name: Naval Hospital Camp Lejeune
First posted: 2017-08-15
Enrollment: 58
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Maternal weight gain
timeFrame: Pre-pregnancy to delivery
Secondary outcomes:
measure: Infant birth weight
timeFrame: Birth
measure: Development of gestational diabetes
timeFrame: Gestation
measure: Need for induction of labor and methods of labor induction used
timeFrame: Labor and delivery
measure: Mode of Delivery
timeFrame: Birth
measure: Length of Labor
timeFrame: Onset of latent phase of labor to delivery of the placenta and fetal membranes
measure: Need for anesthesia or analgesics and forms of anesthesia or analgesics used during labor
timeFrame: Labor and delivery
Other outcomes:
Locations:
city: Camp Lejeune
country: United States
facility: Naval Hospital Camp Lejeune
state: North Carolina
Study officials:
affiliation: Uniformed Services University of the Health Sciences
name: Mark Stephens, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Naval Hospital Camp Lejeune
name: Linda Chan, MD
role: PRINCIPAL_INVESTIGATOR
References: