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Preventing Obesity in Military Communities: Mother-Baby

Primary Purpose

Pregnancy, Overweight, Obesity

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Positive-Gain Counseling (PGC)
Usual Care
Sponsored by
Henry M. Jackson Foundation for the Advancement of Military Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pregnancy focused on measuring Pregnancy, Overweight, Obesity, Prevention, Positive-gain counseling

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Naval Hospital Camp Lejeune

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Positive-Gain Counseling (PGC)

Usual Care (UC)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Maternal weight gain

Secondary Outcome Measures

Infant birth weight
Data will be collected from the participant's inpatient medical records (Essentris) at Naval Hospital Camp Lejeune
Development of gestational diabetes
Data will be collected for all participants from the outpatient electronic medical records (AHLTA) at Naval Hospital Camp Lejeune
Need for induction of labor and methods of labor induction used
Data will be collected from the participant's inpatient medical records (Essentris) at Naval Hospital Camp Lejeune
Mode of Delivery
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
Length of Labor
The length of labor will be collected from the participant's inpatient medical records (Essentris) at Naval Hospital Camp Lejeune
Need for anesthesia or analgesics and forms of anesthesia or analgesics used during labor
Data will be collected from the participant's inpatient medical records (Essentris) at Naval Hospital Camp Lejeune

Full Information

First Posted
June 20, 2017
Last Updated
August 10, 2017
Sponsor
Henry M. Jackson Foundation for the Advancement of Military Medicine
Collaborators
Naval Hospital Camp Lejeune
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1. Study Identification

Unique Protocol Identification Number
NCT03249324
Brief Title
Preventing Obesity in Military Communities: Mother-Baby
Official Title
Preventing Obesity in Military Communities: Mother-Baby
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 2014 (undefined)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
September 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Henry M. Jackson Foundation for the Advancement of Military Medicine
Collaborators
Naval Hospital Camp Lejeune

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Overweight, Obesity
Keywords
Pregnancy, Overweight, Obesity, Prevention, Positive-gain counseling

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Positive-Gain Counseling (PGC)
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care (UC)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Positive-Gain Counseling (PGC)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Maternal weight gain
Time Frame
Pre-pregnancy to delivery
Secondary Outcome Measure Information:
Title
Infant birth weight
Description
Data will be collected from the participant's inpatient medical records (Essentris) at Naval Hospital Camp Lejeune
Time Frame
Birth
Title
Development of gestational diabetes
Description
Data will be collected for all participants from the outpatient electronic medical records (AHLTA) at Naval Hospital Camp Lejeune
Time Frame
Gestation
Title
Need for induction of labor and methods of labor induction used
Description
Data will be collected from the participant's inpatient medical records (Essentris) at Naval Hospital Camp Lejeune
Time Frame
Labor and delivery
Title
Mode of Delivery
Description
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
Time Frame
Birth
Title
Length of Labor
Description
The length of labor will be collected from the participant's inpatient medical records (Essentris) at Naval Hospital Camp Lejeune
Time Frame
Onset of latent phase of labor to delivery of the placenta and fetal membranes
Title
Need for anesthesia or analgesics and forms of anesthesia or analgesics used during labor
Description
Data will be collected from the participant's inpatient medical records (Essentris) at Naval Hospital Camp Lejeune
Time Frame
Labor and delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Stephens, MD
Organizational Affiliation
Uniformed Services University of the Health Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Linda Chan, MD
Organizational Affiliation
Naval Hospital Camp Lejeune
Official's Role
Principal Investigator
Facility Information:
Facility Name
Naval Hospital Camp Lejeune
City
Camp Lejeune
State/Province
North Carolina
ZIP/Postal Code
28547
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Preventing Obesity in Military Communities: Mother-Baby

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