Preventing Obesity in Military Communities: Mother-Baby

NCT03249324 | Unknown

• 1 other identifier: NHCL.2012.0011
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy; Overweight; Obesity

Keywords

Pregnancy; Overweight; Obesity; Prevention; Positive-gain counseling

Outcome Measures

Primary Outcomes (1)

• Maternal weight gain

  Pre-pregnancy to delivery

Secondary Outcomes (6)

• Infant birth weight

  Birth

• Development of gestational diabetes

  Gestation

• Need for induction of labor and methods of labor induction used

  Labor and delivery

• Mode of Delivery

  Birth

• Length of Labor

  Onset of latent phase of labor to delivery of the placenta and fetal membranes

Study Arms (2)

Positive-Gain Counseling (PGC)

EXPERIMENTAL

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.

Behavioral: Positive-Gain Counseling (PGC)

Usual Care (UC)

ACTIVE COMPARATOR

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.

Other: Usual Care

Interventions

Positive-Gain Counseling (PGC) BEHAVIORAL

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.

Positive-Gain Counseling (PGC)

Usual Care OTHER

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.

Usual Care (UC)

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Henry M. Jackson Foundation for the Advancement of Military Medicine: lead
• Naval Hospital Camp Lejeune: collaborator

Study Sites (1)

Naval Hospital Camp Lejeune

Marine Corps Base Camp Lejeune, North Carolina, 28547, United States

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mark Stephens, MD

  Uniformed Services University of the Health Sciences

  PRINCIPAL INVESTIGATOR

• Linda Chan, MD

  Naval Hospital Camp Lejeune

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2017
• First Posted: August 15, 2017
• Study Start: November 1, 2014
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: August 15, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)