Gestational Weight Gain and Postpartum Weight Loss in Active Duty Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 430
- 试验地点
- 4
- 主要终点
- Changes in the Mother's Body Weight Pre and Post Pregnancy
研究概览
简要总结
The purpose of this study is to enroll approximately 450 subjects to see if a behavioral weight management program is successful in helping TRICARE beneficiaries who are pregnant or post-partum to manage their weight during and after their pregnancy.
详细描述
Investigators will randomize 450 consented participants to 1 of 3 interventions: a) a gestational weight gain intervention (GWG-only); b) a postpartum weight loss intervention (PPWL-only), or c) a combined gestational weight gain and postpartum weight loss intervention (GWG+PPWL) to determine the efficacy of the interventions on GWG as well as PPWL.
Procedures: Interested individuals will be directed to call the study telephone number to learn more and determine whether eligibility criteria is met. Individuals who meet the telephone screening eligibility criteria will be invited to schedule a Screening Visit, during which written informed consent will be obtained. At this visit, eligibility will be assessed and measures will be administrated. The potential participant will also be asked to complete a one-week dietary and exercise self-monitoring run-in and receive medical clearance from their obstetrician to participate. Should she continue to be interested, she will return for a Baseline Visit and will be randomized.
Randomized participants will have 5 in person scheduled visits after their Screening Visit and Baseline Visit to the Wilford Hall Ambulatory Surgical Center (WHASC) or San Antonio Military Medical Center (SAMMC) Obstetrics (OB) clinic. These visits will be scheduled at gestational week 32, 36, as well as at 6- weeks, 6-months, and 12- month postpartum. At these visits, physical measurements will be collected and participants will complete various questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Participants will be active duty military, dependents or retired with TRICARE benefits
- •Participants must be less than 12 weeks gestation upon recruitment (based on the date of their last menstrual period and then confirmed by their physician at their first prenatal visit, which typically occurs at 6-8 weeks gestation at WHASC and SAMMC)
- •Participants also must be within the normal, overweight, or obese BMI ranges
- •Are generally in good health
- •Currently not smoking more than 5 cigarettes per day at the time of conception
排除标准
- •Expecting multiple babies (e.g. twins)
- •Not interested in participating in a program for 21 months
结局指标
主要结局
Changes in the Mother's Body Weight Pre and Post Pregnancy
时间窗: Baseline to 6 months postpartum
At all measurement visits, weight will be recorded in kilograms. Weight will be measured on a calibrated digital scale in duplicate, with the participant wearing light clothing and no shoes. While Investigators obtain the mother's weight at baseline, there will also be a self reported pregravid weight (before the last menstrual period).
次要结局
- Maternal and Fetal Conditions During Pregnancy(Baseline (13 weeks gestational to delivery))
- Birth Weight of Infant(Delivery)
- Length of Infant(Delivery)
- Waist Circumference on Fitness Test Scores(Baseline and 12 months postpartum)
- Number of Push Ups on Fitness Test Scores(Baseline and 12 months postpartum)
- Number of Sit Ups on Fitness Test Scores(Baseline and 12 months postpartum)
- 1.5 Mile Run on Fitness Test Scores(Baseline and 12 months postpartum)
- Moms Fit 2 Fight Program Evaluation Form(12 months postpartum)