Expecting Success: Personalized Management of Body Weight During Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Count of Women Who Have Excess Gestational Weight Gain
研究概览
简要总结
The purpose of this study is to determine how to help manage weight gain during pregnancy. This study is part of the National Consortium 'LIFE-Moms: Lifestyle interventions in expectant moms'. LIFE-Moms is 7 studies funded to test different lifestyle interventions in overweight and obese pregnant women.
详细描述
The study will last 22 months, from screening until study completion. The entire study will include 3 screening visits, receipt of weight management advice, second trimester testing, third trimester testing and three follow up visits during the first year after the baby is born. Participants will randomly be assigned to 1 of 3 programs to help manage their weight during pregnancy:
- Physician Directed group
- SmartMoms-Clinic group
- SmartMoms-Phone group
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Are pregnant.
- •Are between 18 and 40 years old.
- •Have a BMI (a number calculated from your height and weight) equal to or above 25kg/m
- •Establish prenatal care before 12 weeks of your pregnancy.
- •Can read, speak and understand English.
排除标准
- •Do not plan to deliver your baby at Woman's Hospital, Baton Rouge, LA
- •Are pregnant with more than one infant.
- •Have habitually smoked during the last 6 months.
- •Currently abuse or have abused illegal or prescription drugs in the last 6 months.
- •Consume more than 2 alcoholic drinks per week.
- •Are unwilling to avoid pregnancy for 12 months following delivery.
- •Are unwilling to enroll your baby in the 12 month follow-up testing planned in this study.
- •Are planning to move out of the area within the next 2 years or plan to be out of the study area for more than 1 month in the next year.
- •Are unwilling to be assigned at random to any of the intervention groups.
- •Are planning to terminate your pregnancy.
- •Are planning to give your baby up for adoption.
- •Are pregnant with a baby who has a known fetal anomaly.
- •Have a reason that exercising is unsafe (determined by your physician or study staff).
- •Have had or plan to have bariatric surgery within 1 year of your expected delivery.
- •Currently have or have a history of the following:
- •3 or more first trimester miscarriages
- •High blood pressure
- •Type 1 diabetes
- •Diagnosis of pregnancy related diabetes during screening
- •HIV or AIDS
- •Psychotic disorder, major depressive episode, bipolar disorder or eating disorder
- •Any other pregnancy, blood, heart, lung, hormone, or digestive problem that your doctor considers unsafe for participation in this study
研究组 & 干预措施
SmartMoms-Clinic
If picked for this group, you will attend study meetings with a weight management counselor. During the second trimester study meetings occur 4 times per month. During the third trimester you will attend study meetings 2 times per month. These meetings will cover many topics to help you learn about weight management during pregnancy. You will be taught how to use different tools provided to help you monitor your weight. We will ask you to record your body weight (using a scale we will provide) as well as your food intake and exercise habits.
干预措施: SmartMoms (Behavioral)
SmartMoms-Phone
If picked for this group, you will have two individual sessions with a weight management counselor. At the first session, you will receive a scale and other technology to help manage your weight during pregnancy. Each week you will receive information from a weight management counselor via a Smartphone (you can use your own Smartphone or one will be provided to you). The information will cover topics to help manage your weight during pregnancy. You will be taught how to use different tools provided to help you monitor your weight. We will ask you to measure your body weight (using a scale we will provide) as well as monitor your food intake and exercise habits with the Smartphone.
干预措施: SmartMoms (Behavioral)
Physician Directed
If picked for this group, you will receive weight management advice from your physician's office.
结局指标
主要结局
Count of Women Who Have Excess Gestational Weight Gain
时间窗: Approximately 6 months (from 10-13 weeks gestation to 35-36 weeks gestation)
Count of pregnant women who gain more weight during pregnancy than is recommended by the Institute of Medicine Gestational Weight Gain guidelines
次要结局
- Total Gestational Weight Gain(Approximately 6 months (from 10-13 weeks gestation to 35-36 weeks gestation))
- Gestational Weight Gain Per Week(Approximately 6 months (from 10-13 weeks gestation to 35-36 weeks gestation))
研究者
Leanne Redman
Principal Investigator
Pennington Biomedical Research Center