Personalized Management of Body Weight During Pregnancy

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Expecting Success: Personalized Management of Body Weight During Pregnancy

Conditions
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Weight Gain During Pregnancy

Intervention / Treatment
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* Behavioral: SmartMoms


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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/m2. Establish prenatal care before 12 weeks of your pregnancy. Can read, speak and understand English. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SmartMoms-Clinic<br>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. | Behavioral: SmartMoms<br>* This intervention 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.<br>|
| Experimental: SmartMoms-Phone<br>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. | Behavioral: SmartMoms<br>* This intervention 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.<br>|
| No Intervention: Physician Directed<br>If picked for this group, you will receive weight management advice from your physician's office. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Count of Women Who Have Excess Gestational Weight Gain | Count of pregnant women who gain more weight during pregnancy than is recommended by the Institute of Medicine Gestational Weight Gain guidelines | Approximately 6 months (from 10-13 weeks gestation to 35-36 weeks gestation) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Gestational Weight Gain |  | Approximately 6 months (from 10-13 weeks gestation to 35-36 weeks gestation) | 
| Gestational Weight Gain Per Week | per week is included to adjust for the different length of time between weight measurements | Approximately 6 months (from 10-13 weeks gestation to 35-36 weeks gestation) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, Gestational weight gain