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Completed

NCT Number: NCT01610752

Personalized Management of Body Weight During Pregnancy

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.

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Key information

Conditions

Weight Gain During Pregnancy Body Weight Body Weight Changes Gestational Weight Gain Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Gain

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Pennington Biomedical Research Center, Baton Rouge, Louisiana, United States

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SmartMoms

Behavioral

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.

Primary outcomes

  1. Count of Women Who Have Excess Gestational Weight Gain

    Time frame: 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

Secondary outcomes

  1. Total Gestational Weight Gain

    Time frame: Approximately 6 months (from 10-13 weeks gestation to 35-36 weeks gestation)

  2. Gestational Weight Gain Per Week

    Time frame: Approximately 6 months (from 10-13 weeks gestation to 35-36 weeks gestation)

    "per week" is included to adjust for the different length of time between weight measurements

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Expecting Success: Personalized Management of Body Weight During Pregnancy

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Jun 4, 2012
Registry last updated
Sep 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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