Personalized Management of Body Weight During Pregnancy

This study is currently recruiting participants.
Verified January 2013 by Pennington Biomedical Research Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Leanne Redman, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT01610752
First received: May 31, 2012
Last updated: January 18, 2013
Last verified: January 2013

May 31, 2012
January 18, 2013
December 2012
June 2016   (final data collection date for primary outcome measure)
Proportion of pregnant women who gain more weight during pregnancy than is recommended by the Institute of Medicine [ Time Frame: Approximately 6 months (from 1st trimester of pregnancy to delivery) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01610752 on ClinicalTrials.gov Archive Site
  • Relationship between weight gain during pregnancy, the mother's physical activity and diet on the chance of the mother getting diabetes during pregnancy [ Time Frame: 6 months (from 1st trimester until delivery) ] [ Designated as safety issue: No ]
  • Relationship between weight gain during pregnancy, the mother's physical activity and diet on the baby's weight at birth [ Time Frame: 6 months (from 1st trimester until delivery) ] [ Designated as safety issue: No ]
  • Relationship between weight gain during pregnancy, the mother's physical activity and diet on the mother and baby's body fatness [ Time Frame: 18 months (from 1st trimester until 1 year after delivery) ] [ Designated as safety issue: No ]
  • Relationship between weight gain during pregnancy, the mother's physical activity and diet on how much pregnancy weight the mother keeps after she delivers her baby [ Time Frame: 18 months (from 1st trimester until 1 year after delivery) ] [ Designated as safety issue: No ]
  • Relationship between weight gain during pregnancy, the mother's physical activity and diet on how much the baby eats [ Time Frame: 12 months (from 1st trimester until 6 months after delivery) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Personalized Management of Body Weight During Pregnancy
Expecting Success: 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.

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:

  1. Physician Directed group
  2. SmartMoms-Clinic group
  3. SmartMoms-Phone group
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Weight Gain During Pregnancy
Behavioral: SmartMoms
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.
  • Experimental: 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.
    Intervention: Behavioral: SmartMoms
  • Experimental: 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.
    Intervention: Behavioral: SmartMoms
  • No Intervention: Physician Directed
    If picked for this group, you will receive weight management advice from your physician's office.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
306
September 2016
June 2016   (final data collection date for primary outcome measure)

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 and below 40kg/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 have your DNA and RNA collected, stored and used for future analysis.
  • 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:
  • Preterm labor (delivery before 37 weeks of your pregnancy)
  • 3 or more first trimester miscarriages
  • High blood pressure
  • Pregnancy related high blood pressure (also called preeclampsia)
  • Type 1 diabetes
  • Pregnancy related diabetes (also called gestational diabetes) or 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
Female
18 Years to 40 Years
Yes
Contact: Elizabeth A Frost, B.S. 225-763-2794 elizabeth.frost@pbrc.edu
Contact: Leanne M Redman, Ph.D. 225-763-0947 doctors@pbrc.edu
United States
 
NCT01610752
PBRC11024 Expecting Success, U01DK094418-01
Yes
Leanne Redman, Pennington Biomedical Research Center
Pennington Biomedical Research Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Leanne M Redman, Ph.D. Pennington Biomedical Research Center
Principal Investigator: Corby K Martin, Ph.D. Pennington Biomedical Research Center
Pennington Biomedical Research Center
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP