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Personalized Management of Body Weight During Pregnancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01610752
Recruitment Status : Completed
First Posted : June 4, 2012
Results First Posted : December 12, 2018
Last Update Posted : September 17, 2021
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Leanne Redman, Pennington Biomedical Research Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Weight Gain During Pregnancy Behavioral: SmartMoms Not Applicable

Detailed Description:

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Expecting Success: Personalized Management of Body Weight During Pregnancy
Actual Study Start Date : December 2012
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 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-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.
 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.
No Intervention: Physician Directed
If picked for this group, you will receive weight management advice from your physician's office.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01610752


Locations
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United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Woman's Hospital
Baton Rouge, Louisiana, United States, 70815
Sponsors and Collaborators
Pennington Biomedical Research Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Leanne M Redman, Ph.D. Pennington Biomedical Research Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Leanne Redman, Principal Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT01610752    
Other Study ID Numbers: PBRC 11024
U01DK094418-01 ( U.S. NIH Grant/Contract )
First Posted: June 4, 2012    Key Record Dates
Results First Posted: December 12, 2018
Last Update Posted: September 17, 2021
Last Verified: August 2021
Keywords provided by Leanne Redman, Pennington Biomedical Research Center:
Pregnancy
Gestational weight gain
Additional relevant MeSH terms:
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Body Weight
Weight Gain
Body Weight Changes