Personalized Management of Body Weight During Pregnancy - Full Text View

Purpose

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	Intervention	Phase
Weight Gain During Pregnancy	Behavioral: SmartMoms	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Expecting Success: Personalized Management of Body Weight During Pregnancy

Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	306
Study Start Date:	December 2012
Estimated Study Completion Date:	September 2016
Estimated Primary Completion Date:	June 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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:

Physician Directed group
SmartMoms-Clinic group
SmartMoms-Phone group

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders 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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01610752

Contacts

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

Locations

United States, Louisiana
Pennington Biomedical Research Center	Recruiting
Baton Rouge, Louisiana, United States, 70808
Principal Investigator: Leanne M Redman, Ph.D.
Principal Investigator: Corby K Martin, Ph.D.
Sub-Investigator: Stewart Gordon, M.D.
Sub-Investigator: William Johnson, Ph.D.
Woman's Hospital	Not yet recruiting
Baton Rouge, Louisiana, United States, 70815
Sub-Investigator: Karen Elkind-Hirsch, Ph.D.
Sub-Investigator: Jeffrey Breaux, M.D.

Sponsors and Collaborators

Pennington Biomedical Research Center

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

Investigators

Principal Investigator:	Leanne M Redman, Ph.D.	Pennington Biomedical Research Center
Principal Investigator:	Corby K Martin, Ph.D.	Pennington Biomedical Research Center

More Information

No publications provided

Responsible Party:	Leanne Redman, Principal Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:	NCT01610752 History of Changes
Other Study ID Numbers:	PBRC11024 Expecting Success, U01DK094418-01
Study First Received:	May 31, 2012
Last Updated:	January 18, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Pennington Biomedical Research Center:

Pregnancy
Gestational weight gain

Additional relevant MeSH terms:

Body Weight
Weight Gain
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on June 18, 2013