Personalized Management of Body Weight During Pregnancy

Weight Gain During Pregnancy Clinical Trial

Official title:

Expecting Success: Personalized Management of Body Weight During Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01610752
• Other study ID #: PBRC 11024
• Secondary ID: U01DK094418-01
• Status: Completed
• Phase: N/A
• Start date: December 2012
• Est. completion date: October 2015

Study information

• Verified date: August 2021
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: October 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Weight Gain
• Weight Gain During Pregnancy

Intervention

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.

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana
United States	Woman's Hospital	Baton Rouge	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Total Gestational Weight Gain		Approximately 6 months (from 10-13 weeks gestation to 35-36 weeks gestation)
Secondary	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)