Personalized Management of Body Weight During Pregnancy

August 23, 2021 updated by: Leanne Redman, Pennington Biomedical Research Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Pennington Biomedical Research Center
      • Baton Rouge, Louisiana, United States, 70815
        • Woman's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Approximately 6 months (from 10-13 weeks gestation to 35-36 weeks gestation)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Gestational Weight Gain
Time Frame: Approximately 6 months (from 10-13 weeks gestation to 35-36 weeks gestation)
Approximately 6 months (from 10-13 weeks gestation to 35-36 weeks gestation)
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
Approximately 6 months (from 10-13 weeks gestation to 35-36 weeks gestation)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pennington Biomedical Research Center

Collaborators

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

Investigators

  • Principal Investigator: Leanne M Redman, Ph.D., Pennington Biomedical Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2012

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

May 31, 2012

First Submitted That Met QC Criteria

May 31, 2012

First Posted (Estimate)

June 4, 2012

Study Record Updates

Last Update Posted (Actual)

September 17, 2021

Last Update Submitted That Met QC Criteria

August 23, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PBRC 11024
  • U01DK094418-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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