CompletedPhase 3

Lifestyle Interventions for Expectant Mothers (LIFE-Moms Phoenix) - Phoenix

United States123 participantsStarted 2013-03-28

Plain-language summary

Background: \- LIFE-Moms (Lifestyle Interventions for Expectant Moms) is a national project that is studying pregnant women who are overweight or obese. It is looking at ways they can manage their weight gain in pregnancy and how this may affect them and their babies health at birth and through the first year. Researchers want to recruit pregnant women who are being treated at the Phoenix Indian Medical Center. They will participate in a two-part study. Objectives: \- To study pregnant women who are in the LIFE-Moms project at the Phoenix Indian Medical Center. Eligibility: * Pregnant women at least 18 years of age who are overweight or obese. * Participants must be receiving care at the Phoenix Indian Medical Center. * Participants must be having only one child in their pregnancy (no twins or other multiple births). Design: * This study will have two parts. The first part will have three visits to obtain data about health early in pregnancy. It will also let participants and researchers find out if the participants are eligible and should continue in the second part of the study. In the second part, participants will be monitored throughout their pregnancy and during the first year after the baby s birth to test the effects of a lifestyle intervention to control weight gain during pregnancy. * On the Part 1 study visits, participants will have a physical exam and medical history. They will provide blood, urine, hair, and other samples to be examined for possible genetic conditions. * For the Part 2 study visits, participants will be placed in one of two treatment groups. Each group will receive the same prenatal and postnatal care that they would get if they did not join the study. * The first group will have a lifestyle intervention program. They will spend about 2 hours every week with other members of their group to learn diet and activity behaviors that may help with their health. * The second group will have an enhanced care program. They will be given additional information about health and pregnancy and be invited to attend three classes to learn about staying healthy during pregnancy.

Who can participate

SexALL

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Inclusion criteria

✓. At least 18 years of age.
✓. Receive prenatal care at the nurse midwifery/obstetrics service of PIMC and plan to continue receiving such care throughout the pregnancy.
✓. Able to have an OGTT prior to 16 weeks gestation. Hyperemesis can preclude some pregnant women from successfully completing the OGTT; these women will not be excluded if the fasting blood samples can be obtained.
✓. Able to have an ultrasound examination to estimate fetal age.
✓. Complete initial run-in screening visits to determine whether the woman can manage the tasks required of participation in an intensive intervention if randomized to the intervention group.
✓. Able to commit the time required for the interventions and follow-up.
✓. Singleton viable pregnancy. A twin pregnancy reduced to singleton before 14(0) weeks by project gestational age is acceptable. An ultrasound must be conducted before randomization that shows a fetal heartbeat; there should be no evidence of more than one fetus on the most recent pre-randomization ultrasound.
✓. Gestational age at randomization no earlier than 9 weeks 0 days and no later than 15(6) weeks based on an algorithm that compares the LMP date and data from the earliest ultrasound.

What they're measuring

Gestational weight gain

Timeframe: 36 weeks

Trial details

NCT IDNCT01812694

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

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2017-03-27

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