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
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial focused on lifestyle changes during pregnancy to manage weight gain — since it's now completed, can you tell me what the results showed and whether those findings might apply to my situation?
2The trial studied pregnant women with obesity, and some participants may have had Type 2 diabetes — given my own health profile, would a structured lifestyle intervention like the one tested here be appropriate or safe for me during pregnancy?
3Since this was a Phase 3 trial, there should be a fairly solid body of evidence about how well these lifestyle interventions work for controlling gestational weight gain — based on those findings, is this approach now considered a standard recommendation, or is the evidence still being evaluated?
4The program was called 'Lifestyle Interventions for Expectant Mothers,' which suggests things like diet changes and possibly physical activity — realistically, how demanding would a program like this be to follow during pregnancy, and are there similar programs available to me now?
5If managing gestational weight gain is a concern for me, are there proven alternatives to a structured lifestyle intervention program, or would my doctor recommend combining standard prenatal care with some of the strategies tested in this trial?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Gestational weight gain
Timeframe: 36 weeks
Trial details
NCT IDNCT01812694
SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
. 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.