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

Completed · Phase 3

Conditions studied: Obesity, Diet Therapy, Diabetes Type 2

In brief

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.

Key facts

Study ID

NCT01812694

Run by

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

People needed

123

Starts

2013-03-28

Expected to finish

2017-03-27

Last updated by the study team

2026-06-30

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Diagnosis of diabetes prior to pregnancy or any of the following results of the oral glucose tolerance test at visit #1 that suggest diabetes prior to pregnancy: HbA1c greater than or equal 6.5 %, FPG greater than or equal 126 milligrams per deciliter, or 2-hour post-load plasma glucose greater than or equal 200 milligrams per deciliter (75 grams oral glucose tolerance test). All potential participants will have HbA1c and a 75 grams oral glucose tolerance test performed prior to randomization.
• Women who meet the above criteria for diagnosed or presumed diabetes prior to pregnancy will be excluded. Others who meet criteria for GDM will be eligible. Criteria for GDM diagnosis will be based on ADA 2012 criteria (at least one of FPG greater than or equal to 92 milligrams per deciliter, 1 hour PG greater than or equal 180 milligrams per deciliter, or 2 hour PG greater than or equal to 153 milligrams per deciliter.)
• Known fetal anomaly
• Planned termination of pregnancy
• History of three or more consecutive first trimester miscarriages
• Past history of anorexia or bulimia by medical history or patient report. Binge eating disorder (BED) is not an exclusion.
• Current eating disorder diagnosed by EDE-Q questions 2-4 and confirmed after discussion with the participant by study staff
• Actively suicidal defined as a value greater than or equal 2 on the BDI-II question 9
• Prior or planned (within 1 year of expected delivery) bariatric surgery
• Current use of one or more of the following medications:
• Metformin
• Systemic steroids
• Antipsychotic agents (e.g., Abilify (apriprazole), Haldol (haloperidol), Risperdal (resperidone), Seroquel (quetipapine), Zyprexa (olanzapine))
• Anti-seizure medications or mood stabilizers that would be expected to have a significant impact on body weight (e.g., Depakote (valproic acid), Lamictal (lamotrigine), Lithium, Neurontin (gabapentin), Tegretol (carbamazepine), Topamax (topiramate), Keppra (levetiracetam)
• Medications for ADHD including amphetamines and methylphenidate
• Any teratogenic agent Class D or X (site specific)
• Continued use of weight loss medication including OTC and dietary supplements for weight loss (e.g., Adipex (phentermine), Suprenza(phentermine) Tenuate (dietheylpropion), Xenical (orlistat), Alli (orlistat), conjugated linoleic acid, Hoodia, Green tea extract, Guar gum, HydroxyCut, Sensa, Corti-slim, Chromium, chitosan, Bitter orange)
• Contraindications to aerobic exercise in pregnancy specified in the ACOG Committee Opinion #267, 2002
• Hemodynamically significant heart disease defined as an AHA class II (short of breath with exercise) or greater
• Restrictive lung disease (e.g. pulmonary fibrosis)
• Poorly controlled hyperthyroidism
• Poorly controlled seizure disorder
• Poorly controlled hypertension defined as a blood pressure greater than or equal 160/110 millimeters of mercury
• History of extreme sedentary lifestyle (e.g. bed bound)
• Orthopedic limitations to aerobic exercise

Where it is running

• NIDDK, Phoenix — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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