CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 123 enrolled / 123 target
Drug / intervention
Enhanced standard care +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01812694
NCT01812694Phase 3CompletedOn Track (0.8/mo)Completion was 111mo ago

Lifestyle Interventions for Expectant Moms (LIFE-Moms) Phoenix

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·interventional·Posted Mar 18, 2013·Updated Jun 30, 2026

In Brief

A Phase 3 clinical trial evaluating Enhanced standard care and Intensive lifestyle intervention for Obesity and 2 related conditions. Completed, enrolled 123 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 18, 2013
Enrollment StartMar 28, 2013
Primary CompletionMar 27, 2017
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 13.3 years ago

Arms & Interventions

Enhanced Standard Careactive_comparator

Standard prenatal care plus education

Behavioral: Enhanced standard care
Intensive lifestyle interventionexperimental

Intervention to limit excess gestational weight gain

Behavioral: Intensive lifestyle intervention

Interventions

Enhanced standard carebehavioral

Standard prenatal care plus education

Intensive lifestyle interventionbehavioral

Intervention to limit excess gestational weight gain