NCT01812694

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

Completed Phase 3 Last updated 1 April 2026

What this trial tests

Phase 3 trial testing Enhanced standard care in Obesity in 123 participants. Completed in 27 March 2017.

Timeline

28 March 2013

Primary endpoint
27 March 2017

27 March 2017

Quick facts

Lead sponsor	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	123
Start date	28 March 2013
Primary completion	27 March 2017
Estimated completion	27 March 2017
Sites	1 location across United States

Drugs / interventions tested

• Enhanced standard care
• Intensive lifestyle intervention

Conditions studied

• Obesity — all drugs for Obesity →
• Diet Therapy — all drugs for Diet Therapy →
• Diabetes Type 2 — all drugs for Diabetes Type 2 →

Sponsor

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

Who can join

Eligibility, any sex, with Obesity or Diet Therapy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Lifestyle Interventions Limit Gestational Weight Gain in Women with Overweight or Obesity: LIFE-Moms Prospective Meta-Analysis.
   Peaceman AM, Clifton RG, Phelan S, Gallagher D, et al · · 2018 · cited 121× · PMID 30230252 · DOI 10.1002/oby.22250
2. Design of lifestyle intervention trials to prevent excessive gestational weight gain in women with overweight or obesity.
   Clifton RG, Evans M, Cahill AG, Franks PW, et al · · 2016 · cited 58× · PMID 26708836 · DOI 10.1002/oby.21330
3. One-year postpartum anthropometric outcomes in mothers and children in the LIFE-Moms lifestyle intervention clinical trials.
   Phelan S, Clifton RG, Haire-Joshu D, Redman LM, et al · · 2020 · cited 26× · PMID 31292531 · DOI 10.1038/s41366-019-0410-4
4. Maternal 24-h movement patterns across pregnancy and postpartum: The LIFE-Moms consortium.
   Kracht CL, Drews KL, Flanagan EW, Keadle SK, et al · · 2024 · cited 11× · PMID 38707249 · DOI 10.1016/j.pmedr.2024.102740
5. Attenuated early pregnancy weight gain by prenatal lifestyle interventions does not prevent gestational diabetes in the LIFE-Moms consortium.
   Redman LM, Drews KL, Klein S, Horn LV, et al · · 2021 · cited 9× · PMID 33238176 · DOI 10.1016/j.diabres.2020.108549
6. The moderating role of the built environment in prenatal lifestyle interventions.
   Phelan S, Marquez F, Redman LM, Arteaga S, et al · · 2021 · cited 3× · PMID 33637948 · DOI 10.1038/s41366-021-00782-w
7. LIFE-Moms: effects of multicomponent lifestyle randomized control trial on physical activity during pregnancy in women with overweight and obesity.
   Cabre HE, Drews KL, Pomeroy J, Keadle SK, et al · · 2025 · cited 2× · PMID 41029405 · DOI 10.1186/s12966-025-01805-9
8. Metabolic Health and Heterogenous Outcomes of Prenatal Interventions: A Secondary Analysis of a Randomized Clinical Trial.
   Flanagan EW, Drews KL, Cade WT, Franks PW, et al · · 2025 · PMID 40839263 · DOI 10.1001/jamanetworkopen.2025.28264