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

NCT01812694 | Completed Phase 3

• 2 other identifiers: 99991305513-DK-N055
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity; Diet Therapy; Diabetes Type 2

Keywords

Pregnancy; Weight Control; Weight Gain

Outcome Measures

Primary Outcomes (1)

• Gestational weight gain

  Weight at 36 weeks minus weight at baseline, kg

  36 weeks

Secondary Outcomes (1)

• Gestational Diabetes

  24-28 weeks gestation, 6 weeks post-partum and 1 year post partum

Study Arms (2)

Enhanced Standard Care

ACTIVE COMPARATOR

Standard prenatal care plus education

Behavioral: Enhanced standard care

Intensive lifestyle intervention

EXPERIMENTAL

Intervention to limit excess gestational weight gain

Behavioral: Intensive lifestyle intervention

Interventions

Enhanced standard care BEHAVIORAL

Standard prenatal care plus education

Enhanced Standard Care

Intensive lifestyle intervention BEHAVIORAL

Intervention to limit excess gestational weight gain

Intensive lifestyle intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Body mass index greater than or equal to 25 kilogram / square meter based on first trimester measured weight and on measured height. The earliest weight measurement before randomization, measured specifically for the study, will be used. Reported pre-pregnancy weight will not be used to determine eligibility because of the potential for inaccuracy. If the earliest weight measurement is conducted at 14(0) to 14(6) weeks or 15(0) to 15(6) weeks, 1 pound or 2 pounds will be subtracted from the measured weight, respectively, to adjust to a first trimester weight. This weight and the resultant BMI are defined as the baseline weight and BMI, respectively.

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
• 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)

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (1)

NIDDK, Phoenix

Phoenix, Arizona, 85014, United States

Location

Related Publications (5)

• Cabre HE, Drews KL, Pomeroy J, Keadle SK, Arteaga SS, Franks PW, Haire-Joshu D, Knowler WC, Pi-Sunyer X, Van Horn L, Wing RR, Cahill AG, Clifton RG, Couch KA, Gallager D, Josefson JL, Joshipura K, Klein S, Martin CK, Peaceman AM, Phelan S, Thom EA, Redman LM; LIFE-Moms Research Group. LIFE-Moms: effects of multicomponent lifestyle randomized control trial on physical activity during pregnancy in women with overweight and obesity. Int J Behav Nutr Phys Act. 2025 Sep 30;22(1):119. doi: 10.1186/s12966-025-01805-9.

  PMID: 41029405 DERIVED

• Flanagan EW, Drews KL, Cade WT, Franks PW, Gallagher D, Phelan S, Van Horn L, Redman LM. Metabolic Health and Heterogenous Outcomes of Prenatal Interventions: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2025 Aug 1;8(8):e2528264. doi: 10.1001/jamanetworkopen.2025.28264.

  PMID: 40839263 DERIVED

• Redman LM, Drews KL, Klein S, Horn LV, Wing RR, Pi-Sunyer X, Evans M, Joshipura K, Arteaga SS, Cahill AG, Clifton RG, Couch KA, Franks PW, Gallagher D, Haire-Joshu D, Martin CK, Peaceman AM, Phelan S, Thom EA, Yanovski SZ, Knowler WC; LIFE-Moms Research Group. Attenuated early pregnancy weight gain by prenatal lifestyle interventions does not prevent gestational diabetes in the LIFE-Moms consortium. Diabetes Res Clin Pract. 2021 Jan;171:108549. doi: 10.1016/j.diabres.2020.108549. Epub 2020 Nov 22.

  PMID: 33238176 DERIVED

• Peaceman AM, Clifton RG, Phelan S, Gallagher D, Evans M, Redman LM, Knowler WC, Joshipura K, Haire-Joshu D, Yanovski SZ, Couch KA, Drews KL, Franks PW, Klein S, Martin CK, Pi-Sunyer X, Thom EA, Van Horn L, Wing RR, Cahill AG; LIFE-Moms Research Group. Lifestyle Interventions Limit Gestational Weight Gain in Women with Overweight or Obesity: LIFE-Moms Prospective Meta-Analysis. Obesity (Silver Spring). 2018 Sep;26(9):1396-1404. doi: 10.1002/oby.22250. Epub 2018 Sep 6.

  PMID: 30230252 DERIVED

• Clifton RG, Evans M, Cahill AG, Franks PW, Gallagher D, Phelan S, Pomeroy J, Redman LM, Van Horn L; LIFE-Moms Research Group. Design of lifestyle intervention trials to prevent excessive gestational weight gain in women with overweight or obesity. Obesity (Silver Spring). 2016 Feb;24(2):305-13. doi: 10.1002/oby.21330. Epub 2015 Dec 26.

  PMID: 26708836 DERIVED

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2; Weight Gain

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Body Weight Changes

Study Officials

• Mary A Hoskin, R.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2013
• First Posted: March 18, 2013
• Study Start: March 28, 2013
• Primary Completion: March 27, 2017
• Study Completion: March 27, 2017
• Last Updated: April 29, 2026

Record last verified: 2026-02-12

Locations

US (1)