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Weight Management in Obese Pregnant Underserved African American Women (LIFE-Moms)

Primary Purpose

Obesity, Pregnancy, Weight Gain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard Parents As Teachers (PAT)
Parents As Teachers Plus (PAT+)
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Pregnancy, Body Weight Changes, Diet Therapy

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Pregnant, African American, Socioeconomically disadvantaged
  • Established prenatal care at our clinic before 15-6/7 weeks gestation
  • Singleton viable pregnancy
  • Gestational age 9 to 15 weeks
  • Body Mass Index (BMI) of 25-45 kg/m²

Exclusion Criteria:

  • Diagnosis of diabetes prior to pregnancy, or test results suggestive of pre-pregnancy diabetes
  • Current use of certain medications
  • Contraindications to aerobic exercise in pregnancy
  • History of contraindicated medical conditions

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Parents As Teachers + Lifestyle Int.

Standard Parents as Teachers (PAT)

Arm Description

Participants assigned to this group will receive Parents As Teachers Plus (PAT+). This will be a diet and physical activity lifestyle intervention integrated within the standard Parents As Teachers home visiting curriculum. There will be a total of 28 home visits, delivered over 24 months (6 month prenatal phase and 18 month post-partum phase).

Participants assigned to this group will receive the standard Parents As Teachers (PAT) home visiting curriculum, focusing on parenting and child development. There will be a total of 28 home visits, delivered over 24 months (6 month prenatal phase and 18 month post-partum phase).

Outcomes

Primary Outcome Measures

Percent of women whose gestational weight gain exceeds Institute of Medicine recommendations

Secondary Outcome Measures

Full Information

First Posted
January 11, 2013
Last Updated
February 1, 2018
Sponsor
Washington University School of Medicine
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT01768793
Brief Title
Weight Management in Obese Pregnant Underserved African American Women
Acronym
LIFE-Moms
Official Title
Weight Management in Obese Pregnant Underserved African American Women
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This project will test a novel lifestyle intervention to help overweight and obese socioeconomically disadvantaged African American women achieve healthy weight control during and after pregnancy and improve the health of their offspring. The treatment will be given through an existing national home visiting program, Parents As Teachers (PAT), which will facilitate sustainability and nationwide dissemination, if effective. We hypothesize that compared with standard PAT monitoring and counseling (PAT), women randomized to the lifestyle intervention program (PAT+) will have a lower percentage who exceed Institute of Medicine recommendations for gestational weight gain.
Detailed Description
Maternal overweight/obesity and inappropriate gestational weight gain increase both maternal and neonatal morbidity and mortality. In addition, offspring of overweight/obese women are at increased risk for neurodevelopmental delay, becoming obese, and developing metabolic diseases. Women who are socioeconomically disadvantaged (SED), especially from African American populations, are particularly susceptible to adverse pregnancy-related outcomes because of their high prevalence rates of obesity. Therefore, successful weight management during pregnancy in SED, African American women has considerable public health implications. We have experience in testing lifestyle interventions among SED nonpregnant women that have been implemented and sustained within community organizations such as Parents As Teachers (PAT), a national home visiting program that provides parent-child education and services free-of-charge to high-needs women, prenatally and post-partum, with up to 25 home visits per year until kindergarten. We propose to conduct a 24-month (6-month prenatal and 18-month post-partum) randomized, controlled trial in overweight and obese SED African American women to evaluate the ability of an innovative lifestyle intervention program (PAT+), delivered by PAT parent educators during prenatal and post-partum home visits, to improve maternal and neonatal/infant weight, metabolic and health outcomes, relative to the standard PAT program (PAT). A programmatic evaluation will determine the applicability of the PAT+ intervention in real world settings by measuring programmatic reach, implementation, acceptability, and sustainability. If effective, PAT+ can be disseminated through this national organization, which currently reaches over 249,000 mothers and 319,000 children participating in 2,173 PAT programs across all 50 states.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Pregnancy, Weight Gain
Keywords
Obesity, Pregnancy, Body Weight Changes, Diet Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
267 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Parents As Teachers + Lifestyle Int.
Arm Type
Experimental
Arm Description
Participants assigned to this group will receive Parents As Teachers Plus (PAT+). This will be a diet and physical activity lifestyle intervention integrated within the standard Parents As Teachers home visiting curriculum. There will be a total of 28 home visits, delivered over 24 months (6 month prenatal phase and 18 month post-partum phase).
Arm Title
Standard Parents as Teachers (PAT)
Arm Type
Active Comparator
Arm Description
Participants assigned to this group will receive the standard Parents As Teachers (PAT) home visiting curriculum, focusing on parenting and child development. There will be a total of 28 home visits, delivered over 24 months (6 month prenatal phase and 18 month post-partum phase).
Intervention Type
Behavioral
Intervention Name(s)
Standard Parents As Teachers (PAT)
Intervention Description
Participants will receive visits by Parent Educators, who will deliver the standard PAT curriculum. Participants will receive 28 total visits over the course of approximately 2 years.
Intervention Type
Behavioral
Intervention Name(s)
Parents As Teachers Plus (PAT+)
Intervention Description
Participants will receive the standard PAT curriculum, plus lifestyle intervention focusing on healthy diet and exercise, through 28 home visits over the course of approximately 2 years.
Primary Outcome Measure Information:
Title
Percent of women whose gestational weight gain exceeds Institute of Medicine recommendations
Time Frame
Delivery (when the baby is delivered)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pregnant, African American, Socioeconomically disadvantaged Established prenatal care at our clinic before 15-6/7 weeks gestation Singleton viable pregnancy Gestational age 9 to 15 weeks Body Mass Index (BMI) of 25-45 kg/m² Exclusion Criteria: Diagnosis of diabetes prior to pregnancy, or test results suggestive of pre-pregnancy diabetes Current use of certain medications Contraindications to aerobic exercise in pregnancy History of contraindicated medical conditions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel Klein, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
36150208
Citation
Cade WT, Mittendorfer B, Patterson BW, Haire-Joshu D, Cahill AG, Stein RI, Schechtman KB, Tinius RA, Brown K, Klein S. Effect of excessive gestational weight gain on insulin sensitivity and insulin kinetics in women with overweight/obesity. Obesity (Silver Spring). 2022 Oct;30(10):2014-2022. doi: 10.1002/oby.23533.
Results Reference
derived
PubMed Identifier
33238176
Citation
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.
Results Reference
derived
PubMed Identifier
32908956
Citation
Tabak RG, Furtado K, Schwarz CD, Haire-Joshu D. Neighborhood Perceptions Among Pregnant African American Women in St. Louis, Missouri, Before and After the Shooting of Michael Brown. Health Equity. 2020 Aug 19;4(1):353-361. doi: 10.1089/heq.2019.0125. eCollection 2020.
Results Reference
derived
PubMed Identifier
30900408
Citation
Haire-Joshu D, Cahill AG, Stein RI, Cade WT, Woolfolk CL, Moley K, Mathur A, Schwarz CD, Schechtman KB, Klein S. Randomized Controlled Trial of Home-Based Lifestyle Therapy on Postpartum Weight in Underserved Women with Overweight or Obesity. Obesity (Silver Spring). 2019 Apr;27(4):535-541. doi: 10.1002/oby.22413.
Results Reference
derived
PubMed Identifier
30230252
Citation
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.
Results Reference
derived
PubMed Identifier
29912571
Citation
Lewkowitz AK, Lopez JD, Stein RI, Rhoades JS, Schulz RC, Woolfolk CL, Macones GA, Haire-Joshu D, Cahill AG. Effect of a Home-Based Lifestyle Intervention on Breastfeeding Initiation Among Socioeconomically Disadvantaged African American Women with Overweight or Obesity. Breastfeed Med. 2018 Jul/Aug;13(6):418-425. doi: 10.1089/bfm.2018.0006. Epub 2018 Jun 18.
Results Reference
derived
PubMed Identifier
29464907
Citation
Cahill AG, Haire-Joshu D, Cade WT, Stein RI, Woolfolk CL, Moley K, Mathur A, Schechtman K, Klein S. Weight Control Program and Gestational Weight Gain in Disadvantaged Women with Overweight or Obesity: A Randomized Clinical Trial. Obesity (Silver Spring). 2018 Mar;26(3):485-491. doi: 10.1002/oby.22070.
Results Reference
derived
PubMed Identifier
26708836
Citation
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.
Results Reference
derived
Links:
URL
https://lifemoms.bsc.gwu.edu/
Description
Study Consortium website

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Weight Management in Obese Pregnant Underserved African American Women

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