Weight Management in Obese Pregnant Underserved African American Women (LIFE-Moms)
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Purpose
This project will test a novel lifestyle intervention to help 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 greater percentage who meet Institute of Medicine recommendations for gestational weight gain.
| Condition | Intervention |
|---|---|
|
Obesity Pregnancy Weight Gain |
Behavioral: Standard Parents As Teachers (PAT) Behavioral: Parents As Teachers Plus (PAT+) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Weight Management in Obese Pregnant Underserved African American Women |
- Percent of women whose gestational weight gain exceeds Institute of Medicine recommendations [ Time Frame: Delivery (when the baby is delivered) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 266 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | March 2016 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Parents As Teachers + Lifestyle Interven
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).
|
Behavioral: Parents As Teachers Plus (PAT+)
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.
|
|
Active Comparator: Standard Parents as Teachers (PAT)
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).
|
Behavioral: Standard Parents As Teachers (PAT)
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.
|
Detailed Description:
Maternal obesity and inappropriate gestational weight gain increase both maternal and neonatal morbidity and mortality. In addition, offspring of 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 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). An extensive 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.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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 30-45
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
Contacts and Locations| Contact: Carla Chung, RN, BSN | (314) 362-4661 | chungc@wudosis.wustl.edu |
| United States, Missouri | |
| Washington University School of Medicine | Recruiting |
| Saint Louis, Missouri, United States, 63110 | |
| Principal Investigator: Samuel Klein, MD | |
| Principal Investigator: | Samuel Klein, MD | Washington University School of Medicine |
More Information
Additional Information:
No publications provided
| Responsible Party: | Washington University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01768793 History of Changes |
| Other Study ID Numbers: | 201110073, 5U01DK094416 |
| Study First Received: | January 11, 2013 |
| Last Updated: | March 4, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Washington University School of Medicine:
|
Obesity Pregnancy Body Weight Changes Diet Therapy |
Additional relevant MeSH terms:
|
Obesity Weight Gain Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms Body Weight Changes |
ClinicalTrials.gov processed this record on May 23, 2013