Weight Management in Obese Pregnant Underserved African American Women (LIFE-Moms)
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|ClinicalTrials.gov Identifier: NCT01768793|
Recruitment Status : Completed
First Posted : January 15, 2013
Last Update Posted : February 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Obesity Pregnancy Weight Gain||Behavioral: Standard Parents As Teachers (PAT) Behavioral: Parents As Teachers Plus (PAT+)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||267 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Weight Management in Obese Pregnant Underserved African American Women|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||December 2017|
Experimental: Parents As Teachers + Lifestyle Int.
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.
- Percent of women whose gestational weight gain exceeds Institute of Medicine recommendations [ Time Frame: Delivery (when the baby is delivered) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01768793
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Samuel Klein, MD||Washington University School of Medicine|