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