Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:01 AM
Ignite Modification Date:
2025-12-25 @ 1:01 AM
NCT ID:
NCT01768793
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.
Study:
NCT01768793
Study Brief:
Protocol Section:
NCT01768793