Targeting Pregnancy-related Weight Gain to Reduce Disparities in Obesity
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|ClinicalTrials.gov Identifier: NCT02229708|
Recruitment Status : Completed
First Posted : September 1, 2014
Last Update Posted : October 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pregnancy Body Weight Changes Behavioral Obesity||Behavioral: Healthy Lifestyle Group||Not Applicable|
Black women are in particular need for obesity prevention and treatment. The childbearing period represents a critical life stage of heightened vulnerability for new or persistent obesity, especially among Black women, who retain 2-3 times more weight after pregnancy than White women. Pregnancy weight gain is the strongest identified risk factor for retaining a substantial amount of weight after pregnancy, yet few published interventions have been effective in reducing excessive weight gain in pregnancy, particularly among low-income Black mothers.
The proposed research aims to meets the needs of low-income, Black mothers by developing a novel pregnancy intervention that 1) focuses solely on Black women, 2) incorporates Black mothers' information needs, values, and social context, and 3) uses technology to facilitate participant engagement.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||262 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Targeting Pregnancy-related Weight Gain to Reduce Disparities in Obesity: a Randomized Controlled Trial|
|Study Start Date :||September 2014|
|Actual Primary Completion Date :||July 16, 2017|
|Actual Study Completion Date :||July 17, 2019|
No Intervention: Usual Care
The Usual Obstetric Care group will receive usual advice about nutrition and activity during pregnancy from their obstetrician along with some additional information about pregnancy and childbirth through readings from The American College of Obstetricians and Gynecologists. In addition, participants will receive weekly text messages to maintain contact and ensure follow-up.
Experimental: Healthy Lifestlye Group
The Healthy Lifestyle Group will take part in an individual, technology-based behavioral intervention program which will include specific information about nutrition and physical activity, and strategies for helping them make changes to their diet, physical activity, and weight-related behaviors during pregnancy. Participants will receive information through print materials, text messages, a private Facebook group, and in-person visits and phone calls from a health coach who is part of our research team.
Behavioral: Healthy Lifestyle Group
- Change in maternal weight from early pregnancy to 6 months and 1 year postpartum [ Time Frame: Approximately 18 months ]
- Change in maternal cardiometabolic risk factors (glucose tolerance, blood pressure) from early pregnancy to 6 months and 1 year postpartum [ Time Frame: Approximately 18 months ]
- Change in infant weight and length from birth to 6 months and 1 year of age [ Time Frame: Approximately 12 months ]
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): NCT02229708
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19140|
|Principal Investigator:||Sharon J Herring, MD, MPH||Temple University|