Maternal, Adiposity, Metabolism, and Stress Study (MAMAS)
|ClinicalTrials.gov Identifier: NCT01307683|
Recruitment Status : Unknown
Verified April 2015 by University of California, San Francisco.
Recruitment status was: Active, not recruiting
First Posted : March 3, 2011
Last Update Posted : April 6, 2015
|Condition or disease||Intervention/treatment|
|Obesity Gestational Weight Gain||Behavioral: Mindful Moms|
The MAMAS study is adapting and testing interventions - "Moms in Joy," based on Emotional Brain Training (EBT) (developed by Laurel Mellin) and "Mindful Moms," (MIND) based on the Mindful Motherhood Training (developed by Cassandra Vieten, PhD), Mindfulness-Based-Eating and Awareness Training (MB-EAT) (developed by Jean Kristeller, PhD), and other mindfulness- and acceptance-based interventions.
In the first phase of this study, the investigators conducted in-depth focus groups with over 60 overweight, low to middle-income, pregnant women to learn more about what they might be looking for in such an intervention. In the second phase, which began in fall 2010, 48 low- to middle-income overweight pregnant women were randomly assigned to one of the interventions. Based on the knowledge gained from Phase 2, we refined the MIND intervention and are conducting an efficacy trial in Phase 3.
During Phase 3, we will enroll 220 overweight, low to middle-income, pregnant women in a trial of MIND to test feasibility and to examine changes in hypothesized mechanisms (stress, opioid tone), non-homeostatic eating, and in health outcomes (abdominal fat, insulin sensitivity, weight change) in the intervention group (n=110). Intervention participants will complete a battery of psychological and clinical measures (weight, BMI, waist/hip ratio, body composition) at baseline, post-intervention, 32-34 weeks gestation, and 3 and 9 months postpartum. Control participants (n=110) will complete the same battery of psychological measures at baseline and 8-10 weeks after baseline. All study participants will complete brief psychological, weight and waist/hip ratio measures at 6 months postpartum. Additionally, we will obtain prenatal and labor/delivery medical records for all study participants.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||202 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Maternal, Adiposity, Metabolism, and Stress Study (MAMAS)|
|Study Start Date :||September 2009|
|Estimated Primary Completion Date :||August 2015|
|Estimated Study Completion Date :||December 2015|
Active Comparator: Mindful Moms
Based on the Mindful Motherhood Training (developed by Cassandra Vieten, PhD), Mindfulness-Based-Eating and Awareness Training (MB-EAT) (developed by Jean Kristeller, PhD), and other mindfulness- and acceptance-based interventions
Behavioral: Mindful Moms
8 weekly 2-hour sessions, 2 "booster" telephone sessions, and 1 postpartum "booster" session
No Intervention: Comparison Group
Usual prenatal care
- Adequacy of gestational weight gain, as determined by Institute of Medicine guidelines [ Time Frame: Duration of pregnancy ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01307683
|United States, California|
|University California San Francisco|
|San Francisco, California, United States, 94118|
|Principal Investigator:||Elissa Epel, PhD||University of California, San Francisco|