NCT01307683

Maternal, Adiposity, Metabolism, and Stress Study

Maternal, Adiposity, Metabolism, and Stress Study (MAMAS)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 202 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The MAMAS study is built on the premise that simple recommendations for diet and exercise may not be enough to encourage healthy weight gain during pregnancy. Psychological skills training may be necessary to help women deal with stress and cravings; learn to regulate difficult emotions; increase awareness; and encourage healthy eating and physical activity. The goal of this study is to find out whether a behavioral stress reduction intervention can help women achieve healthy weight gain during pregnancy and reduce stress.

Detailed description

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.

Conditions

• Obesity
• Gestational Weight Gain

Interventions

Type	Name	Description
BEHAVIORAL	Mindful Moms	8 weekly 2-hour sessions, 2 "booster" telephone sessions, and 1 postpartum "booster" session

Timeline

• Start date: 2011-08-01
• Primary completion: 2015-08-01
• Completion: 2015-12-01
• First posted: 2011-03-03
• Last updated: 2021-01-26

Locations

1 site across 1 country: United States