Maternal, Adiposity, Metabolism, and Stress Study

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.

Inclusion Criteria:

- Women

- Currently pregnant, target 8-19 weeks gestation (intervention starts at 12-19 weeks
gestation)

- Singleton gestation

- Age 18 to 45 years

- Pre-pregnancy BMI 25-41 and < 300 pounds

- Income to poverty ratio ≤ 500% specific to family size

Exclusion Criteria:

- Inability to provide informed consent or speak English (intervention is in English)

- Needle phobic or fainting in response to blood draw

- Substance abuse, mental health, or medical condition that, in the opinion of
investigators, will make it difficult for the potential participant to participate in
the group intervention and/or affects baseline metabolism or body composition (e.g.,
hypertension, asthma, arthritis, severe food allergies, HIV).

- Eating disorder which would make it difficult for the potential participant to follow
the exercise, diet, and mind-body training guidelines.

- Polycystic ovarian syndrome treated with Metformin since this is indicative of
insulin resistance and makes long term weight loss difficult, which are relevant
outcomes in this study

- Diabetes or positive early diabetes screening test in the current pregnancy (weight
loss is affected by insulin resistance)

- Previous or current mindfulness meditation practice with a typically sitting
meditation of 20 or more minutes two or more times per week

- Recent weight loss (more than 5% within past 6 months). In addition, women with a
history of known coronary artery disease (CAD), or typical or atypical anginal chest
pain will require a letter from the participant's physician that he or she has been
adequately evaluated and that a moderate exercise program is appropriate. A study
physician must review the case and agree. Study participation involves a moderate
exercise program. Although moderate exercise is recommended for persons with CAD, we
want to ensure that steps have been taken to limit the risks of the exercise
component.

- Chronic use of systemic (oral or IV) corticosteroids in the 6 months prior to
enrollment (steroid use may reduce the efficacy of the intervention)

- History of gastric bypass surgery

- Multiple gestation