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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
California Pacific Medical Center Research Institute
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01307683
First received: January 19, 2011
Last updated: April 30, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Obesity
Gestational Weight Gain
Behavioral: Mindful Moms

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Maternal, Adiposity, Metabolism, and Stress Study (MAMAS)

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Adequacy of gestational weight gain, as determined by Institute of Medicine guidelines [ Time Frame: Duration of pregnancy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in abdominal fat from baseline to 9 months postpartum [ Time Frame: 9 months postpartum ] [ Designated as safety issue: No ]

Enrollment: 202
Study Start Date: September 2009
Estimated Study Completion Date: June 2014
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01307683

Locations
United States, California
University California San Francisco
San Francisco, California, United States, 94118
Sponsors and Collaborators
University of California, San Francisco
California Pacific Medical Center Research Institute
Investigators
Principal Investigator: Elissa Epel, PhD University of California, San Francisco
  More Information

Additional Information:
No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01307683     History of Changes
Other Study ID Numbers: 1U01HL097973
Study First Received: January 19, 2011
Last Updated: April 30, 2014
Health Authority: United States: Federal Government

Keywords provided by University of California, San Francisco:
Pregnancy
Overweight
Obese
Stress
Mindfulness

Additional relevant MeSH terms:
Obesity
Weight Gain
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on July 10, 2014