Maternal, Adiposity, Metabolism, and Stress Study

Completed · Not applicable

Conditions studied: Obesity, Gestational Weight Gain

In brief

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.

Key facts

Study ID

NCT01307683

Run by

University of California, San Francisco

People needed

202

Starts

2011-08-01

Expected to finish

2015-12-01

Last updated by the study team

2021-01-26

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University California San Francisco — San Francisco, California, United States

Full record on ClinicalTrials.gov

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