Obesity Clinical Trial
— MAMASOfficial title:
Maternal, Adiposity, Metabolism, and Stress Study (MAMAS)
NCT number | NCT01307683 |
Other study ID # | 1U01HL097973 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 2011 |
Est. completion date | December 2015 |
Verified date | January 2021 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 202 |
Est. completion date | December 2015 |
Est. primary completion date | August 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University California San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco | California Pacific Medical Center Research Institute |
United States,
Epel E, Laraia B, Coleman-Phox K, Leung C, Vieten C, Mellin L, Kristeller JL, Thomas M, Stotland N, Bush N, Lustig RH, Dallman M, Hecht FM, Adler N. Effects of a Mindfulness-Based Intervention on Distress, Weight Gain, and Glucose Control for Pregnant Low — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adequacy of gestational weight gain, as determined by Institute of Medicine guidelines | For weight change, difference between weight at the last prenatal visit before delivery, and pre-pregnancy was calculated, and categorized as inadequate, adequate and excessive weight gain according to IOM categories. | Duration of pregnancy |
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