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

Primary Purpose

Obesity, Gestational Weight Gain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindful Moms
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring Pregnancy, Overweight, Obese, Stress, Mindfulness

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University California San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Mindful Moms

Comparison Group

Arm Description

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

Usual prenatal care

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 19, 2011
Last Updated
January 22, 2021
Sponsor
University of California, San Francisco
Collaborators
California Pacific Medical Center Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01307683
Brief Title
Maternal, Adiposity, Metabolism, and Stress Study
Acronym
MAMAS
Official Title
Maternal, Adiposity, Metabolism, and Stress Study (MAMAS)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
August 2011 (Actual)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
California Pacific Medical Center Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Gestational Weight Gain
Keywords
Pregnancy, Overweight, Obese, Stress, Mindfulness

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
202 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindful Moms
Arm Type
Active Comparator
Arm Description
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
Arm Title
Comparison Group
Arm Type
No Intervention
Arm Description
Usual prenatal care
Intervention Type
Behavioral
Intervention Name(s)
Mindful Moms
Intervention Description
8 weekly 2-hour sessions, 2 "booster" telephone sessions, and 1 postpartum "booster" session
Primary Outcome Measure Information:
Title
Adequacy of gestational weight gain, as determined by Institute of Medicine guidelines
Description
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.
Time Frame
Duration of pregnancy

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elissa Epel, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30993601
Citation
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-Income Women: A Quasi-Experimental Trial Using the ORBIT Model. Int J Behav Med. 2019 Oct;26(5):461-473. doi: 10.1007/s12529-019-09779-2.
Results Reference
result
PubMed Identifier
31934809
Citation
Parikh NI, Laria B, Nah G, Singhal M, Vittinghoff E, Vieten C, Stotland N, Coleman-Phox K, Adler N, Albert MA, Epel E. Cardiovascular Disease-Related Pregnancy Complications Are Associated with Increased Maternal Levels and Trajectories of Cardiovascular Disease Biomarkers During and After Pregnancy. J Womens Health (Larchmt). 2020 Oct;29(10):1283-1291. doi: 10.1089/jwh.2018.7560. Epub 2020 Jan 14.
Results Reference
derived
PubMed Identifier
29859038
Citation
Vieten C, Laraia BA, Kristeller J, Adler N, Coleman-Phox K, Bush NR, Wahbeh H, Duncan LG, Epel E. The mindful moms training: development of a mindfulness-based intervention to reduce stress and overeating during pregnancy. BMC Pregnancy Childbirth. 2018 Jun 1;18(1):201. doi: 10.1186/s12884-018-1757-6.
Results Reference
derived
Links:
URL
http://www.chc.ucsf.edu/coast/
Description
University of California, San Francisco Center for Obesity Assessment, Study and Treatment

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Maternal, Adiposity, Metabolism, and Stress Study

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