Maternal, Adiposity, Metabolism, and Stress Study

NCT01307683 | Completed DMC

• 1 other identifier: 1U01HL097973
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Gestational Weight Gain

Keywords

Pregnancy; Overweight; Obese; Stress; Mindfulness

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Mindful Moms

ACTIVE COMPARATOR

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

Comparison Group

NO INTERVENTION

Usual prenatal care

Interventions

Mindful Moms BEHAVIORAL

8 weekly 2-hour sessions, 2 "booster" telephone sessions, and 1 postpartum "booster" session

Mindful Moms

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• University of California, San Francisco: lead
• California Pacific Medical Center Research Institute: collaborator

Study Sites (1)

University California San Francisco

San Francisco, California, 94118, United States

Location

Related Publications (4)

• 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.

  PMID: 30993601 RESULT

• Roubinov DS, Epel ES, Coccia M, Coleman-Phox K, Vieten C, Adler NE, Laraia B, Bush NR. Long-term effects of a prenatal mindfulness intervention on depressive symptoms in a diverse sample of women. J Consult Clin Psychol. 2022 Dec;90(12):942-949. doi: 10.1037/ccp0000776. Epub 2022 Nov 28.

  PMID: 36441994 DERIVED

• 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.

  PMID: 31934809 DERIVED

• 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.

  PMID: 29859038 DERIVED

Related Links

• University of California, San Francisco Center for Obesity Assessment, Study and Treatment

MeSH Terms

Conditions

Obesity; Gestational Weight Gain; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Weight Gain; Body Weight Changes

Study Officials

• Elissa Epel, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2011
• First Posted: March 3, 2011
• Study Start: August 1, 2011
• Primary Completion: August 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 26, 2021

Record last verified: 2021-01

Locations

US (1)