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ObesityMAMASNCT01307683

Maternal, Adiposity, Metabolism, and Stress Study

A study testing Mindful Moms in people with Obesity and Gestational Weight Gain, run by University of California, San Francisco at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Obesity, Gestational Weight Gain
What is being tested?
Mindful Moms
Could I receive a placebo?
No, everyone receives an active treatment
How many people
202 participants
Where
1 siteUnited States
Study dates
Aug 2011to Dec 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University California San Francisco

    San Francisco, California, 94118

Other trials in United States

About this study

Official title: Maternal, Adiposity, Metabolism, and Stress Study (MAMAS)

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.

Read the 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.

Being tested
Mindful Moms
Keywords
Pregnancy, Overweight, Obese, Stress, Mindfulness
Medical subject headings
Obesity, Gestational Weight Gain, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mindful MomsBehavioural

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

Study groups in NCT01307683
Study groupRoleWhat they receive
Mindful MomsActive comparatorBased 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
Receives: Behavioral: Mindful Moms
Comparison GroupNo interventionUsual prenatal care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Duration of pregnancy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2011 (estimated)
  2. Study startAug 2011
  3. Primary completionAug 2015
  4. Study completionDec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
202 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01307683
Sponsor's protocol ID
1U01HL097973
Acronym
MAMAS
Status last verified
Jan 2021
First submitted
19 Jan 2011
Last updated
26 Jan 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 30993601

  • 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.

    PubMed 36441994

  • 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.

    PubMed 31934809

  • 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.

    PubMed 29859038

Questions about this trial

What is this clinical trial studying?

A study testing Mindful Moms in people with Obesity and Gestational Weight Gain, run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adequacy of gestational weight gain, as determined by Institute of Medicine guidelines (time frame: Duration of pregnancy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01307683, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2021.

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Maternal, Adiposity, Metabolism, and Stress Study | AzTrials