Maternal, Adiposity, Metabolism, and Stress Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

202 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Healthy Motivations for Moms-to-be Study

NCT03063528

Weight Gain Pregnancy Stress, Emotional +2 more

COMPLETED NA

Using Mental Imagination to Prevent Excessive Gestational Weight Gain in Overweight and Obese Pregnant Women

NCT04623008

Obesity Weight Gain, Maternal

COMPLETED NA

Effectiveness of a Childbirth and Parenthood Preparation Education in Primigravidas

NCT05976776

Pregnancy Related Anxiety

COMPLETED NA

Weight Gain During Pregnancy - a Randomized Controlled Trial of Intervention to Prevent Excessive Gestational Weight Gain

NCT00451425

Weight Gain

UNKNOWN NA

The MOTHER (Mobile Technologies to Help Enhancing Regular Physical Activity) Trial for Pregnant Women

NCT01461707

Physical Activity

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity Gestational Weight Gain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Mindful Moms

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

Group Type ACTIVE_COMPARATOR

Mindful Moms

Intervention Type BEHAVIORAL

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

Comparison Group

Usual prenatal care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mindful Moms

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes