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Mentors Offering Maternal Support (M-O-M-S™): A Prenatal Program for Decreasing Maternal Anxiety and Depression (M-O-M-S)

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ClinicalTrials.gov Identifier: NCT03393637
Recruitment Status : Recruiting
First Posted : January 8, 2018
Last Update Posted : May 16, 2019
Sponsor:
Collaborators:
Joint Program Committee - 5
59th Medical Wing Science and Technology
United States Naval Medical Center, San Diego
Madigan Army Medical Center
711th Human Performance Wing
Information provided by (Responsible Party):
Karen L. Weis, University of the Incarnate Word

Brief Summary:
The M-O-M-S project evaluates the effectiveness of the M-O-M-S program for improving birth outcomes and maternal-infant attachment and role satisfaction in a large military sample.

Condition or disease Intervention/treatment Phase
Anxiety Fear Prenatal Depression Infant, Low Birth Weight Preterm Birth Maternal Behavioral: Mentors Offering Maternal Support (M-O-M-S) Not Applicable

Detailed Description:
The M-O-M-S project is a longitudinal, multi-site, randomized controlled trial to test program effectiveness for decreasing prenatal maternal anxiety and depression and increasing self-esteem and resilience and assess the relationship to pregnancy complications, birth outcomes, postpartum maternal-infant attachment, role satisfaction and parental stress.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1080 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Following consent, the participants will randomized to either the treatment or control groups using a computer-generated randomization table developed prior to study start. They will be randomized to either the MOMS intervention or prenatal care without the MOMS. Women randomized to the MOMS program will be assigned to a MOMS group in the first trimester.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mentors Offering Maternal Support (M-O-M-S™): A Prenatal Program Building Maternal Self-Esteem, Coping, and Resilience and Decreasing Depression.
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : September 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: M-O-M-S Intervention
M-O-M-S intervention is 10, 1 hour prenatal mentored support groups
Behavioral: Mentors Offering Maternal Support (M-O-M-S)
10, 1 hour, structured classes meeting every-other-week in person beginning in the first trimester of pregnancy and unlimited access to mentor support.

No Intervention: Routine Prenatal Care
Routine prenatal care in accordance with the Department of Defense Pregnancy Guidelines



Primary Outcome Measures :
  1. Lederman Self-Evaluation Questionnaire [ Time Frame: assessing change between gestational weeks 12, 16, 24, and 32 of pregnancy ]
    Seven dimensions of pregnancy-specific anxiety

  2. Rosenberg Self-Esteem Scale [ Time Frame: assessing change between gestational weeks 12, 16, 24, and 32 of pregnancy and 1, 3, & 6 months postpartum ]
    10-item scale measuring the degree to which one values oneself

  3. Family Adaptability and Cohesion Evaluation Scales [ Time Frame: assessing change between gestational weeks 12, 16, 24, and 32 of pregnancy and 1, 3, & 6 months postpartum ]
    30-item instrument measuring the ability of the family (couple) to change its roles, rules, and power structure.

  4. Edinburgh Postnatal Depression Scale [ Time Frame: assessing change between gestational weeks 12, 16, 24, and 32 of pregnancy and 1, 3, & 6 months postpartum ]
    10-item scale measuring prenatal or postpartum symptoms of depression

  5. Social Support Index [ Time Frame: assessing change between gestational weeks 12, 16, 24, and 32 of pregnancy and 1, 3, & 6 months postpartum ]
    17-item scale measuring the extent to which families are integrated into the community, view the community as a source of support, and feel that the community can provide emotional, esteem, and network support

  6. Family Index Coherence [ Time Frame: assessing change between gestational weeks 12, 16, 24, and 32 of pregnancy and 1, 3, & 6 months postpartum ]
    17-item instrument measuring the degree to which families feel committed to the military mission and identify a subscale of family coping to manage life changes and stresses

  7. Brief Resilience Scale [ Time Frame: assessing change between gestational weeks 12, 16, 24, and 32 of pregnancy and 1, 3, & 6 months postpartum ]
    6-item instrument developed to measure the concept of "bouncing back from stress."

  8. Postpartum Self-Evaluation Questionnaire [ Time Frame: assessing change between 1, 3, & 6 months postpartum ]
    82-items measuring the woman's perceived postpartum adaptation to motherhood


Secondary Outcome Measures :
  1. Infant birthweight [ Time Frame: delivery weight of infant documented at delivery ]
    exact measure obtained from the delivery or infant record of the infants weight at birth in grams

  2. Gestational age at birth [ Time Frame: at first prenatal appointment up to 12 weeks ]
    Gestational age in weeks at birth determined from last menstrual period (LMP) and/or first trimester ultrasound



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant military women in the first trimester of pregnancy
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Prima or multigravida, first trimester of pregnancy at consent, greater than or equal to 18 years old, active duty, a wife of an active duty service member, or a retiree

Exclusion Criteria:

  • Anticipated permanent change of station during the study (unless going to another one of the study sites or able to complete all treatment components prior to move), dependent daughter of active duty or retired military, greater than 12 weeks gestation at consent, less than 18 years of age and inability to understand English.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03393637


Contacts
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Contact: Karen L Weis, PhD 210.829.3987 weis@uiwtx.edu
Contact: Katherine C Walker, MSN 210.841.7257/7258 kcwalker@uiwtx.edu

Locations
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United States, California
Naval Medical Center San Diego Not yet recruiting
San Diego, California, United States, 92134
Contact: Monica Lutgendorf, MD    619-532-7461    monica.a.lutgendorf.mil@mail.mil   
United States, Texas
Joint Base San Antonio Recruiting
San Antonio, Texas, United States, 78236
Contact: Jacqueline M Killian, PhD RN    210-292-2097    jacqueline.m.killian.mil@mail.mil   
Contact: Katherine C Walker, MSN RN    210-378-3057    kcwalker@uiwtx.edu   
United States, Washington
Madigan Army Medical Center Not yet recruiting
Tacoma, Washington, United States, 98431
Contact: Meagan S Petersen, PhD    253-968-1406    meagan.s.petersen.civ@mail.mil   
Sponsors and Collaborators
University of the Incarnate Word
Joint Program Committee - 5
59th Medical Wing Science and Technology
United States Naval Medical Center, San Diego
Madigan Army Medical Center
711th Human Performance Wing
Investigators
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Principal Investigator: Karen L Weis, PhD University of the Incarnate Word

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Responsible Party: Karen L. Weis, Professor, Brigadier General Lillian Dunlap Endowed Chair, University of the Incarnate Word
ClinicalTrials.gov Identifier: NCT03393637     History of Changes
Other Study ID Numbers: FWH20170069H
First Posted: January 8, 2018    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data will be available to the local site PIs and to Department of Defense (DoD) OB Consultants. Study protocols are available upon request for DoD leaders within obstetrics.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Data will be come available o/a February 2020
Access Criteria: As time approaches for complete data, will have available site with data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Karen L. Weis, University of the Incarnate Word:
prenatal anxiety
pregnancy
depression
military
intervention

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Anxiety Disorders
Birth Weight
Premature Birth
Behavioral Symptoms
Mood Disorders
Mental Disorders
Body Weight
Signs and Symptoms
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications