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

NCT ID: NCT03393637

Last Updated: 2022-09-01

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1717 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2022-03-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Anxiety Fear Prenatal Depression Infant, Low Birth Weight Preterm Birth Maternal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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M-O-M-S Intervention

M-O-M-S intervention is 10, 1 hour prenatal mentored support groups

Group Type EXPERIMENTAL

Mentors Offering Maternal Support (M-O-M-S)

Intervention Type BEHAVIORAL

10, 1 hour, structured classes meeting every-other-week in person beginning in the first trimester of pregnancy and unlimited access to mentor support.

Routine Prenatal Care

Routine prenatal care in accordance with the Department of Defense Pregnancy Guidelines

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Joint Program Committee - 5

UNKNOWN

Sponsor Role collaborator

59th Medical Wing

FED

Sponsor Role collaborator

United States Naval Medical Center, San Diego

FED

Sponsor Role collaborator

Madigan Army Medical Center

FED

Sponsor Role collaborator

711th Human Performance Wing

UNKNOWN

Sponsor Role collaborator

University of the Incarnate Word

OTHER

Sponsor Role lead

Responsible Party

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Karen L. Weis

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karen L Weis, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

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Naval Medical Center San Diego

San Diego, California, United States

Site Status

Joint Base San Antonio

San Antonio, Texas, United States

Site Status

Madigan Army Medical Center

Tacoma, Washington, United States

Site Status

Countries

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United States

References

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Weis KL, Ryan TW. Mentors offering maternal support: a support intervention for military mothers. J Obstet Gynecol Neonatal Nurs. 2012 Mar;41(2):303-314. doi: 10.1111/j.1552-6909.2012.01346.x.

Reference Type BACKGROUND
PMID: 22834852 (View on PubMed)

Weis KL, Lederman RP, Lilly AE, Schaffer J. The relationship of military imposed marital separations on maternal acceptance of pregnancy. Res Nurs Health. 2008 Jun;31(3):196-207. doi: 10.1002/nur.20248.

Reference Type BACKGROUND
PMID: 18213640 (View on PubMed)

Weis KL, Lederman RP, Walker KC, Chan W. Mentors Offering Maternal Support Reduces Prenatal, Pregnancy-Specific Anxiety in a Sample of Military Women. J Obstet Gynecol Neonatal Nurs. 2017 Sep-Oct;46(5):669-685. doi: 10.1016/j.jogn.2017.07.003. Epub 2017 Jul 24.

Reference Type RESULT
PMID: 28751158 (View on PubMed)

O'Connell MA, Khashan AS, Leahy-Warren P, Stewart F, O'Neill SM. Interventions for fear of childbirth including tocophobia. Cochrane Database Syst Rev. 2021 Jul 7;7(7):CD013321. doi: 10.1002/14651858.CD013321.pub2.

Reference Type DERIVED
PMID: 34231203 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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FWH20170069H

Identifier Type: -

Identifier Source: org_study_id

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