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

NCT03393637 | Completed

• 1 other identifier: FWH20170069H
• Study Type: interventional
• Target: 1,717
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Keywords

prenatal anxiety; pregnancy; depression; military; intervention

Outcome Measures

Primary Outcomes (8)

• Lederman Self-Evaluation Questionnaire

  Seven dimensions of pregnancy-specific anxiety

  assessing change between gestational weeks 12, 16, 24, and 32 of pregnancy

• Rosenberg Self-Esteem Scale

  10-item scale measuring the degree to which one values oneself

  assessing change between gestational weeks 12, 16, 24, and 32 of pregnancy and 1, 3, & 6 months postpartum

• Family Adaptability and Cohesion Evaluation Scales

  30-item instrument measuring the ability of the family (couple) to change its roles, rules, and power structure.

  assessing change between gestational weeks 12, 16, 24, and 32 of pregnancy and 1, 3, & 6 months postpartum

• Edinburgh Postnatal Depression Scale

  10-item scale measuring prenatal or postpartum symptoms of depression

  assessing change between gestational weeks 12, 16, 24, and 32 of pregnancy and 1, 3, & 6 months postpartum

• Social Support Index

  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

  assessing change between gestational weeks 12, 16, 24, and 32 of pregnancy and 1, 3, & 6 months postpartum

• Family Index Coherence

  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

  assessing change between gestational weeks 12, 16, 24, and 32 of pregnancy and 1, 3, & 6 months postpartum

• Brief Resilience Scale

  6-item instrument developed to measure the concept of "bouncing back from stress."

  assessing change between gestational weeks 12, 16, 24, and 32 of pregnancy and 1, 3, & 6 months postpartum

• Postpartum Self-Evaluation Questionnaire

  82-items measuring the woman's perceived postpartum adaptation to motherhood

  assessing change between 1, 3, & 6 months postpartum

Secondary Outcomes (2)

• Infant birthweight

  delivery weight of infant documented at delivery

• Gestational age at birth

  at first prenatal appointment up to 12 weeks

Study Arms (2)

M-O-M-S Intervention

EXPERIMENTAL

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

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

Routine Prenatal Care

NO INTERVENTION

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

Interventions

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

M-O-M-S Intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant military women in the first trimester of pregnancy
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of the Incarnate Word: lead
• Joint Program Committee - 5: collaborator
• 59th Medical Wing: collaborator
• United States Naval Medical Center, San Diego: collaborator
• Madigan Army Medical Center: collaborator
• 711th Human Performance Wing: collaborator

Study Sites (3)

Naval Medical Center San Diego

San Diego, California, 92134, United States

Location

Joint Base San Antonio

San Antonio, Texas, 78236, United States

Location

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

Location

Related Publications (4)

• 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.

  PMID: 22834852 BACKGROUND

• 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.

  PMID: 18213640 BACKGROUND

• 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.

  PMID: 28751158 RESULT

• 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.

  PMID: 34231203 DERIVED

MeSH Terms

Conditions

Premature Birth; Depression

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Behavioral Symptoms; Behavior

Study Officials

• Karen L Weis, PhD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: November 1, 2017
• First Posted: January 8, 2018
• Study Start: December 1, 2017
• Primary Completion: March 15, 2022
• Study Completion: March 15, 2022
• Last Updated: September 1, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be come available o/a February 2021
• Access Criteria: As time approaches for complete data, will have available site with data.

Locations

US (3)