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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03393637
Other study ID # FWH20170069H
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2017
Est. completion date March 15, 2022

Study information

Verified date August 2022
Source University of the Incarnate Word
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1717
Est. completion date March 15, 2022
Est. primary completion date March 15, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

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.

Locations

Country Name City State
United States Joint Base San Antonio San Antonio Texas
United States Naval Medical Center San Diego San Diego California
United States Madigan Army Medical Center Tacoma Washington

Sponsors (6)

Lead Sponsor Collaborator
University of the Incarnate Word 59th Medical Wing, 711th Human Performance Wing, Joint Program Committee - 5, Madigan Army Medical Center, United States Naval Medical Center, San Diego

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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 — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Lederman Self-Evaluation Questionnaire Seven dimensions of pregnancy-specific anxiety assessing change between gestational weeks 12, 16, 24, and 32 of pregnancy
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary Postpartum Self-Evaluation Questionnaire 82-items measuring the woman's perceived postpartum adaptation to motherhood assessing change between 1, 3, & 6 months postpartum
Secondary Infant birthweight exact measure obtained from the delivery or infant record of the infants weight at birth in grams delivery weight of infant documented at delivery
Secondary Gestational age at birth Gestational age in weeks at birth determined from last menstrual period (LMP) and/or first trimester ultrasound at first prenatal appointment up to 12 weeks
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