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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)

Primary Purpose

Anxiety Fear, Prenatal Depression, Infant, Low Birth Weight

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mentors Offering Maternal Support (M-O-M-S)
Sponsored by
University of the Incarnate Word
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Fear focused on measuring prenatal anxiety, pregnancy, depression, military, intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Naval Medical Center San Diego
  • Joint Base San Antonio
  • Madigan Army Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

M-O-M-S Intervention

Routine Prenatal Care

Arm Description

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

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

Outcomes

Primary Outcome Measures

Lederman Self-Evaluation Questionnaire
Seven dimensions of pregnancy-specific anxiety
Rosenberg Self-Esteem Scale
10-item scale measuring the degree to which one values oneself
Family Adaptability and Cohesion Evaluation Scales
30-item instrument measuring the ability of the family (couple) to change its roles, rules, and power structure.
Edinburgh Postnatal Depression Scale
10-item scale measuring prenatal or postpartum symptoms of depression
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
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
Brief Resilience Scale
6-item instrument developed to measure the concept of "bouncing back from stress."
Postpartum Self-Evaluation Questionnaire
82-items measuring the woman's perceived postpartum adaptation to motherhood

Secondary Outcome Measures

Infant birthweight
exact measure obtained from the delivery or infant record of the infants weight at birth in grams
Gestational age at birth
Gestational age in weeks at birth determined from last menstrual period (LMP) and/or first trimester ultrasound

Full Information

First Posted
November 1, 2017
Last Updated
August 29, 2022
Sponsor
University of the Incarnate Word
Collaborators
Joint Program Committee - 5, 59th Medical Wing, United States Naval Medical Center, San Diego, Madigan Army Medical Center, 711th Human Performance Wing
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1. Study Identification

Unique Protocol Identification Number
NCT03393637
Brief Title
Mentors Offering Maternal Support (M-O-M-S™): A Prenatal Program for Decreasing Maternal Anxiety and Depression
Acronym
M-O-M-S
Official Title
Mentors Offering Maternal Support (M-O-M-S™): A Prenatal Program Building Maternal Self-Esteem, Coping, and Resilience and Decreasing Depression.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
March 15, 2022 (Actual)
Study Completion Date
March 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of the Incarnate Word
Collaborators
Joint Program Committee - 5, 59th Medical Wing, United States Naval Medical Center, San Diego, Madigan Army Medical Center, 711th Human Performance Wing

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Fear, Prenatal Depression, Infant, Low Birth Weight, Preterm Birth, Maternal
Keywords
prenatal anxiety, pregnancy, depression, military, intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
1717 (Actual)

8. Arms, Groups, and Interventions

Arm Title
M-O-M-S Intervention
Arm Type
Experimental
Arm Description
M-O-M-S intervention is 10, 1 hour prenatal mentored support groups
Arm Title
Routine Prenatal Care
Arm Type
No Intervention
Arm Description
Routine prenatal care in accordance with the Department of Defense Pregnancy Guidelines
Intervention Type
Behavioral
Intervention Name(s)
Mentors Offering Maternal Support (M-O-M-S)
Intervention Description
10, 1 hour, structured classes meeting every-other-week in person beginning in the first trimester of pregnancy and unlimited access to mentor support.
Primary Outcome Measure Information:
Title
Lederman Self-Evaluation Questionnaire
Description
Seven dimensions of pregnancy-specific anxiety
Time Frame
assessing change between gestational weeks 12, 16, 24, and 32 of pregnancy
Title
Rosenberg Self-Esteem Scale
Description
10-item scale measuring the degree to which one values oneself
Time Frame
assessing change between gestational weeks 12, 16, 24, and 32 of pregnancy and 1, 3, & 6 months postpartum
Title
Family Adaptability and Cohesion Evaluation Scales
Description
30-item instrument measuring the ability of the family (couple) to change its roles, rules, and power structure.
Time Frame
assessing change between gestational weeks 12, 16, 24, and 32 of pregnancy and 1, 3, & 6 months postpartum
Title
Edinburgh Postnatal Depression Scale
Description
10-item scale measuring prenatal or postpartum symptoms of depression
Time Frame
assessing change between gestational weeks 12, 16, 24, and 32 of pregnancy and 1, 3, & 6 months postpartum
Title
Social Support Index
Description
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
Time Frame
assessing change between gestational weeks 12, 16, 24, and 32 of pregnancy and 1, 3, & 6 months postpartum
Title
Family Index Coherence
Description
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
Time Frame
assessing change between gestational weeks 12, 16, 24, and 32 of pregnancy and 1, 3, & 6 months postpartum
Title
Brief Resilience Scale
Description
6-item instrument developed to measure the concept of "bouncing back from stress."
Time Frame
assessing change between gestational weeks 12, 16, 24, and 32 of pregnancy and 1, 3, & 6 months postpartum
Title
Postpartum Self-Evaluation Questionnaire
Description
82-items measuring the woman's perceived postpartum adaptation to motherhood
Time Frame
assessing change between 1, 3, & 6 months postpartum
Secondary Outcome Measure Information:
Title
Infant birthweight
Description
exact measure obtained from the delivery or infant record of the infants weight at birth in grams
Time Frame
delivery weight of infant documented at delivery
Title
Gestational age at birth
Description
Gestational age in weeks at birth determined from last menstrual period (LMP) and/or first trimester ultrasound
Time Frame
at first prenatal appointment up to 12 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant military women in the first trimester of pregnancy
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen L Weis, PhD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Naval Medical Center San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92134
Country
United States
Facility Name
Joint Base San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78236
Country
United States
Facility Name
Madigan Army Medical Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98431
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
Data will be come available o/a February 2021
IPD Sharing Access Criteria
As time approaches for complete data, will have available site with data.
Citations:
PubMed Identifier
22834852
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.
Results Reference
background
PubMed Identifier
18213640
Citation
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.
Results Reference
background
PubMed Identifier
28751158
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 Jul 24.
Results Reference
result
PubMed Identifier
34231203
Citation
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.
Results Reference
derived

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

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