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| Name | Class |
|---|---|
| Joint Program Committee - 5 | UNKNOWN |
| 59th Medical Wing | FED |
| United States Naval Medical Center, San Diego | FED |
| Madigan Army Medical Center |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| M-O-M-S Intervention | Experimental | M-O-M-S intervention is 10, 1 hour prenatal mentored support groups |
|
| Routine Prenatal Care | No Intervention | Routine prenatal care in accordance with the Department of Defense Pregnancy Guidelines |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Gestational age at birth |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant military women in the first trimester of pregnancy
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| Name | Affiliation | Role |
|---|---|---|
| Karen L Weis, PhD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Naval Medical Center San Diego | San Diego | California | 92134 | United States | ||
| Joint Base San Antonio |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22834852 | Background | 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. | |
| 18213640 | 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. |
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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.
Data will be come available o/a February 2021
As time approaches for complete data, will have available site with data.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Dec 6, 2019 | Feb 20, 2020 |
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| FED |
| 711th Human Performance Wing | UNKNOWN |
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.
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| 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 |
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 |
| San Antonio |
| Texas |
| 78236 |
| United States |
| Madigan Army Medical Center | Tacoma | Washington | 98431 | United States |
| 28751158 | Result | 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. |
| 34231203 | Derived | 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. |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D003863 | Depression |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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