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Trial record 21 of 8170 for:    Pregnancy

Centering Pregnancy Care + Yoga for Diverse Pregnant Women (CPC+Y)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02873481
First Posted: August 19, 2016
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Sigma Theta Tau International- the Honor Society of Nursing
Southern Nursing Research Society
Information provided by (Responsible Party):
Patricia Anne Kinser, Virginia Commonwealth University
  Purpose
This is a pilot longitudinal mixed-methods study of pregnant women (n=20) who participate in CPC+Y at the VCU Health System Nelson Clinic or the Virginia Department of Health Richmond Health District's prenatal clinic (RHD) during their pregnancies. This pilot project will provide the necessary preliminary data to fuel an appropriately powered randomized controlled trial to evaluate the effects of CPC+Y in controlling weight gain, enhancing stress resilience, and improving maternal-child outcomes among overweight/obese diverse women. Because increasing physical activity has been found to have important mental health effects and maternal-child outcomes, it stands to reason that this innovative intervention has the potential to impact the way prenatal care is delivered in high risk populations.

Condition Intervention
Pregnancy Behavioral: Centering Pregnancy Care plus Yoga (CPC+Y)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Centering Pregnancy Care + Yoga for Diverse Pregnant Women

Further study details as provided by Patricia Anne Kinser, Virginia Commonwealth University:

Primary Outcome Measures:
  • feasibility of retention/ adherence [ Time Frame: through study completion, an average of 20 weeks ]
    Numbers of women who stayed in the study through their pregnancy and attended all intervention sessions


Secondary Outcome Measures:
  • Self-efficacy for physical activity [ Time Frame: baseline (early pregnancy), mid-pregnancy (approx 4-5 months), end of pregnancy (approx 10 months) ]
    Physical Activity Self-Efficacy Scale (PASES)

  • Salivary biomarkers (NGF and α-amylase) [ Time Frame: baseline (early pregnancy), mid-pregnancy (approx 4-5 months), end of pregnancy (approx 10 months) ]
    salivary measure

  • Depressive symptoms [ Time Frame: baseline (early pregnancy), mid-pregnancy (approx 4-5 months), end of pregnancy (approx 10 months) ]
    Patient Health Questionnaire-9 (PHQ9)

  • Stress [ Time Frame: baseline (early pregnancy), mid-pregnancy (approx 4-5 months), end of pregnancy (approx 10 months) ]
    Perceived Stress Scale (PSS)

  • Focus Group [ Time Frame: at intervention completion, an average of 20 weeks ]
    Women will discuss their experiences (acceptability) with the intervention through focus groups conducted following the intervention period

  • recruitment feasibility [ Time Frame: at intervention completion, an average of 20 weeks ]
    Numbers of women who agreed to participate in the study;


Enrollment: 20
Study Start Date: July 2015
Study Completion Date: December 2016
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Yoga (CPC+Y)
Women in Centering Pregnancy Care (CPC) will receive the intervention which is a 30 minute yoga sessions during each of the 2-hour CPC meetings (CPC+Y)
Behavioral: Centering Pregnancy Care plus Yoga (CPC+Y)
Gentle prenatal yoga for 30 minutes at the end of the Centering Pregnancy Care session
No Intervention: Comparison (CPC alone)
To strengthen our ability to examine causal relationships between the intervention and outcomes, we will use longitudinal comparison group data contributed from deidentified archival data from an existing IRB-approved study (PI: Masho) which includes pregnant women who participated in the CPC model of care alone (without the yoga component) and were followed throughout their pregnancies using numerous measures identical to those in the proposed study, including weight/BMI, depressive symptoms, anxiety, and stress.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • pregnant women age 18 years or older
  • currently participating in CPC at the VCU Health System Nelson Clinic or Richmond Health District

Exclusion Criteria:

  • current physical conditions preventing participation in physical activity (ACOG guidelines: restrictive lung disease, hemodynamically significant heart disease, incompetent cervix, multiple gestation at risk of premature labor, persistent 2nd or 3rd trimester bleeding, placenta previa after 26 weeks gestation, premature labor, ruptured membranes, preeclampsia, severe anemia)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02873481


Locations
United States, Virginia
Virginia Commonwealth University School of Nursing
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Sigma Theta Tau International- the Honor Society of Nursing
Southern Nursing Research Society
Investigators
Principal Investigator: Patricia Kinser, PhD VCU
  More Information

Responsible Party: Patricia Anne Kinser, Assistant Professor, Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT02873481     History of Changes
Other Study ID Numbers: HM20005136
First Submitted: April 5, 2016
First Posted: August 19, 2016
Last Update Posted: October 12, 2017
Last Verified: February 2017