- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02873481
Centering Pregnancy Care + Yoga for Diverse Pregnant Women (CPC+Y)
June 4, 2018 updated by: Patricia Anne Kinser, Virginia Commonwealth University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Virginia
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Richmond, Virginia, United States, 23298
- Virginia Commonwealth University School of Nursing
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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)
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Gentle prenatal yoga for 30 minutes at the end of the Centering Pregnancy Care session
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of Retention/ Adherence
Time Frame: through study completion, an average of 20 weeks
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Numbers of women who stayed in the study through their pregnancy and attended all intervention sessions
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through study completion, an average of 20 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-efficacy for Physical Activity
Time Frame: baseline (early pregnancy), end of pregnancy (approx 10 months)
|
Physical Activity Self-Efficacy Scale (PASES): The Physical Activity Self-Efficacy Scale (PASES) is an 8 question scale which contains items about SM of physical activities and social support regarding PA.
This psychometrically sound scale was selected because of its specific focus on SM of PA.
Originally designed for adolescents, the wording has been slightly adapted for an adult sample.
A higher score indicates higher levels of self-efficacy.
Lowest possible score is 8; highest possible score is 40.
Only participants in the intervention arm receive this particular instrument.
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baseline (early pregnancy), end of pregnancy (approx 10 months)
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Salivary Biomarkers (α-amylase)
Time Frame: baseline (early pregnancy), mid-pregnancy (approx 4-5 months), end of pregnancy (approx 10 months)
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salivary biomaker measure.
This is an exploratory measure related to acute stress, yet it does not currently have known clinical associations with certain numeric levels of this measure (i.e., there is no identified "high" or "low" level of alpha-amylase).
Only collected in the intervention group.
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baseline (early pregnancy), mid-pregnancy (approx 4-5 months), end of pregnancy (approx 10 months)
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Depressive Symptoms
Time Frame: baseline (early pregnancy), end of pregnancy (approx 10 months)
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Patient Health Questionnaire-9 (PHQ9): The PHQ-9 includes self-report items regarding depressive symptoms over the past two weeks.
Total scores range from 0-27, where 0-4 indicates minimal depression, 5-9 mild depressive symptoms, 10-14 moderate depressive symptoms, 15-19 moderately severe depressive symptoms, and ≥20 severe depressive symptoms.
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baseline (early pregnancy), end of pregnancy (approx 10 months)
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Stress
Time Frame: baseline (early pregnancy), end of pregnancy (approx 10 months)
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Perceived Stress Scale (PSS): The Perceived Stress Scale-10 (PSS-10), a widely used, psychometrically sound instrument, will assess the degree to which a participant perceives stress in her life during the past month.
The PSS-10 asks respondents to report about feelings such as unpredictability, uncontrollability, and overloading of stress in their lives; scores range from 0-40; higher scores correspond to a higher perceived stress level.
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baseline (early pregnancy), end of pregnancy (approx 10 months)
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Number of Subjects Participating in Focus Group
Time Frame: at intervention completion, an average of 20 weeks
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Women will volunteer to discuss their experiences (acceptability) with the intervention through focus groups conducted following the intervention period
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at intervention completion, an average of 20 weeks
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Recruitment Feasibility
Time Frame: at intervention completion, an average of 20 weeks
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Numbers of women who agreed to participate in the study;
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at intervention completion, an average of 20 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Patricia Kinser, PhD, VCU
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2015
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
April 5, 2016
First Submitted That Met QC Criteria
August 16, 2016
First Posted (Estimate)
August 19, 2016
Study Record Updates
Last Update Posted (Actual)
June 6, 2018
Last Update Submitted That Met QC Criteria
June 4, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- HM20005136
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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