An interventional study of Centering Pregnancy Care plus Yoga (CPC+Y) in Pregnancy, sponsored by Virginia Commonwealth University. Completed at 1 site in United States. Open to female participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-06.
Sponsored by Virginia Commonwealth University · Not applicable, Interventional, and Prevention
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.
Virginia Commonwealth University is the lead sponsor of 641 studies on the registry; 82 are open to participants now.
Of its 88 completed or terminated interventional studies of FDA-regulated products, 62 (70%) have results posted.
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Exclusion Criteria:
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)
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.
Gentle prenatal yoga for 30 minutes at the end of the Centering Pregnancy Care session
Feasibility of Retention/ Adherence
Numbers of women who stayed in the study through their pregnancy and attended all intervention sessions
Time frame: through study completion, an average of 20 weeks
Self-efficacy for Physical Activity
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.
Time frame: baseline (early pregnancy), end of pregnancy (approx 10 months)
Salivary Biomarkers (α-amylase)
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.
Time frame: baseline (early pregnancy), mid-pregnancy (approx 4-5 months), end of pregnancy (approx 10 months)
Depressive Symptoms
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.
Time frame: baseline (early pregnancy), end of pregnancy (approx 10 months)
Stress
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.
Time frame: baseline (early pregnancy), end of pregnancy (approx 10 months)
Number of Subjects Participating in Focus Group
Women will volunteer to discuss their experiences (acceptability) with the intervention through focus groups conducted following the intervention period
Time frame: at intervention completion, an average of 20 weeks
Recruitment Feasibility
Numbers of women who agreed to participate in the study;
Time frame: at intervention completion, an average of 20 weeks
| Milestone | Yoga (CPC+Y) | Comparison (CPC Alone) |
|---|---|---|
| Started | 15 | 17 |
| Completed | 15 | 17 |
| Not completed | 0 | 0 |
Numbers of women who stayed in the study through their pregnancy and attended all intervention sessions
| Participants | Yoga (CPC+Y) | Comparison (CPC Alone) |
|---|---|---|
| Feasibility of Retention/ Adherence | 15 | 17 |
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.
| units on a scale | Yoga (CPC+Y) |
|---|---|
| Baseline | 25.8 ± 4.8 |
| End of pregnancy | 25 ± 3.4 |
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.
| U/mL | Yoga (CPC+Y) |
|---|---|
| Baseline | 112.4145 ± 95.886 |
| Mid-pregnancy | 99.59 ± 84.888 |
| End of pregnancy | 127.045 ± 54.539 |
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.
| units on a scale | Yoga (CPC+Y) | Comparison (CPC Alone) |
|---|---|---|
| Baseline | 5.2 ± 4.8 | 6.9 ± 5.3 |
| End of pregnancy | 6.3 ± 5.9 | 12 ± 4.1 |
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.
| units on a scale | Yoga (CPC+Y) | Comparison (CPC Alone) |
|---|---|---|
| Baseline | 1.8 ± 2.2 | 1.3 ± 1.4 |
| End of pregnancy | 0.33 ± 0.8 | 1.3 ± 1.4 |
Women will volunteer to discuss their experiences (acceptability) with the intervention through focus groups conducted following the intervention period
| Participants | Yoga (CPC+Y) |
|---|---|
| Number of Subjects Participating in Focus Group | 8 |
Numbers of women who agreed to participate in the study;
| participants | Yoga (CPC+Y) | Comparison (CPC Alone) |
|---|---|---|
| Recruitment Feasibility | 15 | 17 |
Collected over intervention period (9 months). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Yoga (CPC+Y) | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Comparison (CPC Alone) | 0/17 (0%) | 0/17 (0%) | 0/17 (0%) |
| Age, Continuous(years) | Yoga (CPC+Y) | Comparison (CPC Alone) | Total |
|---|---|---|---|
| Mean | 29.3 ± 6.5 | 24.4 ± 5.6 | 26.6 ± 6.4 |
| Sex: Female, Male(Participants) | Yoga (CPC+Y) | Comparison (CPC Alone) | Total |
|---|---|---|---|
| Female | 15 | 17 | 32 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Yoga (CPC+Y) | Comparison (CPC Alone) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 7 | 8 | 15 |
| White | 8 | 9 | 17 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Yoga (CPC+Y) | Comparison (CPC Alone) | Total |
|---|---|---|---|
| United States | 15 | 17 | 32 |
This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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Virginia Commonwealth University