Pregnancy
Conditions
Brief summary
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.
Interventions
BEHAVIORALCentering Pregnancy Care plus Yoga (CPC+Y)
Gentle prenatal yoga for 30 minutes at the end of the Centering Pregnancy Care session
Sponsors
Sigma Theta Tau International Honor Society of Nursing
Southern Nursing Research Society
Virginia Commonwealth University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Retention/ Adherence | 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
| Measure | Time frame | Description |
|---|---|---|
| Salivary Biomarkers (α-amylase) | baseline (early pregnancy), mid-pregnancy (approx 4-5 months), end of pregnancy (approx 10 months) | 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. |
| Depressive Symptoms | baseline (early pregnancy), end of pregnancy (approx 10 months) | 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. |
| Self-efficacy for Physical Activity | 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. |
| Number of Subjects Participating in Focus Group | at intervention completion, an average of 20 weeks | Women will volunteer to discuss their experiences (acceptability) with the intervention through focus groups conducted following the intervention period |
| Recruitment Feasibility | at intervention completion, an average of 20 weeks | Numbers of women who agreed to participate in the study; |
| Stress | baseline (early pregnancy), end of pregnancy (approx 10 months) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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)
Centering Pregnancy Care plus Yoga (CPC+Y): Gentle prenatal yoga for 30 minutes at the end of the Centering Pregnancy Care session | 15 |
| 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. | 17 |
| Total | 32 |
Baseline characteristics
| Characteristic | Yoga (CPC+Y) | Total | Comparison (CPC Alone) |
|---|---|---|---|
| Age, Continuous | 29.3 years STANDARD_DEVIATION 6.5 | 26.6 years STANDARD_DEVIATION 6.4 | 24.4 years STANDARD_DEVIATION 5.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 15 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 17 Participants | 9 Participants |
| Region of Enrollment United States | 15 participants | 32 participants | 17 participants |
| Sex: Female, Male Female | 15 Participants | 32 Participants | 17 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 17 |
| other Total, other adverse events | 0 / 15 | 0 / 17 |
| serious Total, serious adverse events | 0 / 15 | 0 / 17 |
Outcome results
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Yoga (CPC+Y) | Feasibility of Retention/ Adherence | 15 Participants |
| Comparison (CPC Alone) | Feasibility of Retention/ Adherence | 17 Participants |
Secondary
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Yoga (CPC+Y) | Depressive Symptoms | Baseline | 5.2 units on a scale | Standard Deviation 4.8 |
| Yoga (CPC+Y) | Depressive Symptoms | End of pregnancy | 6.3 units on a scale | Standard Deviation 5.9 |
| Comparison (CPC Alone) | Depressive Symptoms | Baseline | 6.9 units on a scale | Standard Deviation 5.3 |
| Comparison (CPC Alone) | Depressive Symptoms | End of pregnancy | 12 units on a scale | Standard Deviation 4.1 |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Yoga (CPC+Y) | Number of Subjects Participating in Focus Group | 8 Participants |
Secondary
Recruitment Feasibility
Numbers of women who agreed to participate in the study;
Time frame: at intervention completion, an average of 20 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Yoga (CPC+Y) | Recruitment Feasibility | 15 participants |
| Comparison (CPC Alone) | Recruitment Feasibility | 17 participants |
Secondary
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Yoga (CPC+Y) | Salivary Biomarkers (α-amylase) | Baseline | 112.4145 U/mL | Standard Deviation 95.886 |
| Yoga (CPC+Y) | Salivary Biomarkers (α-amylase) | Mid-pregnancy | 99.59 U/mL | Standard Deviation 84.888 |
| Yoga (CPC+Y) | Salivary Biomarkers (α-amylase) | End of pregnancy | 127.045 U/mL | Standard Deviation 54.539 |
Secondary
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Yoga (CPC+Y) | Self-efficacy for Physical Activity | Baseline | 25.8 units on a scale | Standard Deviation 4.8 |
| Yoga (CPC+Y) | Self-efficacy for Physical Activity | End of pregnancy | 25 units on a scale | Standard Deviation 3.4 |
Secondary
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Yoga (CPC+Y) | Stress | Baseline | 1.8 units on a scale | Standard Deviation 2.2 |
| Yoga (CPC+Y) | Stress | End of pregnancy | 0.33 units on a scale | Standard Deviation 0.8 |
| Comparison (CPC Alone) | Stress | Baseline | 1.3 units on a scale | Standard Deviation 1.4 |
| Comparison (CPC Alone) | Stress | End of pregnancy | 1.3 units on a scale | Standard Deviation 1.4 |