Trial Outcomes & Findings for Centering Pregnancy Care + Yoga for Diverse Pregnant Women (NCT NCT02873481)
NCT ID: NCT02873481
Last Updated: 2018-06-06
Results Overview
Numbers of women who stayed in the study through their pregnancy and attended all intervention sessions
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
through study completion, an average of 20 weeks
Results posted on
2018-06-06
Participant Flow
Participant milestones
| Measure |
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
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
17
|
|
Overall Study
COMPLETED
|
15
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Centering Pregnancy Care + Yoga for Diverse Pregnant Women
Baseline characteristics by cohort
| Measure |
Yoga (CPC+Y)
n=15 Participants
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
|
Comparison (CPC Alone)
n=17 Participants
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.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.3 years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
24.4 years
STANDARD_DEVIATION 5.6 • n=7 Participants
|
26.6 years
STANDARD_DEVIATION 6.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
17 participants
n=7 Participants
|
32 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: through study completion, an average of 20 weeksNumbers of women who stayed in the study through their pregnancy and attended all intervention sessions
Outcome measures
| Measure |
Yoga (CPC+Y)
n=15 Participants
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
|
Comparison (CPC Alone)
n=17 Participants
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.
|
|---|---|---|
|
Feasibility of Retention/ Adherence
|
15 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Yoga (CPC+Y)
n=15 Participants
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
|
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.
|
|---|---|---|
|
Self-efficacy for Physical Activity
Baseline
|
25.8 units on a scale
Standard Deviation 4.8
|
—
|
|
Self-efficacy for Physical Activity
End of pregnancy
|
25 units on a scale
Standard Deviation 3.4
|
—
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Yoga (CPC+Y)
n=11 Participants
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
|
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.
|
|---|---|---|
|
Salivary Biomarkers (α-amylase)
Baseline
|
112.4145 U/mL
Standard Deviation 95.886
|
—
|
|
Salivary Biomarkers (α-amylase)
Mid-pregnancy
|
99.59 U/mL
Standard Deviation 84.888
|
—
|
|
Salivary Biomarkers (α-amylase)
End of pregnancy
|
127.045 U/mL
Standard Deviation 54.539
|
—
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Yoga (CPC+Y)
n=15 Participants
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
|
Comparison (CPC Alone)
n=17 Participants
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.
|
|---|---|---|
|
Depressive Symptoms
Baseline
|
5.2 units on a scale
Standard Deviation 4.8
|
6.9 units on a scale
Standard Deviation 5.3
|
|
Depressive Symptoms
End of pregnancy
|
6.3 units on a scale
Standard Deviation 5.9
|
12 units on a scale
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Yoga (CPC+Y)
n=15 Participants
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
|
Comparison (CPC Alone)
n=17 Participants
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.
|
|---|---|---|
|
Stress
Baseline
|
1.8 units on a scale
Standard Deviation 2.2
|
1.3 units on a scale
Standard Deviation 1.4
|
|
Stress
End of pregnancy
|
0.33 units on a scale
Standard Deviation 0.8
|
1.3 units on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: at intervention completion, an average of 20 weeksWomen will volunteer to discuss their experiences (acceptability) with the intervention through focus groups conducted following the intervention period
Outcome measures
| Measure |
Yoga (CPC+Y)
n=8 Participants
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
|
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.
|
|---|---|---|
|
Number of Subjects Participating in Focus Group
|
8 Participants
|
—
|
SECONDARY outcome
Timeframe: at intervention completion, an average of 20 weeksNumbers of women who agreed to participate in the study;
Outcome measures
| Measure |
Yoga (CPC+Y)
n=15 Participants
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
|
Comparison (CPC Alone)
n=17 Participants
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.
|
|---|---|---|
|
Recruitment Feasibility
|
15 participants
|
17 participants
|
Adverse Events
Yoga (CPC+Y)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Comparison (CPC Alone)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Patricia Kinser, Assistant Professor
Virginia Commonwealth University School of Nursing
Phone: 804-828-9140
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place