CPC+Y: Centering Pregnancy Care + Yoga for Diverse Pregnant Women

• Sponsor: Virginia Commonwealth University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02873481
• Collaborator: Sigma Theta Tau International Honor Society of Nursing (Other), Southern Nursing Research Society (Other)
• Enrollment: 40
• Location: 1
• Arms: 2
• Duration (Months): 17.1
• Patients Per Site Per Month: 2.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy	Behavioral: Centering Pregnancy Care plus Yoga (CPC+Y)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Centering Pregnancy Care + Yoga for Diverse Pregnant Women
• Study Start Date: Jul 1, 2015
• Actual Primary Completion Date: Dec 1, 2016
• Actual Study Completion Date: Dec 1, 2016

Arms and Interventions

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)	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.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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

6. Recruitment Feasibility [at intervention completion, an average of 20 weeks]

   Numbers of women who agreed to participate in the study;

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: Female
• Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Virginia Commonwealth University School of Nursing	Richmond	Virginia	United States	23298

Sponsors and Collaborators

• Virginia Commonwealth University
• Sigma Theta Tau International Honor Society of Nursing
• Southern Nursing Research Society

Investigators

• Principal Investigator: Patricia Kinser, PhD, VCU

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Patricia Anne Kinser, Assistant Professor, Virginia Commonwealth University
• ClinicalTrials.gov Identifier: NCT02873481
• Other Study ID Numbers: HM20005136
• First Posted: Aug 19, 2016
• Last Update Posted: Jun 6, 2018
• Last Verified: Jun 1, 2018

Study Results

Participant Flow

Arm/Group Title	Yoga (CPC+Y)	Comparison (CPC Alone)
Arm/Group Description	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	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.
Period Title: Overall Study
STARTED	15	17
COMPLETED	15	17
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Yoga (CPC+Y)	Comparison (CPC Alone)	Total
Arm/Group Description	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	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 of all reporting groups
Overall Participants	15	17	32
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	29.3 (6.5)	24.4 (5.6)	26.6 (6.4)
Sex: Female, Male (Count of Participants)
Female	15 100%	17 100%	32 100%
Male	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	7 46.7%	8 47.1%	15 46.9%
White	8 53.3%	9 52.9%	17 53.1%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	15 100%	17 100%	32 100%

Outcome Measures

1. Primary Outcome

Title	Feasibility of Retention/ Adherence
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Yoga (CPC+Y)	Comparison (CPC Alone)
Arm/Group Description	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	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.
Measure Participants	15	17
Count of Participants [Participants]	15 100%	17 100%

2. Secondary Outcome

Title	Self-efficacy for Physical Activity
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Yoga (CPC+Y)
Arm/Group Description	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
Measure Participants	15
Baseline	25.8 (4.8)
End of pregnancy	25 (3.4)

3. Secondary Outcome

Title	Salivary Biomarkers (α-amylase)
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Yoga (CPC+Y)
Arm/Group Description	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
Measure Participants	11
Baseline	112.4145 (95.886)
Mid-pregnancy	99.59 (84.888)
End of pregnancy	127.045 (54.539)

4. Secondary Outcome

Title	Depressive Symptoms
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Yoga (CPC+Y)	Comparison (CPC Alone)
Arm/Group Description	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	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.
Measure Participants	15	17
Baseline	5.2 (4.8)	6.9 (5.3)
End of pregnancy	6.3 (5.9)	12 (4.1)

5. Secondary Outcome

Title	Stress
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Yoga (CPC+Y)	Comparison (CPC Alone)
Arm/Group Description	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	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.
Measure Participants	15	17
Baseline	1.8 (2.2)	1.3 (1.4)
End of pregnancy	0.33 (0.8)	1.3 (1.4)

6. Secondary Outcome

Title	Number of Subjects Participating in Focus Group
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Yoga (CPC+Y)
Arm/Group Description	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
Measure Participants	8
Count of Participants [Participants]	8 53.3%

7. Secondary Outcome

Title	Recruitment Feasibility
Description	Numbers of women who agreed to participate in the study;
Time Frame	at intervention completion, an average of 20 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Yoga (CPC+Y)	Comparison (CPC Alone)
Arm/Group Description	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	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.
Measure Participants	15	17
Number [participants]	15 100%	17 100%

Adverse Events

Time Frame	intervention period (9 months)
Arm/Group Title	Yoga (CPC+Y)		Comparison (CPC Alone)
Arm/Group Description	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		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.
All Cause Mortality
	Yoga (CPC+Y)		Comparison (CPC Alone)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/17 (0%)
Serious Adverse Events
	Yoga (CPC+Y)		Comparison (CPC Alone)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/17 (0%)
Other (Not Including Serious) Adverse Events
	Yoga (CPC+Y)		Comparison (CPC Alone)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/17 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.