Centering Pregnancy Care + Yoga for Diverse Pregnant Women

Pregnancy Clinical Trial

— CPC+Y  

Official title:

Centering Pregnancy Care + Yoga for Diverse Pregnant Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02873481
• Other study ID #: HM20005136
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: December 2016

Study information

• Verified date: June 2018
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Pregnancy

Intervention

Behavioral:
• Centering Pregnancy Care plus Yoga (CPC+Y)
Gentle prenatal yoga for 30 minutes at the end of the Centering Pregnancy Care session

Locations

Country	Name	City	State
United States	Virginia Commonwealth University School of Nursing	Richmond	Virginia

Sponsors (3)

Lead Sponsor	Collaborator
Virginia Commonwealth University	Sigma Theta Tau International- the Honor Society of Nursing, Southern Nursing Research Society

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of Retention/ Adherence	Numbers of women who stayed in the study through their pregnancy and attended all intervention sessions	through study completion, an average of 20 weeks
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.	baseline (early pregnancy), end of pregnancy (approx 10 months)
Secondary	Salivary Biomarkers (a-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.	baseline (early pregnancy), mid-pregnancy (approx 4-5 months), end of pregnancy (approx 10 months)
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.	baseline (early pregnancy), end of pregnancy (approx 10 months)
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.	baseline (early pregnancy), end of pregnancy (approx 10 months)
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	at intervention completion, an average of 20 weeks
Secondary	Recruitment Feasibility	Numbers of women who agreed to participate in the study;	at intervention completion, an average of 20 weeks