Centering Pregnancy Care + Yoga for Diverse Pregnant Women

NCT02873481 | Completed Results

• 1 other identifier: HM20005136
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Self-efficacy for Physical Activity

  baseline (early pregnancy), end of pregnancy (approx 10 months)

• Salivary Biomarkers (α-amylase)

  baseline (early pregnancy), mid-pregnancy (approx 4-5 months), end of pregnancy (approx 10 months)

• Depressive Symptoms

  baseline (early pregnancy), end of pregnancy (approx 10 months)

• Stress

  baseline (early pregnancy), end of pregnancy (approx 10 months)

• Number of Subjects Participating in Focus Group

  at intervention completion, an average of 20 weeks

Study Arms (2)

Yoga (CPC+Y)

EXPERIMENTAL

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)

Comparison (CPC alone)

NO INTERVENTION

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.

Interventions

Centering Pregnancy Care plus Yoga (CPC+Y) BEHAVIORAL

Gentle prenatal yoga for 30 minutes at the end of the Centering Pregnancy Care session

Yoga (CPC+Y)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• pregnant women age 18 years or older
• currently participating in CPC at the VCU Health System Nelson Clinic or Richmond Health District

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

Virginia Commonwealth University School of Nursing

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Interventions

Yoga

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Results Point of Contact

• Title: Dr. Patricia Kinser, Assistant Professor
• Organization: Virginia Commonwealth University School of Nursing

kinserpa@vcu.edu

804-828-9140

Study Officials

• Patricia Kinser, PhD

  VCU

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 5, 2016
• First Posted: August 19, 2016
• Study Start: July 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: June 6, 2018
• Results First Posted: June 6, 2018

Record last verified: 2018-06

Locations

US (1)