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Completed

NCT Number: NCT02873481

Centering Pregnancy Care + Yoga for Diverse Pregnant Women

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.

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Key information

Conditions

Pregnancy

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University School of Nursing

Richmond, Virginia, 23298, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Centering Pregnancy Care plus Yoga (CPC+Y)

Behavioral

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

Primary outcomes

  1. Feasibility of Retention/ Adherence

    Time frame: 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 outcomes

  1. Self-efficacy for Physical Activity

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: at intervention completion, an average of 20 weeks

    Numbers of women who agreed to participate in the study;

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • Sigma Theta Tau International Honor Society of Nursing
  • Southern Nursing Research Society

Registry information

Acronym: CPC+Y

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 19, 2016
Registry last updated
Jun 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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