Investigating the Feasibility and Preliminary Effects of Yoga on Excessive Gestational Weight Gain
5 de enero de 2021 actualizado por: Jennifer Huberty, Arizona State University
The Power of Yoga: Investigating the Feasibility and Preliminary Effects of Yoga on Excessive Gestational Weight Gain
This study will test the feasibility (i.e., acceptability, demand) of a 12-week prenatal yoga intervention on excessive gestational weight gain (GWG) in pregnant women in the second trimester (enrolled at 12-24 weeks). Participants will be randomized into the prenatal yoga intervention or a pregnancy education (e.g., information on preparing for motherhood, labor and delivery etc.) control group. Participants in both groups will be asked to attend one 75 minute class per week.
The investigators hypothesize that prenatal yoga intervention will be feasible for pregnant women.
The study aims are as follows:
Primary Aim: Determine the feasibility (i.e., acceptability, demand) of a 12-week prenatal yoga intervention in pregnant women. In a randomized controlled pilot study comparing prenatal yoga to a pregnancy education control condition, the investigators will assess 1) acceptability (defined as satisfaction, intent to continue use, perceived appropriateness) and 2) demand (defined as attendance/adherence).
Exploratory Aim 1: Ascertain the preliminary effects of prenatal yoga on excessive GWG [i.e., weight gain exceeding Institute of Medicine (IOM) recommendations]. The investigators will compare weight change between intervention and control groups.
Exploratory Aim 2: Explore the potential mediators (i.e., mindfulness, self-regulation) on the effect of prenatal yoga on excessive GWG.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
49
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Arizona
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Phoenix, Arizona, Estados Unidos, 85004
- Arizona Biomedical Collaborative (ASU)
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Phoenix, Arizona, Estados Unidos, 85006
- Urban Wellness
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 46 años (Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Femenino
Descripción
Inclusion Criteria:
- Women 18-46 years of age (childbearing age)
- Primiparous (women giving birth for the first time)
- 12-24 weeks gestation at onset of intervention
- Reside in the Phoenix Metropolitan area
- Singleton pregnancy
- English speaking
- Not planning on moving before giving birth
- Can attend at least one session per week
Exclusion Criteria:
- Current alcohol or substance abuse
- Engage in ≥150 min of physical activity
- Participation in ≥30 minutes/week of yoga or contemplative practice (i.e., meditation, qigong) for the previous six months
- Pre-pregnancy BMI ≥40 or <18.5
- Denial of physical activity participation from a physician (PARmed-X for pregnancy)
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Prenatal yoga
Each class will be outlined as follows: 1) opening greeting/intention setting, 2) pranayama (i.e., breathing exercises), 3) warm-up/sun salutations (i.e., flowing sequence), 4) yoga sequence (e.g., combination of sun salutations, vinyasa, and standing, seated, and/or balancing poses), 5) cool-down 6) Savasana (i.e., final resting pose), and 7) class closing.
Meditation and breath awareness (e.g., linking each movement with breath) will be emphasized throughout each class.
All classes will focus on safety and alignment and be appropriate for women during pregnancy by incorporating modifications to poses/exercises as necessary (e.g., yoga block, strap).
Certified yoga instructors with a bachelors degree in a health related field and experience teaching pregnant women will instruct all yoga classes.
Participants will be provided with a 'yoga during pregnancy' safety packet that includes a list of prenatal yoga poses that women may do at their own leisure at home.
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The prenatal yoga classes will be offered at Urban Wellness (2024 N. 7th St., Phoenix, AZ 85006).
Classes will be offered Tuesdays's from 4:15-5:30 pm and Saturday's from 9:00-10:15 am.
Participants will be able to attend both classes if they so choose but are only asked to attend 1/week.
Participants will be asked to arrive to class at least 10 minutes early in order for the research team to collect their weight in a private room.
Additionally, if participants have attended at least 70% of classes (1 per week for 8/12 weeks), participants will be able to attend sessions up until birth (beyond the 12-week intervention) if they so choose.
If participants decide to attend classes beyond the 12-week intervention the investigators will continue to collect their weight at each session.
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Comparador activo: Pregnancy education
Participants will be asked to attend a group-based pregnancy education group (similar to a birth education class).
The class format will include a didactic portion followed by group discussion (N=12).
The following evidence-based topics (based on the American College of Obstetrics and Gynecologists) to be discussed may include (but not limited to): financial management in preparation for baby, preparing for labor and delivery, transitioning into motherhood, sleep hygiene, and baby bonding.
A labor and delivery nurse and certified Dula will instruct all classes.
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Pregnancy education classes will be offered at the Arizona Biomedical Collaborative Building on ASU Phoenix Campus.
Classes will be offered on Tuesday's from 5:30-6:45 pm and Saturday's from 9:00-10:15 am.
Participants will be able to attend both classes if they so choose but are only asked to attend 1/week.
Participants will be asked to arrive to class at least 10 minutes early in order for the research team to collect their weight in a private room.
Additionally, if participants have attended at least 70% of classes (1 per week for 8/12 weeks), participants will be able to attend sessions up until birth (beyond the 12-week intervention) if they so choose.
If participants decide to attend classes beyond the 12-week intervention the investigators will continue to collect their weight at each session.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Acceptability via satisfaction survey at post-intervention
Periodo de tiempo: post-intervention (12-weeks)
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Acceptability (defined as satisfaction, intent to continue use, perceived appropriateness); Benchmarks for acceptability include ≥70% of the sample will report the yoga intervention to be a satisfactory, useful, and appropriate modality to prevent excessive GWG.
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post-intervention (12-weeks)
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Demand (attendance/adherence) of yoga intervention
Periodo de tiempo: Weekly (during 12-week intervention)
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Demand was measured using attendance/adherence to the yoga intervention.
Attendance was tracked by a researcher who was present at each yoga session.
Benchmarks for demand include ≥60% of participants in each group will attend one class per week.
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Weekly (during 12-week intervention)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Number of participants with excessive GWG (total GWG from baseline to delivery)
Periodo de tiempo: Weekly (during 12-week intervention) and at delivery (up to 42 weeks gestation)
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Weight gain exceeding IOM recommendations
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Weekly (during 12-week intervention) and at delivery (up to 42 weeks gestation)
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Mindfulness (mean change from baseline)
Periodo de tiempo: Baseline, post-intervention (12-weeks)
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Self-report mindfulness scores via Mindful Attention Awareness Scale (MAAS); 15-item questionnaire with score ranges 1-6.
Higher scores reflect higher levels of dispositional mindfulness.
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Baseline, post-intervention (12-weeks)
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Self-awareness (mean change from baseline)
Periodo de tiempo: Baseline, post-intervention (12-weeks)
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Self-report self-awareness scores via Self-Awareness Outcomes Questionnaire (SAOQ); Consists of 38 items measuring 4 subscales (reflective self-development, acceptance, proactive at work, and emotional costs).
Score ranges for each subscale are between 1-5.
Higher scores represent a greater frequency of experienced outcomes.
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Baseline, post-intervention (12-weeks)
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Emotion Regulation (mean change from baseline)
Periodo de tiempo: Baseline, post-intervention (12-weeks)
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Self-report emotion regulation scores via Emotional Regulation Questionnaire (ERQ); Consists of 10 items measuring 2 subscales (reappraisal items, suppression items).
Score ranges for each subscale are between 1-7.
The higher the scores, the greater the use of the emotional regulation strategy.
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Baseline, post-intervention (12-weeks)
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Sleep Quality (mean change from baseline)
Periodo de tiempo: Baseline, post-intervention (12-weeks)
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Self-report sleep quality via Pittsburgh Sleep Quality Index (PSQI); Consists of 10-items.
In scoring the PSQI, seven component scores are derived ranging from 0 (no difficulty) to 3 (severe difficulty).
The component scores are summed to produce a global score (range 0 to 21).
Higher scores indicate worse sleep quality.
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Baseline, post-intervention (12-weeks)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
12 de junio de 2018
Finalización primaria (Actual)
1 de diciembre de 2019
Finalización del estudio (Actual)
1 de diciembre de 2019
Fechas de registro del estudio
Enviado por primera vez
19 de marzo de 2019
Primero enviado que cumplió con los criterios de control de calidad
26 de marzo de 2019
Publicado por primera vez (Actual)
28 de marzo de 2019
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
7 de enero de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
5 de enero de 2021
Última verificación
1 de enero de 2021
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- STUDY00007808
- FP00012624 (Otro número de subvención/financiamiento: Kripalu Center for Yoga and Health)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
No
Descripción del plan IPD
Consent forms indicate that data will not be shared with anyone other than those listed on the study team.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .