- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT03893708
Investigating the Feasibility and Preliminary Effects of Yoga on Excessive Gestational Weight Gain
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
Arizona
-
Phoenix, Arizona, Verenigde Staten, 85004
- Arizona Biomedical Collaborative (ASU)
-
Phoenix, Arizona, Verenigde Staten, 85006
- Urban Wellness
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: 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.
|
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.
|
Actieve vergelijker: 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.
|
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Acceptability via satisfaction survey at post-intervention
Tijdsspanne: post-intervention (12-weeks)
|
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.
|
post-intervention (12-weeks)
|
Demand (attendance/adherence) of yoga intervention
Tijdsspanne: Weekly (during 12-week intervention)
|
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.
|
Weekly (during 12-week intervention)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Number of participants with excessive GWG (total GWG from baseline to delivery)
Tijdsspanne: Weekly (during 12-week intervention) and at delivery (up to 42 weeks gestation)
|
Weight gain exceeding IOM recommendations
|
Weekly (during 12-week intervention) and at delivery (up to 42 weeks gestation)
|
Mindfulness (mean change from baseline)
Tijdsspanne: Baseline, post-intervention (12-weeks)
|
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.
|
Baseline, post-intervention (12-weeks)
|
Self-awareness (mean change from baseline)
Tijdsspanne: Baseline, post-intervention (12-weeks)
|
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.
|
Baseline, post-intervention (12-weeks)
|
Emotion Regulation (mean change from baseline)
Tijdsspanne: Baseline, post-intervention (12-weeks)
|
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.
|
Baseline, post-intervention (12-weeks)
|
Sleep Quality (mean change from baseline)
Tijdsspanne: Baseline, post-intervention (12-weeks)
|
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.
|
Baseline, post-intervention (12-weeks)
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- STUDY00007808
- FP00012624 (Ander subsidie-/financieringsnummer: Kripalu Center for Yoga and Health)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Gewichtstoename
-
Incyte CorporationVerkrijgbaarSTAT1 Gain-of-Function-ziekte
-
University of SheffieldMid Yorkshire Hospitals NHS TrustIngetrokkenObesitas, Acceptance and Commitment Therapy, Weight Management ServiceVerenigd Koninkrijk
Klinische onderzoeken op Prenatal yoga
-
University of Texas at AustinVoltooid
-
The Bird and Be Co IncWervingOnvruchtbaarheid, man | Spermatogenese en spermastoornissenCanada
-
Adiyaman University Research HospitalVoltooidDepressie | Spanning | Ongerustheid | Psychologische veerkrachtKalkoen
-
NMP Medical Research InstituteYog-Kulam; Department of Zoology, University of Rajasthan, IndiaVoltooid
-
NMP Medical Research InstituteWarwick Research Services; Yog-KulamVoltooid
-
Northwestern UniversityVoltooid
-
University of MinnesotaVoltooid
-
Ohio State University Comprehensive Cancer CenterNational Cancer Institute (NCI)VoltooidDepressie | Pijn | Borstkanker | VermoeidheidVerenigde Staten
-
Emory UniversityNational Cancer Institute (NCI); National Institutes of Health (NIH)Actief, niet wervendProstaatcarcinoomVerenigde Staten
-
Manhattan Physical Medicine and Rehabilitation,...New York UniversityVoltooid