Investigating the Feasibility and Preliminary Effects of Yoga on Excessive Gestational Weight Gain
2021년 1월 5일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (실제)
49
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Arizona
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Phoenix, Arizona, 미국, 85004
- Arizona Biomedical Collaborative (ASU)
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Phoenix, Arizona, 미국, 85006
- Urban Wellness
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
여성
설명
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)
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Acceptability via satisfaction survey at post-intervention
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Number of participants with excessive GWG (total GWG from baseline to delivery)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2018년 6월 12일
기본 완료 (실제)
2019년 12월 1일
연구 완료 (실제)
2019년 12월 1일
연구 등록 날짜
최초 제출
2019년 3월 19일
QC 기준을 충족하는 최초 제출
2019년 3월 26일
처음 게시됨 (실제)
2019년 3월 28일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 1월 7일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 1월 5일
마지막으로 확인됨
2021년 1월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- STUDY00007808
- FP00012624 (기타 보조금/기금 번호: Kripalu Center for Yoga and Health)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니
IPD 계획 설명
Consent forms indicate that data will not be shared with anyone other than those listed on the study team.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .