Investigating the Feasibility and Preliminary Effects of Yoga on Excessive Gestational Weight Gain
2021年1月5日 更新者：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.
調査の概要
研究の種類
介入
入学 (実際)
49
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Arizona
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Phoenix、Arizona、アメリカ、85004
- Arizona Biomedical Collaborative (ASU)
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Phoenix、Arizona、アメリカ、85006
- Urban Wellness
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～46年 (大人)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
女性
説明
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)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Acceptability via satisfaction survey at post-intervention
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Number of participants with excessive GWG (total GWG from baseline to delivery)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2018年6月12日
一次修了 (実際)
2019年12月1日
研究の完了 (実際)
2019年12月1日
試験登録日
最初に提出
2019年3月19日
QC基準を満たした最初の提出物
2019年3月26日
最初の投稿 (実際)
2019年3月28日
学習記録の更新
投稿された最後の更新 (実際)
2021年1月7日
QC基準を満たした最後の更新が送信されました
2021年1月5日
最終確認日
2021年1月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- STUDY00007808
- FP00012624 (その他の助成金/資金番号：Kripalu Center for Yoga and Health)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
Consent forms indicate that data will not be shared with anyone other than those listed on the study team.
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米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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