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Effect of Exercise on Perinatal Depression

2021年1月12日 更新者:University of Minnesota

Exercise Intervention for Preventing Perinatal Depression

Fifteen percent of women experience depression during pregnancy or postpartum (i.e., perinatal depression). Furthermore, 38% of low income women experience postpartum depression. Given few women with perinatal depression seek treatment, there is a need for innovative, low cost interventions that can be integrated within existing community-based programs serving women in need (e.g., low income women). The primary aim of this study is to examine the efficacy of a novel exercise intervention designed to prevent perinatal depression among women attending federally qualified health centers serving high risk women.

調査の概要

状態

完了

介入・治療

詳細な説明

Approximately 15% of women experience perinatal depression (depression during pregnancy or postpartum). Furthermore, 38% of low income women experience postpartum depression (Gree-Smith et al., 2012). Perinatal depression is associated with numerous maternal (e.g., weight retention), infant (e.g., poor infant-child bond), and lifespan (e.g., behavior problems) consequences (Barker et al., 2011, Herring et al., 2008, Hipwell et al., 2000). Psychosocial interventions are efficacious for perinatal depression; however, only 10% of women seek treatment (Oppo et al., 2009). There is a need for innovative, low cost interventions that can be integrated within existing community-based programs serving women in need (e.g., low income women). Preliminary evidence indicates that exercise may be a novel, efficacious intervention. The primary aim of this study is to examine the efficacy of a novel exercise intervention designed to prevent perinatal depression among women attending federally qualified health centers serving high risk women. Possible effects on gestational weight gain and retention will also be explored. This study will build upon the study team's previous work by recruiting low income women and integrating the intervention with community-based clinics. Participants (n=200) who are low income and pregnant (less than 20 weeks) will be randomly assigned to either a telephone-based intervention that has been previously shown to increase exercise among perinatal women (Lewis et al., 2011) or usual care.

With regard to the primary aim, the investigators predict that participants randomized to the exercise intervention will report fewer depressive symptoms (as measured by Edinburgh Postnatal Depression Scale) at 36 weeks gestation and three months postpartum than women in the usual care condition. The secondary aim is to examine the efficacy of an exercise intervention on moderating prenatal weight gain and facilitating postpartum weight loss. The investigators will also examine several potential mediators (e.g., depression coping, self-efficacy, perceived stress, sleep, fatigue) and the effect of the exercise intervention on maternal (e.g., hypertension, gestational diabetes, mode of delivery) and infant outcomes (e.g., birth weight, gestational age at delivery, breastfeeding, safe sleep).

研究の種類

介入

入学 (実際)

111

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

    • Minnesota
      • Minneapolis、Minnesota、アメリカ、55455
        • Beth Lewis

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年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

女性

説明

Inclusion Criteria:

  • less than 20 weeks pregnant
  • must speak English or Spanish
  • willing to be randomly assigned to either of the two study arms
  • healthcare provider consent
  • access to a telephone (92% of low income women have access to a telephone and Minnesota offers free phone access for low income individuals; Fasts, 2015)
  • being at risk for depression (defined as having a history of depression) but are not currently depressed.
  • consistent with prior research, history of depression will be defined as ever being told by a healthcare provider that she has depression and/or being prescribed an antidepressant for depression.

Exclusion Criteria:

  • less than 18 years of age
  • currently exercising 60 or more minutes per week
  • unable to exercise for 20 minutes continuously
  • history of heart disease, lung disease, anemia, musculoskeletal problems (e.g., arthritis, gout, osteoporosis, or back, hip or knee pain that may interfere with exercising), poorly controlled hypertension, seizure disorder, exercise induced asthma, or any other medical condition that would make exercise unsafe
  • taking medication that interferes with heart rate responses to exercise such as beta blockers; participating in another exercise or weight management study
  • another member of the household participating in the study
  • currently receiving antidepressant medication or psychotherapy for depression; - hospitalization for a psychiatric disorder during previous six months
  • pregnant with multiple fetuses.
  • participants depressed at the baseline assessment will be referred to their healthcare provider.
  • there will have a safety protocol in place for worsening symptoms of depression and suicidal ideation

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:独身

武器と介入

参加者グループ / アーム
介入・治療
実験的:Exercise
The intervention will last 8-10 months depending on when during pregnancy the participant is randomized. The intervention will consist of three components (i.e., telephone, print materials, and exercise log/goal setting) designed to increase exercise. Social Cognitive Theory (SCT) and Self-Determination Theory will guide the exercise intervention. The counseling sessions will be a collaboration between the counselor and participants on how to best integrate exercise into the participant's daily routine. Participants will receive 15 intervention phone calls lasting approximately 15-20 minutes each. There will be a one-month intensive phase (weekly contacts), followed by bi-weekly contacts for two months, and then monthly until delivery. Beginning at 6 weeks postpartum, bi-weekly contacts will resume through 3 months postpartum.
See description above.
介入なし:Usual Care
Participants in the usual care condition will follow their usual standard of care as suggested by their healthcare provider. Participants will complete the same assessments and incentives as the active interventions but will not receive the exercise counseling sessions. Following completion of the nine-month follow-up, the usual care arm can choose to receive a six-month version of the exercise intervention.

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
時間枠
Edinburgh Postnatal Depression Scale
時間枠:Change from baseline to 3 months postpartum
Change from baseline to 3 months postpartum

二次結果の測定

結果測定
時間枠
Postpartum Weight Retention
時間枠:Change from baseline to 3 months postpartum
Change from baseline to 3 months postpartum

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。

スポンサー

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)

2017年2月23日

一次修了 (実際)

2020年6月15日

研究の完了 (実際)

2020年6月15日

試験登録日

最初に提出

2016年5月27日

QC基準を満たした最初の提出物

2016年6月1日

最初の投稿 (見積もり)

2016年6月7日

学習記録の更新

投稿された最後の更新 (実際)

2021年1月13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12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

キーワード

その他の研究ID番号

  • R40MC29454

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