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The Effect After 12 Weeks of Having Received a Pedometer and a Pedometer Program on Physical Activity and Health

2010年2月19日 更新者:University of Southern Denmark

The Effect After 12 Weeks of Having Received a Pedometer and a Pedometer Program on Physical Activity, Health Measurements, Self-rated Health, Stress, and Sleep Quality: a Randomized Controlled Trial

Physical activity is associated with a reduced risk of several chronic diseases in addition to all-cause mortality. Hence for public health purposes, knowledge of effective interventions to increase the physical activity level in the population is important.

The objective of this randomized controlled trial was to examine the effect 12 weeks after having received a pedometer and a pedometer program on physical activity, health measurements, self-rated health, stress, and sleep quality.

A total of 223 men and 445 women were randomly assigned to either a pedometer group (n = 333) in which participants received a pedometer and pedometer program or a control group (n = 335). Of the participants included in the study 198 and 178 completed the health examination, and 192 and 187 completed the questionnaire at follow up in the pedometer group and in the control group, respectively.

調査の概要

状態

完了

条件

詳細な説明

The results from the KRAM Study are used as baseline for this intervention. In the KRAM study all adult citizens (18+ years) in 13 Danish municipalities were invited by letter to take part in an internet based questionnaire concerning socio-demography, life style, and other health aspects. Furthermore, a random sample of the citizens was invited to participate in a health examination. A total of 76.484 of the invited 538.497 citizens filled in the entire or partially the questionnaire and 18.065 of the invited 180.103 citizens completed the health examination. The examination included the following measurements: Blood pressure, height, weight, fat percentage, blood samples, pulmonary function, bone mineral density, muscle strength, balance test, and aerobic fitness.

Intervention The intervention was carried out in three of the 13 municipalities (Silkeborg, Frederiksberg, and Varde). Participants with a low aerobic fitness (defined for men and women in different age groups) or those who reported being sedentary or light physically active in leisure time were - after they had accomplished the health examination - invited to participate in the intervention. Participants were not included if they participated in other interventions initiated in relation with the KRAM Study or if they were pregnant. All participants gave informed consent. The protocol was approved by the Scientific Ethical Committee B for the Capital Region of Denmark (H-B-2008-097).

The participants were randomly assigned to either a pedometer group or a control group by drawing a sealed envelope with a unique randomizing number. The participants in the pedometer group received a pedometer (Yamax Digi-Walker SW-200), a book with a pedometer program, a handout with a summary of the pedometer program, and a calendar for registration of daily steps. The aim of the program is to guide people to use a pedometer and increase their steps with 20 % each week until they reach their goal. During the trial period, they were asked to reset the pedometer every morning and to wear it during the entire day. In the evening, they should take the pedometer off and register the total number of steps in the calendar. After three, six, and nine weeks, the participants in the pedometer group got a mail to encourage them to keep using the pedometer and follow the program. Participants assigned to the control group received a leaflet from the National Board of Health in Denmark recommending all adults to be physical active for 30 minutes each day of moderate intensity.

Follow up After 12 weeks, participants were invited by letter to answer a short questionnaire. Furthermore, they were invited to participate in a health examination including the measurements of blood pressure, weight, fat percentage, and aerobic fitness. The researchers who performed the examinations were blinded to group assignment.

研究の種類

介入

入学 (実際)

668

段階

  • フェーズ 3

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

      • Frederiksberg、デンマーク
        • The municipiality of Frederiksberg
      • Silkeborg、デンマーク
        • The municipiality of Silkeborg
      • Varde、デンマーク
        • The municipiality of Varde

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

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  • Low aerobic fitness (defined for men and women in different age groups)
  • Reported being sedentary or light physically active in leisure time

Exclusion Criteria:

  • Participated in other interventions initiated in relation with the KRAM Study
  • Were pregnant

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
介入なし:Control group
Participants assigned to the control group received a leaflet from the National Board of Health in Denmark recommending all adults to be physical active for 30 minutes each day of moderate intensity.
The participants were randomly assigned to either a pedometer group or a control group by drawing a sealed envelope with a unique randomizing number. The participants in the pedometer group received a pedometer (Yamax Digi-Walker SW-200), a book with a pedometer program(18), a handout with a summary of the pedometer program, and a calendar for registration of daily steps. During the trial period they were asked to reset the pedometer every morning and to wear it during the entire day. In the evening they should take the pedometer off and register the accumulated steps in the calendar. After three, six, and nine weeks, the participants in the pedometer group got a mail to encourage them to keep using the pedometer and follow the program.
他の名前:
  • 睡眠
  • 歩数計
  • ストレス
  • Randomized controlled trial
  • Pedometer program
  • Health
  • Self-rated health
実験的:Pedometer group
Received a pedometer (Yamax Digi-Walker SW-200), a book with a pedometer program, a handout with a summary of the pedometer program, and a calendar for registration of daily steps.
The participants were randomly assigned to either a pedometer group or a control group by drawing a sealed envelope with a unique randomizing number. The participants in the pedometer group received a pedometer (Yamax Digi-Walker SW-200), a book with a pedometer program(18), a handout with a summary of the pedometer program, and a calendar for registration of daily steps. During the trial period they were asked to reset the pedometer every morning and to wear it during the entire day. In the evening they should take the pedometer off and register the accumulated steps in the calendar. After three, six, and nine weeks, the participants in the pedometer group got a mail to encourage them to keep using the pedometer and follow the program.
他の名前:
  • 睡眠
  • 歩数計
  • ストレス
  • Randomized controlled trial
  • Pedometer program
  • Health
  • Self-rated health

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
Physical activity (walking time, sitting time, physical activity level in leisure time)
時間枠:12 weeks
12 weeks

二次結果の測定

結果測定
時間枠
Health measurements (blood pressure, weight, fat percentage, and aerobic fitness), self-rated health, stress, and sleep quality
時間枠:12 weeks
12 weeks

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。

捜査官

  • スタディディレクター:Morten Grønbæk, professor、National Institut of Public Health, University of Southern Denmark

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

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

2008年8月1日

一次修了 (実際)

2009年1月1日

研究の完了 (実際)

2009年1月1日

試験登録日

最初に提出

2010年2月18日

QC基準を満たした最初の提出物

2010年2月18日

最初の投稿 (見積もり)

2010年2月19日

学習記録の更新

投稿された最後の更新 (見積もり)

2010年2月22日

QC基準を満たした最後の更新が送信されました

2010年2月19日

最終確認日

2010年2月1日

詳しくは

本研究に関する用語

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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