このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

PathMate2: The Impact of Health Information System Services on the Effects of Therapy in Overweight Teenagers (PM2)

2020年1月5日 更新者:Dagmar l'Allemand、Ostschweizer Kinderspital
Randomised controlled trial in overweight adolescents using a health App.

調査の概要

詳細な説明

Problem In Switzerland, 20% of children are overweight and novel methods are urgently needed to control the epidemic. Foundations of chronic diseases develop during childhood and track into adulthood obesity in more than 75% of patients, contributing to a significant increase in public health costs.

Multi-professional programs combining physical activity, nutritional and behavioral components have positive effects on therapy outcomes and co-morbidities, but these interventions induce high costs and are time-consuming for health providers, patients and families, in particular those living in rural regions. In fact, less than 0.2% of overweight children can participate in these programs. Thus, health information systems (HIS) have not only the potential to improve outcomes of obesity therapy but also to reduce health costs and increase access to health care in remote regions. Most HIS have indeed not been evaluated in this regard.

Preparation work In the PathMate project (SNF grant #135552), a mobile HIS has been developed for teenagers to support therapy and to prevent obesity in accordance with state-of-the-art multiprofessional programs and, in contrast to commercially available IT applications, with a high standard of data protection and safety. The IS effects of this HIS have been successfully evaluated in first longitudinal studies. In parallel, the impact of multi-professional therapies in Swiss children as well as potential confounders have been established in several longitudinal cohort studies with up to two-years follow-up.

Objectives

The overall goal of PathMate2 is to assess the impact of HIS services on the degree of obesity measured by the body mass index (BMI) incl. other health outcomes. Individual and shared understanding between patients and therapists are assessed as mediating factors. Specific goals are:

  1. to assess the effects of a child-friendly IT-mediated low-threshold intervention under the supervision of primary care providers and obesity experts, compared to expensive on-site consultations in highly specialized pediatric obesity centers
  2. to automatically capture and process obesity-related biosignals by smart sensors and use results for immediate feedback for the patients and medical providers based on permissions and communication patterns and
  3. to design evidence-based selfregulation interventions for teenager in their everyday life by coupling Neuro Information Systems (NeuroIS) services with Smart Health Sensors (SHS).

Methods HIS services are collaboratively developed by design-science research and evaluated by medical experts, patients, IS researcher and computer scientists. First, HIS services from PathMate are enhanced with SHS enabling real-time data analytics on mobile devices and results can be seen by both therapists and patients. Second, a randomized controlled trial (RCT) is conducted by a physician in a specialized pediatric obesity center in St. Gall with the goal to evaluate the effects of the re-designed and improved HIS services on adherence to therapy of the patient and his parents as well as on BMI and other health outcomes; a second RCT is conducted in parallel to assess the effects of these services in a community setting in the French-speaking part of Switzerland.

Importance and impact Building on the preliminary results of the PathMate project it is expected that the improved HIS services that are going to be designed and evaluated in PathMate2 have the potential for a significant impact on individual health and the quality of healthcare systems in general.

研究の種類

介入

入学 (実際)

40

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

    • Saint Gallen
      • St. Gallen、Saint Gallen、スイス、9006
        • Ostschweizer Kinderspital

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

11年~18年 (子、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

全て

説明

Inclusion Criteria:

  • obesity, BMI > P. 97 (Jenni et al., 2011) or overweight, BMI >P.90, plus risk factors or co-morbidity
  • ability and parent's permission to use pre-configured study smartphones handed out to the children
  • readiness to use the personal smartphone number and to spend the sum allocated exclusively for the study SMS during the 6 months of intervention

Exclusion Criteria:

  • major somatic or psychiatric disease without adequate treatment,
  • weight-relevant medication (antiepileptic drugs, methylphenhydate and similar medication),
  • inability or lack of parent's or caregivers' permission to use a study smartphone with a mobile phone contract,
  • lack of informed consent from children and parents and
  • undue consumption of the amount allocated for study SMS for non-study purposes,
  • overuse of smartphone e.g. without night beak for at least 8 hours.

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:処理
  • 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
アクティブコンパレータ:Intervention SG
Therapy during 6 months with PathMate2 design. 6 therapy visits + PathMate2 over 6 months
To improve self-regulation of overweight adolescents and subsequently their weight status, we tested, whether a biofeedback relaxation exercise decreases stress and whether relaxation services as well as sensor data integration implemented in a novel Smartphone App supported intervention have effects on stress, physical activity and weight outcomes. During the intensive phase of 6 months, patients of the intervention group (IG) are equipped with a smartphone and a specially designed chat App with game character, which encourages them through a virtual coach to achieve daily activity, healty lifestyle or relaxation challenges and earn virtual rewards, to increase adherance to the health information system.
他の名前:
  • Mobile-coach obesity intervention in adolescents
介入なし:Control SG
Therapy during 6 months with usual care. 10 therapy visits over 6 months
アクティブコンパレータ:Intervention VD
Adapted sport session 1h/week + PathMate-S during 6 months
Overweight or obese adolescents of the treatment as-usual group (CG) have monthly visits on site during the intensive phase. Counseling for physical activity, healthy eating and lifestyle as well as psychosocial wellbeing is provided by a pediatrician.
他の名前:
  • コントロール
介入なし:Control VD
Adapted sport session 1h/week during 6 months

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
Body Mass Index
時間枠:12 months
Main outcome parameter is Body Mass Index, as BMI-SDS adjusted for gender & age. Group size of 4*20 was based on an expected decrease by -0.23±0.02 (SDS, Mean±SD) after 1 year, from initially 2.88±0.7.
12 months

二次結果の測定

結果測定
メジャーの説明
時間枠
fitness / physical capability
時間枠:12 months
Eurofit-test
12 months
fitness / physical activity
時間枠:12 months
accelerometry
12 months
stress reduction, biological measure
時間枠:12 months
Cortisol levels in blood
12 months
stress and arousal
時間枠:12 months
Self-Assessment Manikin (SAM) Scale
12 months
reduction of chronic stress
時間枠:12 months
Trierer Stress Inventar questionnaire (TICS)
12 months
stress and arousal, biophysical measure
時間枠:12 months
skin conductance (Nexus 10)
12 months
well-being
時間枠:12 months
KIDSCREEN
12 months
waist circumference
時間枠:12 months
Waist-to-Height-ratio or SDS according to Fredricks 2005
12 months

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

捜査官

  • 主任研究者:Dagmar lAllemand, Prof. MD、Ostschweizer Kinderspital, St. Gallen, Switzerland

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 (実際)

2017年1月30日

一次修了 (実際)

2018年12月31日

研究の完了 (実際)

2018年12月31日

試験登録日

最初に提出

2017年7月26日

QC基準を満たした最初の提出物

2017年8月30日

最初の投稿 (実際)

2017年9月1日

学習記録の更新

投稿された最後の更新 (実際)

2020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

2020年1月5日

最終確認日

2020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

  • 2016-01965

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

医薬品およびデバイス情報、研究文書

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

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。

購読する