Live Your Life Without Diabetes
2018年9月6日 更新者：University of Aarhus
Effectiveness of a Brief Theory-based Health Promotion Intervention Among Adults at High Risk of Type 2 Diabetes: One-year Results From a Randomised Trial in a Community Setting
Aim: To examine the effect of a brief theory-based health promotion intervention delivered in the community on health behaviour and diabetes-related risk factors among Danish adults at high risk of diabetes.
Methods: A randomised trial was conducted among 127 individuals aged 28 to 70 with fasting plasma glucose: 6.1-6.9 mmol/l and/or HbA1c : 6.0-<6.5% (42- < 48 mmol/mol) recruited from general practice in Holstebro, Denmark. Participants were randomised to a control group or to receive the intervention delivered over four 2 h group sessions during five weeks, and two further sessions after one and six months. Questionnaire data and clinical measures were collected at baseline, three months and one year after intervention.
調査の概要
研究の種類
介入
入学 (実際)
127
段階
- 適用できない
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～70年 (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:
- resident in the Municipality of Holstebro
- aged <70 years
- a measurement of fasting plasma glucose: 6.1-6.9 mmol/l (the thresholds for Impaired Fasting Glucose according to clinical guidelines) and/or HbA1c : 6.0-<6.5% (42- <48 mmol/mol) within the previous six months.
Exclusion Criteria:
- none
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 |
|---|---|
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実験的：Intervention
Participants in the intervention group received the offer of four 2h group sessions during five weeks, and two further sessions after one and six months.
The attendance rates of the sessions were 95%, 88%, 87%, 73%, 67% and 51%, respectively.
The course was delivered by health care staff in the Holstebro Health Care Centre, including a dietitian and an occupational therapist, both with health pedagogic competences.
It was delivered to seven intervention groups, which varied in size from 5 to 15 participants.
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The intervention is depicted using a PaT Plot in the published paper: Juul, L et al.
Effectiveness of a brief theory-based health promotion intervention among adults at high risk of type 2 diabetes: One-year results from a randomised trial in a community setting.
Primary Care Diabetes 1 0 ( 2 0 1 6 ) 111-120.
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介入なし：Control
Usual practice
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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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weight
時間枠：baseline to one-year follow-up
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change in weight / the proportion with weight reduction >5% of baseline weight at one-year
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baseline to one-year follow-up
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total-fat intake <30% of energy intake
時間枠：change from baseline to one-year follow-up
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Information on diet was obtained using a validated self-administrated 198-item food frequency questionnaire (FFQ), the Inter99 FFQ.
Portion size was set according to gender.
Daily nutrient intake was translated into energy intake and nutrient intake using the Danish Food Com- position Databank (version 7.01) and the software program FoodCalc version 1.3
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change from baseline to one-year follow-up
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saturated-fat intake <10% of energy intake
時間枠：change from baseline to one-year follow-up
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Information on diet was obtained using a validated self-administrated 198-item food frequency questionnaire (FFQ), the Inter99 FFQ.
Portion size was set according to gender.
Daily nutrient intake was translated into energy intake and nutrient intake using the Danish Food Com- position Databank (version 7.01) and the software program FoodCalc version 1.3
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change from baseline to one-year follow-up
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fibre-intake ≥15g/1000kcal changes in physical activity level.
時間枠：change from baseline to one-year follow-up
|
Information on diet was obtained using a validated self-administrated 198-item food frequency questionnaire (FFQ), the Inter99 FFQ.
Portion size was set according to gender.
Daily nutrient intake was translated into energy intake and nutrient intake using the Danish Food Com- position Databank (version 7.01) and the software program FoodCalc version 1.3
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change from baseline to one-year follow-up
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changes in physical activity.
時間枠：change from baseline to one-year follow-up
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Physical activity was measured using the International Physical Activity Questionnaire (IPAQ).
Increased MET (min/week)=increased physical activity
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change from baseline to one-year follow-up
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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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patient activation
時間枠：change from baseline to one-year follow-up
|
patient activation was measured using the Patient Activation Measure (PAM)
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change from baseline to one-year follow-up
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waist circumference
時間枠：change from baseline to one-year follow-up
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Waist circumference was recorded as the average of two measurements of waist circumference using a tape measure halfway between the lowest point of the rib cage and the anterior supe- rior iliac crests when standing.
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change from baseline to one-year follow-up
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total energy intake
時間枠：change from baseline to one-year follow-up
|
Information on diet was obtained using a validated self-administrated 198-item food frequency questionnaire (FFQ), the Inter99 FFQ.
Portion size was set according to gender.
Daily nutrient intake was translated into energy intake and nutrient intake using the Danish Food Com- position Databank (version 7.01) and the software program FoodCalc version 1.3
|
change from baseline to one-year follow-up
|
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blood pressure, systolic and diastolic
時間枠：change from baseline to one-year follow-up
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Systolic and diastolic blood pressure was calculated as the mean of three measurements performed after at least 10 min rest, while participants were seated with the cuff on the right arm at the level of the heart.
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change from baseline to one-year follow-up
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HbA1c
時間枠：change from baseline to one-year follow-up
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Blood tests were analysed in a central laboratory.
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change from baseline to one-year follow-up
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cholesterol
時間枠：change from baseline to one-year follow-up
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Total, LDL, HDL, Blood tests were analysed in a central laboratory.
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change from baseline to one-year follow-up
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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。
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)
2011年1月19日
一次修了 (実際)
2013年1月9日
研究の完了 (実際)
2013年1月9日
試験登録日
最初に提出
2018年8月29日
QC基準を満たした最初の提出物
2018年9月6日
最初の投稿 (実際)
2018年9月10日
学習記録の更新
投稿された最後の更新 (実際)
2018年9月10日
QC基準を満たした最後の更新が送信されました
2018年9月6日
最終確認日
2018年8月1日
詳しくは
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