Live Your Life Without Diabetes
2018년 9월 6일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (실제)
127
단계
- 해당 없음
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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간섭 없음: Control
Usual practice
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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weight
기간: 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
기간: 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
기간: 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.
기간: 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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changes in physical activity.
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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patient activation
기간: change from baseline to one-year follow-up
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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
기간: 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
기간: 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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blood pressure, systolic and diastolic
기간: 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
기간: 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
기간: 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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여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2011년 1월 19일
기본 완료 (실제)
2013년 1월 9일
연구 완료 (실제)
2013년 1월 9일
연구 등록 날짜
최초 제출
2018년 8월 29일
QC 기준을 충족하는 최초 제출
2018년 9월 6일
처음 게시됨 (실제)
2018년 9월 10일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 9월 10일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 9월 6일
마지막으로 확인됨
2018년 8월 1일
추가 정보
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