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Live Your Life Without Diabetes

Primary Purpose

Pre Diabetes

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Brief theory-based health promotion intervention (group-based)
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pre Diabetes

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention

    Control

    Arm Description

    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.

    Usual practice

    Outcomes

    Primary Outcome Measures

    weight
    change in weight / the proportion with weight reduction >5% of baseline weight at one-year
    total-fat intake <30% of energy intake
    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
    saturated-fat intake <10% of energy intake
    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
    fibre-intake ≥15g/1000kcal changes in physical activity level.
    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
    changes in physical activity.
    Physical activity was measured using the International Physical Activity Questionnaire (IPAQ). Increased MET (min/week)=increased physical activity

    Secondary Outcome Measures

    patient activation
    patient activation was measured using the Patient Activation Measure (PAM)
    waist circumference
    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.
    total energy intake
    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
    blood pressure, systolic and diastolic
    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.
    HbA1c
    Blood tests were analysed in a central laboratory.
    cholesterol
    Total, LDL, HDL, Blood tests were analysed in a central laboratory.

    Full Information

    First Posted
    August 29, 2018
    Last Updated
    September 6, 2018
    Sponsor
    University of Aarhus
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03663803
    Brief Title
    Live Your Life Without Diabetes
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 19, 2011 (Actual)
    Primary Completion Date
    January 9, 2013 (Actual)
    Study Completion Date
    January 9, 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Aarhus

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pre Diabetes

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    127 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Usual practice
    Intervention Type
    Behavioral
    Intervention Name(s)
    Brief theory-based health promotion intervention (group-based)
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    weight
    Description
    change in weight / the proportion with weight reduction >5% of baseline weight at one-year
    Time Frame
    baseline to one-year follow-up
    Title
    total-fat intake <30% of energy intake
    Description
    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
    Time Frame
    change from baseline to one-year follow-up
    Title
    saturated-fat intake <10% of energy intake
    Description
    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
    Time Frame
    change from baseline to one-year follow-up
    Title
    fibre-intake ≥15g/1000kcal changes in physical activity level.
    Description
    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
    Time Frame
    change from baseline to one-year follow-up
    Title
    changes in physical activity.
    Description
    Physical activity was measured using the International Physical Activity Questionnaire (IPAQ). Increased MET (min/week)=increased physical activity
    Time Frame
    change from baseline to one-year follow-up
    Secondary Outcome Measure Information:
    Title
    patient activation
    Description
    patient activation was measured using the Patient Activation Measure (PAM)
    Time Frame
    change from baseline to one-year follow-up
    Title
    waist circumference
    Description
    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.
    Time Frame
    change from baseline to one-year follow-up
    Title
    total energy intake
    Description
    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
    Time Frame
    change from baseline to one-year follow-up
    Title
    blood pressure, systolic and diastolic
    Description
    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.
    Time Frame
    change from baseline to one-year follow-up
    Title
    HbA1c
    Description
    Blood tests were analysed in a central laboratory.
    Time Frame
    change from baseline to one-year follow-up
    Title
    cholesterol
    Description
    Total, LDL, HDL, Blood tests were analysed in a central laboratory.
    Time Frame
    change from baseline to one-year follow-up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

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    Live Your Life Without Diabetes

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