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Live Your Life Without Diabetes

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ClinicalTrials.gov Identifier: NCT03663803
Recruitment Status : Completed
First Posted : September 10, 2018
Last Update Posted : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

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.


Condition or disease Intervention/treatment Phase
Pre Diabetes Behavioral: Brief theory-based health promotion intervention (group-based) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 127 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : January 19, 2011
Actual Primary Completion Date : January 9, 2013
Actual Study Completion Date : January 9, 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Behavioral: Brief theory-based health promotion intervention (group-based)
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.

No Intervention: Control
Usual practice



Primary Outcome Measures :
  1. weight [ Time Frame: baseline to one-year follow-up ]
    change in weight / the proportion with weight reduction >5% of baseline weight at one-year

  2. total-fat intake <30% of energy intake [ Time Frame: 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

  3. saturated-fat intake <10% of energy intake [ Time Frame: 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

  4. fibre-intake ≥15g/1000kcal changes in physical activity level. [ Time Frame: 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

  5. changes in physical activity. [ Time Frame: change from baseline to one-year follow-up ]
    Physical activity was measured using the International Physical Activity Questionnaire (IPAQ). Increased MET (min/week)=increased physical activity


Secondary Outcome Measures :
  1. patient activation [ Time Frame: change from baseline to one-year follow-up ]
    patient activation was measured using the Patient Activation Measure (PAM)

  2. waist circumference [ Time Frame: change from baseline to one-year follow-up ]
    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.

  3. total energy intake [ Time Frame: 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

  4. blood pressure, systolic and diastolic [ Time Frame: change from baseline to one-year follow-up ]
    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.

  5. HbA1c [ Time Frame: change from baseline to one-year follow-up ]
    Blood tests were analysed in a central laboratory.

  6. cholesterol [ Time Frame: change from baseline to one-year follow-up ]
    Total, LDL, HDL, Blood tests were analysed in a central laboratory.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03663803    
Other Study ID Numbers: 2018-02-3065
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Prediabetic State
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases