Live Your Life Without Diabetes

University of Aarhus

Status: Completed

Conditions: Pre Diabetes

Treatments: Behavioral: Brief theory-based health promotion intervention (group-based)

Study type: Interventional

Funder types: Other

Identifiers

NCT03663803

2018-02-3065

Details and patient eligibility

About

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.

Enrollment: 127 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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127 participants in 2 patient groups

Intervention

Experimental group

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.

Treatment:

Behavioral: Brief theory-based health promotion intervention (group-based)

Control

No Intervention group

Description:

Usual practice