Live Your Life Without Diabetes

NCT03663803 | Completed

• 1 other identifier: 2018-02-3065
• Study Type: interventional
• Target: 127
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pre Diabetes

Outcome Measures

Primary Outcomes (5)

• weight

  change in weight / the proportion with weight reduction \>5% of baseline weight at one-year

  baseline to one-year follow-up

• 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

  change from baseline to one-year follow-up

• 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

  change from baseline to one-year follow-up

• 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

  change from baseline to one-year follow-up

• changes in physical activity.

  Physical activity was measured using the International Physical Activity Questionnaire (IPAQ). Increased MET (min/week)=increased physical activity

  change from baseline to one-year follow-up

Secondary Outcomes (6)

• patient activation

  change from baseline to one-year follow-up

• waist circumference

  change from baseline to one-year follow-up

• total energy intake

  change from baseline to one-year follow-up

• blood pressure, systolic and diastolic

  change from baseline to one-year follow-up

• HbA1c

  change from baseline to one-year follow-up

Study Arms (2)

Intervention

EXPERIMENTAL

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)

Control

NO INTERVENTION

Usual practice

Interventions

Brief theory-based health promotion intervention (group-based) BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• none

Sponsors & Collaborators

• University of Aarhus: lead

MeSH Terms

Conditions

Glucose Intolerance

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2018
• First Posted: September 10, 2018
• Study Start: January 19, 2011
• Primary Completion: January 9, 2013
• Study Completion: January 9, 2013
• Last Updated: September 10, 2018

Record last verified: 2018-08