Efficacy of health promotion interventions in adults with lifestyle and health risk factors for dementia

Not Applicable

Completed

• Conditions: Risk of Alzheimer's disease and dementia; Unhealthy lifestyle; Cognitive decline; Cardiovascular disease risk; Neurological - Alzheimer's disease; Public Health - Health promotion/education; Neurological - Dementias

• Registration Number: ACTRN12616000868482
• Lead Sponsor: Professor Kaarin J Anstey

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-07-04
• Study Completion: 2019-01-15
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

Inclusion criteria are those used by the General Practice for referring patients to the Practice's Lifestyle Management Program which it offers for free. Adults who are overweight or obese (BMI (kg/m2)>= 25 and <=35), with a chronic health condition (such as high blood pressure, heart disease, type 2 diabetes or 'pre-diabetes', osteoporosis, osteoarthritis, PCOS, kidney or liver disease, depression/anxiety) and who live in the ACT and surrounding areas. In addition for our project, all participants will be required to have internet access at home, and agree to participate in the baseline and four follow-up assessments.

Note: The LMP program involves a baseline and followup assessment when offered (i.e. not as a research condition) and patients are evaluted on outcomes in usual care, so the assessments for this trial were designed to coincide with usual care as far as possible.

Exclusion Criteria

Presence of life-threatening medical conditions and psychiatric conditions that would prevent participation in the trial, sensory deficits or mobility limitations that would prevent or substantially restrict the delivery of the assessment or intervention, poor English language skills, cognitive impairment defined as MMSE <24.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The Primary Outcome measure is the score on the ANU-ADRI. The ANU-ADRI is comprised of validated scales assessing 15 individual risk and protective factors for Alzhiemer's disease and dementia.<br>[ANU-ADRI assessments will be assessed at baseline, immediately after the intervention for LMP and BBL groups, and 13 weeks for the Active control. The Active control assessment is aligned with the BBL time-point for followup at 13 weeks immediately post intervention. The LMP and BBL interventions are of different lengths (6 and 12 weeks). We have decided that it is more important to capture change immediately post intervention for all groups, than to align the time point for the first follow-up. (It is not possible for us to do both). This is a constraint of conducting a trial in a real-life setting and comparing BBL-GP to an existing program. Follow-ups will also occur for all 3 groups at 18, 36 and 62 weeks after commencement of the intervention.]