Effects of Primary Prevention in Elderly People-The Healthy Aging Initiative

NCT03312439 | Unknown

• 1 other identifier: VCC-LIFE-1
• Study Type: interventional
• Target: 10,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

The number of elderly will increase rapidly in Europe in the next 30 years, which affects the country's economic and social development, welfare, health care, and also the individuals. Future challenges include creating opportunities for people to maintain a high well-being in later stages of life, and coping with diseases and disability. Physical exercise and avoiding obesity have the potential to increase quality of life in the elderly by preventing CVD and stroke. The proposed project is a intervention study where the overarching aim is to evaluate whether a primary prevention with the focus of decreasing obesity and increasing objective measures of physical activity will decrease the future risk of the endpoints cardiovascular disease, stroke, diabetes, falls, fractures, dementia and death, in a population based cohort of 70-year-old women and men. Specific aims: In a population based cohort of 5000, 70-year old women and men;

1. 1.Investigate the association between risk factors assessed at baseline, with focus on objective measures of physical activity and body fat distribution, and the endpoints described above.
2. 2.To investigate whether individuals given the prevention will have a lower future risk of the endpoints described above than 70-year olds in general Swedish population, after adjustments for differences in the different covariates at baseline.

Conditions

Cardiovascular Diseases; Non-communicable Disease

Keywords

Myocardial infarction; Stroke; Diabetes; Depression; Dementia; Fractures

Outcome Measures

Primary Outcomes (1)

• Non-communicable disease assessed by the Swedish national patient register

  The primary outcome is non-communicable disease including cardiovascular disease, stroke, diabetes, dementia, depression, falls and fractures.

  5 years

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

Will be given advice as described above

Behavioral: Given advice

Control group

NO INTERVENTION

Consisting of subjects from the general Swedish population.

Interventions

Given advice BEHAVIORAL

Based on results of testing the participants will be give advice with the general aim to decrease the future risk of non-communicable disease by increasing physical activity,

Intervention group

Eligibility Criteria

• Age: 70 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Individuals living in Umeå municipal area.
• years of age

You may not qualify if:

• None

Sponsors & Collaborators

• Region Västerbotten: lead

MeSH Terms

Conditions

Cardiovascular Diseases; Noncommunicable Diseases; Myocardial Infarction; Stroke; Diabetes Mellitus; Depression; Dementia; Fractures, Bone

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Heart Diseases; Vascular Diseases; Infarction; Ischemia; Necrosis; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavioral Symptoms; Behavior; Neurocognitive Disorders; Mental Disorders; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Professor

Model Details: The intervention group are tested and given advice based on the results with the general aim to increase physical activity and reduce obesity. The risk of future non-communicable disease is compared to the general Swedish population of the same age. Different models will be used. The first model will include a control group consisting of all Swedish citizens of the same age, and the results will be adjusted for differences in baseline characteristics. In a second each participant in the intervention group will be matched against 3 controls (or more) from the general population based on propensity scores.

Study Record Dates

• First Submitted: October 12, 2017
• First Posted: October 17, 2017
• Study Start: June 1, 2012
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: October 18, 2017

Record last verified: 2017-10