Genetic Information as a Life Style Change Motivator (APOE4MOT)

Natural Resources Institute Finland

Status: Completed

Conditions: Alzheimer Disease, Protection Against; Health Behavior

Treatments: Behavioral: information on the risk gene status; Behavioral: life style advise

Study type: Interventional

Funder types: Other

Identifiers

NCT03794141

41007-00040400

Details and patient eligibility

About

The study investigates whether information on having a risk genotype (ApoE4) and life style advisory information affects lifestyle changes and sensory preferences. The project studies also the ethic aspects of giving the information of risk genotype.

Full description

We will run intervention based on our earlier pilot study. It includes intensive intervention and a modification of our earlier pilot intervention. Our intervention methods are general lectures of the effects of healthy diet (Finnish Nutrition Recommendations 2014) and healthy lifestyle for all participants. Effects on motivation, attitudes and preferences will be studied and verified by questionnaires and risk factors of cardiovascular disease and Alzheimer disease by analyzing clinical markers of lipid metabolism, general phenotype markers and profiles of nutritional markers. Nutritional biomarkers will verify also the self-reported changes of diet in the questionnaires and in digital food diaries.

Enrollment: 333 patients

Sex: All

Ages: 40 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age between 40 and 60 years
• overall good health (no chronic conditions e.g. mental disorders, cancer, liver or kidney disease, current or previous diagnosis),
• body mass index (BMI) under 35 kg/m2,
• blood pressure under 140/90 mmHg (medication allowed),
• serum total cholesterol under 7.25 mmol/l (medication allowed)
• fasting plasma glucose level under 7 mmol/l.

Exclusion criteria

• Abnormal values of the alanine amino transferase, alkaline phosphatase, haptoglobin and thyroid stimulating hormone

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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333 participants in 3 patient groups

Tervas

Experimental group

Description:

Follow up group from an earlier study. Information on risk gene status. All test persons were given information on healthy diet and life style.

Treatment:

Behavioral: information on the risk gene status

Behavioral: life style advise

Informed

Experimental group

Description:

Information on risk gene status was given before intervention. All test persons were given information on healthy diet and life style.

Treatment:

Behavioral: information on the risk gene status

Behavioral: life style advise

non informed

Active Comparator group

Description:

Information on risk gene status was not given before intervention. All test persons were given information on healthy diet and life style.

Treatment:

Behavioral: life style advise