Genetic Information as a Life Style Change Motivator

Study Overview
=================
Brief Summary
-----------------
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.

Detailed 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.

Official Title
-----------------
Effects of ApoE4 Genotype Information and Intervention Intensity on the Fulfillment of Lifestyle Changes and Sensory Preferences

Conditions
-----------------
Health Behavior, Alzheimer Disease, Protection Against

Intervention / Treatment
-----------------
* Behavioral: information on the risk gene status
* Behavioral: life style advise


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tervas<br>Follow up group from an earlier study. Information on risk gene status. All test persons were given information on healthy diet and life style. | Behavioral: information on the risk gene status<br>* information on risk gene status (APOE4 allele or not) was given before intervention<br>Behavioral: life style advise<br>* all test persons were given information on healthy diet and life style<br>|
| Experimental: Informed<br>Information on risk gene status was given before intervention. All test persons were given information on healthy diet and life style. | Behavioral: information on the risk gene status<br>* information on risk gene status (APOE4 allele or not) was given before intervention<br>Behavioral: life style advise<br>* all test persons were given information on healthy diet and life style<br>|
| Active Comparator: non informed<br>Information on risk gene status was not given before intervention. All test persons were given information on healthy diet and life style. | Behavioral: life style advise<br>* all test persons were given information on healthy diet and life style<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with good quality of dietary fat | A questionnaire according to Finnish guidelines of Suomen Sydänliitto ry, Helldán & Helakorpi, (2015) | 2 years | 
| Dietary habits, number of participants | A questionnaire asking for Fish intake at least twice per week Consumption of high fat and sugar foods Consumption of vegetables Alcohol consumption Physical activity at least twice per week | 2 years | 
| Food choice questionnaire, health and taste attitude | Scale 1-7 (7 most important, fully agree) | 2 years | 
| Food involvement and Food mavenism, scale 1-5 | 5 fully agree | 2 years | 
| Health concern, scale 1-9 | 1 not concerned at all | 2 years | 
| Life-orientation test, scale 1-5 | 1 fully agree | 2 years | 
| Locus of Control, state-trait anxiety inventory, Three-Factor Eating Questionnaire (TFEQ) scale 1-4 | 4 fully agree | 2 years | 
| weight kg |  | 2 years | 
| height m |  | 2 years | 
| Waist circumference, cm |  | 2 years | 
| Visceral fat level (1-30) |  | 2 years | 
| blood pressure, mmHg |  | 2 years | 
| Serum lipid levels mmol/L |  | 2 years | 
| Blood glucose levels, mmol/L |  | 2 years | 
| Serum lipid peroxidation, MDA/µM |  | 2 years | 
| Serum Sensitive C reactive protein, mg/L |  | 2 years | 
| Serum Hemoglobin, g/L |  | 2 years | 
| Serum Alkaline phosphatase, U/L |  | 2 years | 
| Serum Alanine aminotransferase, U/L |  | 2 years | 
| Serum haptoglobin, g/L |  | 2 years | 
| Plasma thyrotropin, mU/L |  | 2 years | 
| serum APOE protein, mg/L |  | 2 years | 
| serum brain-derived neurotrophic factor, ng/ml |  | 2 years | 
| serum Fatty acids, g/100g fatty acids |  | 2 years | 
| serum Carotenoids, retinol and α-tocopherol, Plasma total phenolics ng/µl |  | 2 years | 
| Blood cell count |  | 2 years | 
| APOE and BDNF genotype |  | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body mass index | weight and height will be combined to report BMI in kg/m^2 | 2 years |