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Table 1 Components of the intervention program (intervention group A)

From: – study protocol of a pragmatic multi-center cluster-randomized controlled prevention trial against cognitive decline in older primary care patients

Intervention Component Description
Nutritional counseling - Based on the guidelines of the German Nutrition Society [33] including recommendations e.g. on intake of cereal products, fruit and vegetables, fish, sugar, salt, and of fluid.
- Anthropometric measurements (height, weight, BMI)
Physical activity enhancement - Combined training program including (i) muscle-strengthening activity, (ii) flexibility activity/balance exercise, on 2 days/week, and (iii) aerobic activity (3–5 days a week for 20–30 min). Strength and flexibility/balance training can be conducted at home. Aerobic training will be planned with each participant individually
- Participants will receive a pedometer to record the number of steps walked daily
Cognitive training - Information on cognitive functioning and the impact of cognitive activity/training on cognitive performance and dementia risk; information on strategies to train cognition in everyday life
- Cognitive training at home on a regular basis (3 times/week, 15 min per session) with tablet computers (software: NeuroNation;
Optimization of medication - Collection of baseline information (i) from the GP on participants’ medication, diagnoses, and lab values (creatinine, hemoglobin A1c) and (ii) from the participants on their actual medication
- Electronically supported data evaluation to identify potentially inappropriate medication (e.g. anticholinergics, using a list based on Gray and coworkers [13], potentially missing drugs (using START criteria A1 to A8; [34]), contraindicated drug combinations, and contraindications in patients with renal impairment (using databases from the electronic drug information system AiDKlinik). Discrepancies in the information on medication collected from the participant and the GP will be identified.
- Reports including recommendations on the medication of a participant will be transmitted to the GP. For recommended drugs, this will include information on potentially serious drug-drug interactions and on drug dose adjustment in patients with renal impairment. A procedure is established in case of emergencies, e.g. if an important drug for a serious condition is not administered by the patient. If a patient reports difficulties with drug administration (difficulties swallowing tablets or capsules, tablet splitting, subcutaneous injections, use of inhalers, transdermal patch application, or with the administration of eye drops, nose drops, ear drops, or rectal or vaginal drug administration), specific information is provided to the patient.
Management of vascular risk factors - Assessment of medication and diagnoses, lab values, health parameters, lifestyle factors, blood pressure and anthropometric measurements (height, weight)
- Information on further vascular risk factors (e.g. smoking, medical history)
- Feedback on vascular risk, importance of reducing the risk, and possible ways of achieving such a reduction
- Nutritional counseling, recommendation of weight loss (if necessary), physical activity enhancement, and optimization of medication as described above
Enhancement of social engagement - Assessment of level of social activity and risk of social isolation
- Information on the importance of an active lifestyle including high social engagement for dementia risk
- Enhancement of social engagement will be planned together with each study participant individually
Bereavement, grief and depressive symptoms - Assessment of depressive symptoms and underlying risk factors (e.g. bereavement, grief)
- If necessary, participants will be encouraged to contact their GP and will be provided with adequate support and care (e.g. referring participants to groups, psychiatrists, psychotherapists, psychiatric hospitals). Additionally, participants will receive written information on addresses and helplines which can be contacted in case of grief and/or depressive symptoms.
- If applicable, encouragement to use MoodGym – a scientifically developed and evaluated free web-based training program to prevent and reduce depressive symptoms (
Motivational tasks across all components - Personnel continuity regarding the contact person for the participants
- Study nurses will be trained in motivational interviewing techniques and participants will be strongly encouraged to contact their contact person, whenever necessary
- Birthday/Christmas/holiday cards originally signed by trial authorities/principal investigators
- Participants of intervention A will receive a brochure including recommendations (additional tips and suggestions each week for an active lifestyle, e.g. recipes, suggestions for physical activity, and information on healthy ageing) as well as a weekly diary to track their activities in the intervention components.