ΗINTreat

The Hypertension Intensive Nutrition Treatment (HINTreat) trial was initiated with the aim of investigating the effects of a six-month intensive lifestyle treatment versus usual care, among patients with stage 1 essential hypertension.

pragmatic, community based, parallel group, single blind randomized controlled trial

The intervention was home based

Inclusion criteria involved: 1) untreated stage 1 EH, 2) age> 18 years old, and 3) agreement to participate. Exclusion criteria were: 1) diagnosis of secondary hypertension, 2) diabetes mellitus, 3) cardiovascular disease (CVD), 4) any known inflammatory condition, 5) malignancy, 6) or other significant comorbidities affecting arterial BP, 7) treatment with antihypertensive agents or other significant medication, including diuretics.

Patients were divided into two groups. Participants in the first group acted as controls, receiving baseline standard advise concerning lifestyle modifications,according to the ESH guidelines. The second group formed the intervention group, receiving intensive lifestyle treatment concerning nutrition modification and exercise, in accordance with the ESH guidelines. At baseline, the intervention group received a one-to-one a 1h nutrition education session with a dietitian , and a personalized diet plan. Emphasis was given on the dietary changes needed to be adhered, including an increase in fruit and vegetables consumption, a reduction in the salt intake, the effects of weight loss and the need for regular physical activity.

Office BP, 24h & Day BP (ABPM), carotid intima-media thickness (IMT), carotid stiffness, pulse wave velocity (PWV), lipid profile (Total Cholesterol, TG, HDL, LDL)

Randomization of participants to either the intensive lifestyle intervention treatment or the usual care group, was performed on blocks of 1, using the StatTrek software. Investigators, participants and statisticians were all aware of the allocation at every step of the progress.

Participants were not aware of the group allocation or of the existence of other groups with different treatment protocols. Each participant performed the baseline and follow-up measurements alone, therefore no contact was performed with other participants. None of the examiners provided information on the two different treatments to the participants.

participants might be identified

in one year

in one year

every reasonable request

individual patient information protected

nutrients journal

ethical permission