Hypocaloric Mediterranean Diet or Physical Activity to Lower Cardiometabolic Risk

NCT ID: NCT04155112

Last Updated: 2023-05-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-21
• Study Completion Date: 2025-09-30

Brief Summary

The purpose of this randomized controlled trial is to test the effects of a hypocaloric Mediterranean diet or of physical activity in participants who take at least 2 antihypertensive drugs but do not reach blood pressure treatment goal.

This study is a randomized, controlled, single-center, parallel group trial with three arms: hypocaloric Mediterranean diet (MeDi), physical activity (PA), or control. The control group will receive usual care (no intervention). This study will not be blinded.

The interventions will last 6 months, while the study follow-up will last 12 months. Four study visits will take place: baseline, at 3 months, at 6 months, at 12 months. The primary outcome is change in mean 24-hour ambulatory systolic blood pressure and diastolic blood pressure among groups after 6 months of intervention. Secondary and exploratory outcomes include change in other measures of blood pressure, body composition, other markers of cardiometabolic disease, inflammation markers, safety outcomes, and quality of life, among others.

Conditions

Overweight or Obesity; Obesity, Abdominal; Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Physical activity (PA)

For 6 months, the participants will be recommended to increase physical activity to ≥ 150 min of moderate intensity or ≥ 75 min of vigorous intensity aerobic PA (or an equivalent combination) and ≥ 2 days of resistance exercise a week. The participants will take part in supervised group classes, twice per week. Each participant will receive a heart rate monitor to bring home and to use while reporting activity via a physical activity diary.

Group Type: EXPERIMENTAL

Physical activity

Intervention Type: BEHAVIORAL

Increased physical activity to the minimum recommended by health authorities (≥ 150 min of moderate intensity or ≥ 75 min of vigorous intensity aerobic PA (or an equivalent combination) and ≥ 2 days of resistance exercise a week).

Hypocaloric Mediterranean diet (MeDi)

For 6 months, the participants will be recommended to consume a diet for 5-10% body weight loss. This diet will be based on the Mediterranean diet pattern. For the 6 months of the intervention, the participants will weigh themselves weekly and report their progress to the investigator. Adaptations to the diet will be made to ensure the goal of 5-10% weight loss is achieved. Each participant will receive a scale to bring home and to use while reporting weight loss.

Group Type: EXPERIMENTAL

Hypocaloric Mediterranean diet

Intervention Type: BEHAVIORAL

Energy deficit to reach 5-10% weight loss within 6 months, based on the Mediterranean diet pattern.

Control

At baseline, participants will receive usual care, which consists of general information regarding the importance of lifestyle for BP. This information will not be reinforced throughout the study duration.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Physical activity

Increased physical activity to the minimum recommended by health authorities (≥ 150 min of moderate intensity or ≥ 75 min of vigorous intensity aerobic PA (or an equivalent combination) and ≥ 2 days of resistance exercise a week).

Intervention Type: BEHAVIORAL

Hypocaloric Mediterranean diet

Energy deficit to reach 5-10% weight loss within 6 months, based on the Mediterranean diet pattern.

Intervention Type: BEHAVIORAL

Other Intervention Names

PA; MeDi

Eligibility Criteria

Inclusion Criteria

• Men and women
• 18 - 70 years
• Taking ≥ 2 antihypertensive drugs (includes combination therapy)
• Office SBP ≥ 140mmHg and/or DBP ≥ 90mmHg on two occasions
• BMI 25 - 40 kg/m2
• Waist circumference ≥ 88 cm (women) or ≥ 102 cm (men)
• Sedentary lifestyle (< 150 minutes/week of moderate intensity physical activity)
• Weight stable (± 5 kg in the last 6 months)
• Not on a weight loss diet
• Willing to comply to an intervention of either a hypocaloric Mediterranean diet or physical activity (or control) for 6 months

Exclusion Criteria

• Unable to provide informed consent
• Pregnant or lactating
• Office BP ≥ 160/100 mmHg
• Diabetes mellitus type 1
• History of cardiovascular disease (including uncompensated heart failure, recent infarction or stroke in the last 6 months, severe arrhythmia, heart failure or unstable angina pectoris)
• Chronic kidney disease stages 4 or 5
• Cancer in the last 5 years
• Changes in concurrent medication (anti-hypertensives, anti-diabetics, lipid-lowering drugs) in the last 3 months
• Regular use of oral corticosteroids in excess of 5 mg prednisolone (or equivalent) during the last month
• Use of GLP-1 analogues for < 1 year
• Drug or alcohol abuse
• Eating disorders or severe dietary restrictions
• Impediments to physical activity at recommended levels due to musculoskeletal and other conditions.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The National Association for Public Health, Norway

OTHER_GOV

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kari Anne Sveen

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kari Anne Sveen, MD, PhD

Role: STUDY_CHAIR

Oslo University Hospital

Locations

Oslo University Hospital, Aker

Oslo, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Kari Anne Sveen, MD, PhD

Role: CONTACT

kasvee@ous-hf.no

0047 915 02 770

Ana Sousa, MSc

Role: CONTACT

anaseq@ous-hf.no

0047 230 33 588

Facility Contacts

Kari Anne Sveen, MD, PhD

Role: primary

kasvee@ous-hf.no

Other Identifiers

2019/696

Identifier Type: -

Identifier Source: org_study_id