Hypocaloric Mediterranean Diet or Physical Activity to Lower Cardiometabolic Risk

NCT04155112 | Unknown

• 1 other identifier: 2019/696
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Keywords

Hypertension; Lifestyle; Mediterranean diet; Physical activity; Weight loss

Outcome Measures

Primary Outcomes (2)

• Change in 24-hour ambulatory SBP among subjects, after 6 months.

  24-hour ambulatory blood pressure will be measured with a device that allows free-living. Change = (6 month measurement - baseline measurement).

  Baseline to 6 months

• Change in 24-hour ambulatory DBP among subjects, after 6 months.

  24-hour ambulatory blood pressure will be measured with a device that allows free-living. Change = (6 month measurement - baseline measurement).

  baseline to 6 months

Secondary Outcomes (5)

• Change in other measures of blood pressure, within and among subjects, after 6 and 12 months.

  Baseline to 6 months, baseline to 12 months

• Change in body composition, within and among subjects, after 6 months.

  Baseline to 6 months

• Change in markers of cardiometabolic risk, within and among subjects, after 6 and 12 months.

  Baseline to 6 months, baseline to 12 months

• Change in inflammation markers, within and among subjects, after 6 and 12 months.

  Baseline to 6 months, baseline to 12 months

• Change in safety outcomes, within and among subjects, after 6 and 12 months.

  Baseline to 6 months, baseline to 12 months

Other Outcomes (1)

• Change in quality of life, within and among subjects, after 3, 6 and 12 months.

  Baseline to 6 months, baseline to 12 months

Study Arms (3)

Physical activity (PA)

EXPERIMENTAL

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.

Behavioral: Physical activity

Hypocaloric Mediterranean diet (MeDi)

EXPERIMENTAL

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.

Behavioral: Hypocaloric Mediterranean diet

Control

NO INTERVENTION

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.

Interventions

Physical activity 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).

Also known as: PA

Physical activity (PA)

Hypocaloric Mediterranean diet BEHAVIORAL

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

Also known as: MeDi

Hypocaloric Mediterranean diet (MeDi)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oslo University Hospital: lead
• The National Association for Public Health, Norway: collaborator

Study Sites (1)

Oslo University Hospital, Aker

Oslo, 0424, Norway

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity; Obesity, Abdominal; Hypertension; Motor Activity; Weight Loss

Interventions

Exercise

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Behavior; Body Weight Changes

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Kari Anne Sveen, MD, PhD

  Oslo University Hospital

  STUDY CHAIR

Central Study Contacts

Kari Anne Sveen, MD, PhD

CONTACT

0047 915 02 770; kasvee@ous-hf.no

Ana Sousa, MSc

CONTACT

0047 230 33 588; anaseq@ous-hf.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: October 23, 2019
• First Posted: November 7, 2019
• Study Start: April 21, 2023
• Primary Completion: October 1, 2024
• Study Completion: September 1, 2025
• Last Updated: May 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)