Active not recruitingNAINTERVENTIONAL

Evaluation of Lifestyle Modification on Cardiovascular Risk

This study wants to find out if 8 weeks of home-based exercise, either by itself or combined with a Mediterranean diet, can improve heart health and metabolic health for women aged 45 to 65. These women are overweight or obese and have gone through menopause. Many of these women might be at risk of conditions like metabolic syndrome, heart disease, or type 2 diabetes. Researchers believe these lifestyle changes could help by affecting a hunger hormone called ghrelin. Participants will be split into three groups: one doing exercise only, another doing exercise plus the Mediterranean diet, and a third group that doesn't change their routine. The goal is to see which approach works best to boost overall health.

At a glance

Status

Active not recruiting

Phase

Sponsor

Swansea University

Enrolment target

Start

15 Aug 2022

Estimated completion

15 Aug 2025

Metabolic Syndrome Menopause Cardiovascular Diseases Obesity Type2diabetes

What is this study about?

This research study is looking into how certain lifestyle changes can help women improve their health. Specifically, it's focused on women aged 45 to 65 who have already gone through menopause and are overweight or obese. These women might be at a higher risk of developing health problems like heart disease, type 2 diabetes, or metabolic syndrome, which is a collection of serious risk factors.

The study wants to see if an 8-week program of home-based exercise, which doesn't need any special equipment, can make a difference. It's also exploring if adding a Mediterranean diet to this exercise makes it even more effective. Scientists are particularly interested in how these changes might affect a hormone called ghrelin, which is involved in hunger, and how this could then lead to better heart health and metabolic health, meaning how your body handles things like blood sugar and fats.

To do this, women taking part will be randomly placed into one of three distinct groups: one group will do the exercise program, another group will do the exercise program and also follow a Mediterranean diet, and a third group will continue their usual daily routines without any specific intervention. By comparing the health changes in these groups after 8 weeks, the researchers hope to learn the best ways to help women reduce their risk of serious health conditions.

Key takeaways

Study is for women aged 45-65 who are postmenopausal and overweight/obese.
It investigates exercise and a Mediterranean diet for 8 weeks.
Aims to improve heart health and metabolic health.
No special equipment needed for the exercise.
Participation involves being in one of three groups (exercise, exercise+diet, or usual routine).
You can withdraw from the study at any time.

Who may be eligible?

To be considered for this study, you must be a woman between 45 and 65 years old. You should have gone through menopause naturally, meaning you haven't had a period for at least 12 months. Your Body Mass Index (BMI) should be between 25 and 35, which means you are overweight or moderately obese. You should also be generally healthy with no known serious medical conditions and not regularly exercising (less than 60 minutes of planned exercise per week in the last six months). You need to feel well enough to start an exercise program.

There are several reasons why you might not be able to join. These include if you have any existing heart problems (like an abnormal heart tracing or heart disease), cancer, kidney or liver disease, pancreatitis, or bowel conditions like Inflammatory Bowel Disease or Irritable Bowel Syndrome. Also, if you currently smoke, have a history of substance or excessive alcohol use, or have been on hormone therapy for less than six months, you won't be eligible. Lastly, if you are currently taking certain medications for high blood pressure (like anti-hypertensive or beta-blocker drugs), you won't be able to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a woman aged between 45 and 65?
Have you gone through menopause (no period for 12 months)?
Are you overweight or moderately obese (BMI between 25 and 35)?
Are you generally healthy with no serious medical conditions?
Do you currently do less than 60 minutes of planned exercise per week?
Are you not taking certain blood pressure medications or hormone therapy (for less than 6 months)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it will last for a total of 8 weeks. During this time, you will be placed into one of three groups. If you're in an exercise group, you'll follow a home-based exercise program without needing special equipment. If you're in the diet group, you'll also follow a Mediterranean diet. If you're in the control group, you'll continue your normal daily routine. The study will involve some initial health checks and measurements, and then further checks at the end of the 8 weeks to see any changes in your body composition, heart health, and metabolic markers. There are no study medications involved.

Potential risks and benefits

Participating in this study could potentially offer benefits such as improving your heart and metabolic health through lifestyle changes like exercise and diet. While the exercise program is home-based and equipment-free, there's always a small risk of discomfort or injury with any new physical activity, especially if you're not used to exercising. You will be monitored to ensure your safety. It's important to remember that you are a volunteer; you can choose to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Swansea University
Verified postcode
Swansea, United Kingdom

Common questions

What does 'home-based, equipment-free exercise' mean?

It means you'll do exercises at home without needing gym equipment. This might include bodyweight exercises like squats, lunges, or walking.

What is a Mediterranean diet?

It's a way of eating rich in fruits, vegetables, whole grains, nuts, seeds, olive oil, and fish, with less red meat and processed foods.

What is a 'control group'?

A control group is people who continue their usual routine. This helps researchers compare the effects of the active treatments against no specific intervention.

Will I know which group I'm in?

Yes, you will know if you are in an exercise group, an exercise and diet group, or the control group.

What type of measurements will be taken?

Researchers will check things like your body measurements, certain markers related to heart health and metabolism (likely through blood tests), and hormone levels.