RecruitingNAINTERVENTIONAL

Effects of a Lifestyle and Sleep Intervention in Non-exercising Adults

This study is for adults who don't get much exercise. We know that heart diseases are a big problem worldwide, and healthy living can help. Many lifestyle programmes focus on diet and exercise, but often forget about sleep. However, poor sleep can also harm your health. This research aims to find out if adding sleep advice to a programme that includes diet and exercise makes a bigger difference to people's quality of life and how much they move their bodies. We're comparing people who get lifestyle coaching, people who get lifestyle and sleep coaching, and a group receiving standard health information.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Grenoble

Enrolment target

201

Start

02 May 2024

Estimated completion

01 May 2028

Inactivity, Physical Lifestyle Risk Reduction

What is this study about?

Many serious health conditions, especially heart problems, are unfortunately very common. Healthy living, which includes eating well and exercising, is known to be really important in helping prevent these conditions and improving how people feel day-to-day. Most programmes that help people live healthier lives focus on food and physical activity.

However, we also know that lots of people don't get enough good quality sleep, and this can also have a big impact on health. What's interesting is that sleep isn't usually a major part of these healthy living programmes. This study wants to see if we can do even better. We're exploring if offering advice and support to improve sleep, alongside healthy eating and exercise tips, can lead to even greater improvements in people's overall well-being and how active they are.

The main goal of this research is to compare different approaches. We want to see if a healthy lifestyle programme that includes sleep support makes a bigger positive difference than a healthy lifestyle programme on its own when it comes to people's quality of life and their physical activity levels. We hope the results will help health professionals plan even better programmes for people in the future.

Key takeaways

This study explores how healthy lifestyle changes, including sleep, affect health.
It's for adults aged 18-80 who don't exercise much.
You could get diet, exercise, and/or sleep support.
Participation involves check-ups over 12 months.
The goal is to find better ways to help people live healthier.
You cannot have a diagnosed sleep order or be pregnant to join.

Who may be eligible?

This study is looking for adults aged 18 to 80 years old who don't currently do much physical activity (less than 2 and a half hours of moderate exercise per week).

You would need to be well enough to safely take part in regular exercise and be able to understand and sign a consent form. You also need to be part of a social security or similar health insurance system.

However, you wouldn't be able to join if a doctor thinks it's not suitable for you, or if you've already been diagnosed with and are being treated for a sleep problem like sleep apnea or insomnia. Also, if you are pregnant, involved in another medical study, or considered a vulnerable person legally, you wouldn't be able to take part.

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 between 18 and 80 years old?
Do you currently do less than 2.5 hours of moderate exercise per week?
Are you able to start exercising safely?
Do you NOT have a diagnosed and treated sleep condition (like sleep apnea or insomnia)?
Are you NOT pregnant and NOT currently in another medical study?

Answer every question to see your result.

What does participation involve?

If you take part, you'll first be assigned to one of three groups by chance: a lifestyle group (exercise and diet), a lifestyle and sleep group, or a group receiving general health information. You won't be able to choose your group.

Depending on your group, you might have an initial meeting to start physical activity, followed by supervised exercise once a week for six months. You might also have a meeting with a dietitian and attend three group sessions about healthy eating. If you're in the sleep group, you'll have one-on-one meetings to help improve your sleep habits.

Throughout the study, you'll have checks at the beginning, after six months, and again after 12 months. These checks will look at your quality of life, how active you are, and some measures related to your heart and metabolism. The total duration of your participation, including follow-up, will be 12 months.

Potential risks and benefits

Taking part in this study could potentially improve your physical activity levels, diet, and sleep, possibly leading to better overall health and quality of life. However, as with any exercise or diet change, there's always a small risk of discomfort or injury, especially if you're not used to being active. The study will aim to minimise these risks. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Grenoble University Hospital
Verified postcode
Grenoble, France· Recruiting

Common questions

What kind of exercise will I do?

The study mentions supervised physical activity once a week, but the specific types of exercise would be explained to you by the study team.

Will I have to pay to take part?

The information doesn't mention any costs for participants. Clinical studies generally cover study-related expenses.

How will I know if I'm in the sleep group?

You will be randomly assigned to one of three groups, and the study team will let you know which group you are in and what that involves.

How long does the study last?

You will be involved for 12 months, with checks at the start, 6 months, and 12 months.

Can I still take part if I occasionally have trouble sleeping?

You cannot take part if you have a diagnosed and treated sleep problem like sleep apnea or insomnia. If your sleep issues are not diagnosed or treated, you might still be eligible, but you should discuss this with the study team.

How to find out more

Monique Mendelson, PhD

mmendelson@chu-grenoble.fr +33 4 76 76 72 26 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.