RecruitingNAINTERVENTIONAL

A Nutrition and Exercise Lifestyle Intervention Program Participant Choice Approach

This study is investigating whether giving pregnant individuals a choice in how they receive a diet and exercise program can help them stick to it better. The program, called NELIP, aims to help manage healthy weight gain during pregnancy. They're comparing people who get to choose when they start the diet and exercise parts (either together, diet first, or exercise first) with those who don't have a choice. The main goal is to see if having a choice makes it easier to follow the recommendations and maintain health during pregnancy. Researchers want to understand if this 'participant choice' method can improve how well people stay on track with the healthy living changes. This could be important for preventing too much weight gain in pregnancy.

At a glance

Status

Recruiting

Phase

Sponsor

Western University, Canada

Enrolment target

120

Start

01 Jan 2024

Estimated completion

01 Nov 2029

Lifestyle, Healthy Pregnancy Related Adherence, Treatment Nutrition, Healthy Weight Gain, Maternal

What is this study about?

This research project is designed to understand how best to support pregnant people in managing their weight gain through healthy eating and gentle exercise. It's known that sticking to these healthy changes can sometimes be difficult, and this study explores a new approach: giving participants a say in their program. The idea is that if you get to choose how your diet and exercise plan is introduced, you might find it easier to follow through. The overall aim is to help pregnant people maintain a healthy weight gain, which is important for both their well-being and their baby's health.

The study offers three different ways the healthy eating and exercise parts of the program can be introduced. Some people will start both at the same time early in pregnancy. Others will begin with the diet changes first and add exercise later, around 25 weeks of pregnancy. A third group will do the opposite, starting with exercise and introducing the diet component later. Researchers want to see if letting participants pick which of these three schedules suits them best makes a difference in their commitment to the program. They are comparing this 'choice' group to a 'no choice' group to see if having a say truly leads to better adherence.

Ultimately, the study hopes to find out if giving pregnant individuals more control over their lifestyle intervention plan leads to better long-term commitment and improves health outcomes for pregnancy. This could help create more effective and supportive programs for future pregnant people, making it easier to adopt and maintain healthy habits throughout pregnancy.

Key takeaways

This study explores if having a choice in your health plan helps during pregnancy.
It focuses on healthy eating and gentle walking to manage weight gain.
You might get to choose how and when you start the diet and exercise parts.
The study lasts through pregnancy, with follow-ups for a year after birth.
It aims to find better ways to support pregnant people's health.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to be between 12 and 18 weeks pregnant and expecting one baby. You'll also need to complete a simple health questionnaire to make sure that taking part in the exercise part of the program is safe for you.

There are some reasons why you wouldn't be able to join. These include if you can't walk, have serious medical conditions, have high blood pressure, uncontrolled chest pain, or a lung condition that isn't under control. You also can't participate if you had diabetes before pregnancy, have a history of drug or alcohol misuse, or if your doctor has advised against exercise. If you're already part of another research study, you won't be able to join this one. Participants must be 18 years old or older.

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 12 and 18 weeks pregnant?
Are you expecting only one baby?
Are you 18 years old or older?
Can you safely participate in a walking program (after completing a health questionnaire)?
Do you have any serious medical conditions like uncontrolled high blood pressure or diabetes before pregnancy?

Answer every question to see your result.

What does participation involve?

If you decide to take part, your first step will be to be randomly assigned to either the 'choice' group or the 'no-choice' group. If you're in the 'choice' group, you'll pick one of three ways to start the diet and exercise program: either both at once, diet first then exercise, or exercise first then diet. If you're in the 'no-choice' group, you'll be matched with someone in the 'choice' group and follow the plan they chose.

Throughout the study, you'll follow a modified healthy eating plan originally designed for gestational diabetes, which aims for around 2000 calories per day, focusing on balanced carbohydrates, protein, and fat. A nutritionist will help tailor this to you. The exercise part is a walking program. You'll stick with your chosen or assigned eating and exercise plan until you give birth, with the main measurements happening between 34-36 weeks of pregnancy. After your baby is born, there will be follow-up checks at 6-18 hours, 2, 6, and 12 months post-delivery.

Potential risks and benefits

Participating in this study involves making healthy lifestyle changes, which generally have benefits for both you and your baby during pregnancy. These include learning about healthy eating and incorporating safe exercise, which can help manage weight gain. As the study involves supervised dietary advice and a walking program, serious risks are expected to be low. However, as with any exercise, there's always a small risk of discomfort or minor injury. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Exercise and Pregnancy Lab, 2245, 3-M Centre - University of Western Ontario
Verified postcode
London, Canada· Recruiting

Common questions

What is the main goal of this study?

The main goal is to see if giving pregnant people a choice in their diet and exercise plan helps them stick to it better and manage healthy weight gain during pregnancy.

What is the 'NELIP' program?

NELIP stands for Nutrition and Exercise Lifestyle Intervention Program. It's a plan designed to help pregnant people eat healthily and exercise safely.

Will I have to take any new medication?

No, this study focuses on changes to diet and exercise, not on new medications.

How long will I be involved in the study?

You'll be involved throughout your pregnancy until delivery, with follow-up appointments occurring up to 12 months after your baby is born.

What if I decide I don't want to continue with the study?

You can withdraw from the study at any time without giving a reason, and it won't affect your medical care.

How to find out more

Michelle F Mottola, PhD

mmottola@uwo.ca 519-661-2111 Official trial record

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