Home/Get Matched/NCT06187675
Recruiting
View on ClinicalTrials.gov

Testing Nutrition and Exercise Lifestyle for healthy lifestyle

Official title: A Nutrition and Exercise Lifestyle Intervention Program Participant Choice Approach

A Participant Choice Approach to Improve Adherence and Investigate Pregnancy Outcomes to Lifestyle Interventions

Condition: Lifestyle, HealthySponsor: Western University, CanadaTarget enrollment: 120
  • 2 groups
  • One site, in London
  • Recruiting
Exercise and Pregnancy Lab, 2245, 3-M Centre - University of Western Ontario, London, Ontario

Interventions

  • Behavioural therapy

    Nutrition and Exercise Lifestyle Intervention Program

    Nutrition and Exercise components for pregnancy

Canadian Sites (1)

1 of 1 recruiting

  • Exercise and Pregnancy Lab, 2245, 3-M Centre - University of Western Ontario

    London, Ontario

    Recruiting

Eligibility Criteria

See who this study is looking for12 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

  • +between 12 to 18 weeks of pregnancy
  • +a singleton fetus
  • +medically screenedScreeningThe checks done before joining, to see whether a study fits.Read more → with the Get Active Questionnaire for Pregnancy to determine eligibilityEligibility criteriaThe full list of requirements for taking part in a study.Read more → for participation in the exercise component

Exclusion

  • inability to walk
  • serious medical problems
  • high blood pressure
  • uncontrolled chest pain
  • uncontrolled symptomatic lung disease
  • a history of recreational substance use disorder
  • any contraindication to exercise
  • enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more → in another clinical trialInterventional studyA study where participants are given something to see what happens.Read more →.
  • diabetes before pregnancy
5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning 
What this study is

This study is testing a way to prevent a condition from developing.

This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.

From the trial registry

Built from these fields:

  • designModule.designInfo.primaryPurpose
  • designModule.phases
Who receives what

There are 2 groups in this study.

Group A, the comparison group, receives Nutrition and Exercise Lifestyle Intervention Program.

Registry label: A: Choice

Group B receives Nutrition and Exercise Lifestyle Intervention Program.

Registry label: B: No choice

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].label
  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
How the study is run

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

One group of people involved — usually the participants — is not told which treatment is which.

From the trial registry

Built from these fields:

  • designModule.designInfo.allocation
  • designModule.designInfo.maskingInfo.masking
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

One group receives an existing treatment, so the two can be compared.

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for

The study lists a minimum age of 18 years, with no upper limit given.

The study lists female participants only.

The study accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.

These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.

From the trial registry

Built from these fields:

  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How big and how long

The study aims to enrol about 120 people.

The study is currently expected to finish around November 2029.

The main measurement is taken over: Measured once per week from baselineBaselineYour starting measurements, taken before treatment begins.Read more → (12-18 weeks gestation) to end of the intervention (34-36 weeks gestation).

From the trial registry

Built from these fields:

  • designModule.enrollmentInfo.count
  • statusModule.completionDateStruct.date
  • outcomesModule.primaryOutcomes[].timeFrame
What the study measures

Adherence to the intervention strategy — measured over Measured once per week from baselineBaselineYour starting measurements, taken before treatment begins.Read more → (12-18 weeks gestation) to end of the intervention (34-36 weeks gestation).

From the trial registry

Built from these fields:

  • outcomesModule.primaryOutcomes[].measure
  • outcomesModule.primaryOutcomes[].timeFrame

Source: NCT06187675 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?

What is being tested — in plain terms

About Nutrition and Exercise Lifestyle Intervention ProgramBehavioural

Nutrition and Exercise components for pregnancy

From the trial registry — its own words, unedited.

What a behavioural is here: A programme, therapy, education, or lifestyle approach being studied.

Read the full explanation → · in clinical review

Common questions

Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.

Am I eligible for this trial?

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.

What the study lists: a minimum age of 18 years.

The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.

The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.eligibilityCriteria
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

One group receives an existing treatment so the two can be compared.

From the trial registry
  • armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?

One group of people involved — usually the participants — is not told which treatment is which.

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

From the trial registry
  • designModule.designInfo.maskingInfo.masking
  • designModule.designInfo.allocation
Who can join?

The study lists a minimum age of 18 years, with no upper limit given.

It lists female participants only.

It accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How long would this take?

The study's main measurement is taken over: Measured once per week from baselineBaselineYour starting measurements, taken before treatment begins.Read more → (12-18 weeks gestation) to end of the intervention (34-36 weeks gestation).

The study as a whole is currently expected to finish around 2029-11.

How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.

From the trial registry
  • outcomesModule.primaryOutcomes[].timeFrame
  • statusModule.completionDateStruct.date
How many people are taking part?

The study aims to enrol about 120 people.

From the trial registry
  • designModule.enrollmentInfo.count
Where is this happening?

This study lists one location: London, Ontario, Canada.

Sites can open and close during a study, so confirm with the team before travelling.

From the trial registry
  • trial_locations

About This Trial

Interventions that target excessive gestational weight gain (EGWG) with nutrition and exercise behavior change struggle with low program adherence. The investigators recently examined adherence in a randomized controlled trial to a previously established lifestyle program called the Nutrition and Exercise Lifestyle Intervention Program (NELIP) and found that those individuals with high adherence to the program were more likely to prevent EGWG. Perhaps offering participants a choice to intervention strategies may improve adherence. The current research question is: What impact does participant choice have on adherence to the introduction of nutrition and exercise components during 3 intervention strategies offered to pregnant individuals compared to no choice and does choice maintain pregnancy health outcomes? The strategies are: Group A - introducing both the nutrition and exercise components simultaneous at baseline (12-18 weeks of pregnancy) that is followed to delivery (NELIP); Group B - introducing the nutrition component first and then at 25 weeks adding the exercise component; or Group C - starting with the exercise component first, followed with introducing the nutrition component at 25 weeks. Both Groups B and C follow the full NELIP from 25 weeks to delivery (final intervention measures will occur at 34-36 weeks gestation). Follow-up will occur at birth (6-18 hours), 2, 6 and 12 months post delivery.

Think this trial might be right for you?

Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.

See if this trial could fit you

This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.