Exercise and Nutrition in IBD & Preconception (IBDPreconcep)

June 11, 2018 updated by: Sharyle Fowler, University of Saskatchewan

Exercise and Nutrition as Treatment Alternatives in Women With Inflammatory Bowel Disease During Preconception: Saskatchewan Multidisciplinary Inflammatory Bowel Diseases Clinic (MDIBDC)

The objectives are to: 1) Assess the independent and synergistic efficacy of exercise and nutrition interventions to manage major symptomatic concerns of inflammatory bowel diseases (IBD), 2) Assess the independent and synergistic efficacy of exercise and nutrition to mitigate inflammation in IBD, and 3) Assess the feasibility of such an intervention in preconception women with IBD. The investigators hypothesize that the combination of anti-inflammatory exercise and nutritional interventions will have a synergistic effect on managing major symptomatic concerns associated with IBD, reducing inflammation, and improving fertility status in preconception women with IBD, as compared to either intervention independently.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Potential participants will be recruited from the Preconception and Pregnancy Clinic recently established within the Saskatchewan Multidisciplinary Inflammatory Bowel Disease Clinic [MDIBDC]. Eligible participants will be randomized [stratified] to one of four groups: 1) Exercise and dietary plan, 2) Exercise and no dietary plan, 3) Stretching [placebo exercise] and dietary plan, 4) Stretching and no dietary plan. Participants will be assessed at baseline, midway [3 months], and post-intervention [6 months] for indications of disease activity, quality of life, fertility status, and bone health.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
        • Royal University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female
  • Confirmed diagnosis of Inflammatory Bowel Disease
  • Child-bearing age

Exclusion Criteria:

  • Currently following a Mediterranean diet
  • Currently performing resistance training on a regular basis (within the past 6 months)
  • Failed Physical Activity Readiness Questionnaire-Plus (PAR-Q+).
  • Past ileal pouch anal anastomosis
  • Unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal, gastrointestinal, or other medical disorder that, in the opinion of the investigator, would confound the study results or compromise subject safety

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Exercise and dietary plan
Combination cardiovascular and resistance training and Mediterranean dietary plan
Other: Exercise
Exercise intervention will entail 30 minutes of moderate intensity cardiovascular training 3 days/week and full body resistance training 2 days/week (supervised). Cardiovascular training will entail any weight-bearing activity that would achieve target heart rate, such as walking, jogging, stair climbing, dancing, etc. Resistance training will entail 2-3 sets of 8-12 repetitions of exercises targeting all major muscle groups with an external load applied, such as a dumbbell, barbell, medicine ball, etc.
Other: Dietary plan
Mediterranean dietary plan, which contains foods, such as fish, vegetables, nuts, and oils, which are anti-inflammatory in nature.
Experimental: Exercise and no dietary plan
Combination cardiovascular and resistance training and participants regular diet (control diet)
Other: Exercise
Exercise intervention will entail 30 minutes of moderate intensity cardiovascular training 3 days/week and full body resistance training 2 days/week (supervised). Cardiovascular training will entail any weight-bearing activity that would achieve target heart rate, such as walking, jogging, stair climbing, dancing, etc. Resistance training will entail 2-3 sets of 8-12 repetitions of exercises targeting all major muscle groups with an external load applied, such as a dumbbell, barbell, medicine ball, etc.
Experimental: Stretching and dietary plan
Flexibility training (control exercise) and Mediterranean dietary plan
Other: Dietary plan
Mediterranean dietary plan, which contains foods, such as fish, vegetables, nuts, and oils, which are anti-inflammatory in nature.
Other: Stretching
Stretching intervention will entail 30 minutes of flexibility training 3 days/week of stretches targeting all major muscle groups held for 20-30 seconds.
Active Comparator: Stretching and no dietary plan
Flexibility training (control exercise) and participants regular diet (control diet)
Other: Stretching
Stretching intervention will entail 30 minutes of flexibility training 3 days/week of stretches targeting all major muscle groups held for 20-30 seconds.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from Baseline Inflammatory Bowel Disease Questionnaire score
Time Frame: Baseline, 3 months, and 6 months
Inflammatory Bowel Disease Questionnaire (score on a scale); measures quality of life
Baseline, 3 months, and 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from Baseline Interleukin-6
Time Frame: Baseline, 3 months, and 6 months
Serum Interleukin-6 (pg/mL); measures inflammation
Baseline, 3 months, and 6 months
Change from Baseline in Follicle Stimulating Hormone
Time Frame: Baseline, 3 months, and 6 months
Serum Follicle Stimulating Hormone (mIU/ml); measures fertility status
Baseline, 3 months, and 6 months
Change from Baseline in Leisure Time Physical Activity Questionnaire score
Time Frame: Baseline, 3 months, and 6 months
Leisure Time Physical Activity Questionnaire (arbitrary score); measures physical activity levels outside intervention
Baseline, 3 months, and 6 months
Change from Baseline in Estradiol
Time Frame: Baseline, 3 months, and 6 months
Serum estradiol (pg/mL); measures fertility status
Baseline, 3 months, and 6 months
Change from Baseline in Total Body Lean Mass
Time Frame: Baseline, 3 months, and 6 months
Total body lean mass (grams) via dual energy x-ray absorptiometry scan; measures body composition
Baseline, 3 months, and 6 months
Change from Baseline in Total Body Fat Mass
Time Frame: Baseline, 3 months, and 6 months
Total body fat mass (grams) via dual energy x-ray absorptiometry scan; measures body composition
Baseline, 3 months, and 6 months
Change from Baseline in Body Composition
Time Frame: Baseline, 3 months, and 6 months
Body fat percentage (%) via dual energy x-ray absorptiometry scan; measures body composition
Baseline, 3 months, and 6 months
Change from Baseline in Femoral Neck Bone Mineral Density
Time Frame: Baseline, 3 months, and 6 months
Femoral neck bone mineral density (g/cm^2) via dual energy x-ray absorptiometry scan; measures bone health
Baseline, 3 months, and 6 months
Change from Baseline in Total Body Bone Mineral Density
Time Frame: Baseline, 3 months, and 6 months
Total body bone mineral density (g/cm^2) via dual energy x-ray absorptiometry scan; measure bone health
Baseline, 3 months, and 6 months
Change from Baseline in Harvey Bradshaw Index
Time Frame: Baseline, 3 months, and 6 months
Harvey Bradshaw Index for Crohn's disease (score on a scale); measures clinical disease activity
Baseline, 3 months, and 6 months
Change from Baseline in partial Mayo Score
Time Frame: Baseline, 3 months, and 6 months
Partial Mayo Score for ulcerative colitis (score on a scale); measures clinical disease activity
Baseline, 3 months, and 6 months
Change from Baseline Fecal Calprotectin
Time Frame: Baseline, 3 months, and 6 months
Fecal calprotectin (mg/kg); measures clinical disease activity
Baseline, 3 months, and 6 months
Change from Baseline Protein Consumption
Time Frame: Baseline, 3 months, and 6 months
Food Frequency Questionnaire average protein consumption per day (grams); measures nutritional status
Baseline, 3 months, and 6 months
Change from Baseline Carbohydrate Consumption
Time Frame: Baseline, 3 months, and 6 months
Food Frequency Questionnaire average carbohydrate consumption per day (grams); measures nutritional status
Baseline, 3 months, and 6 months
Change from Baseline Fat Consumption
Time Frame: Baseline, 3 months, and 6 months
Food Frequency Questionnaire average fat consumption per day (grams); measures nutritional status
Baseline, 3 months, and 6 months
Change from Baseline EuroQol Five Dimensions Questionnaire (EQ-5D) score
Time Frame: Baseline, 3 months, and 6 months
The EQ-5D (score on a scale); measures quality of life
Baseline, 3 months, and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Saskatchewan

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Saskatchewan Health Research Foundation
Crohn's and Colitis Canada

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sharyle Fowler, MD, University of Saskatchewan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 27, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 26, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 13, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16-132

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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