Exercise and Nutrition in IBD & Preconception

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Inflammatory Bowel Diseases

Intervention / Treatment
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* Other: Exercise
* Other: Dietary plan
* Other: Stretching


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise and dietary plan<br>Combination cardiovascular and resistance training and Mediterranean dietary plan | Other: Exercise<br>* 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.<br>Other: Dietary plan<br>* Mediterranean dietary plan, which contains foods, such as fish, vegetables, nuts, and oils, which are anti-inflammatory in nature.<br>|
| Experimental: Exercise and no dietary plan<br>Combination cardiovascular and resistance training and participants regular diet (control diet) | Other: Exercise<br>* 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.<br>|
| Experimental: Stretching and dietary plan<br>Flexibility training (control exercise) and Mediterranean dietary plan | Other: Dietary plan<br>* Mediterranean dietary plan, which contains foods, such as fish, vegetables, nuts, and oils, which are anti-inflammatory in nature.<br>Other: Stretching<br>* Stretching intervention will entail 30 minutes of flexibility training 3 days/week of stretches targeting all major muscle groups held for 20-30 seconds.<br>|
| Active Comparator: Stretching and no dietary plan<br>Flexibility training (control exercise) and participants regular diet (control diet) | Other: Stretching<br>* Stretching intervention will entail 30 minutes of flexibility training 3 days/week of stretches targeting all major muscle groups held for 20-30 seconds.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Inflammatory Bowel Disease Questionnaire score | Inflammatory Bowel Disease Questionnaire (score on a scale); measures quality of life | Baseline, 3 months, and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Interleukin-6 | Serum Interleukin-6 (pg/mL); measures inflammation | Baseline, 3 months, and 6 months | 
| Change from Baseline in Follicle Stimulating Hormone | 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 | Leisure Time Physical Activity Questionnaire (arbitrary score); measures physical activity levels outside intervention | Baseline, 3 months, and 6 months | 
| Change from Baseline in Estradiol | Serum estradiol (pg/mL); measures fertility status | Baseline, 3 months, and 6 months | 
| Change from Baseline in Total Body Lean Mass | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Fecal calprotectin (mg/kg); measures clinical disease activity | Baseline, 3 months, and 6 months | 
| Change from Baseline Protein Consumption | Food Frequency Questionnaire average protein consumption per day (grams); measures nutritional status | Baseline, 3 months, and 6 months | 
| Change from Baseline Carbohydrate Consumption | Food Frequency Questionnaire average carbohydrate consumption per day (grams); measures nutritional status | Baseline, 3 months, and 6 months | 
| Change from Baseline Fat Consumption | 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 | The EQ-5D (score on a scale); measures quality of life | Baseline, 3 months, and 6 months |