Exercise and Nutrition as Treatment Alternatives in Women With Inflammatory Bowel Disease During Preconception: Saskatchewan Multidisciplinary Inflammatory Bowel Diseases Clinic (MDIBDC)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- University of Saskatchewan
- Enrollment
- 3
- Locations
- 2
- Primary Endpoint
- Change from Baseline Inflammatory Bowel Disease Questionnaire score
Study Overview
Brief Summary
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
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Arms & Interventions
Exercise and dietary plan
Combination cardiovascular and resistance training and Mediterranean dietary plan
Intervention: Exercise (Other)
Exercise and dietary plan
Combination cardiovascular and resistance training and Mediterranean dietary plan
Intervention: Dietary plan (Other)
Exercise and no dietary plan
Combination cardiovascular and resistance training and participants regular diet (control diet)
Intervention: Exercise (Other)
Stretching and dietary plan
Flexibility training (control exercise) and Mediterranean dietary plan
Intervention: Dietary plan (Other)
Stretching and dietary plan
Flexibility training (control exercise) and Mediterranean dietary plan
Intervention: Stretching (Other)
Stretching and no dietary plan
Flexibility training (control exercise) and participants regular diet (control diet)
Intervention: Stretching (Other)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Change from Baseline in Body Composition(Baseline, 3 months, and 6 months)
- Change from Baseline in Femoral Neck Bone Mineral Density(Baseline, 3 months, and 6 months)
- Change from Baseline Protein Consumption(Baseline, 3 months, and 6 months)
- Change from Baseline in Estradiol(Baseline, 3 months, and 6 months)
- Change from Baseline in Harvey Bradshaw Index(Baseline, 3 months, and 6 months)
- Change from Baseline Fat Consumption(Baseline, 3 months, and 6 months)
- Change from Baseline Interleukin-6(Baseline, 3 months, and 6 months)
- Change from Baseline in Follicle Stimulating Hormone(Baseline, 3 months, and 6 months)
- Change from Baseline in Leisure Time Physical Activity Questionnaire score(Baseline, 3 months, and 6 months)
- Change from Baseline in Total Body Lean Mass(Baseline, 3 months, and 6 months)
- Change from Baseline in Total Body Fat Mass(Baseline, 3 months, and 6 months)
- Change from Baseline Fecal Calprotectin(Baseline, 3 months, and 6 months)
- Change from Baseline Carbohydrate Consumption(Baseline, 3 months, and 6 months)
- Change from Baseline EuroQol Five Dimensions Questionnaire (EQ-5D) score(Baseline, 3 months, and 6 months)
- Change from Baseline in Total Body Bone Mineral Density(Baseline, 3 months, and 6 months)
- Change from Baseline in partial Mayo Score(Baseline, 3 months, and 6 months)
Investigators
Sharyle Fowler
M.D.
University of Saskatchewan