Exercise and Nutrition in IBD & Preconception (IBDPreconcep)

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: Terminated
• Conditions: Inflammatory Bowel Diseases
• Intervention / Treatment: Other: Exercise; Other: Dietary plan; Other: Stretching

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: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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

Collaborators and Investigators

• Sponsor: University of Saskatchewan
• Collaborators: Saskatchewan Health Research Foundation; Crohn's and Colitis Canada
• Investigators: Principal Investigator: Sharyle Fowler, MD, University of Saskatchewan

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: September 27, 2016
• First Submitted That Met QC Criteria: October 24, 2016
• First Posted (Estimate): October 26, 2016

Study Record Updates

• Last Update Posted (Actual): June 13, 2018
• Last Update Submitted That Met QC Criteria: June 11, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Intestinal Diseases
• Other Study ID Numbers: 16-132

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO