Inflammatory Bowel Disease - Lifestyle Food and Exercise (IBD-LiFE) study

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2022
INTERVENTION: Personalised care This is a six‐month personalised nutrition and exercise intervention. Participants will be asked to attend two study appointments (baseline and after 6 months of intervention), each 1‐1.5 hours at the Department of Medicine, Dunedin Hospital, New Zealand. Participants will also receive a monthly 15‐minute follow up phone call from the research team. All intervention will be provided by the research dietitian during the entire study duration. Nutrition education will be based off the Heart Foundation “Eating for a Healthy Heart” booklet. Topic of focus will include benefits of fruit and vegetables, wholegrain, fibre, and fat intake and how to incorporate these into diet. During the first study visit, the research dietitian will go through the booklet with participants and set dietary goals together which will take approximately 30 minutes. Each month, the research dietitian will contact participants and review the dietary goals from the booklet. A seasonal produce bo Xalong with recipes compiled from New Zealand websites (Heart Foundation, 5aday, and vegetables) will be provided each week for the first month to facilitate change. Participants will be asked to report their weekly consumption of the produce bo Xwith a short online questionnaire. The Inflammatory Bowel Disease (IBD) exercise programme planner (Fagan G, Osborne H, Schultz M. Inflamm Intest Dis. 2021;6:61–9) will be used to encourage more physical activity. The main components of the exercise programme planner consist of information on how to get started with being more active, tips on setting exercise goals, and troubleshooting when necessary. Examples of activities such as walking, deep‐water running, High Intensity Interval Training (HIIT), and body‐weight exercises CONDITION: Inflammatory bowel disease; ; Inflammatory bowel disease Oral and Gastrointestinal ‐ Inflammatory bowel disease PRIMARY OUTCOME: 1. Changes in body fat mass (kg) measured by Dual Energy X‐ray Absorptiometry (DEXA)[ Baseline and endpoint (after 6 months of intervention)] INCLUSION CRITERIA: All adults aged 18 years and above with a confirmed diagnosis of IBD, on stable medical therapy for at least two months and have a body mass inde Xbetween 25 and 35 kg/m2. SECONDARY OUTCOME: Changes IBD biomarkers (serum C‐reactive protein and faecal calprotectin) ; [Baseline and endpoint (after 6 months of intervention) ; ] Changes in anthropometric measurements (waist‐hip ratio). This will be measured using a body tape measure. ; ; [Baseline and endpoint (after 6 months of intervention) ; ] Changes in dietary intake and adherence to the nutrition intervention using 3‐day food records. This will be assessed as a composite outcome.[Baseline, 1 month, and endpoint (after 6 months of intervention) ; ] Changes in IBD‐disease activity measures: disease severity scores using Harvey Bradshaw Inde X(HBI) or Simple Clinical Colitis Activity Inde X(SCCAI)[Baseline, 1 month, and endpoint (after 6 months of intervention)] Changes in nutrition serum biomarkers (lipid profile, vitamin B12, vitamin D, folate, iron studies). This will be assessed as a composite outcome.[Baseline and endpoint (after 6 months of intervention)] Changes in other body composition parameters (lean muscle mass and visceral adipose tissue) measured by Dual Energy X‐ray Absorptiometry (DEXA). This will be assessed as a composite outcome.[Baseline and endpoint (after 6 months of intervention)] Changes in physical activity level and adherence to exercise intervention using International Physical Activity Questionnaire (IPAQ) short form. This will be assessed as a composite outcome.[Baseline, 1 month, and endpoint (after 6 months of intervention)] Changes in quality of life measured by Simple Inflammatory Bowel Disease Questionnaire (SIBDQ) and Food Related Quality of Life‐29 (FR‐QoL‐29). This will be assessed as a composite outcome.[Baseline, 1 month, and endpoint (after 6 months of intervention) ; ]
Epistemonikos ID: 8b9676fd9d7f120967df2e75acf2836fa25b1999
First added on: Aug 26, 2024