None listed
Conditions
Brief summary
This is a randomised controlled trial to assess the effectiveness of a combined personalised nutrition and exercise intervention on people with inflammatory bowel disease (IBD) in Dunedin, New Zealand with the aim of improving body composition. IBD is a group of diseases characterised by chronic recurring and relapsing gut accompanied by systemic inflammation. People with IBD may suffer from bowel (bloody diarrhoea, abdominal pain, bowel incontinence, rectal bleeding) and non-bowel (fatigue, loss of appetite, fever, problems with the skin, eyes, joints, bones) symptoms. The early onset of IBD (between 15 and 30 years old) in the presence of malnutrition, medical therapy side effects, and suboptimal lifestyle habits associated with IBD, can increase the risk of developing heart disease and metabolic syndrome. Preliminary analysis of our observational IBD exercise and diet ((IBDeat), University of Otago Human Ethics Committee H21/135) study showed that more than half of the IBD cohort have elevated fat mass, high waist-hip ratio, and abnormal lipid profile. Majority of the cohort also avoided high fibre rich foods such as fruits, vegetables, and wholegrain which are an essential part of a healthy balanced diet. Almost all participants (99%) exceeded the recommended saturate fat intake and 95% of them did not meet the recommended 5+ fruits and vegetable daily. In conjunction with that, we also found that half of the cohort reported IBD-related barriers to becoming more physically active (mainly fatigue, joint pain, and bowel incontinence). These findings suggest that our IBD cohort may be at risk developing heart diseases and metabolic syndrome. It is well established that lifestyle interventions involving nutrition and exercise can positively influence body composition, reduce disease burden, and prevent the development of heart diseases and metabolic syndrome. Therefore, in this study, we aim to assess the effectiveness of a multimodal lifestyle approach (nutrition and exercise) to therapy for people with IBD. The intervention group will receive a personalised nutrition and exercise program while the usual care group will receive standard care (general healthy eating and exercise guidelines). It is hypothesised that a personalised nutrition and exercise intervention will improve nutritional status and body composition and thereby, positively influence disease burden and comorbidity risks, compared with the provision of standard recommendations.
Interventions
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
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 box along 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 box with 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 are also available in the programme for reference. The physical activity suggestions will be mainly tailored to participant’s exercise preference, goals, motivations, and perceived barriers. Participants will be provided a gold star chart as a motivation and an exercise programme logbook to assess engagement with and completion of the physical activities. Monthly follow up phone calls will be made to maintain engagement and compliance to the intervention. Three standard questions on disease activity, nutrition, and exercise goals will be asked to assess participant’s progress and perception of the nutrition and exercise intervention. The research dietitian will provide support, motivate, and encourage participants to achieve or sustain their goals accordingly.
Sponsors
University of Otago
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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 index between 25 and 35 kg/m2.
Exclusion criteria
- Severely active IBD (Harvey-Bradshaw Index score greater than 16 and Simple Clinical Colitis Activity Index score greater than or equal to 12) - Currently pregnant or lactating - Consuming only a liquid diet (e.g., exclusive enteral nutrition) or parenteral nutrition - Scheduled for an IBD-related surgery within the next 6 months or had a surgery in the last month - Have medical implants such as defibrillators or pacemakers - Medical condition preventing participation in regular physical activity (assessed by PAR-Q+) - Have a high fibre intake (greater than 25g/day)
Outcome results
None listed