Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001417774
Ethics application status
Approved
Date submitted
27/10/2022
Date registered
7/11/2022
Date last updated
2/12/2022
Date data sharing statement initially provided
7/11/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Inflammatory Bowel Disease - Lifestyle Food and Exercise (IBD-LiFE) study
Scientific title
Inflammatory Bowel Disease-Lifestyle, Food, and Exercise (IBD-LiFE) study : A randomised controlled trial to assess the effectivenessof a personalised nutrition and exercise intervention for people with inflammatory bowel disease in Aotearoa, New Zealand
Secondary ID [1] 307963 0
Nil known
Universal Trial Number (UTN)
Trial acronym
IBD-LiFE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammatory bowel disease 327620 0
Condition category
Condition code
Oral and Gastrointestinal 324709 324709 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 324420 0
Lifestyle
Comparator / control treatment
Usual care

Participants in the control group will receive the Heart Foundation "Eat for Health" pamphlet and a compiled physical activity information available on the New Zealand Heart Foundation website titled 'Physical Activity' without any personalisation.

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.
Control group
Active

Outcomes
Primary outcome [1] 332736 0
1. Changes in body fat mass (kg) measured by Dual Energy X-ray Absorptiometry (DEXA)
Timepoint [1] 332736 0
Baseline and endpoint (after 6 months of intervention)
Secondary outcome [1] 414549 0
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.
Timepoint [1] 414549 0
Baseline and endpoint (after 6 months of intervention)
Secondary outcome [2] 414551 0
Changes in anthropometric measurements (waist-hip ratio). This will be measured using a body tape measure.
Timepoint [2] 414551 0
Baseline and endpoint (after 6 months of intervention)
Secondary outcome [3] 414552 0
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.
Timepoint [3] 414552 0
Baseline, 1 month, and endpoint (after 6 months of intervention)
Secondary outcome [4] 414553 0
Changes in dietary intake and adherence to the nutrition intervention using 3-day food records. This will be assessed as a composite outcome.
Timepoint [4] 414553 0
Baseline, 1 month, and endpoint (after 6 months of intervention)
Secondary outcome [5] 414554 0
Changes in nutrition serum biomarkers (lipid profile, vitamin B12, vitamin D, folate, iron studies). This will be assessed as a composite outcome.
Timepoint [5] 414554 0
Baseline and endpoint (after 6 months of intervention)
Secondary outcome [6] 414555 0
Changes in IBD-disease activity measures: disease severity scores using Harvey Bradshaw Index (HBI) or Simple Clinical Colitis Activity Index (SCCAI)
Timepoint [6] 414555 0
Baseline, 1 month, and endpoint (after 6 months of intervention)
Secondary outcome [7] 415247 0
Changes IBD biomarkers (serum C-reactive protein and faecal calprotectin)
Timepoint [7] 415247 0
Baseline and endpoint (after 6 months of intervention)
Secondary outcome [8] 415250 0
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.
Timepoint [8] 415250 0
Baseline, 1 month, and endpoint (after 6 months of intervention)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The research biostatistician will generate a randomisation table using a statistical software, Stata.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified random sampling will be used to assign participants evenly into the usual care group and the personalised care group based on IBD diagnosis, sex, and smoking status.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Specifying a two-sided alpha level of 0.05 (Type I error) and assuming approximately equal standard deviations in each group, a total sample size of 64 (32 per group, assuming a 20% dropout rate after the original restricted recruitment of 80 individuals) will ensure there is over 80% power to detect a 0.75 standard deviation difference (medium-large effect size) in body fat mass changes between the intervention and control group.

General linear regression models will be used to investigate the association between the intervention and the body composition primary outcome measure (body fat mass) and will include baseline values as a covariate. This approach will allow the incorporation of potential important covariates such as age, ethnicity, and medications in a multivariable adjusted model. Standard diagnostics will be used to assess the residuals of each model for evidence of heteroscedasticity and non-normal distribution. Stata software version 17.0 will be used for all statistical analyses with two-sided p<0.05 considered statistically significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/02/2023
Actual
Date of last participant enrolment
Anticipated
1/12/2023
Actual
Date of last data collection
Anticipated
28/06/2024
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 25047 0
New Zealand
State/province [1] 25047 0
Dunedin

Funding & Sponsors
Funding source category [1] 312230 0
University
Name [1] 312230 0
Gut Health Network, University of Otago
Country [1] 312230 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
201 Great King St
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 313765 0
None
Name [1] 313765 0
Address [1] 313765 0
Country [1] 313765 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311609 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 311609 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 311609 0
New Zealand
Date submitted for ethics approval [1] 311609 0
07/10/2022
Approval date [1] 311609 0
21/11/2022
Ethics approval number [1] 311609 0
2022 EXP 13602

Summary
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.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121702 0
Prof Michael Schultz
Address 121702 0
Department of Medicine
University of Otago, Dunedin
362 Leith Street
Dunedin
9016
Country 121702 0
New Zealand
Phone 121702 0
+64 474 0999
Fax 121702 0
Email 121702 0
michael.schultz@otago.ac.nz
Contact person for public queries
Name 121703 0
Miss Jia Yap
Address 121703 0
Department of Medicine
University of Otago, Dunedin
362 Leith Street
Dunedin
9016
Country 121703 0
New Zealand
Phone 121703 0
+64 0275451072
Fax 121703 0
Email 121703 0
yapji273@student.otago.ac.nz
Contact person for scientific queries
Name 121704 0
Miss Jia Yap
Address 121704 0
Department of Medicine
University of Otago, Dunedin
362 Leith Street
Dunedin
9016
Country 121704 0
New Zealand
Phone 121704 0
+64 0275451072
Fax 121704 0
Email 121704 0
yapji273@student.otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No consent has be obtained for this


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.