McNelly 2016.

Methods	RCT, 2 x 2 factorial design, part‐blinded
Participants	Diagnosed with Crohn's disease or ulcerative colitis in remission (CRP < 5 mg/dL and HBI < 5/SCCI < 3), who are self‐reporting fatigue, willing to increase current activity levels and able to take medication with ingredients derived from animal or fish sources. Exclusion criteria: At least 60 minutes of moderate‐to‐vigorous exercise performed per week; concurrent course of anticoagulant medications; concurrent participation in another randomised control trial; concurrent pregnancy; consumption of oily fish at least twice per week or eight times per month; Omega‐3 fatty acid supplements taken in the 12 weeks before screening; fatigue‐related comorbidities. A total of 74 participants were randomised (n = 52 completed the trial according to protocol) to one of four treatment groups (No physical activity advice (PAA) and omega 3 n = 14; PAA and omega 3 n = 11; No PAA and placebo n = 12; PAA and placebo n = 15). Age [Median(IQR) years] : No PAA with omega 3: 45 (36, 51); PAA with omega 3: 31 (29, 55); No PAA and placebo: 31 (27, 51); PAA and placebo: 35 (28, 43) Gender: No PAA and omega 3 (7 males, 7 females); PAA and omega 3 (6 males and 5 females); No PAA and placebo (4 males, 8 females); PAA and placebo (8 males and 7 females) Disease type: No PAA and omega (7 CD, 7 UC); PAA and omega 3 (6 CD and 5 UC); No PAA and placebo (6 CD, 6 UC); PAA and placebo (6 CD, 8 UC, 1 unclassified) Loss to follow‐up: n = 8; No PAA and omega 3 n = 0; PAA and omega 3 n = 4; no PAA and placebo n = 2; PAA and placebo n = 2 (author information). Reasons included clinically active disease (n = 3), pregnancy (n = 2), anaemia (n = 1); musculoskeletal injury (n = 1) and lack of time (n = 1).
Interventions	a) Physical activity advice ‐ received advice about initiating and maintaining motivation (using techniques of imagery, goal‐setting [for each week and the whole programme]) and discussed overcoming barriers to exercise (physical limitations and fears of worsening symptoms of IBD) b) Active supplementation ‐ two capsules containing a total of 2970 mg of omega‐3 fatty acids (EPA, 2250 mg; DHA, 150 mg) Mode of delivery a) face‐to‐face individual consultation with a personal trainer and one researcher b) orally with food Duration: a) 15 minutes b) daily for 12 weeks Setting of trial: Single‐centre London tertiary referral hospital (author information) Setting of delivery: IBD outpatient clinic. The exercise programme was undertaken either at home or at a gym. Comparision treatment: a) Placebo (capsules containing capric and caprylic acid) b) No physical activity advice (15 minute face‐to‐face individual consultation with the researcher discussing current dietary habits and general health) Co‐interventions: None
Outcomes	Fatigue was assessed using the FACIT‐F; MFI and IBD‐F. Quality of life was assessed using the IBDQ. Adverse events were recorded in the medication diary and assessed by the researcher during the 6 follow‐up contact time points. Other outcomes assessed: Depression; physical activity (diary and accelerometer), disease activity (HBI; SCCAI); body composition; Hgb; CRP Assessment time points: Baseline and week 12. All groups were contacted by the researcher on six occasions (a week following their second study visit, and then every two weeks) using email, text or telephone to discuss progress.
Notes	4‐arm trial Additional information was supplied by the author. The study was supported by the Big Lottery Fund [grant number GFTTAFR] and Crohn's and Colitis UK was the fund holder. No power calculation undertaken Data analysed with per protocol analyses
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Block randomisation using computer‐generated random numbers
Allocation concealment (selection bias)	Unclear risk	For the capsule assignment, sequentially named drug containers of identical appearance were provided by UCHL pharmacy. The first author performed the randomisation and enrollment of the participants for the physical activity advice intervention (open allocation) (author information).
Blinding of participants and personnel (performance bias) All outcomes	High risk	Participants and researchers were blinded to capsule type, but could not be blinded to the consultation type due to the nature of the intervention.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Self‐reported outcomes and participants not blinded to the physical activity advice group
Incomplete outcome data (attrition bias) All outcomes	Low risk	Loss to follow‐up relatively similar across the four groups and reasons comparable
Selective reporting (reporting bias)	Low risk	All information on outcomes were transparent and outcomes assessed were reported.
Other bias	Low risk	Baseline characteristics were similar between treatment groups. No apparent sources of bias