Aim: This study aimed to conduct a process evaluation of a 3-arm parallel randomised controlled trial which tested the provision of early and intensive nutrition intervention delivered via synchronous, telephone based approach or an asynchronous, mobile based approach to improve quality of life in patients with upper gastrointestinal cancers.
Methods: The nutrition intervention was delivered via telephone or mobile health (m-health) using behaviour change techniques to assist in goal achievement. A range of analysis techniques were used to test for predictive relationships of between health related quality of life and nutrition outcomes.
Results: The telephone group had 1.98 (95% CI 1.67-2.36, p<0.001) times increased frequency of contact with the research dietitian; increased frequency of goal achievement (IRR 2.37 95% CI: 1.1 to 5.11, p=0.028) with the dose of intervention positively impacting on participant goal achievement (RR 0.03, 95% CI: 0.01 to 0.04, p<0.001), with a higher baseline MST score (-0.04, 95% CI: -0.08 to -0.00, p=0.05) predicting a small decrease in health related quality of life at 6 months, all compared to the mobile application group. The mobile application based group also had a higher risk of withdrawal from the intervention (risk ratio 0.16, 95% CI 0.02 to 1.25) and had less engagement with the nutrition intervention.
Conclusion: This process and mechanisms of action study revealed that synchronous, telephone based early and intensive nutrition interventions allowed individuals to engage more with the intervention, set more goals and achieve more behaviour change which resulted in better health related quality of life at 6 months than the asynchronous, electronic group. Higher risk of withdrawal in the mobile application group highlights issues with engagement and overall intervention dose received.