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Table 1 PRECIS-2 Scoring Tool [51]

From: Study protocol of a pragmatic randomized controlled trial incorporated into the Group Lifestyle Balance™ program: the nutrigenomics, overweight/obesity and weight management trial (the NOW trial)

PRECIS-2 Domain

Score [Likert scale 1 (very explanatory) - 5 (very pragmatic)]

1. Eligibility: To what extent are the participants in the trial similar to those who would receive this intervention if it was part of usual care?

5

2. Recruitment: How much extra effort is made to recruit participants over and above what would be used in the usual care setting to engage with patients?

5

3. Setting: How different are the settings of the trial from the usual setting?

5

4. Organization: How different are the resources, provider expertise, and the organization of care delivery in the intervention arm of the trial from those available in usual care?

4

5. Flexibility (delivery): How different is the flexibility in how the intervention is delivered and the flexibility anticipated in usual care?

4

6. Flexibility (adherence): How different is the flexibility in how participants are monitored and encouraged to adhere to the intervention from the flexibility anticipated in usual care?

4

7. Follow-up: How different is the intensity of measurement and follow-up of participants in the trial from the typical follow-up in usual care?

3

8. Primary outcome: To what extent is the trial’s primary outcome directly relevant to participants?

5

9. Primary analysis: To what extent are all data included in the analysis of the primary outcome?

TBD

Mean score:

4.4