Meal replacement v2: test feasibility before efficacy
Real sources · Illustrative request · Sample version
Customer question
A fictional meal replacement v2 proposes a four-week study of acceptability and a prespecified satiety outcome in healthy adults.
Start with feasibility measurement, or is there enough information to design an efficacy study?
Recruitment, adherence and measurement completion address feasibility. Satiety effects need an appropriate comparator and prespecified analysis.
Measurement plan for a four-week pilot
| Check / stage | Chart content |
|---|---|
| Before start | Product/safety review, aims, ethics and data permissions |
| Week 0 | Baseline, usual diet and satiety-measurement rules |
| Weeks 1–4 | Use, adherence, adverse experiences, withdrawal and missing measures |
| Week 4 | Prespecified outcomes and feasibility data; no effect numbers yet |
| Stage decision | Continue, modify or stop against predefined conditions |
Four weeks and use are assumptions to assess, not nutrition recommendations. Sample size follows the primary outcome and feasibility aims; no favourable result is assumed.
Analysis excerpt
| Check | Finding / sample content | Use |
|---|---|---|
| Primary question | Willingness to buy does not replace the prespecified satiety outcome | Define commercial, experiential and health measures separately |
| Decision gate | First establish recruitment, delivery and data feasibility | Then decide efficacy-study design and budget |
Delivery manifest
| File | Format | Contents |
|---|---|---|
| study-question-brief.pdf | Evidence gaps, priority question and stage-decision conditions for one version. | |
| pilot-protocol.docx | DOCX | Protocol framework: comparator, primary outcome, measurements, withdrawal and adverse-experience recording. |
| data-dictionary.xlsx | XLSX | Variables, measures, time points, units, missing-data codes and analysis roles. |
This is an illustrative formal delivery manifest. This pack supplies an HTML report, CSV tables and a source register. Agree formal formats, quantities and scope in the quote.
Acceptance criteria
- Business-experience measures and health outcomes are separated; the primary outcome and timing are prespecified.
- Comparator, key confounding, adherence, missingness and adverse experiences are addressed.
- Sample-size parameters are sourced or labelled as assumptions. Design, execution and external-cost boundaries enable provider quotations.
Sources
- EFSA 2021: Scientific and technical guidance for health claim applications
https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2021.6554 - CONSORT 2016: Extension for randomised pilot and feasibility trials
https://doi.org/10.1136/bmj.i5239