10 Weeks, visits, and REDCap instruments
This document explains how the study weeks, visits, and REDCap instruments relate to each other within the feasibility study. The main study will have included many of these details into the design of REDCap.
The feasibility study for ON LiMiT is divided into three sections, or phases, with a pre-phase section for screening and initial consent. The study is conducted over a period of 52 weeks, with a number of study site visits and dietician-led group sessions. The table below shows the relationship between the study weeks (not calendar weeks), visits, and instruments used in the feasibility study.
10.1 Phases of the study
In this section we will describe the different phases of the study and how they relate solely to the REDCap collected data. There are a number of other data collection points that are not captured in REDCap, such as scans, blood tests, diet compliance, and exercise data. These are not captured in REDCap and will be described in a separate section.
10.1.1 Pre-phase: The screening phase
This phase is leading up to active participation in the study. This comprise of study week -5 up to and including week 0 and this is where study site visits 1 to 4 takes place where the bulk of the demographic data is captured alongside a number of questionnaires and other relevant data.
10.1.2 Phase 1: The weight loss phase
This is the first 12 study weeks from 1-12 where study site visits 5 and 6 fall. In this phase the participants have two large visit days as well as five sessions with dieticians. The challenge with the feasibility data is that the dieticians have decided to group their meetings based on the phases, whereas the study site visits are individual events with a clear naming based on the visit number.
There is a mismatch between the name of the instruments for the dietician-led group sessions and the instrument names. The name the dieticians see on screen is referencing weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18. The instrument names in REDCap are referencing weeks 1, 3, 5, 7, 9, 11, 13, 15, 17, and 18.
The date field from the first dietician-led group session is used to determine the start of the study for the individual participants. This can in turn be used to determine the week number for all the instruments that do not have a week number associated with them.
10.1.3 Phase 2: The re-introduction of food phase
This phase is weeks 13-18 where normal food is slowly re-introduced. There are two study visits (7 in week 16 and 8 in week 18), and five dietician-led group sessions.
10.1.4 Phase 3: The maintenance phase
This is weeks 19-52 for feasibility. There are two weeks where the participants HbA1c is measured (weeks 30 and 42) and two study site visits (9 in week 51 and 10 in week 52). There are also four individual sessions with the dieticians. At the end of the study (in week 52) the participants will have a final study site visit where the same questionnaires and data are captured as in the pre-phase.
10.2 Table of weeks, visits, and instruments
This section shows the relationship between the weeks, visits, and instruments where the instruments have a relationship to a fixed study week (or weeks). The numbering in brackets after the instrument name indicates that this instrument is collected multiple times throughout the study. For instance (1. time) shows that this is the visit where the instrument is completed the first time. REDCap will automatically create a new instance of the instrument for each time it is set to be used in the Event planning.
| Phase | Study week | Visit | Instrument name | Repetition times |
|---|---|---|---|---|
| Pre | -5 | 0 | prscreening_telefoninterview_frste_kontakt | |
| Pre | -4 | 1 | besg_1_screening | |
| Pre | -4 | 1 | bedq | 1 |
| Pre | -3 | 2 | besoegsdag_2 | |
| Pre | -3 | 2 | vas | 1 |
| Pre | -2 | 3 | besoegsdag_3 | |
| Pre | -2 | 3 | vas | 2 |
| Pre | -1 | 4 | besoegsdag_4 | |
| Pre | -1 | 4 | vas | 3 |
| Pre | -1 | 4 | randomisering | |
| Pre | -1 | 4 | sociodemografiske_karakteristika | 1 |
| Pre | -1 | 4 | diabetes_status | 1 |
| Pre | -1 | 4 | pittsburgh_sleep_quality_index_psqi | 1 |
| Pre | -1 | 4 | physical_and_mental_health_sf12 | 1 |
| Pre | -1 | 4 | european_quality_of_life_5_dimensions_eq5d5l | 1 |
| Pre | -1 | 4 | tobacco_and_nicotine_use | 1 |
| Pre | -1 | 4 | sefnc_baseline_v4 | 1 |
| Pre | -1 | 4 | item_bodily_distress_syndrome_checklist | 1 |
| Pre | -1 | 4 | the_three_item_loneliness_scale_tils | 1 |
| Pre | -1 | 4 | yale_food_addiction_scale_yfas | 1 |
| Pre | -1 | 4 | social_support_for_eating_habits | 1 |
| Pre | -1 | 4 | diabetes_distress_paid5_scale | 1 |
| 1 | 0 | gruppemde_uge_1 | ||
| 1 | 2 | gruppemde_uge_3 | ||
| 1 | 4 | gruppemde_uge_5 | ||
| 1 | 6 | gruppemde_uge_7 | ||
| 1 | 8 | gruppemde_uge_9 | ||
| 1 | 11 | 5 | besgsdag_5 | |
| 1 | 12 | gruppemde_uge_11 | ||
| 1 | 12 | 6 | besgsdag_6 | |
| 1 | 12 | 6 | vas | 4 |
| 1 | 12 | 6 | pittsburgh_sleep_quality_index_psqi | 2 |
| 1 | 12 | 6 | physical_and_mental_health_sf12 | 2 |
| 1 | 12 | 6 | european_quality_of_life_5_dimensions_eq5d5l | 2 |
| 1 | 12 | 6 | tobacco_and_nicotine_use | 2 |
| 1 | 12 | 6 | sefnc_week12_v6 | |
| 1 | 12 | 6 | item_bodily_distress_syndrome_checklist | 2 |
| 1 | 12 | 6 | the_three_item_loneliness_scale_tils | 2 |
| 1 | 12 | 6 | yale_food_addiction_scale_yfas | 2 |
| 1 | 12 | 6 | social_support_for_eating_habits | 2 |
| 1 | 12 | 6 | diabetes_distress_paid5_scale | 2 |
| 2 | 14 | gruppemde_uge_13 | ||
| 2 | 16 | gruppemde_uge_15 | ||
| 2 | 16 | 7 | besgsdag_7 | |
| 2 | 16 | gruppemde_uge_17 | ||
| 2 | 18 | 8 | besgsdag_8 | |
| 2 | 18 | 8 | vas | 5 |
| 2 | 18 | gruppemde_uge_18 | ||
| 3 | 30 | hba1c_uge_30 | ||
| 3 | 42 | hba1c_uge_42 | ||
| 3 | 51 | 9 | besoegsdag_9 | |
| 3 | 52 | 10 | besgsdag_10_5f76 | |
| 3 | 52 | 10 | vas | 6 |
| 3 | 52 | 10 | sociodemografiske_karakteristika_short | |
| 3 | 52 | 10 | diabetes_status | 2 |
| 3 | 52 | 10 | pittsburgh_sleep_quality_index_psqi | 3 |
| 3 | 52 | 10 | physical_and_mental_health_sf12 | 3 |
| 3 | 52 | 10 | european_quality_of_life_5_dimensions_eq5d5l | 3 |
| 3 | 52 | 10 | tobacco_and_nicotine_use | 3 |
| 3 | 52 | 10 | selfefficacy_for_nutrition_change_sefnc_week_52 | |
| 3 | 52 | 10 | item_bodily_distress_syndrome_checklist | 3 |
| 3 | 52 | 10 | the_three_item_loneliness_scale_tils | 3 |
| 3 | 52 | 10 | yale_food_addiction_scale_yfas | 3 |
| 3 | 52 | 10 | social_support_for_eating_habits | 3 |
| 3 | 52 | 10 | diabetes_distress_paid5_scale | 3 |
10.3 Recurring REDCap instruments
In this section is shown the REDCap instruments that are not tied to a specific week or visit, meaning they are collected throughout the study. All of these instruments have a manually entered date field that is used to calculate the week number.
| Instrument | Description | Start study week | End study week |
|---|---|---|---|
| stamdata | Basic information about the participant as well as information about drop-out or completion of study | 1 | 52 |
| adverse_events | Any adverse event the participant experience throughout the study | 1 | 52 |
| fase_1_ditetiske_afvigelser | Any deviation from the NUPO diet | 1 | 11 |
| fase_2_ditetiske_afvigelser | Any deviation from the reintroduction of normal meals | 12 | 18 |
| fase_3_ditetiske_afvigelser | Any deviation from the recommended diet | 18 | 52 |
| trningsafvigelser | Any deviation from the recommended exercise | 18 | 52 |
| ekstra_kontakt | Any contact between study staff and the participant that falls outside the standard touch points. The form as a date for the contact and it is expected that the form is completed on the day of the contact. | 1 | 52 |
| hba1c_follow_up | Any extra HbA1c testing done at the lab if the study team suspects that there is a problem | 1 | 52 |
| medicine_changes | Any changes to medicine during the study | 1 | 52 |
| individual_ditistsamtale_1 | Allocated time to catch up with each participant during phase 3 | 18 | 52 |
| individual_ditistsamtale_2 | Allocated time to catch up with each participant during phase 3 | 18 | 52 |
| individual_ditistsamtale_3 | Allocated time to catch up with each participant during phase 3 | 18 | 52 |
| individual_ditistsamtale_4 | Allocated time to catch up with each participant during phase 3 | 18 | 52 |