Category of measurement | Instrument and stage (by whom) | Topics measured | Scale | Results |
---|---|---|---|---|
Fidelity measures | Checklists | Coverage of the role of the trainer and the participants | Checklist coverage: yes/no tick box | Observations with checklists showed that all modules were delivered. The role of the trainer and the objectives for participants were covered. |
-during the intervention sessions(Observers) | ||||
Evaluations | Engagement of participants | Observations | Engagement was high, demonstrated by active questioning by participants, active participation at the calorie games, most participants completing the homework assignment and attendance in both group sessions. | |
-after each group session (Observers and Trainer) | ||||
Attrition was low: one participant was absent at the second session. | ||||
Ā | Ā | Empowerment philosophy | Observations | The trainer supports the empowerment philosophy during both sessions, see checklist for items of empowerment. |
Quotes of participants written down on flip-over sheets | Do relatives of T2DM patients have: | Quotes of participants | Participants have worries about: | |
1. Relatives (for example āworries about my mom/dad/ childrenā | ||||
2. Own health: (for example, āIām afraid of getting diabetes myselfā; āI think Iām too young to get it [diabetes]!ā | ||||
-during the first session (Trainer) | 1. worries? | |||
2. questions? | Quotes of participants | Main themes of burning questions: | ||
1. Diabetes causality and its relation to lifestyle (for example, āWhat is the primary cause of T2DM? Does stress affect development of T2DMā, āHow important is eating healthy food, and what is considered to be healthy?ā) | ||||
2. Questions about diabetes treatment and complications (for example, āWhy do some people receive pills and others insulin treatment?ā, āHow can someone prevent getting polyneuropathy?ā). | ||||
3. interests in relation diabetes prevention? | Quotes of participants | Categories of reasons to participate: | ||
1. Risk awareness and worry (for example āMy risk of getting diabetes is highā) | ||||
2. Information seeking (for example, āHow are lifestyle and diabetes risk related?ā) | ||||
3. Motivation (for example, āStimulates me to improve my exercise behaviorā). | ||||
Questionnaire | - perceptions of worry[13] | 1ā=ātotally not worried | No significant changes for worry about personal risk and personal control of developing T2DM, for example: | |
-at baseline | ||||
7ā=āvery worried | ||||
Indicate your feelings when thinking about chance of getting diabetes: baseline 5.0āĀ±ā1.6; follow-up 5.0āĀ±ā1.6; Pā=ā0.92) | ||||
ā4āweeks follow-up (Participant) | ||||
Ā | - personal control[13] | 1ā=ātotally disagree | No significant changes for personal control of developing T2DM, for example: | |
5ā=ātotally agree | ||||
I think I have little influence on getting T2DM: baseline 2.5āĀ±ā1.1; follow-up 1.9āĀ±ā1.0; Pā=ā0.08 | ||||
I can reduce my risk of getting diabetes: baseline 4.3āĀ±ā0.7; follow-up 4.3āĀ±ā1.2; Pā=ā0.92 | ||||
I think I have little control over my own health: baseline 1.8āĀ±ā0.7; follow-up 1.8āĀ±ā0.7; Pā=ā0.85 | ||||
- perceived consequences of T2DM[13] | 1ā=ātotally disagree | Significant increase of perceived consequences of getting T2DM, for example: | ||
5ā=ātotally agree | ||||
Major implications for life: baseline 4.2āĀ±ā0.8; follow-up 4.5āĀ±ā0.7; Pā=ā0.04 | ||||
Major financial implicationsa: baseline 2.9āĀ±ā1.1; follow-up 3.4āĀ±ā1.0; P <0.01 | ||||
Feasibility measures | Questionnaire | - which recruitment strategies were appropriate / How did participants knew about the study? | Multiple choice including 1 open-ended option. | Recruitment through flyers and advertisements nā=ā14 (66%), announcement on internet nā=ā3 (14.4%) and via a relative nā=ā3 (14.4%) |
-at baseline (Participant) | ||||
Observations | - time, duration of the modules/sessions | Minutes per module reported on checklist | All modules were delivered within 2āĆā150āminutes; duration of modules deviated sometimes from planned time. | |
-during the intervention sessions (Observer) | ||||
Questionnaire | - length of sessions was good: | 1ā=ātotally disagree | 90% of the participants evaluated the length of the sessions āgoodā score ā„3 | |
-follow-up 4ā weeks (Participant) | ||||
4ā=ātotally agree | ||||
Evaluation form | - group size | Multiple choice: too small, just right, too large | All participants evaluated the group size ājust rightā | |
-at the end of second session (Participant) | ||||
Acceptability measures | Evaluation form | - generic grade for total intervention: (meanāĀ±āSD) | 1 (lowest grade) | 8.0āĀ±ā1.0 |
-at the end of second session (Participant) | ||||
10 (highest grade) | ||||
- usefulness of the separate modules (meanāĀ±āSD) | 1ā=āvery useful | Introduction 1.5 Ā±0.5; Risk factors 1.3 Ā±0.5; Development of diabetes 1.3 Ā±0.6; Homework 1.8 Ā±0.9; Information about physical activity 1.4 Ā±0.5; Information about diet 1.5 Ā±0.8; Action plan 1.7 Ā±0.8; Questions 1.5 Ā±0.7 | ||
5ā=ātotally not useful | ||||
Questionnaire | - participants manual: instructive and clear | 1ā=ātotally disagree | Instructive 3.4 Ā±0.5; clear 3.4 Ā±0.5 | |
-follow-up 4ā weeks (Participant) | ||||
4ā=ātotally agree | ||||
- action plan: managed to make one and useful | 1ā=ātotally disagree | Managed to make an action plan 2.8 Ā±0.5; useful to create a personal action plan 3.1 Ā±0.6 | ||
4ā=ātotally agree | ||||
Ā | Ā | (meanāĀ±āSD) | Ā | Ā |