Background
Methods
Recruitment
Intervention
Measures
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. | ||||
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 ‘worries about my mom/dad/ children’ | ||||
2. Own health: (for example, ‘I’m afraid of getting diabetes myself’; ‘I think I’m too young to get it [diabetes]!’ | ||||
-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, ‘What is the primary cause of T2DM? Does stress affect development of T2DM’, ‘How important is eating healthy food, and what is considered to be healthy?’) | ||||
2. Questions about diabetes treatment and complications (for example, ‘Why do some people receive pills and others insulin treatment?’, ‘How can someone prevent getting polyneuropathy?’). | ||||
3. interests in relation diabetes prevention? | Quotes of participants | Categories of reasons to participate: | ||
1. Risk awareness and worry (for example ‘My risk of getting diabetes is high’) | ||||
2. Information seeking (for example, ‘How are lifestyle and diabetes risk related?’) | ||||
3. Motivation (for example, ‘Stimulates me to improve my exercise behavior’). | ||||
Questionnaire | - perceptions of worry[13] | 1 = totally not worried | No significant changes for worry about personal risk and personal control of developing T2DM, for example: | |
-at baseline | ||||
7 = very worried | ||||
Indicate your feelings when thinking about chance of getting diabetes: baseline 5.0 ± 1.6; follow-up 5.0 ± 1.6; P = 0.92) | ||||
−4 weeks follow-up (Participant) | ||||
- personal control[13] | 1 = totally disagree | No significant changes for personal control of developing T2DM, for example: | ||
5 = totally agree | ||||
I think I have little influence on getting T2DM: baseline 2.5 ± 1.1; follow-up 1.9 ± 1.0; P = 0.08 | ||||
I can reduce my risk of getting diabetes: baseline 4.3 ± 0.7; follow-up 4.3 ± 1.2; P = 0.92 | ||||
I think I have little control over my own health: baseline 1.8 ± 0.7; follow-up 1.8 ± 0.7; P = 0.85 | ||||
- perceived consequences of T2DM[13] | 1 = totally disagree | Significant increase of perceived consequences of getting T2DM, for example: | ||
5 = totally agree | ||||
Major implications for life: baseline 4.2 ± 0.8; follow-up 4.5 ± 0.7; P = 0.04 | ||||
Major financial implicationsa: baseline 2.9 ± 1.1; follow-up 3.4 ± 1.0; 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 n = 14 (66%), announcement on internet n = 3 (14.4%) and via a relative n = 3 (14.4%) |
-at baseline (Participant) | ||||
Observations | - time, duration of the modules/sessions | Minutes per module reported on checklist | All modules were delivered within 2 × 150 minutes; duration of modules deviated sometimes from planned time. | |
-during the intervention sessions (Observer) | ||||
Questionnaire | - length of sessions was good: | 1 = totally disagree | 90% of the participants evaluated the length of the sessions ‘good’ score ≥3 | |
-follow-up 4 weeks (Participant) | ||||
4 = totally agree | ||||
Evaluation form | - group size | Multiple choice: too small, just right, too large | All participants evaluated the group size ‘just right’ | |
-at the end of second session (Participant) | ||||
Acceptability measures
| Evaluation form | - generic grade for total intervention: (mean ± SD) | 1 (lowest grade) | 8.0 ± 1.0 |
-at the end of second session (Participant) | ||||
10 (highest grade) | ||||
- usefulness of the separate modules (mean ± SD) | 1 = very useful | Introduction 1.5 ±0.5; Risk factors 1.3 ±0.5; Development of diabetes 1.3 ±0.6; Homework 1.8 ±0.9; Information about physical activity 1.4 ±0.5; Information about diet 1.5 ±0.8; Action plan 1.7 ±0.8; Questions 1.5 ±0.7 | ||
5 = totally not useful | ||||
Questionnaire | - participants manual: instructive and clear | 1 = totally disagree | Instructive 3.4 ±0.5; clear 3.4 ±0.5 | |
-follow-up 4 weeks (Participant) | ||||
4 = totally agree | ||||
- action plan: managed to make one and useful | 1 = totally disagree | Managed to make an action plan 2.8 ±0.5; useful to create a personal action plan 3.1 ±0.6 | ||
4 = totally agree | ||||
(mean ± SD) |
Determinant of behavioral change (HAPA) | Domain and instrument | Questions (scale) | Baseline | Follow-up |
---|---|---|---|---|
N = 17 | N = 16 | |||
Risk perception
| 1. Causal beliefs: (Revised Illness Perception Questionnaire)[14] |
Indicate the extent to which you believe that a given cause could be a cause of diabetes (1 = definitely not; 5 = definitely)
| ||
- Heredity | 4.3 ±0.7 | 4.4 ±0.9 | ||
- Aging | 4.2 ±0.8 | 4.1 ±1.0 | ||
- Lifestyle (smoking, alcohol use, lack of physical activity and nutrition habits)a,b
| 4.0 ±0.6 | 4.0 ±1.0 | ||
- Stress or worry | 3.3 ±1.3 | 3.2 ±1.4 | ||
- Country of origin | 3.2 ±1.6 | 4.1 ±1.0e
| ||
2. Comparative risk: adopted from Claassen et al.[13] | What is the chance of you getting diabetes compared with an average man/woman your age? (1 = a lot lower; 7 = a lot higher)
| 5.4 ±1.0 | 4.7 ±1.3 | |
3. Risk estimation[13] |
How big is the chance of you getting diabetes within the next 5 years? ( 1 = very small; 7 = very big )
| 4.7 ±1.5 | 4.7 ±1.3 | |
Outcome expectancies
| For healthy diet and increasing physical activity: adopted from Schwarzer et al.[15] | 1. Diet: If I eat healthy foods: I feel healthy/I will lose weight/I will look better/I feel relaxed (1 = totally disagree; 5 = totally agree) (sum score 4 to 20)
a,b
| 16.0 ±2.5 | 15.9 ±1.7 |
2. Physical activity: If I exercise more: I feel healthy/I will lose weight/I will look better (1 = totally disagree; 5 = totally agree) (sum score 3 to 15)
a,c
| 12.2 ±1.4 | 12.5 ±1.4 | ||
Self-efficacy
| For healthy diet and physical activity: adopted from Schwarzer et al.[16] | 1. Diet: I am confident that I can eat healthy food - even if I: need a long time to develop the necessary routines/try several times until it works/have to rethink my entire way of nutrition/do not receive a great deal of support from others when making my first attempts/have to make a detailed plan (1 = very unconfident; 4 = very confident) (sum score 4 to 20)
b
| 13.8 ±3.2 | 13.8 ±3.1 |
2. Physical activity: I can manage to carry out my exercise intentions even when I: have worries and problems/feel depressed/feel tense/am tired/am busy. (1 = very unconfident; 4 = very confident) (sum score 4 to 20)
b
| 12.0 ±3.3 | 12.6 ±4.0 | ||
Intentions
| For healthy diet, physical activity losing weight[15] |
In the next three months I’m going to: (1 = totally disagree; 5 = totally agree)
| ||
1. eat healthy | 3.7 ±0.9 | 3.6 ±1.0 | ||
2. exercise more | 3.7 ±0.9 | 3.8 ±0.9 | ||
3. lose weight | 3.9 ±0.7 | 3.7 ±1.0 | ||
Planning
| For healthy diet and physical activity[15] | 1. Diet: I have concrete plans… what/how to change nutrition habits/what to do in difficult situations in order to stick to my intentions.
| ||
(1 = totally disagree to 4 = tot ally agree) (sum score 3 to 12)
a,b
| ||||
2. Physical activity: I have concrete plans when/where/how/how many times/with whom I’m going to exercise/what to do in difficult situations in order
| ||||
to stick to my intentions (1 = totally disagree; 4 = totally agree) (sum score 6 to 24)
d
|
Participant characteristics
Fidelity measures
Feasibility measures
Acceptability measures
Determinants of behavioral change
Data analysis
Results
Participant characteristics
Characteristic (N = 21) | |
---|---|
Age (years)
| 47.9 ±9.7 |
Female
| 18 (85.7%) |
Positive family history
| |
A first degree relative only | 20 (95.2%) |
A second degree relative only | 1 (4.8%) |
Both first and second degree relatives | 6 (28.6) |
Weight (kg)
| 81.1 ±17.5 |
Body mass index (kg/m
2
)
| 29.0 ±6.3 |
Normal (18 to 25) | 4 (19%) |
Overweight (25 to 30) | 10(47.6%) |
Obese (≥30) | 7 (33.3%) |
Reported elevated blood sugar in the past (yes)
| 7 (33.3%) |
Earlier attempts weight loss attempts (yes)
| 13 (61.9%) |
Mean number of attempts | 5.9 ±4.5 |
Current smoker (yes)
| 6 (28.5%) |
Education
a
| |
Lower | 10 (47.6%) |
Middle | 4 (19.0%) |
Higher | 7 (33.3%) |
Employed (yes)
| 12 (57.1%) |
Marital state - living with partner
| 11 (52.4%) |
Self reported ethnicity
| |
Dutch | 15 (71.4%) |
Other | 6 (28.6%) |