Background
Methods/design
Study design
Recruitment of the study population
Study population and invitation procedure
Initial screening
Measurements | Method or sample used | Screening -recruitment period | RCT | |||||
---|---|---|---|---|---|---|---|---|
Baseline (T0) | 6 Months | 1 year (T1) | 2 years (T2) | |||||
SC | HV | SC | HV | |||||
I. Laboratory assessments
| ||||||||
1.Fasting plasma glucose, HbA1c, insulin | Fasting venous blood sample | x | x | x | d | x | d | |
2.2-h Postload glucose | 2-h postload glucose | b | x | x | x | |||
3.Triglycerides, HDL, LDL, cholesterol, creatinine, hs-CRP | Fasting venous blood sample | x | x | x | ||||
4.Albumin and creatinine (urine) | Fasting urine sample | x | x | x | x | x | x | |
5.Blood sample storage (serum, EDTA) | Fasting venous blood sample | b | c | x | ||||
II.Anthropometry
| ||||||||
6.Weight, height, blood pressure (Omron M5-1) | SOP: twice, blood pressure measured 5 times | x | x | x | x | x | x | |
7. Waist and hip circumferences, fat percentage (Omron 500) | SOP: twice | b | x | x | x | |||
III. Behavior
| ||||||||
Questionnaire (interview) | x | x | x | x | x | |||
9.Diet (based on guideline for healthful diet) | Questionnaire (interview) | x | x | x | x | x | x | |
10.Smoking [24] | Questionnaire (interview) | x | x | x | x | x | x | |
11.Alcohol [25] | Questionnaire (interview) | x | x | x | x | x | x | |
IV. Other measurements
a
| ||||||||
12.Ethnicity, household information | Questionnaire | x | ||||||
13.Education, income, insurance, religion [26] | Questionnaire (interview) | education | x | x | x | x | x | |
14.Physical health (cardiovascular risk profile; [27]) | Questionnaire (interview) | f | g | g | g | g | g | |
SOP | x | x | x | |||||
Questionnaire (interview) | x | x | x | x | x | |||
17.Distress (part of 4DSQ; [32]) | Questionnaire (interview) | x | x | x | x | x | ||
18.Risk perception ([33] and our own questionnaire) | Questionnaire (interview) | x | x | x | x | x | x | |
19.Attitude, knowledge, social support, self-efficacy, and stages of change in PA and diet | Questionnaire (interview) | x | x | x | x | x | ||
20.Perception of one’s own body | Questionnaire (interview) | x | x | x | x | x | ||
V. Process
| ||||||||
21.Dose received (participation in intervention components, frequency, leaflet, satisfaction) | Questionnaire (interview) | x | ||||||
VI. Costs
| ||||||||
1.Use of health care | Questionnaire (interview) | x | x | x | x | x | ||
2.Costs of screening and lifestyle intervention | Questionnaire (interview) | h | x | x | x | x | x |
Inclusion and exclusion criteria
Response and participation
Participation in the initial screening
Participation in the randomized controlled trial
All eligible people | Participants | Nonparticipants | Significance* | |
---|---|---|---|---|
n = 956^
|
n = 536 |
n = 420 | ||
Median age in years | 44 (36–51) | 45 (37–52) | 44 (35–51) | 0.13 |
Men (%) | 468 (49.0) | 265 (49.4) | 203 (48.3) | 0.73 |
18–34 years (%) | 212 (22.2) | 109 (20.3) | 103 (24.5) | |
35–44 years (%) | 280 (29.3) | 159 (29.7) | 121 (28.8) | |
45–60 years (%) | 464 (48.5) | 268 (50.0) | 196 (46.7) | |
Education (%) | 0.02** | |||
Elementarya
| 126 (13.6) | 61 (11.7) | 65 (16.1) | |
Intermediateb
| 645 (69.8) | 364 (70.0) | 281 (69.6) | |
University or equivalentc
| 153 (16.6) | 95 (18.3) | 58 (14.4) | |
Relatives with DM (%)d
| 685 (73.7) | 398 (76.2) | 287 (70.3) | 0.04** |
Median weight in kg | 73.5 (64.8–82.0) | 73.3 (65.0–82.1) | 73.8 (64.0–82.1) | 0.90 |
Median BMI in kg/m2
| 26.8 (24.4–29.9) | 26.8 (24.5–29.7) | 26.7 (24.1–30.3) | 0.98 |
Overweight: ≥ 23 kg/m2 (%)e
| 419 (44.9) | 246 (46.9) | 173 (42.3) | 0.17 |
Obesity: ≥ 27.5 kg/m2 (%)e
| 412 (44.1) | 227 (43.2) | 185 (45.2) | 0.54 |
Median SBP in mm Hg | 128.0 (119.0–38.0) | 127.0 (118.0–137.0) | 129.0 (120.0–0.0) | 0.07 |
Median DBP in mm Hg | 83.0 (76.0–90.0) | 82.0 (76.0–90.0) | 84.0 (76.0–92.0) | 0.06 |
Hypertension (%)f|
| 62 (38.4) | 196 (37.1) | 166 (40.1) | 0.34 |
Median FPG (mmol/l) | 5.3 (4.9–5.7) | 5.3 (4.9–5.7) | 5.4 (5.0–5.7) | 0.61 |
Elevated FPG†(%) | 332 (34.8) | 174 (32.5) | 158 (37.9) | 0.08 |
Median HbA1c in percentage | 5.7 (5.4–6.0) | 5.7 (5.4–6.0) | 5.7 (5.4–5.9) | 0.36 |
Elevated HbA1c: ≥ 6.0% (%) | 238 (25.1) | 138 (25.8) | 100 (24.2) | 0.57 |
Median HOMA in mmol/mol | 3.2 (2.6–4.4) | 3.2 (2.5–4.3) | 3.3 (2.7–4.4) | 0.36 |
HOMA-IR: ≥ 2.39 (%) | 800 (84.0) | 453 (84.5) | 347 (83.4) | 0.65 |
Baseline characteristics of the participants
Participants | Intervention group | Control group | Significance* | |
---|---|---|---|---|
n = 536 |
n = 283 |
n = 253 | ||
Median age in years | 45 (37–52) | 45 (37–52) | 44 (37–51) | 0.49 |
Men (%) | 265 (49.4) | 136 (48.1) | 129 (51.0) | 0.50 |
Education (%) | 0.36 | |||
Elementarya
| 61 (11.7) | 27 (9.9) | 34 (13.7) | |
Intermediateb
| 364 (70.0) | 192 (70.6) | 172 (69.4) | |
University or equivalentc
| 95 (18.3) | 53 (19.5) | 42 (16.9) | |
Family with DM (%)d
| 398 (76.2) | 214 (77.8) | 184 (74.5) | 0.37 |
Median BMI in kg/m2
| 26.9 (24.5–29.6) | 26.9 (24.7–29.5) | 27.0 (24.4–29.8) | 0.90 |
Mean waist circumference in cm | ||||
Men | 95.0 (10.9) | 95.0 (10.5) | 95.0 (11.4) | 0.99 |
Women | 90.7 (10.5) | 90.4 (10.6) | 91.1 (10.4) | 0.60 |
Median SBP in mm Hg | 125.5 (117.0–37.3) | 125.7 (117.5–7.5) | 125.0 (116.5–36.5) | 0.53 |
Mean DBP in mm Hg | 83.0 (10.0) | 83.3 (9.9) | 82.7 (10.2) | 0.51 |
Hypertension (%)e|
| 200 (38.6) | 105 (38.3) | 95 (38.9) | 0.89 |
Plasma glucose in mmol/l | ||||
Mean FPG | 5.3 (0.5) | 5.3 (0.6) | 5.3 (0.5) | 0.77 |
Median 2-h postload glucose | 5.8 (4.8–6.9) | 5.9 (5.0–7.0) | 5.5 (4.8–6.9) | 0.12 |
Median HbA1c in % | 5.7 (5.4–5.9) | 5.7 (5.4–5.9) | 5.6 (5.4–5.9) | 0.31 |
Median HOMA-IR | 3.1 (2.2–4.1) | 3.1 (2.2–4.2) | 3.0 (2.3–4.1) | 0.91 |
Median insulin in pmol/l | 12.9 (9.6–17.3) | 13.4 (9.6–17.5) | 12.8 (9.6–17.1) | 0.86 |
Mean LDL in mmol/l | 3.2 (0.9) | 3.2 (0.8) | 3.2 (0.9) | 0.83 |
Median HDL in mmol/l) | 1.2 (1.0–1.4) | 1.2 (1.1–1.4) | 1.2 (1.0–1.4) | 0.27 |