Introduction
Methods
Study design
Recruitment
Screening
Inclusion criteria
Ethical issues
Randomisation and consent
Interventions
DPM training and characteristics
Outcome measures
Health economic analysis
Statistical analysis and power estimates
CON | INT | INT-DPM | ||||
---|---|---|---|---|---|---|
n | n | n | ||||
Age (years) | 149 | 63.5 (10.0) | 142 | 64.6 (10.1) | 141 | 64.1 (9.9) |
Sex (n; %) | ||||||
Male | 149 | 63 (42.3%) | 142 | 61 (43.0 %) | 141 | 57 (40.4%) |
Female | 86 (57.7%) | 81 (57.0%) | 84 (59.6%) | |||
Family history type 2 diabetes (n; %) | 149 | 73 (49.0 %) | 142 | 58 (40.8%) | 141 | 63 (44.7%) |
Ethnicity | ||||||
White | 148 | 91.9 | 140 | 96.4 | 141 | 92.9 |
South Asian | 1.4 | 1.4 | 3.5 | |||
Black | 1.4 | 1.4 | 1.4 | |||
Others (%) | 5.4 | 0.7 | 2.1 | |||
Family history cardiovascular disease (n; %) | 13 (8.7) | 22 (15.5) | 25 (17.7) | |||
Social deprivation scorea | 149 | 16.8 (10.6) | 142 | 17.2 (13.7) | 141 | 16.3 (9.5) |
Weight (kg) | 149 | 93.3 (19.3) | 142 | 93.0 (17.4) | 141 | 93.7 (19.7) |
Body mass index (kg/m2) | 149 | 32.4 (6.4) | 142 | 32.4 (5.4) | 141 | 32.8 (6.4) |
Waist circumference (cm) | 149 | 108.6 (14.2) | 142 | 108.5(12.5) | 141 | 109.1 (14.2) |
Body fat mass (kg)b | 142 | 35.9 (9.6) | 139 | 36.5 (9.1) | 138 | 36.2 (8.7) |
Visceral fat scoreb | 142 | 15.2 (5.2) | 139 | 15.4 (4.6) | 138 | 16.0 (5.7) |
HbA1c (mmol/mol) | 149 | 52.5 (10.2) | 142 | 52.7 (11.3) | 141 | 51.1 (8.1) |
HbA1c < 58 mmol/mol (n; %)c | 149 | 129 (86.6%) | 142 | 124 (87.3%) | 141 | 129 (91.5%) |
HbA1c < 86 mmol/mol (n; %)c | 149 | 147 (98.7%) | 142 | 136 (95.8%) | 141 | 139 (98.6%) |
Fasting plasma glucose (mmol/l) | 149 | 7.2 (1.7) | 142 | 7.3 (1.8) | 141 | 7.1 (1.4) |
Fasting HDL cholesterol (mmol/l) | 140 | 1.26 (0.3) | 136 | 1.22 (0.3) | 139 | 1.23 (0.36) |
Fasting LDL cholesterol (mmol/l) | 136 | 3.2 (1.1) | 135 | 3.1 (1.0) | 136 | 3.1 (1.1) |
Fasting plasma insulin (pmol/l) | 142 | 106.3 (65.6) | 133 | 137.1 (107) | 138 | 124.3 (87.1) |
HOMA insulin sensitivity (%)d | 141 | 70.4 (54.3) | 131 | 55.9 (38.8) | 137 | 59.3 (39.5) |
HOMA beta cell function (%)d | 141 | 77.2 (36.8) | 131 | 93.3 (57.6) | 137 | 88.6 (48.3) |
Physical activity: MET minutes per weeke | 97 | 2523 (2590) | 97 | 2786 (2861) | 96 | 2786 (2912) |
Physical activity: minutes sitting per weeke | 107 | 445 (258) | 106 | 527 (336) | 99 | 473 (265) |
Dietary fibre intake scalef | 112 | 2.46 (0.37) | 116 | 2.40 (0.38) | 111 | 2.41 (0.38) |
Dietary fat scalef | 114 | 2.32 (0.32) | 116 | 2.33 (0.31) | 111 | 2.38 (0.28) |
ADD QoLg | 106 | 1.41 (0.94) | 108 | 1.17 (1.1) | 100 | 1.1 (1.01) |
W-BQ12g | 106 | 25.8 (5.7) | 102 | 23.6 (7.5) | 98 | 22.7 (7.7) |
EQ-5Df | 111 | 0.84 (0.18) | 112 | 0.82 (0.23) | 108 | 0.75 (0.27) |
Results
Participant recruitment and characteristics
Primary outcome
Analysis | INT-DPM vs INT | p | INT vs CONTROL | p | INT- DPM vs CONTROL | p | Combined INT vs CONTROL | p |
---|---|---|---|---|---|---|---|---|
Adjusted | −0.55 (−2.46, 1.35) | 0.57 | −2.14 (−4.33, 0.05) | 0.06 | −2.57 (−4.52,−0.61) | 0.01 | −2.38 (−4.08, −0.68) | 0.01 |
Imputed adjusted | −0.83 (−2.82, −1.15) | 0.41 | −1.92 (−4.01, 0.18) | 0.07 | −2.62 (−4.50, −0.74) | 0.007 | −2.30 (−3.96, −0.64) | 0.007 |
Subgroup analyses
INT-DPM vs INT | p | INT vs CONTROL | p | INT- DPM vs CONTROL | p | Combined intervention vs CONTROL | p | |
---|---|---|---|---|---|---|---|---|
Male | −0.13 (−2.38, 2.13) | 0.42 | −3.78 (−6.81, −0.74) | 0.1 | −3.90 (−6.91, −0.89) | 0.29 | −3.84 (−6.18, −1.49) | 0.09 |
Female | −1.78 (−5.28, 1.72) | 0.19 (−3.43, 3.82) | −1.58 (−4.59, 1.43) | −0.70 (−3.56, 2.17) | ||||
Age < 65 years | −2.55 (−5.55, 0.46) | 0.15 | −3.46 (−7.53, 0.62) | 0.24 | −6.01 (−9.56, −2.46) | 0.007 | −4.76 (−7.75, −1.78) | 0.02 |
Age ≥ 65 years | 0.46 (−2.25, 3.16) | −0.68 (−3.31, 1.96) | −0.22 (−2.70, 2.25) | −0.46 (−2.67, 1.75) | ||||
Deprivation quartile 1 (low) | −1.1 (−4.43, 2.24) | 0.27 | 0.58 (−2.53, 3.68) | 0.41 | −0.52 (−3.96, 2.93) | 0.48 | 0.07 (−2.78,2.92) | 0.42 |
Deprivation quartile 2 | 2.2 (−0.82, 5.22) | −4.9 (−9.49, −0.31) | −2.7 (−7.4, 2.0) | −3.8 (−7.33, −0.27) | ||||
Deprivation quartile 3 | −1.59 (−5.19, 2) | −1.94 (−5.96, 2.08) | −3.53 (−7.44, 0.37) | −2.72 (−5.84, 0.41) | ||||
Deprivation quartile 4 (high) | −3.29 (−9.34, 2.77) | −1.84 (−8.73, 5.06) | −5.13 (−10.23, −0.02) | −3.55 (−8.55, 1.45) | ||||
aBody mass index quartile 1 (low) | −0.21 (−3.06, 2.65) | 0.34 | −0.25 (−2.79, 2.28) | 0.23 | −0.46 (−3.1, 2.18) | 0.35 | −0.34 (−2.46, 1.78) | 0.21 |
Body mass index quartile 2 | −3.75 (−8.35, 0.85) | 0.02 (−5.52, 5.55) | −3.73 (−7.43, −0.03) | −1.76 (−5.93, 2.41) | ||||
Body mass index quartile 3 | 1.01 (−3.69, 5.71) | −3.27 (−8.6, 2.05) | −2.26 (−6.68, 2.16) | −2.64 (−6.5, 1.21) | ||||
Body mass index quartile 4 (high) | −0.34 (−4.11, 3.43) | −5.52 (−11.15, 0.1) | −5.86 (−12.0, 0.31) | −5.68 (−10.11, −1.25) |
Analysis | INT-DPM vs INT | p | INT vs CONTROL | p | INT-DPM vs CONTROL | p | Combined INT vs CONTROL | p |
---|---|---|---|---|---|---|---|---|
Oral hypoglycaemic use | −2.8 (−7.2, 1.49) | 0.19 | −4.2 (−9.3, 0.77) | 0.09 | −7.0 (−11.5, −2.5) | 0.003 | −5.45 (−9.3, −1.6) | 0.006 |
No oral hypoglycaemic use | −0.79 (−1.12, 2.69) | 0.41 | −0.93 (−2.46, 0.59) | 0.23 | − 0.68 (2.27, 0.92) | 0.40 | − 0.7 (−2.92, 0.72) | 0.33 |
Secondary outcomes
Analysis | INT-DPM vs INT | p | INT vs CONTROL | p | INT-DPM vs CONTROL | p | Combined intervention vs CONTROL | p |
---|---|---|---|---|---|---|---|---|
Fasting plasma glucose (mmol/l) | −0.17 (−0.54, 0.19) | 0.35 | −0.03 (−0.41, 0.35) | 0.87 | −0.21 (−0.52, 0.1) | 0.19 | −0.12 (−0.42, 0.18) | 0.44 |
Weight (kg) | −0.29 (−1.63, 1.05) | 0.67 | 0.03 (−1.46, 1.53) | 0.96 | −0.34 (−1.82, 1.15) | 0.66 | −0.16 (−1.37, 1.05) | 0.79 |
Body mass index (kg/m2) | −0.13 (−0.6, 0.35) | 0.60 | 0.06 (−0.46, 0.58) | 0.82 | −0.09 (−0.6, 0.43) | 0.74 | −0.02 (−0.44, 0.41) | 0.94 |
Body fat (%)a | −0.4 (−1.4, 0.6) | 0.43 | 0.93 (1.9, 2.01) | 0.09 | 0.54 (−0.45, 1.54) | 0.28 | 0.74 (−0.12, 1.59) | 0.09 |
Body fat mass (kg)a | −0.57 (−1.82, 0.69) | 0.38 | 0.7 (−0.7, 2.1) | 0.32 | 0.12 (−1.15, 1.38) | 0.86 | 0.41 (−0.69, 1.51) | 0.46 |
Visceral fat scorea | 0.29 (−0.17, 0.76) | 0.21 | −0.12 (−0.6, 0.37) | 0.63 | −0.38(− 0.9, 0.15) | 0.16 | −0.08 (−0.3, 0.49) | 0.70 |
Waist (cm) | 0.17 (−1.4,1.74) | 0.83 | 0.33 (−1.29, 1.95) | 0.69 | 0.44 (−1.24, 2.13) | 0.61 | 0.37 (−0.99, 1.73) | 0.59 |
Physical activity: MET min/weekb | −958 (−2192, 276) | 0.13 | 671 (−478, 1820) | 0.25 | −234 (−1478, 1011) | 0.71 | 298 (−680, 1277) | 0.55 |
Physical activity: resistance days/wkb | 0.71 (0.29, 1.70) | 0.44 | 4.22 (1.71, 10.44) | 0.01 | 3.32 (1.25,8.80) | 0.02 | 3.81 (1.69, 8.61) | 0.01 |
Physical activity: min sitting/wkb | 71.8 (−33, 176) | 0.18 | −33 (−121, 54) | 0.45 | 38.1 (−56, 133) | 0.43 | −0.03 (−78, 77) | 1.0 |
Fat scale scorec | 0.17 (0.05, 0.29) | 0.01 | −0.26 (−0.07, 0.58) | 0.28 | 0.11 (0, 0.23) | 0.06 | 0.02 (−0.08, 0.11) | 0.74 |
Fibre scale scorec | −0.01 (−0.15, 0.13) | 0.92 | −0.05 (−0.15, 0.05) | 0.57 | 0.01 (−0.12, 0.14) | 0.84 | 0.02 (−0.08, 0.12) | 0.71 |
General well-being score WBQ-12d | −0.54 (−2.35, 1.27) | 0.55 | −0.12 (−1.21, 1.44) | 0.86 | −0.61 (−2.16, 0.94) | 0.44 | −0.27 (−1.52, 0.99) | 0.68 |
EQ-5Dd | 0.06 (0, 0.12) | 0.07 | −0.03 (−0.09, 0.02) | 0.25 | 0.03 (−0.03, 0.09) | 0.36 | 0 (−0.05, 0.04) | 0.86 |
ADDqold | −0.17 (−0.49, 0.16) | 0.31 | 0.1 (−0.18, 0.37) | 0.48 | −0.06 (−0.34, 0.21) | 0.65 | 0.03 (−0.2, 0.27) | 0.79 |
HOMA–B (%)e | −5.6 (−13.89, 2.68) | 0.18 | 3.38 (−4.8, 11.5) | 0.42 | −0.43 (−7.53, 6.67) | 0.91 | 1.37 (−5.24, 7.97) | 0.68 |
HOMA–S (%)e | 5.28 (−5.87, 16.44) | 0.35 | −3.6 (−15.3, 8.1) | 0.55 | −1.01 (−14.65, 12.63) | 0.88 | −1.32 (−11.71, 9.07) | 0.80 |
Analysis | INT-DPM vs INT | p | INT vs CONTROL | p | INT-DPM vs CONTROL | p | Combined intervention vs CONTROL | p |
---|---|---|---|---|---|---|---|---|
HbA1c (mmol/mol) | 0.11 (−2.46, 2.67) | 0.93 | −1.29 (−3.77, 1.19) | 0.31 | −1.18 (−3.8, 1.5) | 0.38 | −1.24 (−3.35, 0.87) | 0.25 |
Fasting plasma glucose (mmol/l) | −0.09 (−0.5, 0.32) | 0.66 | 0.01 (−0.38, 0.41) | 0.95 | −0.06 (−0.5, 0.4) | 0.78 | −0.03 (−0.36, 0.31) | 0.87 |
Weight (kg) | −0.46 (−2.43, 1.51) | 0.39 | −1.51 (−4.97, 1.94) | 0.39 | −1.93 (−5.6, 1.7) | 0.30 | −1.7 (−4.34, 0.94) | 0.2 |
Body mass index (kg/m2) | −0.17 (−0.87, 0.54) | 0.46 | −0.47 (−1.72, 0.79) | 0.46 | −0.63 (−1.96, 0.7) | 0.35 | −0.54 (−1.5, 0.41) | 0.26 |
Body fat (%)a | −0.29 (−1.65, 1.07) | 0.67 | 1.46 (−0.02, 2.94) | 0.05 | 1.14 (−0.32, 2.59) | 0.13 | 1.3 (0.1, 2.49) | 0.03 |
Body fat mass (kg)a | −0.62 (−2.36, 1.12) | 0.48 | 0.98 (−0.95, 2.92) | 0.32 | 0.37 (−1.58, 2.33) | 0.71 | 0.69 (−0.87, 2.26) | 0.38 |
Visceral fat scorea | 0.16 (−0.5, 0.82) | 0.63 | −0.27 (−0.99, 0.45) | 0.45 | −0.36 (−1.15, 0.43) | 0.37 | −0.06 (−0.66, 054) | 0.84 |
Waist (cm) | 0.41 (−2.76, 1.93) | 0.73 | −0.05 (−1.91, 1.81) | 0.87 | −0.28 (−2.6, 2.1) | 0.81 | −0.05 (−1.91, 1.81) | 0.96 |
Physical activity: MET min/weekb | −698 (−2079, 683) | 0.32 | 482 (−718, 1681) | 0.43 | −223 (−1433, 987) | 0.71 | 198 (−823, 1220) | 0.70 |
Physical activity: resistance days/wkb | 1.03 (0.32, 3.31) | 0.96 | 2.06 (0.71, 5.99) | 0.18 | 1.71 (0.59, 4.94) | 0.32 | 1.90 (0.79, 4.59) | 0.15 |
Physical activity: min sitting/wkb | −115 (−220, −11) | 0.03 | 18.5 (−91.9, 129) | 0.74 | −94.6 (−200, 11) | 0.08 | −27.7 (−115, 60) | 0.53 |
Fat scale scorec | 0.04 (−0.11, 0.18) | 0.6 | 0.11 (−0.02, 0.23) | 0.09 | 0.15 (0.02, 0.27) | 0.02 | 0.12 (0.02, 0.23) | 0.02 |
Fibre scale scorec | 0.02 (−0.1, 0.15) | 0.7 | 0.07 (−0.08, 0.21) | 0.36 | 0.09 (−0.07, 0.25) | 0.26 | 0.08 (−0.04, 0.19) | 0.19 |
General well-being score WBQ-12d | −0.91 (−2.91, 1.09) | 0.37 | 1.09 (−0.69, 2.88) | 0.23 | 0.48 (−1.41, 2.37) | 0.62 | 0.76 (−0.76, 2.27) | 0.33 |
EQ-5Dd | −0.08 (−0.5, 0.33) | 0.69 | −0.07 (−0.43, 0.29) | 0.7 | −0.14 (−0.5, 0.22) | 0.44 | −0.1 (−0.4, 0.19) | 0.5 |
ADDqold | 0 (−0.07, 0.08) | 0.97 | −0.01 (−0.07, 0.05) | 0.72 | 0 (−0.07, 0.07) | 0.99 | 0 (−0.06, 0.05) | 0.89 |
HOMA–B (%)e | −3.05 (−14.5, 8.5) | 0.6 | 2.8 (−7.04, 12.6) | 0.57 | 1.41 (−7.47, 10.29) | 0.75 | 2.32 (−6.02, 10.66) | 0.58 |
HOMA–S (%)e | −5.3 (−19.6, 8.9) | 0.46 | 0.95 (−15.6, 13.7) | 0.90 | −5.88 (−20.9, 9.2) | 0.44 | −3.12 (−15.3, 9.05) | 0.61 |
Dose of intervention attained and outcomes
Intervention group | Intervention group-DPM | |||||||
---|---|---|---|---|---|---|---|---|
Moderate dose | p | High dose | p | Moderate dose | p | High dose | p | |
12 months | ||||||||
HbA1c (mmol/mol) Adjusted | 1.69 (−3.4, 6.7) | 0.50 | −3.45 (−7.69, 0.78) | 0.11 | −3.00 (−6.88, 0.89) | 0.13 | −3.17 (−6.72, 0.38) | 0.08 |
HbA1c (mmol/mol) Unadjusted | −1.43 (−8.8, 6.0) | 0.70 | −8.96 (−15.6, −2.3) | 0.01 | 0.9 (−3.81, 5.62) | 0.70 | 1.56 (−2.7, 5.8) | 0.47 |
Weight (kg) Adjusted | 1.36 (−2.5, 5.3) | 0.48 | −3.6 (−6.9, −0.2) | 0.04 | −0.73 (−4.67, 3.22) | 0.71 | −1.03 (−4.55, 2.49) | 0.56 |
Weight (kg) Unadjusted | −1.06 (−4.2, 2.1) | 0.51 | −3.28 (−6.1, −0.4) | 0.02 | 0.72 (−2.2, 3.7) | 0.63 | −0.07 (−2.69, 2.54) | 0.96 |
Fasting plasma glucose (mmol/l) Adjusted | 0.40 (−0.44, 1.23) | 0.34 | 0.06 (−0.65, 0.76) | 0.88 | −0.08 (−0.85, 0.68) | 0.83 | −0.06 (−0.76, 0.64) | 0.87 |
Fasting plasma glucose (mmol/l) Unadjusted | −0.62 (−1.8,0.56) | 0.30 | −1.2 (−2.25, −0.15) | 0.03 | 0 (−0.8, 0.79) | 0.99 | 0.15 (−0.57, 0.86) | 0.68 |
24 months | ||||||||
HbA1c (mmol/mol) Adjusted | −0.05 (−5.09, 5.00) | 0.99 | −3.77 (−8.31, 0.78) | 0.10 | 4.71 (−1.62, 11.04) | 0.14 | 2.29 (−3.44, 8.03) | 0.42 |
HbA1c (mmol/mol) Unadjusted | −0.21 (−6.9, 6.4) | 0.95 | −2.74 (−8.9, 3.5) | 0.38 | 3.51 (−2.9, 9.9) | 0.277 | 1.77 (−4.13, 7.67) | 0.55 |
Weight (kg) Adjusted | −2.18 (−7.41, 3.06) | 0.40 | −5.19 (−9.65, −0.74) | 0.02 | −1.45 (−6.07, 3.16) | 0.52 | −1.15 (−5.13, 2.83) | 0.55 |
Weight (kg) Unadjusted | 0.24 (−3.7, 4.2) | 0.90 | −2.56 (−6.3, 1.15) | 0.17 | −0.75 (−5.23, 3.74) | 0.74 | −1.6 (−5.73, 2.54) | 0.44 |
Fasting plasma glucose (mmol/l) Adjusted | −0.05 (−0.77, 0.67) | 0.90 | −0.42 (−1.09, 0.24) | 0.20 | 0.09 (−0.77, 0.95) | 0.84 | 0.10 (−0.68, 0.88) | 0.79 |
Fasting plasma glucose (mmol/l) Unadjusted | 0.02 (−1.34, 1.37) | 0.98 | − 0.17 (−1.43, 1.09) | 0.79 | 0.16 (−0.76, 1.07) | 0.73 | 0.44 (−0.45, 1.33) | 0.32 |