The main results from the PACE-UP trial are published,93 and are reproduced here under the terms of the Creative Commons Attribution License (CC BY 4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided that the original author and source are credited.
Recruitment of participants
The CONSORT diagram of participant flow (Figure 3) shows that of the 11,015 people invited to participate, 6399 did not respond and 548 were excluded as a result of self-reported PA guideline achievement; therefore, 1023 out of 10,467 (10%) were randomised.
FIGURE 3 The PACE-UP trial CONSORT flow diagram. Adapted from Harris et al.93 This is an open access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0. (Figure not reproduced here; see the original article.)
Baseline characteristics of the study population (Table 4)
Participants recruited to the trial were evenly spread across the age groups. Just over one-third of those recruited were men, around two-thirds were married and around one-fifth took part in the trial as a couple. The majority were in full- or part-time employment, mostly in high-level manual, administrative or professional jobs, with a minority in intermediate or routine and manual occupations. About 80% of those recruited were of white ethnicity, around 10% were black/African/Caribbean or black British and approximately 7% were Asian or Asian British. In terms of health factors, just under 10% were current smokers, around 80% reported their health as being good or very good, the majority had one or more chronic disease and some self-reported pain, around 60% reported no current disability, around 10% had a high depression score, around 20% had a high anxiety score, and around two-thirds of participants were overweight or obese. Recruitment occurred throughout all four seasons, but was slightly higher in summer and slightly lower in winter. All of these factors were well balanced between the three randomised groups.
| Characteristic | Trial arm | ||
|---|---|---|---|
| Control (N = 338) | Postal (N = 339) | Nurse (N = 346) | |
| Age (years) at randomisation, n (%) | |||
| 45–54 | 101 (30) | 118 (35) | 121 (35) |
| 55–64 | 138 (41) | 125 (37) | 124 (36) |
| 65–75 | 99 (29) | 96 (28) | 101 (29) |
| Sex (male) , n (%) | 115 (34) | 124 (37) | 128 (37) |
| Marital status (married), n (%) | 213 (64) | 215 (65) | 230 (68) |
| Randomised as a couple,a n (%) | 66 (20) | 68 (20) | 73 (21) |
| Employment status,79 n (%) | |||
| In full- or part-time employment | 190 (57) | 193 (59) | 190 (56) |
| Retired | 102 (31) | 96 (29) | 101 (30) |
| Other | 39 (12) | 39 (12) | 50 (15) |
| NS-SEC (current or previous job),79 n (%) | |||
| High-level managerial, administrative, professional | 199 (62) | 191 (60) | 184 (56) |
| Intermediate occupations | 70 (22) | 85 (27) | 95 (29) |
| Routine and manual occupations | 51 (16) | 44 (14) | 52 (16) |
| Ethnicity,79 n (%) | |||
| White | 253 (78) | 270 (83) | 267 (80) |
| Black/African/Caribbean/black British | 30 (9) | 31 (10) | 40 (12) |
| Asian/Asian British | 26 (8) | 20 (6) | 22 (7) |
| Other | 15 (5) | 4 (1) | 6 (2) |
| Current smoker, n (%) | 27 (8) | 29 (9) | 26 (8) |
| General health:79 very good or good, n (%) | 265 (80) | 277 (84) | 277 (82) |
| Chronic diseases, n (%) | |||
| None | 129 (39) | 135 (41) | 117 (35) |
| One or two | 183 (55) | 171 (51) | 188 (55) |
| ≥ 3 | 21 (6) | 27 (8) | 34 (10) |
| Presence of self-reported pain,77 n (%) | 220 (66) | 236 (71) | 234 (70) |
| Limiting long-standing illness,79 n (%) | 76 (23) | 73 (22) | 74 (22) |
| Townsend disability score,80 n (%) | |||
| None (0) | 190 (57) | 196 (59) | 210 (62) |
| Slight or some disability (1–6) | 127 (38) | 130 (39) | 124 (36) |
| Appreciable or severe disability (7–18) | 15 (5) | 8 (2) | 7 (2) |
| HADS depression score:75 borderline or high, n (%) | 36 (11) | 33 (10) | 42 (12) |
| HADS anxiety score:75 borderline or high, n (%) | 65 (19) | 64 (19) | 71 (21) |
| Low self-efficacy score,74 n (%) | 102 (31) | 96 (29) | 117 (35) |
| Month of baseline measure, n (%) | |||
| March–May | 80 (24) | 75 (22) | 76 (22) |
| June–August | 105 (31) | 106 (31) | 110 (32) |
| September–November | 88 (26) | 82 (24) | 92 (27) |
| December–February | 65 (19) | 76 (22) | 68 (20) |
| Physical characteristics | |||
| Overweight/obese: BMI of ≥ 25 kg/m2, n (%) | 227 (67) | 221 (65) | 233 (67) |
| Fat mass (kg), mean (SD) | 26 (10) | 27 (11) | 26 (11) |
| Waist circumference (cm), mean (SD) | 93 (14) | 94 (14) | 93 (13) |
| PA data | |||
| Accelerometry | |||
| Adjusted baseline step count per day, mean (SD) | 7379 (2696) | 7402 (2476) | 7653 (2826) |
| Total weekly minutes of MVPA in ≥ 10-minute bouts, mean (SD) | 84 (97) | 92 (90) | 105 (116) |
| Average daily sedentary time (minutes), mean (SD) | 613 (68) | 614 (71) | 619 (78) |
| Average daily wear time (minutes), mean (SD) | 789 (73) | 787 (78) | 797 (84) |
| 150 minutes of MVPA in ≥ 10-minute bouts (yes), n % | 61 (18) | 68 (20) | 89 (26) |
| IPAQ score72 | |||
| IPAQ MVPA score: total weekly minutes of MVPA in ≥ 10-minute bouts (N = 909), mean (SD) | 197 (314) | 147 (256) | 172 (279) |
| IPAQ walking score: total weekly minutes of walking in ≥ 10-minute bouts (N = 888), mean (SD) | 333 (333) | 330 (338) | 312 (277) |
| 150 weekly minutes of IPAQ MVPA score (N = 909): yes, n (%) | 110 (37) | 91 (30) | 109 (35) |
| 150 weekly minutes of IPAQ walking score (N = 888): yes, n (%) | 193 (65) | 190 (66) | 208 (69) |
| GPPAQ score,73 n (%) | |||
| PAI score (N = 973) | |||
| Inactive | 159 (49) | 153 (48) | 156 (47) |
| Moderately inactive | 69 (21) | 66 (21) | 83 (25) |
| Moderately active | 50 (16) | 63 (20) | 60 (18) |
| Active | 44 (14) | 36 (11) | 34 (10) |
| PAI score, including walking (GPPAQ walking score; N = 973) | |||
| Inactive | 129 (40) | 134 (42) | 133 (40) |
| Moderately inactive | 57 (18) | 56 (18) | 63 (19) |
| Moderately active | 43 (13) | 49 (15) | 47 (14) |
| Active | 93 (29) | 79 (25) | 90 (27) |
In terms of objectively measured baseline PA levels, the nurse-support group had a slightly higher baseline-adjusted average daily step count [7653 steps, standard deviation (SD) 2826 steps] and minutes spent weekly in MVPA in bouts of ≥ 10 minutes (105 minutes, SD 116 minutes) than the postal group (7402 steps, SD 2476 steps; 92 minutes, SD 90 minutes) and the control group (7379 steps, SD 2696 steps; 84 minutes, SD 97 minutes). A higher proportion of the nurse-support group participants were achieving the guidelines of ≥ 150 minutes per week of MVPA in bouts of ≥ 10 minutes (26%, 89/346) than participants in the postal group (20%, 68/339) and those in the control group (18%, 61/338). The three groups were similar in terms of average daily sedentary time, at around 10 hours per day.
In terms of self-reported PA levels the patterns were different, with the control group reporting the highest number of weekly minutes of MVPA on the IPAQ, not including walking; however, the nurse-support group reported higher levels of MVPA if walking was included. A slightly higher proportion of participants in the control group than those in the intervention groups reported being active on the GPPAQ PAI, both excluding and including walking.
Losses to follow-up
Figure 3 shows the losses to follow-up. Of the 1023 people randomised, 32 (3%) withdrew and eight (1%) were unable to be contacted at 12 months. In total, 956 out of 1023 participants (93%) provided at least 1 day of 540 minutes’ wear time accelerometer data and were included in the 12-month primary analyses.
Data completeness for accelerometry
Accelerometer wear time was similar between the groups at baseline, the 3-month follow-up point and the 12-month follow-up point (see Tables 4 and 5). Over 90% of all groups provided ≥ 5 days of ≥ 540 minutes’ wear time at 12 months (see Appendix 2, Table 23).
Effect of the intervention on accelerometer-assessed physical activity outcomes (Table 5)
Three-month (interim) outcomes
There were significant differences for the change in average daily step counts from baseline to 3 months between intervention groups and the control group: additional step counts (steps per day) were 692 steps (95% CI 363 to 1020 steps; p < 0.001) for the postal group and 1173 steps (95% CI 844 to 1501 steps; p < 0.001) for the nurse-support group, and the difference between the intervention groups was statistically significant (481 steps, 95% CI 153 to 809 steps; p = 0.004). Findings for the change in time in MVPA levels showed a similar pattern: additional MVPA in bouts of ≥ 10 minutes (minutes per week) was 43 minutes (95% CI 26 to 60 minutes; p < 0.001) for the postal group and 61 minutes (95% CI 44 to 78 minutes; p < 0.001) for the nurse-support group, and the difference between intervention groups was 18 minutes (95% CI 1 to 35 minutes; p = 0.04). There was no difference between the groups for the change in sedentary time. Summary data for the 3-month PA outcomes are shown in Appendix 2, Table 24.
| Outcome | Comparison between trial arms | |||||
|---|---|---|---|---|---|---|
| Postal vs. control | Nurse support vs. control | Nurse support vs. postal | ||||
| Effect (95% CI) | p-value | Effect (95% CI) | p-value | Effect (95% CI) | p-value | |
| Daily step count | ||||||
| 3 months | 692 (363 to 1020) | < 0.001 | 1173 (844 to 1501) | < 0.001 | 481 (153 to 809) | 0.004 |
| 12 months | 642 (329 to 955) | < 0.001 | 677 (365 to 989) | < 0.001 | 36 (–277 to 349) | 0.82 |
| Total weekly minutes of MVPA in ≥ 10-minute bouts | ||||||
| 3 months | 43 (26 to 60) | < 0.001 | 61 (44 to 78) | < 0.001 | 18 (1 to 35) | 0.04 |
| 12 months | 33 (17 to 49) | < 0.001 | 35 (19 to 51) | < 0.001 | 2 (–14 to 17) | 0.83 |
| Daily sedentary time (minutes) | ||||||
| 3 months | –2 (–12 to 7) | 0.59 | –7 (–16 to 3) | 0.16 | –4 (–13 to 5) | 0.38 |
| 12 months | 1 (–8 to 10) | 0.83 | –0.2 (–9 to 9) | 0.96 | –1 (–10 to 8) | 0.79 |
| Daily wear time (minutes) | ||||||
| 3 months | 2 (–8 to 12) | 0.69 | 4 (–6 to 14) | 0.40 | 2 (–8 to 12) | 0.65 |
| 12 months | 9 (–1 to 19) | 0.08 | 9 (–0.8 to 19) | 0.07 | 0.3 (–10 to 10) | 0.96 |
Twelve-month (main) outcomes
Both intervention groups increased their step counts between baseline and 12 months compared with the control group: additional step counts (steps per day) were 642 steps (95% CI 329 to 955 steps; p < 0.001) for the postal group and 677 steps (95% CI 365 to 989 steps; p < 0.001) for the nurse-support group, with no statistically significant difference between intervention groups (36 steps, 95% CI –277 to 349 steps; p = 0.82). Time spent in MVPA in bouts showed a similar pattern, that is, both intervention groups increased at 12 months compared with the control group: additional MVPA in bouts (minutes per week) was 33 minutes (95% CI 17 to 49 minutes; p < 0.001) for the postal group and 35 minutes (95% CI 19 to 51 minutes; p < 0.001) for the nurse-support group, with no statistically significant difference between the two intervention groups (2 minutes, 95% CI –14 to 17 minutes; p = 0.83). Again, there was no difference between the groups for the change in sedentary time. Summary data for the 12-month PA outcomes are shown in Appendix 2, Table 24.
Residuals from the 12-month models for steps and weekly MVPA in ≥ 10-minute bouts were plotted, and the distribution of residuals from both models was normally distributed (see Appendix 2, Figure 18).
Effect of the intervention on self-reported physical activity outcomes at 12 months (Table 6)
At 12 months, the IPAQ weekly minutes of MVPA (not including walking) did not show any effect of the intervention for either intervention group compared with the control group. However, weekly minutes of walking from the IPAQ at 12 months compared with baseline showed significant increases for both groups compared with controls: 69 minutes (95% CI 19 to 119 minutes) in the postal group and 55 minutes (95% CI 5 to 105 minutes) in the nurse-support group; there was no difference between the intervention groups (–14 minutes, 95% CI –64 to 37 minutes). This was also reflected in the odds ratio (OR) for achieving ≥ 150 minutes of activity in a week, conditional on the baseline state, which was not significant for IPAQ MVPA for either intervention group, but was for IPAQ walking (postal group vs. control group: OR 2.1 minutes, 95% CI 1.3 to 3.3 minutes; nurse-support group vs. control group: OR 1.7 minutes, 95% CI 1.1 to 2.6 minutes); there was no difference between the intervention groups (OR 0.8 minutes, 95% CI 0.5 to 1.3 minutes).
| Questionnaire outcome | Comparison between trial arms | |||||
|---|---|---|---|---|---|---|
| Postal vs. control | Nurse support vs. control | Nurse support vs. postal | ||||
| Effect (95% CI) | p-value | Effect (95% CI) | p-value | Effect (95% CI) | p-value | |
| IPAQ72 | ||||||
| Change in weekly minutes of activity | ||||||
| Vigorous and moderate activity (n = 775) | –10 (–58 to 38) | 0.67 | –32 (–80 to 16) | 0.19 | –22 (–70 to 27) | 0.38 |
| Walking (n = 750) | 69 (19 to 119) | 0.01 | 55 (5 to 105) | 0.03 | –14 (–64 to 37) | 0.59 |
| OR for achieving ≥ 150 minutes of activity in a week at follow-up, conditional on baseline state | ||||||
| Vigorous and moderate activity (n = 775) | 1.0 (0.5 to 2.0) | 0.99 | 0.6 (0.3 to 1.3) | 0.18 | 0.6 (0.3 to 1.3) | 0.19 |
| Walking (n = 750) | 2.1 (1.3 to 3.3) | 0.001 | 1.7 (1.1 to 2.6) | 0.01 | 0.8 (0.5 to 1.3) | 0.41 |
| GPPAQ73 | ||||||
| OR for being active at follow-up, conditional on baseline state | ||||||
| PAI (n = 892) | 1.2 (0.7 to 2.1) | 0.46 | 0.9 (0.5 to 1.6) | 0.80 | 0.8 (0.4 to 1.3) | 0.32 |
| PAI, including walking (n = 892) | 1.1 (0.6 to 1.8) | 0.81 | 0.9 (0.5 to 1.5) | 0.64 | 0.8 (0.5 to 1.4) | 0.48 |
For the GPPAQ, the OR for being active at the 12-month follow-up, conditional on the baseline state, did not show a significant effect for either of the intervention groups compared with the control group, whether or not walking was included in the GPPAQ PAI.
Summary data for the effect of the intervention on the IPAQ and the GPPAQ are given in Appendix 2, Table 25.
Effect of the intervention on other health-related outcomes (Table 7)
Fat mass was slightly reduced at 12 months in both intervention groups, but this did not differ significantly from the control group. There was no change in BMI or waist circumference between baseline and 12 months. The interventions had no significant effects on anxiety, depression, quality of life (EQ-5D-5L) or pain scores at either 3 months or 12 months. The exercise self-efficacy score significantly increased in both intervention groups at 3 months compared with the control group, and there was a greater effect in the nurse-support group than in the postal group. By 12 months, the self-efficacy score was significantly higher in the nurse group than in the control group, and the postal group was intermediate between, but not significantly different from, either of the other groups.
| Health-related outcome | Comparison between trial arms | |||||
|---|---|---|---|---|---|---|
| Postal vs. control | Nurse support vs. control | Nurse support vs. postal | ||||
| Effect (95% CI) | p-value | Effect (95% CI) | p-value | Effect (95% CI) | p-value | |
| BMI (kg/m2) | ||||||
| 12 months | –0.1 (–0.3 to 0.1) | 0.24 | –0.03 (–0.2 to 0.1) | 0.71 | 0.07 (–0.1 to 0.3) | 0.42 |
| Fat mass (kg) | ||||||
| 12 months | –0.4 (–0.8 to 0.07) | 0.10 | –0.2 (–0.7 to 0.2) | 0.30 | 0.1 (–0.3 to 0.6) | 0.54 |
| Waist circumference (cm) | ||||||
| 12 months | –0.04 (–0.8 to 0.7) | 0.92 | 0.08 (–0.6 to 0.8) | 0.23 | 0.1 (–0.6 to 0.8) | 0.74 |
| HADS anxiety score75 | ||||||
| 3 months | –0.3 (–0.7 to 0.1) | 0.13 | –0.3 (–0.7 to 0.1) | 0.16 | 0.01 (–0.4 to 0.4) | 0.94 |
| 12 months | –0.2 (–0.6 to 0.2) | 0.28 | –0.2 (–0.6 to 0.2) | 0.28 | 0.0006 (–0.4 to 0.4) | 1.00 |
| HADS depression score75 | ||||||
| 3 months | –0.2 (–0.6 to 0.1) | 0.12 | –0.2 (–0.5 to 0.1) | 0.19 | 0.04 (–0.3 to 0.3) | 0.82 |
| 12 months | –0.1 (–0.5 to 0.2) | 0.44 | –0.02 (–0.4 to 0.3) | 0.91 | 0.1 (–0.2 to 0.5) | 0.51 |
| EQ-5D-5L score76 | ||||||
| 3 months | –0.005 (–0.02 to 0.01) | 0.60 | –0.01 (–0.03 to 0.01) | 0.26 | –0.006 (–0.03 to 0.01) | 0.54 |
| 12 months | –0.01 (–0.03 to 0.01) | 0.30 | –0.01 (–0.03 to 0.01) | 0.23 | –0.002 (–0.02 to 0.02) | 0.87 |
| Exercise self-efficacy score74 | ||||||
| 3 months | 1.1 (0.2 to 2.0) | 0.01 | 2.3 (1.4 to 3.2) | < 0.001 | 1.2 (0.3 to 2.1) | 0.01 |
| 12 months | 0.6 (–0.3 to 1.6) | 0.20 | 1.2 (0.3 to 2.2) | 0.01 | 0.6 (–0.4 to 1.5) | 0.22 |
| Self-reported pain score | ||||||
| 3 months | 0.05 (–0.06 to 0.17) | 0.37 | 0.05 (–0.07 to 0.16) | 0.42 | –0.004 (–0.12 to 0.11) | 0.94 |
| 12 months | 0.05 (–0.06 to 0.17) | 0.35 | 0.02 (–0.10 to 0.13) | 0.76 | –0.04 (–0.15 to 0.08) | 0.53 |
Effect of the intervention on adverse events and serious adverse events (Table 8)
The number of total AEs did not differ between the groups at either 3 months or 12 months, whether using higher numbers of events self-reported from the patient questionnaire (falls, fractures, sprains or injuries) or lower numbers of events from primary care records (any AE – cardiovascular, fracture, sprains/injuries, falls or pain from back or lower limb). There was also no between-group difference in trial SAEs reported for safety monitoring. Self-reported falls were lower in the nurse-support group at 12 months (43/318, 14%) than in the postal group (57/310, 18%) or the control group (71/318, 22%; p = 0.02). Falls reported in primary care records over 12 months were fewer in number, but also in the same direction, although the differences were non-significant (p = 0.13). Primary care-recorded cardiovascular events over 0–12 months were lower in the nurse-support group (2/340, 0.6%) and the postal group (1/331, 0.3%) than in the control group (8/334, 2.4%; p = 0.04).
| AEs | Time frame in each trial arm | |||||||
|---|---|---|---|---|---|---|---|---|
| 0–3 months | 0–12 months | |||||||
| Control, n (%) | Postal, n (%) | Nurse support, n (%) | p-valuea | Control, n (%) | Postal, n (%) | Nurse support, n (%) | p-valuea | |
| AEs reported on the questionnaire | (N = 931) | (N = 946) | ||||||
| Fall, fracture, sprain or injury | 59/313 (19) | 70/310 (23) | 65/308 (21) | 0.51 | 113/318 (36) | 99/310 (32) | 96/318 (30) | 0.34 |
| Fall | 25 (8) | 24 (8) | 24 (8) | 0.99 | 71 (22) | 57 (18) | 43 (14) | 0.02 |
| Fracture | 3 (1) | 3 (1) | 7 (2) | 0.28 | 15 (5) | 10 (3) | 11 (3) | 0.57 |
| Sprain or injury | 49 (16) | 54 (17) | 47 (15) | 0.74 | 66 (21) | 68 (22) | 63 (20) | 0.81 |
| (N = 911) | (N = 924) | |||||||
| Deterioration in health problems already present since the start of the study | 33/311 (11) | 30/303 (10) | 39/297 (13) | 0.42 | 68/313 (22) | 67/300 (22) | 65/311 (21) | 0.91 |
| AEs from primary care recordsb | (N = 1005) | (N = 1005) | ||||||
| Any AE | 29/334 (8.7) | 23/331 (7.0) | 20/340 (5.9) | 0.36 | 85/334 (25.5) | 75/331 (22.7) | 77/340 (22.7) | 0.62 |
| Cardiovascularc | 2 (0.6) | 0 | 1 (0.3) | 0.55 | 8 (2.4) | 1 (0.3) | 2 (0.6) | 0.04 |
| Fracture | 4 (1.2) | 2 (0.6) | 2 (0.6) | 0.68 | 11 (3.3) | 4 (1.2) | 4 (1.2) | 0.11 |
| Sprain/injury | 2 (0.6) | 1 (0.3) | 2 (0.6) | 1.00 | 8 (2.4) | 4 (1.2) | 5 (1.5) | 0.51 |
| Fall | 0 | 0 | 0 | 8 (2.4) | 4 (1.2) | 2 (0.6) | 0.13 | |
| Pain (back or lower limb) | 23 (6.9) | 20 (6.0) | 16 (4.7) | 0.48 | 65 (19.5) | 65 (19.6) | 70 (20.6) | 0.93 |
| SAE spontaneously reportedd | (N = 1023) | (N = 1023) | ||||||
| SAE | 3/338 (0.9) | 1/339 (0.3) | 3/346 (0.9) | 0.65 | 10/338 (3.0) | 5/339 (1.5) | 11/346 (3.2) | 0.30 |
Subgroup analyses (Figure 4)
There was no evidence of effect modification on the change in step count at 12 months for either of the intervention groups versus the control group for any of the following: age, sex, taking part as a couple, BMI, disability, pain, socioeconomic group and exercise self-efficacy.
FIGURE 4 Subgroup analyses. (a) Postal group and control group; and (b) nurse-support group and control group. (Figure not reproduced here; see the original article.)
Sensitivity analyses and imputations (see Appendix 2, Table 26)
The sensitivity analyses on the primary outcome measure (change in average daily step count at 12 months), restricted to those with ≥ 600 minutes’ daily wear time, increased the effect size for both intervention groups versus the control group, but did not change the interpretation (both intervention groups had a significant effect compared with the control group, but there was no significant difference between the interventions). Similarly, imputations with both missing-at-random and missing-not-at-random assumptions made some difference to the effect sizes for both interventions compared with the control group and with each other, but, again, made no difference to the overall interpretation.
Summary of the main trial findings
Overall, 10% (1023/10,467) of those invited participated in the trial, and we had primary outcome data on 93% (956/1023) of participants at 12 months. Although the nurse-supported intervention had a greater effect on objective PA outcomes at 3 months, by the main 12-month outcome, both the postal and nurse-supported pedometer interventions significantly increased step counts by around 10%, and time in MVPA in bouts by around one-third compared with the control group, with no statistically significant difference between the interventions. There was no significant effect of the interventions on sedentary time or anthropometric measures. In terms of the effects on self-reported PA levels, the IPAQ MVPA questions did not show any intervention effect, but both the nurse-supported intervention and the postal intervention showed a significant effect on the IPAQ walking question. The GPPAQ score did not show an intervention effect, even when walking was included in the score. The interventions had no effect on most other patient-reported outcomes, except that exercise self-efficacy was increased in both intervention groups at 3 months, and in the nurse-support group at 12 months, compared with the control group. AEs were not increased by the interventions; some individual AEs were lower in the intervention groups, but this was based on small numbers of events. No important subgroup effects were demonstrated, and the sensitivity analyses and imputations did not change the interpretation of the trial results.
The following chapters present the results relating to other aspects of the trial: the economic evaluation (see Chapter 4), generalisability and representativeness (see Chapter 5), the process evaluation (see Chapter 6), the qualitative evaluation (see Chapter 7) and the 3-year trial follow-up (see Chapter 8). Chapter 9 discusses the trial findings in detail.