Introduction
Methods
Eligibility Criteria
BCT Coding
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Physical activity (objectively measured or self-reported), weight loss, physical function (objectively measured or self-reported); health-related quality of life and depression symptoms.
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Physical activity and weight loss were the prespecified primary outcomes [24]. These outcomes were included to adhere to recommendations from a consensus paper on which outcomes to use in intervention studies, including people with multimorbidity [26]. The choice of these outcomes was also supported by the patient partners of MOBILIZE who were invited to comment on the current systematic review and the outcome measures included.
Author, year, and study acronym | Country, study design, and setting | Condition type, prevalence | Condition diagnosis and severity at baseline | Age (mean), gender, and BMI (mean) | Intervention characteristics | Duration (minutes), frequency, length, and adherence ((number of intervention sessions attended/number of total sessions available)*100) to the behavioural intervention | Outcomes and (outcome measure) |
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Koukouvou et al. [50] | Greece, 2-arm RCT, outpatient fitness centres | D (100%) HF (100%) H (12%) | D (BDI = 18, mild to moderate) HF (NYHA class II to III) H (SBP ≥ 140 DBP ≥ 90) | 52 years 0% female BMI 28 | Exercise therapy | 60 min, 4 times per week for 26 weeks at a moderate intensity. Adherence 78%. | Weight (BMI)* HRQoL (QLI) Depression (BDI) |
Kulcu et al. [49] | Turkey, 2-arm RCT, cardiopulmonary rehabilitation clinic | D (100%) HF (100%) | D (BDI = 19, moderate to severe) HF (NYHA class II to III) | 59 years 27% female | Exercise therapy | 60 min, 3 times per week for 8 weeks at a moderate intensity. Adherence NR. | HRQoL (HQOL) Depression (BDI) |
Katon et al. [43] | USA, 2-arm RCT, primary care clinics | D (100%) T2DM (100%) Coronary heart disease (27%) | D (PHQ-9 = 14, moderate) T2DM (glycated haemoglobin = %8) Coronary heart disease (MI, IHD angina pectoris) | 57 years 52% female BMI 37 | Self-care + pharmacotherapy | Clinic visits every 2 to 3 weeks, for 52 weeks. Adherence NR. | PA (adherence to exercise plan ≥ 2 days per week) Depression (SCL-20) HRQoL (QoL 10 scale) |
Gary et al. [42] | USA, 4-arm RCT, home-based | D (100%) HF (100%) H (88%) T2DM (29%) | D (BDI-II = 20, moderate) HF (NYHA class II to III) H (SBP ≥ 140 DBP ≥ 90) T2DM (NA) | 66 years 57% female | (1) Exercise therapy (2) CBT and exercise therapy (3) CBT | 45 min, 3 times per week for 12 weeks at a moderate intensity. Adherence 82%. | HRQoL (MLHFQ) PF (6MWT) Depression (HADS-D) |
Piette et al. [40] | USA, 2-arm RCT, telephone based + home-based | D (100%) T2DM (100%) | D (BDI = 26, moderate to severe) T2DM (Hba1c (%) = 7.6%) | 56 years 51% female 38 BMI | CBT + walking program | 12 weekly sessions followed by nine monthly booster sessions in 52 weeks. Adherence CBT 64%. | PA (step counts) HRQoL (SF-12 pcs) PF (SF-12 PF) Depression (BDI) |
Åsa et al. [47] | Sweden, 2-arm RCT, outpatient centre-based | HF (100%) T2DM (100%) | HF (NYHA II–III) T2DM (Hba1c (%) = 7.4) | 61 years 20% female BMI 29 | Exercise therapy | 45 min, 3 times a week for 8 weeks at a low to moderate intensity. Adherence 92%. | HRQoL (MLHFQ) PF (6MWT) |
Lynch et al. [44] | USA, 2-arm RCT, community-based | H (100%) T2DM (100%) | H (medication usage) T2DM (medication usage) | 54 years 67% female 36 BMI | Self-management | 120 min, 18 sessions in 26 weeks + weekly telephone calls. Adherence NR. | Self-reported physical activity (CHAMP) Weight loss (kg) |
Dunbar et al. [41] | USA, 2-arm RCT, home-based and clinic-based | HF (100%) T2DM (100%) | HF (NYHA II–IV) T2DM (Hba1c (%) = 8) | 57 years, 34% female, BMI 37 | Integrated self-care Intervention + usual care | One individualised counselling session with family members + one home visit by the research nurse + four telephone calls + one visit clinic. Duration 17 weeks. Adherence NR. | PA (CHAMP) |
Keihani et al. [48] | Iran, 2-arm RCT, institute of cardiovascular rehabilitation in Isfahan | D (100%) HF (100%) | D (BDI = 43, severe) HF (ejection fraction equal to or less than 35%) | 61 years 40% female BMI 29 | Exercise therapy | 60 min, 3 times per week for 8 weeks at a moderate intensity. Adherence NR. | PF (SF-36 PF) Depression (BDI-D) |
Freedland et al. [38] | USA, 2-arm RCT, academic centre | D (100%) HF (100%) H (72%) T2DM (38%) COPD (18%) | D (BDI-II = 30, severe) HF (NYHA class I to III) | 56 years, 46% female, 36 BMI | CBT + usual care | 60 min, once per week for 26 weeks and 4 telephone calls from week 26 to 52. | PA (actigraphy 7-d average activity) PF (6MWT) Depression BDI-II) Weight loss (BMI)* |
Pibernik-Okanović et al. [46] | Croatia, 3-arm RCT, tertiary diabetes clinic | D (100%) T2DM (100%) | D (CES-D = 30, severe) T2DM (Hba1c (%) = 7.3) | 66 years 54% female BMI 30 | (1)Exercise therapy (2)Psychoeducation | 75 min, for once a week for 6 weeks. Adherence NR. | HRQoL (SF-12) Depression (CES-D) |
Huang et al. [39] | Taiwan, 2-arm RCT, clinic | D (100%) T2DM (100%) | D (CES-D ≥ 16, moderate) T2DM (Hba1c (%) = 7.7) | 54 years, 52% female, BMI 26 | CBT + motivational enhancement therapy + usual care | 80 min, once a week for 12 weeks (4 weeks of motivational enhancement therapy and 8 CBT sessions) | Weight loss (BMI) HRQoL (SF-12 pcs) Depression (CES-D) |
Schneider et al. [45] | USA, 2-arm RCT, University of Massachusetts Medical School’s | D (100%) T2DM (100%) | D (BDI-II = 20, moderate) T2DM (Hba1c (%) = 7.9) | 53 years 100% female BMI 31 | Exercise therapy | 90 min, 2 times per week for 12 weeks at a moderate intensity. Adherence 51%. | Depression symptoms (BDI-II) |
de Groot et al. [37] (ACTIVE II) | USA, 2-arm RCT, community fitness centres | D (100%) T2DM (100%) | D (BDI-II = 25, moderate) T2DM (Hba1c (%) ≥ 7%) | 56 years 77% female | (1) Exercise therapy (2) Exercise therapy and CBT (3) CBT | 50 min (10 min warm up and 10 min cool down) 2 times per week for 12 weeks at a moderate intensity | Depression (BDI-II) HRQoL (SF-12 pcs) PF (6MWT) |
Risk of Bias Assessment and Overall Evaluation of the Quality of the Evidence
Synthesis of Results
Meta-regression Analyses and Effectiveness Ratio
Sensitivity and Additional Analyses not Prespecified
Patients’ Involvement
Results
Study Selection and Characteristics
Participant Characteristics
Intervention and Comparator Group Characteristics
Outcome Characteristics
Effect of Behavioural Interventions on Physical Activity
BCTs Associated with Physical Activity (Objectively Measured and Self-Reported)
Effect of Behavioural Interventions on Weight Loss
BCTs Associated with Weight Loss
Effect of Behavioural Interventions on Health-Related Quality of Life
Effect of Behavioural Interventions on Physical Function
Additional Analyses not Prespecified
Sensitivity Analyses
Risk of Bias and Overall Quality of the Evidence
Outcomes | Risk with behavioural intervention | No. of participants (studies) | Certainty of the evidence (GRADE) | Comments |
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Physical activity assessed with: objectively measured follow-up: mean 16 weeks | SMD 0.38 SD higher (0.12 lower to 0.87 higher) | 548 (5 RCTs) | ⨁◯◯◯ VERY LOWa,b,c | Behavioural intervention may increase/have little to no effect on physical activity, at the end of the interventions, but the evidence is very uncertain. Greater short-term effects are associated with the use of the BCT 1.4 ‘action planning’ and the BCT 3.2 ‘social support (practical)’. The evidence is very uncertain for long-term effectiveness (k = 1). |
Physical activity assessed with: self-reported follow-up: range 24 to 52 weeks | Not pooled | 344 (3 RCTs) | ⨁◯◯◯ VERY LOWb,d | The evidence is very uncertain about the effect of behavioural intervention on physical activity. The three studies included reported that the participants in the intervention groups were more physically active than the participants in the comparator groups at the end-treatment follow-up (mean 33 weeks, SD ± 16). Greater short-term effects with the use of the BCT 1.4 ‘action planning’ and the BCT 3.2 ‘social support (practical)’. No assessments were made at long-term follow-ups. |
Weight loss follow-up: mean 18 weeks | MD 0.17 SD lower (1.17 lower to 0.83 higher) | 356 (5 RCTs) | ⨁◯◯◯ VERY LOWa,b,c | The evidence is very uncertain about the effect of behavioural intervention on weight loss. One study not included in meta-analysis (due to the heterogenous weight loss outcome measurement) reported that the intervention group lost 1.8 kg (95% CI −4.3 to 0.8) more than the comparator group. Greater short-term effects are associated with the use of BCT 1.4 ‘action planning’ and the BCT 3.2 ‘social support (practical)’. The evidence is very uncertain also at long-term follow-ups (k = 2). |
Health-related quality of life follow-up: mean 17 weeks | SMD 0.29 SD higher (0.17 higher to 0.42 higher) | 1052 (10 RCTs) | ⨁⨁⨁◯ MODERATEb | Behavioural intervention likely increases the health-related quality of life slightly. At long-term follow-ups, the effect seems to diminish slightly (k = 2), but the evidence is uncertain. |
Physical function follow-up: mean 12 weeks | SMD 0.42 SD higher (0.12 higher to 0.73 higher) | 1042 (10 RCTs) | ⨁⨁◯◯ LOWa,b | Behavioural intervention likely increases physical function slightly. Increasing age, a higher proportion of male participants, and interventions using structured exercise sessions reported higher effect sizes at the end-treatment follow-ups. Interventions, including structured exercise sessions, reported a moderate and possibly clinically relevant improvement compared to interventions without structured exercise sessions. Using the BCT ‘Monitoring of outcome of behaviour without feedback’ and a higher number of BCT used for ‘Goals Settings and Planning’ was associated with lower effect sizes at the end-treatment follow-ups. At long-term follow-ups (k = 1), the effects seemed sustained. |
Depression symptoms follow-up: mean 14 weeks | SMD 0.7 SD lower (0.97 lower to 0.42 lower) | 1038 (11 RCTs) | ⨁⨁⨁◯ MODERATEa | Behavioural intervention likely reduces depression symptoms. Studies including people with a higher BMI, using a higher number of BCTs for ‘goal setting and planning’ and using the BCT ‘feedback and monitoring without feedback’, were associated with a lower reduction of depression symptoms. Depression severity was not associated with effect sizes. At the long-term follow-ups, the effect of behavioural intervention diminished. |