TABLE 3, [Summary of findings from additional...]. - Primary care management of cardiovascular risk for people with severe mental illnesses: the Primrose research programme including cluster RCT

Author and year of publication	Country	Number of participants (diagnosis), follow-up	Intervention and comparator	Setting	Risk of bias	Weight/BMI	Lipids	Glucose	Blood pressure
Behavioural interventions
Álvarez-Jiménez et al. (2010)⁶²	Spain	n = 61 (schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, brief reactive psychosis, or psychosis not otherwise specified), 52 weeks	10–14 individual, face-to-face sessions delivered over 12 weeks by a clinical psychologist. Sessions included psychoeducation, dietary counselling, physical activity, and behaviour therapy vs. usual care + advice on weight monitoring strategies and general dietary recommendations	Outpatients (assumed secondary care)	Low risk	No significant group differences in weight^a or BMI^a at 52-week follow-up	N/A	N/A	N/A
Cordes et al. (2011)⁷⁹	Germany	n = 100, (schizophrenia or schizoaffective disorder and had gained 1.5 kg since starting antipsychotic medication), 48 weeks	12, 90-minute group sessions delivered over 6 weeks by a dietitian. Sessions covered nutrition, physical activity and behavioural support vs. usual care	Secondary care inpatients	Unclear	Waist circumference change:^b intervention: 4.6 cm (SD 8.3 cm); control: 10.1 cm (SD 7.3 cm) F(8,19.073) = 3.144; p = 0.019)	No significant between-group differences for the levels of total cholesterol or triglycerides^b	Fasting glucose change: intervention: 86.4 mg/dl (SD 21.4 mg/dl); control = 110.9 mg/dl (SD 32.4 mg/dl) (t(23) = 2.159; p = 0.042)	No significant group differences for blood pressure^b
No significant group differences in body weight at 24 weeks^a	Significant group × time effects for fasting glucose: (F(2,26.3) = 3.97; p = 0.03)
Methapatara and Srisurapanont (2011)⁸³	Thailand	n = 64 (schizophrenia, BMI of ≥ 23 kg/m²), 12 weeks	Five, 60-minute group sessions delivered over 1 week by study researcher. Sessions included motivational interviewing, education on nutrition and physical activity, information and practice using a pedometer + booster session at 4 weeks healthy lifestyle leaflet vs. healthy lifestyle leaflet	Tertiary care (intervention delivered to inpatients prior to discharge)	Unclear	Weight change:^a intervention: –0.8 kg (SD 3.6 kg); control: 1.4 kg (SD 4.1 kg) (95% CI 4.12 to 0.29, t = –2.30; p = 0.03)	N/A	N/A	N/A
BMI change: intervention: –0.3 kg/m² (SD 1.3 kg/m²); control: 0.5 kg/m² (SD 1.6 kg/m²) (95% CI 1.5 to 0.6, t = –2.2; p = 0.03)
Waist circumference change: intervention: –3.4 cm (SD 4.4 cm); control: 0.9 cm (SD 5.2 cm) (t = –3.53; p < 0.01)
McCreadie et al. (2005)⁸²	UK	n = 100 (schizophrenia), 78 weeks	Free fruit and vegetables for 6 months with diet instructions vs. without instructions vs. usual care	Community	Unclear	No significant group differences for BMI^b	N/A	No significant group differences for glucose^b	N/A
Usher et al. (2013)⁸⁴	Australia	n = 101 (schizophrenia, bipolar disorder), 12 weeks	12 group sessions, once per week delivered by a nurse; sessions included education and discussion on the healthy lifestyle topic of the week (e.g. five food groups), participants’ progress implementing components of the programme into their everyday life. This session was followed by a 30-minute exercise activity vs. healthy lifestyle booklet	Primary care	Unclear	No significant group differences for weight^a or BMI^a	N/A	N/A	N/A
Daumit et al. (2013)⁸⁵	USA	n = 291 (schizophrenia, bipolar disorder), 18 months	12 group sessions, once per week delivered by a nurse; sessions included education and discussion on the healthy lifestyle topic of the week (e.g. five food groups), participants’ progress implementing components of the programme into their everyday life. This session was followed by a 30-minute exercise activity vs. healthy lifestyle booklet	Primary care	Unclear	BMI change:^a intervention: –1.2 kg/m² (95% CI –1.7 to –0.8 kg/m²); control: –0.1 kg/m² (95% CI –0.6 to 0.4 kg/m²) [mean between-group change –1.1 kg/m² (95% CI –1.8 to –0.5 kg/m²; p = 0.001)]	No significant group differences for lipids^b	No significant group differences for glucose^b	No significant group differences for diastolic or systolic blood pressure^b
Weight change:^a intervention: –3.4 kg (95% CI –4.7 to –2.1 kg); control: –0.2 kg (95% CI –1.7 to 1.3 kg) [mean between-group change –3.2 kg (95% CI –5.1 to –1.2 kg; p = 0.002)]
Ratliff et al. (2012)⁸⁶	USA	n = 30 (schizophrenia, schizoaffective disorder), 8 weeks	8 individual sessions, once per week of a standardised lifestyle programme (SIMPLE programme) supporting participants to choose healthy food and identify opportunities for physical activity (e.g. taking stairs instead of the lift) plus payment for attendance vs. SIMPLE programme plus payment for weight loss vs. control	Community mental health centre	Unclear	No significant group differences for weight^a or BMI^a	No significant group differences for lipids^b	No significant group differences for glucose^b	N/A
Combined pharmacological and behavioural interventions
Wu et al., (2008)⁶³	China	n = 128 (schizophrenia), 12 weeks	12-week diet and physical activity intervention (daily in week 1, weekly in weeks 2–12) delivered by dietitian and exercise psychologist + metformin alone or in combination vs. placebo	Secondary care inpatients	Low risk	Significant differences in BMI change between groups (diet and physical activity plus metformin significantly superior to either alone or placebo in reducing BMI): diet and physical activity plus metformin = –1.8 kg/m² (95% CI –2.3 to –1.3 kg/m²); metformin = –1.2k g/m² (95% CI –0.9 to –1.5 kg/m²); diet and physical activity = –0.5 kg/m² (95% CI –0.8 to –0.3 kg/m²); placebo = 1.2 kg/m² (95% CI 0.9 to 1.5 kg/m²)	N/A	Significant differences in fasting glucose change between groups (diet and physical activity plus metformin significantly superior to either alone or placebo in reducing fasting glucose): diet and physical activity plus metformin = –7.2 mg/dl (95% CI –10.8 to –5.4 mg/dl); metformin = –10.8 mg/dl (95% CI –16.2 to –7.2 mg/dl); diet and physical activity = –7.2 mg/dl (95% CI –9.0 to –3.6 mg/dl); placebo = 1.8 mg/dl (95% CI –1.8 to 3.6 mg/dl)	N/A
Significant differences in weight change between groups (diet and physical activity plus metformin significantly superior to either alone or placebo in reducing weight): diet and physical activity plus metformin = –4.7 kg (95% CI –5.7 to –3.4 kg); metformin = –3.2 kg (95% CI –3.9 to –2.5 kg); diet and physical activity = –1.4 kg (95% CI –2.0 to –0.7 kg); placebo = 3.1 kg (95% CI 2.4 to 3.8 kg)

Author and year of publication

Country

Number of participants (diagnosis), follow-up

Intervention and comparator

Setting

Risk of bias

Weight/BMI

Lipids

Glucose

Blood pressure

Behavioural interventions

Álvarez-Jiménez et al. (2010)⁶²

Spain

n = 61 (schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, brief reactive psychosis, or psychosis not otherwise specified), 52 weeks

10–14 individual, face-to-face sessions delivered over 12 weeks by a clinical psychologist. Sessions included psychoeducation, dietary counselling, physical activity, and behaviour therapy vs. usual care + advice on weight monitoring strategies and general dietary recommendations

Outpatients (assumed secondary care)

Low risk

No significant group differences in weight^a or BMI^a at 52-week follow-up

N/A

Cordes et al. (2011)⁷⁹

Germany

n = 100, (schizophrenia or schizoaffective disorder and had gained 1.5 kg since starting antipsychotic medication), 48 weeks

12, 90-minute group sessions delivered over 6 weeks by a dietitian. Sessions covered nutrition, physical activity and behavioural support vs. usual care

Secondary care inpatients

Unclear

Waist circumference change:^b intervention: 4.6 cm (SD 8.3 cm); control: 10.1 cm (SD 7.3 cm) F(8,19.073) = 3.144; p = 0.019)

No significant between-group differences for the levels of total cholesterol or triglycerides^b

Fasting glucose change: intervention: 86.4 mg/dl (SD 21.4 mg/dl); control = 110.9 mg/dl (SD 32.4 mg/dl) (t(23) = 2.159; p = 0.042)

No significant group differences for blood pressure^b

No significant group differences in body weight at 24 weeks^a

Significant group × time effects for fasting glucose: (F(2,26.3) = 3.97; p = 0.03)

Methapatara and Srisurapanont (2011)⁸³

Thailand

n = 64 (schizophrenia, BMI of ≥ 23 kg/m²), 12 weeks

Five, 60-minute group sessions delivered over 1 week by study researcher. Sessions included motivational interviewing, education on nutrition and physical activity, information and practice using a pedometer + booster session at 4 weeks healthy lifestyle leaflet vs. healthy lifestyle leaflet

Tertiary care (intervention delivered to inpatients prior to discharge)

Unclear

Weight change:^a intervention: –0.8 kg (SD 3.6 kg); control: 1.4 kg (SD 4.1 kg) (95% CI 4.12 to 0.29, t = –2.30; p = 0.03)

N/A

BMI change: intervention: –0.3 kg/m² (SD 1.3 kg/m²); control: 0.5 kg/m² (SD 1.6 kg/m²) (95% CI 1.5 to 0.6, t = –2.2; p = 0.03)

Waist circumference change: intervention: –3.4 cm (SD 4.4 cm); control: 0.9 cm (SD 5.2 cm) (t = –3.53; p < 0.01)

McCreadie et al. (2005)⁸²

n = 100 (schizophrenia), 78 weeks

Free fruit and vegetables for 6 months with diet instructions vs. without instructions vs. usual care

Community

Unclear

No significant group differences for BMI^b

N/A

No significant group differences for glucose^b

N/A

Usher et al. (2013)⁸⁴

Australia

n = 101 (schizophrenia, bipolar disorder), 12 weeks

12 group sessions, once per week delivered by a nurse; sessions included education and discussion on the healthy lifestyle topic of the week (e.g. five food groups), participants’ progress implementing components of the programme into their everyday life. This session was followed by a 30-minute exercise activity vs. healthy lifestyle booklet

Primary care

Unclear

No significant group differences for weight^a or BMI^a

N/A

Daumit et al. (2013)⁸⁵

USA

n = 291 (schizophrenia, bipolar disorder), 18 months

Primary care

Unclear

BMI change:^a intervention: –1.2 kg/m² (95% CI –1.7 to –0.8 kg/m²); control: –0.1 kg/m² (95% CI –0.6 to 0.4 kg/m²) [mean between-group change –1.1 kg/m² (95% CI –1.8 to –0.5 kg/m²; p = 0.001)]

No significant group differences for lipids^b

No significant group differences for glucose^b

No significant group differences for diastolic or systolic blood pressure^b

Weight change:^a intervention: –3.4 kg (95% CI –4.7 to –2.1 kg); control: –0.2 kg (95% CI –1.7 to 1.3 kg) [mean between-group change –3.2 kg (95% CI –5.1 to –1.2 kg; p = 0.002)]

Ratliff et al. (2012)⁸⁶

USA

n = 30 (schizophrenia, schizoaffective disorder), 8 weeks

8 individual sessions, once per week of a standardised lifestyle programme (SIMPLE programme) supporting participants to choose healthy food and identify opportunities for physical activity (e.g. taking stairs instead of the lift) plus payment for attendance vs. SIMPLE programme plus payment for weight loss vs. control

Community mental health centre

Unclear

No significant group differences for weight^a or BMI^a

No significant group differences for lipids^b

No significant group differences for glucose^b

N/A

Combined pharmacological and behavioural interventions

Wu et al., (2008)⁶³

China

n = 128 (schizophrenia), 12 weeks

12-week diet and physical activity intervention (daily in week 1, weekly in weeks 2–12) delivered by dietitian and exercise psychologist + metformin alone or in combination vs. placebo

Secondary care inpatients

Low risk

Significant differences in BMI change between groups (diet and physical activity plus metformin significantly superior to either alone or placebo in reducing BMI): diet and physical activity plus metformin = –1.8 kg/m² (95% CI –2.3 to –1.3 kg/m²); metformin = –1.2k g/m² (95% CI –0.9 to –1.5 kg/m²); diet and physical activity = –0.5 kg/m² (95% CI –0.8 to –0.3 kg/m²); placebo = 1.2 kg/m² (95% CI 0.9 to 1.5 kg/m²)

N/A

Significant differences in fasting glucose change between groups (diet and physical activity plus metformin significantly superior to either alone or placebo in reducing fasting glucose): diet and physical activity plus metformin = –7.2 mg/dl (95% CI –10.8 to –5.4 mg/dl); metformin = –10.8 mg/dl (95% CI –16.2 to –7.2 mg/dl); diet and physical activity = –7.2 mg/dl (95% CI –9.0 to –3.6 mg/dl); placebo = 1.8 mg/dl (95% CI –1.8 to 3.6 mg/dl)

N/A

Significant differences in weight change between groups (diet and physical activity plus metformin significantly superior to either alone or placebo in reducing weight): diet and physical activity plus metformin = –4.7 kg (95% CI –5.7 to –3.4 kg); metformin = –3.2 kg (95% CI –3.9 to –2.5 kg); diet and physical activity = –1.4 kg (95% CI –2.0 to –0.7 kg); placebo = 3.1 kg (95% CI 2.4 to 3.8 kg)

From: Appendix 1, Systematic review of pharmacological and behavioural interventions for reducing cardiovascular disease risk in people with severe mental illnesses

Cover of Primary care management of cardiovascular risk for people with severe mental illnesses: the Primrose research programme including cluster RCT

Primary care management of cardiovascular risk for people with severe mental illnesses: the Primrose research programme including cluster RCT.

Programme Grants for Applied Research, No. 7.2.

Osborn D, Burton A, Walters K, et al.

Southampton (UK): NIHR Journals Library; 2019 Apr.

Copyright © Queen’s Printer and Controller of HMSO 2019. This work was produced by Osborn et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.

NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.