Evaluation of Combined Support for the Ambulatory Lifestyle Intervention

NCT05600205 | Unknown

• 1 other identifier: 220307
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

For people with a severe mental illness (SMI) there is no appropriate lifestyle intervention in ambulatory care, while they would benefit greatly from it. With SMI is meant mainly psychotic-, bipolar- and severe mood or anxiety disorders that require long-term care and counseling. People with SMI have a one-and-a-half to two times higher risk of heart disease, diabetes, and reduced mental health than the general population. This combination contributes to up to 15 years shorter life expectancy and reduced quality of life. Lifestyle plays an important role in this. Combined Support for the Ambulatory Lifestyle Intervention (GOAL!) is a multidisciplinary lifestyle support intervention where people with SMI are supervised for a longer period of time by qualified professionals, with attention to individual wishes and perceived challenges. Although the newly introduced so-called combined lifestyle interventions, that were recently introduced on a national level, follow this line of thinking, people with SMI may not benefit sufficiently from this offer. From the common challenge and need to create improved support, GGz Centraal in cooperation with the municipalities in the North Veluwe and local partners developed GOAL! and will pilot its use. This is done in cooperation with health insurers within the framework of an Innovation Policy Rule of the Dutch Healthcare Authority. The aim of this study is to follow this innovation and evaluate the implementation and effectiveness of GOAL!.

Conditions

Severe Mental Illness; Lifestyle

Keywords

Ambulatory; Implementation; Effectiveness

Outcome Measures

Primary Outcomes (1)

• Change in physical activity: SIMPAQ

  Measured by the Simple Physical activity Questionnaire (SIMPAQ). The SIMPAQ consists of five items (boxes), and participants are asked about time spent in bed (box 1), time sedentary, including naps (box 2), time spent walking (box 3), time spent exercising (box 4) and time spent in incidental activity, such as housekeeping (box 5). The total self-reported time spent on moderate-vigorous physical activity (MVPA) can be calculated by adding box 4 and 5.

  At baseline (T0), after 3 months (T1), after 12 months (T2) and after 24 months (T3)

Secondary Outcomes (12)

• Change in dietary intake: MijnEetmeter

  At baseline (T0), after 3 months (T1), after 12 months (T2) and after 24 months (T3)

• Change in sleep: SCOPA-SLEEP

  At baseline (T0), after 3 months (T1), after 12 months (T2) and after 24 months (T3)

• Change in substance use: ASSIST-Lite

  At baseline (T0), after 3 months (T1), after 12 months (T2) and after 24 months (T3)

• Change in weight

  At baseline (T0), after 3 months (T1), after 12 months (T2) and after 24 months (T3)

• Change in BMI

  At baseline (T0), after 3 months (T1), after 12 months (T2) and after 24 months (T3)

Other Outcomes (2)

• Achieving lifestyle goals

  24 months

• Adverse events

  24 months

Study Arms (2)

GOAL!

EXPERIMENTAL

Combined Support for the Ambulatory Lifestyle Intervention

Behavioral: GOAL!

Control group

NO INTERVENTION

Care and counseling as usual (matched for gender, age and diagnosis)

Interventions

GOAL! BEHAVIORAL

GOAL! is a integrated support focused on a combination of lifestyle factors for achieving a healthier lifestyle for people with severe mental illness. The intervention consists of two year of guidance from a lifestyle coach and qualified professionals.

GOAL!

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older;
• Diagnosed with a severe mental illness (SMI; defined as within treatment of a FACT team);
• Excessive abdominal circumference (≥102 cm for men or ≥ 88 cm for women; this is one of five risk factors for metabolic syndrome);
• Presence of at least one of the other four risk factors as clustered in the criteria for metabolic syndrome (hypertension, abnormal triglycerides, fasting blood sugar and HDL cholesterol, or medication use for blood pressure or values).

You may not qualify if:

• If someone lacks the legal capacity to give independent consent for participation and no (legal) representative is willing to give consent;
• If the disease severity at that time does not permit participation (i.e. acute psychological state, acute psychosis, or suicidality).

Sponsors & Collaborators

• GGZ Centraal: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (1)

GGz Centraal

Amersfoort, Utrecht, 3818 EW, Netherlands

Location

Related Publications (9)

• Hjorthoj C, Sturup AE, McGrath JJ, Nordentoft M. Years of potential life lost and life expectancy in schizophrenia: a systematic review and meta-analysis. Lancet Psychiatry. 2017 Apr;4(4):295-301. doi: 10.1016/S2215-0366(17)30078-0. Epub 2017 Feb 22.

  PMID: 28237639 BACKGROUND

• Correll CU, Solmi M, Veronese N, Bortolato B, Rosson S, Santonastaso P, Thapa-Chhetri N, Fornaro M, Gallicchio D, Collantoni E, Pigato G, Favaro A, Monaco F, Kohler C, Vancampfort D, Ward PB, Gaughran F, Carvalho AF, Stubbs B. Prevalence, incidence and mortality from cardiovascular disease in patients with pooled and specific severe mental illness: a large-scale meta-analysis of 3,211,768 patients and 113,383,368 controls. World Psychiatry. 2017 Jun;16(2):163-180. doi: 10.1002/wps.20420.

  PMID: 28498599 BACKGROUND

• Deenik J, Czosnek L, Teasdale SB, Stubbs B, Firth J, Schuch FB, Tenback DE, van Harten PN, Tak ECPM, Lederman O, Ward PB, Hendriksen IJM, Vancampfort D, Rosenbaum S. From impact factors to real impact: translating evidence on lifestyle interventions into routine mental health care. Transl Behav Med. 2020 Oct 8;10(4):1070-1073. doi: 10.1093/tbm/ibz067.

  PMID: 31169897 BACKGROUND

• Deenik J, Tenback DE, Tak ECPM, Hendriksen IJM, van Harten PN. [Thinking inside the box: improving the lifestyle of inpatients with severe mental illness]. Tijdschr Psychiatr. 2020;62(7):564-574. Dutch.

  PMID: 32700302 BACKGROUND

• Firth J, Siddiqi N, Koyanagi A, Siskind D, Rosenbaum S, Galletly C, Allan S, Caneo C, Carney R, Carvalho AF, Chatterton ML, Correll CU, Curtis J, Gaughran F, Heald A, Hoare E, Jackson SE, Kisely S, Lovell K, Maj M, McGorry PD, Mihalopoulos C, Myles H, O'Donoghue B, Pillinger T, Sarris J, Schuch FB, Shiers D, Smith L, Solmi M, Suetani S, Taylor J, Teasdale SB, Thornicroft G, Torous J, Usherwood T, Vancampfort D, Veronese N, Ward PB, Yung AR, Killackey E, Stubbs B. The Lancet Psychiatry Commission: a blueprint for protecting physical health in people with mental illness. Lancet Psychiatry. 2019 Aug;6(8):675-712. doi: 10.1016/S2215-0366(19)30132-4. Epub 2019 Jul 16. No abstract available.

  PMID: 31324560 BACKGROUND

• Firth J, Solmi M, Wootton RE, Vancampfort D, Schuch FB, Hoare E, Gilbody S, Torous J, Teasdale SB, Jackson SE, Smith L, Eaton M, Jacka FN, Veronese N, Marx W, Ashdown-Franks G, Siskind D, Sarris J, Rosenbaum S, Carvalho AF, Stubbs B. A meta-review of "lifestyle psychiatry": the role of exercise, smoking, diet and sleep in the prevention and treatment of mental disorders. World Psychiatry. 2020 Oct;19(3):360-380. doi: 10.1002/wps.20773.

  PMID: 32931092 BACKGROUND

• Suetani S, Rosenbaum S, Scott JG, Curtis J, Ward PB. Bridging the gap: What have we done and what more can we do to reduce the burden of avoidable death in people with psychotic illness? Epidemiol Psychiatr Sci. 2016 Jun;25(3):205-10. doi: 10.1017/S2045796015001043. Epub 2016 Jan 15.

  PMID: 26768358 BACKGROUND

• Firth J, Ward PB, Stubbs B. Editorial: Lifestyle Psychiatry. Front Psychiatry. 2019 Aug 26;10:597. doi: 10.3389/fpsyt.2019.00597. eCollection 2019. No abstract available.

  PMID: 31507466 BACKGROUND

• Noortman-van Meteren CR, van Schothorst MME, den Bleijker NM, Braakhuis-Keuning B, Houwert-Zuidema WMH, van Amelsvoort TAMJ, Deenik J. (Cost-)effectiveness and implementation of a combined lifestyle intervention for outpatients with severe mental illness (GOAL!): a hybrid quasi-experimental study protocol. BMC Psychiatry. 2024 Nov 14;24(1):804. doi: 10.1186/s12888-024-06216-x.

  PMID: 39543515 DERIVED

MeSH Terms

Conditions

Mental Disorders

Central Study Contacts

Jeroen Deenik, Dr.

CONTACT

+31622049524; j.deenik@ggzcentraal.nl

Chermaine Noortman - van Meteren, MSc.

CONTACT

+31651367977; c.vanmeteren@ggzcentraal.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Quasi-experimental with a mixed-method matched design

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: October 31, 2022
• Study Start: November 1, 2022
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: November 2, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)