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Not Yet Recruiting NCT05600205

Evaluation of Combined Support for the Ambulatory Lifestyle Intervention

Conditions: Severe Mental Illness, Lifestyle

Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 100
Sponsor: GGZ Centraal

Location: Netherlands

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!.

Eligibility Criteria

Inclusion Criteria:18 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).Exclusion Criteria: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).

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05600205). StuddyBuddy aggregates publicly available trial information.