Clinical trial NCT05600205: Evaluation of Combined Support for the Ambulatory Lifestyle Intervention
Official title: Evaluation of the Implementation and Effectiveness of a Combined Support for the Ambulatory Lifestyle Intervention (GOAL!)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Severe Mental Illness
Lifestyle
Keywords: Ambulatory
Implementation
Effectiveness
Lead sponsor: GGZ Centraal
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2022-10-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Quasi-experimental with a mixed-method matched design
Primary purpose: TREATMENT

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!.

Detailed description: Study design and setting

GOAL! will be evaluated through a quasi-experimental study with a mixed-method matched design. People with severe mental illness (SMI) receiving ambulatory care within the municipalities of North Veluwe will participate in the intervention. People who participate in GOAL! will be invited to additionally participate in its evaluation on a voluntary basis. Participants will be compared with a group of people with SMI who continue to receive usual counseling and care. This comparison group will be recruited outside municipalities where GOAL! takes place to avoid contamination. The aim is to recruit 50 participants of GOAL! for the evaluation and to create an equal comparison group of 50 participants matched for gender, age, and diagnosis. To evaluate the effects of GOAL! measurements will be conducted at baseline (T0), after 3 months (T1), after 12 months (T2), and after 24 months (T3).

Intervention

GOAL! aims to provide integrated support focused on a combination of lifestyle factors for achieving a healthier lifestyle for people with SMI. The intervention consists of one year of active guidance by the lifestyle coach, after which a maintenance program for another year is available. The participant starts with an intake interview with the lifestyle coach and then starts a basic course of three months in which participants have three group meetings of one hour each week. The group meetings focus on exercise (twice a week) and nutrition (once a week), and are given by qualified professionals in this field. After the basic course of three months a follow-up course of nine months starts with two group meetings of one hour per month given by the lifestyle coach. After the guidance phase of twelve months there is a maintenance program of also twelve months. This program consists of five sessions with individual counseling and three group meetings by the lifestyle coach.

Analysis

To measure the intervention effect, linear mixed models will be used. Although intervention and control groups are matched, potential differences between the groups on participant and disease characteristics are analyzed with independent t-tests (continuous variables) and chi-square tests (categorical variables). All models will be corrected for the baseline value, baseline disease severity, and monthly income category as a potential confounder for lifestyle behaviors. Corrections are made for potential clustering at the level of treatment team, neighborhood and municipality.

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).

Primary outcomes:
measure: Change in physical activity: SIMPAQ
timeFrame: At baseline (T0), after 3 months (T1), after 12 months (T2) and after 24 months (T3)
Secondary outcomes:
measure: Change in dietary intake: MijnEetmeter
timeFrame: At baseline (T0), after 3 months (T1), after 12 months (T2) and after 24 months (T3)
measure: Change in sleep: SCOPA-SLEEP
timeFrame: At baseline (T0), after 3 months (T1), after 12 months (T2) and after 24 months (T3)
measure: Change in substance use: ASSIST-Lite
timeFrame: At baseline (T0), after 3 months (T1), after 12 months (T2) and after 24 months (T3)
measure: Change in weight
timeFrame: At baseline (T0), after 3 months (T1), after 12 months (T2) and after 24 months (T3)
measure: Change in BMI
timeFrame: At baseline (T0), after 3 months (T1), after 12 months (T2) and after 24 months (T3)
measure: Change in metabolic health: waist circumference
timeFrame: At baseline (T0), after 3 months (T1), after 12 months (T2) and after 24 months (T3)
measure: Change in metabolic health: systolic and diastolic blood pressure
timeFrame: At baseline (T0), after 3 months (T1), after 12 months (T2) and after 24 months (T3)
measure: Change in fat percentage
timeFrame: At baseline (T0), after 3 months (T1), after 12 months (T2) and after 24 months (T3)
measure: Change in psychopathology: BSI
timeFrame: At baseline (T0), after 3 months (T1), after 12 months (T2) and after 24 months (T3)
measure: Change in Quality of life: EQ-5D
timeFrame: At baseline (T0), after 3 months (T1), after 12 months (T2) and after 24 months (T3)
measure: Change care use and illness and work: TIC-P
timeFrame: At baseline (T0) and after 24 months (T3)
measure: Barriers and facilitators of the implementation of GOAL!: MIDI
timeFrame: At baseline (T0) and after 24 months (T3)
Other outcomes:
measure: Achieving lifestyle goals
timeFrame: 24 months
measure: Adverse events
timeFrame: 24 months
Locations:
city: Amersfoort
country: Netherlands
facility: GGz Centraal
state: Utrecht
Study officials:
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