Evaluation of the Implementation and Effectiveness of a Combined Support for the Ambulatory Lifestyle Intervention (GOAL!)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in physical activity: SIMPAQ
研究概览
简要总结
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!.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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).
结局指标
主要结局
Change in physical activity: SIMPAQ
时间窗: At baseline (T0), after 3 months (T1), after 12 months (T2) and after 24 months (T3)
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.
次要结局
- 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 fat percentage(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))
- Change in psychopathology: BSI(At baseline (T0), after 3 months (T1), after 12 months (T2) and after 24 months (T3))
- Change in Quality of life: EQ-5D(At baseline (T0), after 3 months (T1), after 12 months (T2) and after 24 months (T3))
- Change care use and illness and work: TIC-P(At baseline (T0) and after 24 months (T3))
- Change in metabolic health: waist circumference(At baseline (T0), after 3 months (T1), after 12 months (T2) and after 24 months (T3))
- Change in metabolic health: systolic and diastolic blood pressure(At baseline (T0), after 3 months (T1), after 12 months (T2) and after 24 months (T3))
- Barriers and facilitators of the implementation of GOAL!: MIDI(At baseline (T0) and after 24 months (T3))