The ABEL Feasibility Study (Adherence, Better Health, Exercise and Life Satisfaction): A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Adherence (attendance) to prescribed exercise sessions
研究概览
简要总结
The ambition of the ABEL feasibility study is to test new "green prescription" follow-up models that can get more women with obesity, regularly active, with improved health and physical fitness. The project will evaluate the effect on exercise behavior, total physical activity level and mental and physical health outcomes by four different follow-up models by an exercise professional: HIGH-dosage in-person exercise coaching (four session monthly), MEDIUM- dosage in-person exercise coaching (two sessions monthly) LOW-dosage in-person exercise coaching (one session monthly). The main aim of this study is to evaluate which of these follow-up models is most effective on improving women's exercise adherence, total physical activity level, physical fitness, and mental and physical health. This will be weighed against the cost of each of the follow-up models, in order to identify the best model from a socioeconomic cost-effectiveness perspective. Moreover, the study will identify potential barriers among patients, General Practitioners and exercise professionals that prevents optimal outcome from the current green prescription model.
详细描述
BACKGROUND:
Obesity, defined as "abnormal or excessive fat accumulation that presents a risk to health" and a body mass index (BMI) of ≥30, represents a major health challenge and economic burden for welfare systems worldwide. Living with obesity is reported to account for 80-85% of the risk of developing non-communicable diseases such as diabetes type 2. Guidance on regular physical activity, exercise and healthy eating is traditionally the first measure taken for patient who undergo treatment for obesity. Treatment for obesity in the primary healthcare service is largely coordinated by general practitioners (GP). Green prescriptions (tailored advice and guidance on lifestyle factors related to development of disease, such as physical activity and healthy eating) can be prescribed as a treatment alternative to patients with chronic disease, such as obesity. However, few GPs in Norway use green prescriptions as a treatment alternative to their patients, and 41% of GPs in 2006 reported that they had newer prescribed green prescriptions to their patients. The lack of sufficient follow-up of patients has been reported as a main limitation with the current green prescription model.
Previous research underlines the importance in-person coaching for patients who receives green prescriptions, as well as establishing collaborations with professions such as exercise professionals to be able to provide sufficient coaching of patients. Hence, in-person coaching by an exercise professional may have the means to get more patients with obesity regularly active, and can potentially be the follow-up alternative the current green prescription model is lacking.
However, considering the expenses and practical considerations associated with in-person coaching, has former studies displayed the advantage of using web-based behavioral support for patients with obesity. Yet, web-based behavioral support often proves to have poor completion rate, and need to be combined with face-to-face guidance and feedback in order to increase adherence. However, when combining in-person coaching and web-based behavioral support, there is still limited knowledge on how frequent in-person coaching needs to occur, in order to increase adherence. More knowledge on frequency of follow-up is essential for an approach towards an economical sustainable green prescription model.
AIMS:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Each participant will be randomly assigned (1:1:1:1) to one intervention group, HIGH, MEDIUM, LOW or CONTROL following a simple computer-based randomization program. All participants included in the study will conduct the baseline assessments before the randomization procedure. The study design will not allow for further masking of study participants or the exercise professional (caregivers to the interventions). Those from the research group involved in inclusion of the participants or follow-up measurements will not have access to the group allocation list. Further, all measurements will be completed and plotted without the research group information of group allocation. The statistical analyses will be done in SPSS, following a predefined analysis plan and before unmasking the study arms.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age between 18 to 65 years
- •No fitness club membership six months prior to recruitment
- •Low-active (<150 minutes of moderate-intensity or 75 minutes of vigorous-intensity per week)
- •Norwegian speaking
- •In possession of a mobile phone.
排除标准
- •Chronic disease or pathology (e.g severe hypertension 180/110 mm Hg), heart disease or lung disease hindering exercise
- •Changing GP during the intervention
- •Functional impairment due to injuries hindering physical activity and exercise.
研究组 & 干预措施
LOW dosage in-person exercise coaching
One in-person exercise session with the exercise professional/monthly, and 15 minutes web-based behavioral support on the non-supervised weeks.Total of five hours of in-person coaching during the 20 weeks intervention.
干预措施: Low dosage in-person exercise coaching (Behavioral)
HIGH dosage in-person exercise coaching
One in-person exercise session with an exercise professional/weekly. A total of 20 hours of in-person coaching during the 20 weeks of intervention.
干预措施: High dosage in-person exercise coaching (Behavioral)
MEDIUM dosage in-person exercise coaching
Two in-person exercise session with an exercise professional/monthly, and 15 minutes web-based behavioral support on the non-supervised weeks.A total of 10 hours in-person coaching during the 20 weeks intervention.
干预措施: Medium dosage in-person exercise coaching. (Behavioral)
CONTROL
Will be asked to continuing with normal life, and will receive regular follow-up care from their GP. This group will be giving the "Norwegian Directorate of Health's" recommendations for physical activity and nutrition, and will have access to the ABEL-app in order to register physical activity and exercise, but will not be provided any coaching during the 20 weeks.
结局指标
主要结局
Adherence (attendance) to prescribed exercise sessions
时间窗: Continuously during the intervention period of 20 weeks
Measures of adherence to exercise sessions will be collected through the ABEL-app (ABEL Technologies). Sessions performed with the exercise professional will be logged through the ABEL-app of the exercise professional, while sessions performed independently will be logged through the ABEL-app of the participant. Participants adherence will be measured by attendance (percentage of exercise sessions completed out of exercise sessions offered).
次要结局
- Blood pressure(At baseline and following the intervention period (20 weeks))
- Cholesterol(At baseline and following the intervention period (20 weeks))
- Heart rate recovery(At baseline and following the intervention period (20 weeks))
- Exercise frequency(At baseline and following the intervention (20 weeks).)
- Health-related quality of life(At baseline and following the intervention period (20 weeks))
- Perceived social support from family and friends(At baseline and following the intervention period (20 weeks))
- Stage of motivational readiness for exercise and physical activity(At baseline and following the intervention period (20 weeks))
- Glycated hemoglobin(At baseline and following the intervention period (20 weeks))
- Height(At baseline and following the intervention period (20 weeks))
- Duration of exercise sessions(At baseline and following the intervention period (20 weeks))
- Mode of physical activity(At baseline and following the intervention period (20 weeks))
- Self-efficacy(at baseline and following the intervention period (20 weeks))
- Barriers to exercise(At baseline and following the intervention period (20 weeks))
- In-depth interview (general practitioners)(Following the intervention period (20 weeks))
- Fulfillment of physical activity recommendations(At baseline and following the intervention period (20 weeks))
- Motivation for exercise and physical activity(At baseline and following the intervention period (20 weeks))
- The Borg Rating of Perceived Exertion (RPE)(At baseline and following the intervention period (20 weeks))
- Working heart rate(At baseline and following the intervention period (20 weeks))
- Muscular strength(At baseline and following the intervention period (20 weeks))
- Urinary incontinence(At baseline and following the intervention period (20 weeks))
- Weight(At baseline and following the intervention period (20 weeks))
- Factors associated with exercise adherence and drop-out(Following the intervention period (20 weeks))
- Basic physicological needs in exercise (BPNES)(Following the intervention period (20 weeks))