Psychological Levers of Commitment and Persistence in Physical Activity in People With Type 2 Diabetes. PerPA2Temps Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Siel Bleu
- 入组人数
- 77
- 试验地点
- 2
- 主要终点
- Change in amount of physical activity assessed by the French Version of GPAQ
研究概览
简要总结
Many programmes exist to enable patients to engage in physical activity, but it is clear that the objectives are often not achieved in terms of quality, quantity or intensity of practice. In this study, the aim is to find alternatives, assuming that strengthening patients' self-efficacy, meeting their basic needs and increasing their level of hope will have an impact on their motivation to practice, which in turn will have an impact on their actual practice. The aim is to develop and implement an innovative intervention programme and to identify the interactions between the variables that are assumed to predict engagement in practice.
详细描述
Type 2 diabetes is one of the chronic pathologies that can be treated, in part or in full, by respecting hygienic-dietary rules (i.e. recommendations on dietary balance and physical activity). Numerous studies have demonstrated the benefits of physical activity (Duclos et al., 2012; Sigal et al., 2013) but few patients change their behaviour over the long term. A field of psychology has put forward certain notions that can be levers for practice: the theory of hope, the feeling of personal efficacy (SEP), motivation and basic psychological needs. Some motivational programmes for physical activity (PA) have been developed on the basis of these concepts in different fields (i.e. work, school) but, to our knowledge, in France, none has yet been developed in the field of health and a fortiori in the management of people with diabetes.
The main objective of this study is to develop and implement an innovative motivational intervention programme in adapted physical activity (APA) for type 2 diabetic patients (T2DM). The aim of this programme is to enable them to improve their chances of engagement and persistence in physical activity. To this end, the investigators would like to study the effect of this type of programme on physical activity.
Secondly, the investigators would like to study, on the one hand, the evolution and the interactions between the different psychological variables in the framework of this innovative intervention programme. On the other hand, the investigators want to study the impact of the intervention on physical fitness, commitment and satisfaction with physical activity.
The study will be set up within the framework of the APA sessions provided by the Siel Bleu association. The subjects will be new exercisers, type 2 diabetics not treated with insulin, having been included through the various partners of Siel Bleu.
the investigators will have an intervention group and a control group. The control group will benefit from a standard APA programme offered by Siel Bleu. A standard APA programme consists of one-hour sessions in a group of up to 15 people. The objective of these Siel Bleu programmes is to maintain or improve the physical capacities of the participants. To achieve this, several session themes are addressed (i.e. endurance, muscular strength of upper and lower limbs, balance, flexibility, coordination). The intervention group will participate in this APA programme with an information and experience sharing session as well as APA challenges and various positive reinforcement exercises. Data will be collected in the form of questionnaires at inclusion, at the end of the programme and at 3, 6 and 12 months after the programme.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Subject over 18 years of age
- •Subject who has given signed consent to participate in the protocol
- •Type 2 diabetic subject not treated with insulin
- •Subject participating for the first time in adapted physical activity sessions provided by Siel Bleu
- •Subject understanding and reading French
排除标准
- •Subjects with major health problems that prevent them from continuing the programme.
- •Subjects who have withdrawn their consent.
结局指标
主要结局
Change in amount of physical activity assessed by the French Version of GPAQ
时间窗: Pre-intervention/immediately after the intervention, at 3, 6 and 12 months after the intervention
The evolution of the quantity of physical activity will be the main criterion of judgment. It will be measured by the Global Physical Activity Questionnaire, which will allow for differentiation of intensities and contexts of practice. This questionnaire will be administered at each evaluation time proposed by the study (before/after, at 3, 6 and 12 months). The higher the score (in Metabolic Equivalent of Task/minutes/weeks), the greater the amount and intensity of physical activity performed. The comparison between the pre- and post-programme assessments (e.g. T0 and T1) will allow the direct effect of the programme on the amount of physical activity to be determined. The other assessments (e.g. T2, T3 and T4) will determine the persistence of this practice over time.
次要结局
- Subject attendance assessed by an attendance grid(Through intervention completion, that is, 12 weeks)
- Change in dispositional hope level assessed by the French Version of the Adult Dispositional Hope Scale(Pre-intervention/immediately after the intervention)
- Change in the satisfaction of basic psychological needs assessed by the French Version of The Basic Psychological Needs.(Pre-intervention/immediately after the intervention, at 3, 6 and 12 months after the intervention)
- Change in dispositional optimism level assessed by the French Version of The Life Orientation Test-Revised(Pre-intervention/immediately after the intervention)
- Change in the subjects' motivational profile towards a more self-determined motivation assessed by the French Version of the Motivation for Physical Activity for Health Scale(Pre-intervention/immediately after the intervention, at 3, 6 and 12 months after the intervention)
- Change in self-efficacy assessed by the French Version of The Self-Efficacy Questionnaire(Pre-intervention/immediately after the intervention, at 3, 6 and 12 months after the intervention)
- Change of initial state hope level assessed by the French Version of the State Hope Scale(Pre-intervention/immediately after the intervention, at 3, 6 and 12 months after the intervention)
- Participant satisfaction assessed by a study-specific questionnaire(Immediately after the intervention)
- Individual demographic and socio-economic data assessed by a specific form for the study(Pre-intervention)
- Initial medical data assessed by a specific form for the study(Pre-intervention)
- Change in physical condition assessed by The 6-Minute Walk Test(Pre-intervention/immediately after the intervention)
- Progressive medical data assessed by a specific form for the study(Pre-intervention/immediately after the intervention, at 3, 6 and 12 months after the intervention)