GO EASY: Eating Habits and Physical Activity in Synergy for Diabetes Prevention in Families
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Participants' self-perceived mode of delivery (questionnaire, 5-items Likert scale, higher score is best)
研究概览
简要总结
Introduction: Type 2 diabetes represents a growing health risk for the society. An easy-access and low-cost intervention for the whole family will be developed to help families with (at risk of) type 2 diabetes maintain diabetes-frendly everyday life. The intervention will be tested for feasibility.
Methods: Following the framework for developing and conduct of complex interventions, the intervention will be developed on the basis of current evidence on family-based diabetes treatment and opinions of families with type 2 diabetes. The feasibility test will have embedded mixed methods one-group study design.
Participants: Families will answer a brief screening questionnaire. Families (n=25) that consist of at least one adult with (in risk of) type 2 diabetes living in the same household with at least one 5-18 yeard old child, and at least one family member living sedentary lifestyle, will participate.
Intervention: The 3-months long hybrid telehealth/face-to-face intervention with weekly 1-hour contacts with health professionals will deliver diabetes education and tailored support to implement more physical activity and healthy meals in the family everyday life. A 3-months long supervised maintenance phase with monthly professional contacts will be included.
Outcomes: Feasibility evaluation will be conducted using quantitative (quantifiable) and qualitative research methods. The feasibility data will be the primary outcomes of the study, collected and evaluated using the predefined research progression criteria applied the green-amber-red method. Sociodemography and secondary outcomes, such as physical activity, dieting habits, daily occupations, occupational balance, health and quality of life will be assessed at baseline and 3 and 6-months follow-ups. The quantitative results will be comprehended through qualitative data from participant interviews which will nuance the feasibility evaluation.
Analysis: Relevant statistical methods and qualitative analysis method will be applied.
Expected results: The intervention will help families achieve sustainable lifestyle changes, e.g., diabetes stabilized blood glucose in adults with type 2 diabetes, increased physical activity time and improved dieting habits, for better family health and well-being.
Ethics and dissemination: The trial does not have any obvious health risks for the participants. All the results - significant, non-significant and/ or inconclusive - will be reported.
详细描述
Note: T2D means type 2 diabetes
Design
The GO EASY intervention is an easy-access and low-cost intervention promoting physical activity and healthier meals in families with (at risk of) T2D. The intervention will be developed and tested for feasibility, following the recommendations on developing and conducting complex interventions from the Medical Research Council (MRC) framework.
Feasibility evaluation of the intervention will be conducted using quantitative (quantifiable) and qualitative research methods. The quantitative results will be comprehended through qualitative data which will help a nuanced in-depth evaluation of feasibility from participant and clinical perspectives.
For the quantitative (quantifiable) data collection on feasibility, predefined research progression criteria will be determined, and the green-amber-red method will be applied. The green-amber-red method with the categories GREEN (Proceed with the RCT/ implementation), AMBER (Proceed, but changes to the protocol need to be discussed and solved) and RED (Do not proceed unless the problem can be solved) will help evaluate the readiness of the intervention to be tested for effectiveness in an RCT. Parameters relevant to T2D research, i.e., dieting habits, routines, and physical activity, will be monitored and assessed before and after the intervention. Several families will participate in objective physical activity assessments using technological devices (activity trackers).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parents (aged 18 or older) with (or at risk of) type 2 diabetes living in the same household with 5-17 years old children
- •At least one family member not meeting the current physical activity recommendations.
排除标准
- •Pregnancy or postpartum period (6 months after birth)
- •Current critical illness, e.g. cancer
- •Participating in other type 2 diabetes treatment programs
结局指标
主要结局
Participants' self-perceived mode of delivery (questionnaire, 5-items Likert scale, higher score is best)
时间窗: 6 months
cf. predefined research progression criteria
Adverse events
时间窗: 6 months
cf. predefined research progression criteria
Satisfaction with the treatment (questionnaire, 5-items Likert scale, higher score is best)
时间窗: 6 months
cf. predefined research progression criteria
Percentage of participants completed the intervention
时间窗: 6 months
cf. predefined research progression criteria
Participants' self-perceived relevance (questionnaire, 5-items Likert scale, higher score is best)
时间窗: 6 months
cf. predefined research progression criteria
Assessment procedure acceptance (questionnaire, 5-items Likert scale, higher score is best)
时间窗: 6 months
cf. predefined research progression criteria
Rate of the participants recruited per months
时间窗: 6 months
cf. predefined research progression criteria
Rate of participants' adherence to the intervention's sessions (attendance registration forms)
时间窗: 6 months
cf. predefined research progression criteria
Participants' self-perceived timing (questionnaire, 5-items Likert scale, higher score is best)
时间窗: 6 months
cf. predefined research progression criteria
Fidelity of delivery (questionnaire, 5-items Likert scale, higher score is best)
时间窗: 6 months
cf. predefined research progression criteria
Contextual appropriateness (questionnaire, 5-items Likert scale, higher score is best)
时间窗: 6 months
Treatment acceptance, cf. predefined research progression criteria
次要结局
- Glucaemic control(Change from baseline to 6 months)
- Weekly physical activity, self-reported(Change from baseline to 6 months)
- Well-being(Change from baseline to 6 months)
- Daily wake-time physical activity, objective(Change from baseline to 6 months)
- Occupational balance(Change from baseline to 6 months)
- Daily walking steps, objective(Change from baseline to 6 months)
- Dieting habits(Change from baseline to 6 months)
- BMI(Change from baseline to 6 months)
- Activities of daily living(Change from baseline to 6 months)
- Self-perceived health today(Change from baseline to 6 months)
- Health-related quality of life(Change from baseline to 6 months)
研究者
Svetlana Solgaard Nielsen
Principal Investigator, Occupational Therapist, PhD, postdoc
Slagelse Hospital