A Personal Nutrition Advisor to Assist Remote Dietary Counselling for Weight Loss and Maintenance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- The overall mean score of the "perceived impact" section from the user version of the mobile application scale (uMARS )
研究概览
简要总结
The purpose of the study is to assess the usability of the PNA and satisfaction with the treatment within the framework of usual care remote nutritional counselling for GLP-1-supported weight management and collect pilot data on its potential to support weight loss.
详细描述
The global prevalence of obesity and overweight is increasing and persistently drives global mortality and morbidity.As overweight and obesity are the result of an imbalance between energy intake and energy use, achieving a negative energy balance build the foundation for weight loss. Whilst dietary modification as a standalone procedure often fail in achieving or maintaining weight loss, the recent advent of supportive Glucagon-like Peptide-1 (GLP-1) based pharmacotherapies have greatly changed the landscape.Dietary counselling help people on GLP-1 based treatment reaching their individual weight goals and continued reimbursement of medication costs. However, nutritional advice provided by dietitians is often generic, not sufficiently aligned to individual weight loss trajectories.
The "Personal Nutrition Advisor" (PNA) is a decision support tool which is built upon an interpretable weight prediction model based on the energy balance equation (energy intake is a function of recorded dietary intake and a latent part dependent on observed weight changes, whereas energy expenditure is a function of weight and physical activity). Food, weight- and activity records captured using a smartphone application represent input data to the model. Output of the model is the predicted body weight trajectory alongside with personalized recommendations to reach a pre-defined target weight.
Integrating the PNA into a remote dietary counselling programme, in which certified dietitians deliver nutritional and lifestyle coaching via an application, has the potential to improve treatment satisfaction and efficacy. Therefore, the purpose of the study assess the usability of the PNA and satisfaction with the treatment within the framework of usual care remote nutritional counselling for GLP-1-supported weight management and collect pilot data on its potential to support weight loss.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Written informed consent
- •Receiving GLP-1-based pharmacotherapy in combination with remote nutritional counselling
- •Achieved weight loss of ≥5 (for baseline BMI 28-35 kg/m2) or ≥7% (for baseline BMI≥35kg/m2) after 4 months of GLP-1 based therapy (1st milestone)
排除标准
- •Inability to give written informed consent
- •Any physical or psychological disease or condition likely to interfere with the normal conduct of the study and interpretation of the study results
- •Self-reported pregnancy, planed pregnancy within next 3 months or breast-feeding
- •Concomitant participation in another trial that interferes with the normal conduct of the study and interpretation of the study results
- •Not proficient in German
研究组 & 干预措施
Study Intervention Group
The study intervention group will be undergoing 3 months of Personalized Nutrition Advisor (PNA)-assisted remote nutritional counselling.The PNA data analysis tool will be used by the dietitians during remote nutritional counselling sessions.The service will be delivered to patients undergoing GLP-1 based obesity treatment as part of their usual care. The study intervention group will report treatment-satisfaction and self-efficacy via questionnaires at baseline, 1.5 - and 3 months.
Patients who expressed their interest in participating in a focus group at the time of study inclusion, will be invited for a 60 min online interview session chaired by an experienced moderator. The focus group will consists of a maximum of 10 participants and address the patient's perspective on the utility of the dietitians' advice, discrepancy from expectations, general feedback and suggestions for PNA improvement using a semi structured discussion guide held in an open and spontaneous format
干预措施: Personal Nutrition Advisor (Other)
结局指标
主要结局
The overall mean score of the "perceived impact" section from the user version of the mobile application scale (uMARS )
时间窗: Post intervention visit (3 months after baseline)
This outcome will evaluate patient satisfaction with the counselling of the "Personal Nutrition Advisor" (PNA) -assisted remote nutritional counselling. The uMARS includes a 5 point likert scale of agreement (5 points=strongly agree, 1 point= strongly disagree) of 5 questions.
Change in the overall mean satisfaction score of the Nutritional and Dietetic Patient Outcomes Questionnaire (NDPOQ)
时间窗: From baseline to 3 months of the respective study period
This outcome will evaluate the patient treatment satisfaction with the counselling of the "Personal Nutrition Advisor" (PNA) -assisted remote nutritional counselling. The NDPOQ includes a 5 point likert scale of agreement (5 points=strongly agree, 1 point= strongly disagree) of 15 questions.
The overall mean score of the Healthcare Systems Usability Scale (HSUS)
时间窗: Post intervention visit (3 months after baseline)
This outcome will evaluate dietitian reported usability of the "Personal Nutrition Advisor" (PNA)- assisted remote nutritional counselling. HSUS includes a 5 point likert scale of agreement (5 points=strongly agree, 1 point= strongly disagree) of 20 questions.
次要结局
- Change in energy expenditure (kcal/day)(From the first day of the respective study period to 3 months thereafter)
- Proportion of patients reaching >5% weight loss(At start of the GLP-1 based pharmacotherapy to 3 months of the respective study period)
- Proportion of patients reaching >15% weight loss(At start of the GLP-1 based pharmacotherapy to 3 months of the respective study period)
- Change in daily number of logged meals and beverages(From the first day of the respective study period to 3 months thereafter)
- Change in relative fiber content (%)(From the first day of the respective study period to 3 months thereafter)
- Change in self-reported exercise engagement per week (hours/week)(At baseline and at 3 months of study intervention)
- Change in the overall mean score of the General Self-efficacy Scale (GSE) from Imperial College London(From baseline to 3 months of the respective study period)
- Collection of open ended PNA specific feedback questionnaires(Post intervention visit (3 months after baseline))
- Change in self reported weight (%)(From baseline to 3 months of the respective study period)
- Change in energy intake (kcal/day)(From the first day of the respective study period to 3 months thereafter)
- Change in relative protein content (%)(From the first day of the respective study period to 3 months thereafter)
- Change in relative fat content (%)(From the first day of the respective study period to 3 months thereafter)
- Change in relative carbohydrate content (%)(From the first day of the respective study period to 3 months thereafter)
- Proportion of patients reaching >10% weight loss(At start of the GLP-1 based pharmacotherapy to 3 months of the respective study period)
- Qualitative collection of patient reported PNA specific feedback.(Post intervention visit (3 months after baseline))
研究者
Lia Bally
Prof. Dr.med. et Dr. phil.
Insel Gruppe AG, University Hospital Bern