Development of an mHealth Tool (ANíMATE) to Assess Self-management, Self-care and Adherence in People With Obesity (ANíMATE)
This trial main purpose is to develop and test an mHealth app aimed at improving self-management, self-care and adherence of people with obesity.
The study population are type I or II obese people, aged more than 18 years old, with or without comorbidities, who have a smartphone or tablet compatible with the app (Android version 9.0 or higher) and access to a scale for regular weight monitoring.
Control group will follow standard care protocol and patients in the intervention group will also be provided with the app. Follow-up will be done for 16 weeks. Both groups will attend 3 face-to-face visits (baseline, 2 and 4 months).
研究概览
研究类型
介入性
注册 (预期的)
36
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Barcelona、西班牙、08025
- 招聘中
- Hospital de la Santa Creu i Sant Pau
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接触：
- Cintia Gonzalez Blanco, MD, PhD
- 电话号码：+34610898918
- 邮箱：cgonzalezb@santpau.cat
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首席研究员：
- Cintia Gonzalez Blanco, MD, PhD
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副研究员：
- Gemma Cuixart Carruesco, MD
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 100年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Patients over 18 years of age.
- People with BMI 30-39.9 kg/m2.
- Have a smartphone or tablet compatible with the app (Android version 9.0 or higher) and have sufficient capabilities to use it.
- Have access to a scale for regular weight monitoring.
Exclusion Criteria:
- Presence of serious major comorbidities: High blood pressure treated with > 3 drugs, diabetes mellitus treated with insulin, dyslipidemia treated with PCSK9 inhibitors, sleep apnea-hypopnea syndrome treated with CPAP, ischemic heart disease or stroke.
- Use of pharmacological treatment with influence on weight started in the 6 months prior to study entry.
- History of weight loss intervention (diet, exercise) in the 6 months prior to study entry.
- History of eating disorder.
- History of bariatric surgery.
- Use of any other app or treatment to lose weight in the 6 months prior to study entry.
- Pregnancy, short-term gestational desire or lactation.
- Any other disease or condition that may interfere with compliance with the protocol or completion of the study.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：ANíMATE mobile application
Standard care protocol (3 face-to-face visits: basal, 2 and 4 months) + ANíMATE mobile application
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mHealth tool ANíMATE (Adherence, Nutrition, PhysIcal Activity, Motivation, medicAtion, Technology and Empowerment) allows the recording of data related to diet and exercise and feedback on behavior through an intelligent data analysis system.
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无干预：Standard care
Standard care protocol (3 face-to-face visits: basal, 2 and 4 months)
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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%TWL at 4 months
大体时间：4 months
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Percentage of total weight loss (%TWL) at 4 months
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4 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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%TWL at 2 months
大体时间：2 months
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Percentage of total weight loss (%TWL) at 2 months
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2 months
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%EWL at 2 and 4 months
大体时间：2 and 4 months
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Percentage of excess weight loss (%EWL) at 2 and 4 months
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2 and 4 months
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BMI change at 2 and 4 months
大体时间：Baseline, 2 and 4 months
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Change in body mass index (BMI) (kg/m^2) from baseline to 2 and 4 months
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Baseline, 2 and 4 months
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Waist change at 2 and 4 months
大体时间：Baseline, 2 and 4 months
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Change in waist circumference (cm) from baseline to 2 and 4 months
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Baseline, 2 and 4 months
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Blood pressure change at 2 and 4 months
大体时间：Baseline, 2 and 4 months
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Change in systolic and diastolic blood pressure (mmhg) from baseline to 2 and 4 months
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Baseline, 2 and 4 months
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HbA1c change at 2 and 4 months
大体时间：Baseline, 2 and 4 months
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Change in HbA1c percent from baseline to 2 and 4 months
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Baseline, 2 and 4 months
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Mediterranean diet adherence change at 4 months
大体时间：Baseline and 4 months
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Change in mediterranean diet adherence questionnaire score (0*-14, *indicates worse questionnaire results) from baseline to 4 months
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Baseline and 4 months
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IPAQ change at 4 months
大体时间：Baseline and 4 months
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Change in International Physical Activity Questionnaire (IPAQ) score (cathegory results: low/inactive*, moderate or high, *indicates worse questionnaire results) from baseline to 4 months
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Baseline and 4 months
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ACTA change at 4 months
大体时间：Baseline and 4 months
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Change in attitudes towards change in eating disorders (ACTA) questionnaire score (0*-236, *indicates worse questionnaire results) from baseline to 4 months
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Baseline and 4 months
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Adherence to records
大体时间：2 and 4 months
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Percentage of records (weight, diet) at 2 and 4 months
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2 and 4 months
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Adherence to recommendations
大体时间：2 and 4 months
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Percentage of recommendations given by the medical team followed at next visit
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2 and 4 months
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Adherence to visits
大体时间：2 and 4 months
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Percentage of face-to-face visits attended
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2 and 4 months
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Adherence to the app
大体时间：2 months after the end of the study
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Percentage of patients who continue using the 2 months app after the end of the study
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2 months after the end of the study
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Quality of life change at 4 months
大体时间：Baseline and 4 months
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Change in Short-Form Health Survey SF-36 questionnaire score (0*-100, *indicates worse questionnaire results) from baseline to 4 months
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Baseline and 4 months
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Satisfaction with the app
大体时间：4 months
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Satisfaction questionnaire in relation to the use of the app score (0*-20, *indicates worse questionnaire results) in the intervention group at the end of the study
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4 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2022年4月20日
初级完成 (预期的)
2023年3月1日
研究完成 (预期的)
2023年6月1日
研究注册日期
首次提交
2022年1月24日
首先提交符合 QC 标准的
2022年2月2日
首次发布 (实际的)
2022年2月11日
研究记录更新
最后更新发布 (实际的)
2022年4月22日
上次提交的符合 QC 标准的更新
2022年4月20日
最后验证
2022年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
ANíMATE mobile application的临床试验
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Klein Buendel, Inc.National Institute on Minority Health and Health Disparities (NIMHD); Pennington Biomedical...完全的
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Environment and Health Group, Inc.Prisma Health完全的
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The Miriam HospitalNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)撤销
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VA Office of Research and Development尚未招聘