Efficacy of a Mobile Application for Weight Loss in Overweight and Obese Adults: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Body mass index (Kg/m2)
研究概览
简要总结
AIM: To assess the efficacy of an intervention that includes the assistance of a weight loss smartphone application targeted to young people aged 18 to 40 years.
DESIGN: Randomisedclinical trial.
SETTING: Primary Health Care centres (PHCCs) in Catalonia.
PARTICIPANTS: Adults aged 18 to 40 years with criteria of obesity or overweight, consulting PHCCs for any reason and who provide written informed consent to participate in the trial.
INTERVENTION GROUP will receive a 12-month weight loss programme that implements recommendations of a Clinical Practice Guideline, complemented with a smartphone app designed specifically for this programme.
CONTROL GROUP will receive the usual care. The outcome measure will be weight loss at 12 months.
EXPECTED RESULTS: The investigators expect a higher weight loss in the intervention group than in control group.
详细描述
DESIGN: Randomised clinical trial.
SETTING: Primary Health Care centres (PHCCs) in Catalonia, Spain.
PARTICIPANTS: Adults aged 18 to 40 years with criteria of obesity or overweight, consulting PHCCs for any reason and who provide written informed consent to participate in the trial.
INTERVENTION GROUP will receive a 12-month weight loss programme that implements recommendations of a Clinical Practice Guideline, complemented with a smartphone app designed specifically for this programme.
CONTROL GROUP will receive the usual care. The outcome measure will be weight loss at 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Young adults aged 18 to 40 years with overweight or obesity
- •availability of the patient's clinical history in the primary care centre
- •access to a smartphone device that meets the app requirements
- •access to an Internet data connection
排除标准
- •Morbid obesity with BMI> 40
- •Secondary Obesity (eg endocrine pathology)
- •eating disorders (the patient or any member of the family);
- •Presence of any significant comorbidity that a specific treatment (type 1 diabetes mellitus, severe mental illness);
- •pregnant or desire pregnancy in the next 12 months;
- •To participate in a weight loss program or taking any medication for weight loss in the moment of the recruitment
- •Take any medication that may influence body weight;
研究组 & 干预措施
Smartphone intervention group
The experimental group will receive the standard diet intervention for weight loss plus free Smartphone app plus a wearable device.
干预措施: Smartphone Application group (Behavioral)
Control group
Control group will receive a 12-month weight loss programmed that implements recommendations of a Clinical Practice Guideline
结局指标
主要结局
Body mass index (Kg/m2)
时间窗: 12 months
change in body mass index at 12 months in the experimental group, compared with the control group.. At each study visit, anthropometrics will be recorded by a primary care nurse or doctor. Body weight will be measured with the participant dressed in light clothing with shoes off on a calibrated balance.
Body weight (Kg)
时间窗: 12 months
Change in body weight at 12 months in the experimental group, compared with the control group. At each study visit, anthropometrics will be recorded by a primary care nurse or doctor. Body weight will be measured with the participant dressed in light clothing with shoes off on a calibrated balance.
次要结局
- Physical activity measured with two brief validated questionnaires(12 months)
- glucemic levels(12 months)
- GPT levels(12 months)
- cholesterol profile (LDL-cholesterol, HDL-Cholesterol, Cholesterol total)(12 months)
- blood pressure(12 months)