En_Línea. An Online Treatment to Change Lifestyle in Overweight and Obesity: Study Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 305
- 试验地点
- 1
- 主要终点
- Maintenance of weight loss 6 months follow-up
研究概览
简要总结
A randomized controlled trial to test the effectiveness of an online weight control program, called en_línea, comparing with a standard group therapy and a control group
详细描述
This is a randomized controlled trial with three intervention arms: en_línea, standard group therapy and control group. To perform this study, 305 adults (18-65 years) with overweight type II (27-29.9 kg/m2) or obesity type I (30-34.9 kg/m2) will be invited to participate. Interventions will last 17 weeks with follow-ups 1, 3, 6 and 12 months after the post-treatment appointment. The primary outcome will be post-treatment weight loss and the maintenance during the follow-ups. Secondary outcomes will be adherence rates, drop outs and quality of life. Participants will be assessed before randomization and they will be sign an inform consent.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Overweight type II or obesity type I. BMI between 27 and 34.9 kg/m2
- •Age between 18 and 65 years old
- •Compliance with all evaluation phases.
排除标准
- •Presence of several physical disease, i.e. diabetes, hypertension, cancer or metabolic disorders
- •Presence of several psychological problem, i.e. depression, anxiety
- •Presence of other eating disorders, i.e. anorexia nervosa, bulimia nervosa, binge eating disorders
- •Use of drugs, i.e. slimming, anovulatory or psychotropic
- •Pregnancy or planned pregnancy for the next six months
- •Following another weight control program at the time of selection.
研究组 & 干预措施
Online intervention, en_línea
Participants will be provided with a username and a password to acess to a website. en_línea program is an online adaptation of the LEARN program. The five treatment areas are: Lifestyle, Exercise, Attitudes, Relationships and Nutrition. We have designed and developed a website (www.programaenlinea.org) with 17 weekly treatment sessions and an exclusive mobile application for self-recording.
干预措施: en_línea (Behavioral)
Standard group therapy
Participants in this arm will received a 10 sessions of standard primary care group therapy. Sessions 1 and 2 will be weekly and sessions from 3 to 10 will be biweekly. Sessions, between 8 and 10 participants, will be conducted by a specialized psychologist and they will last 90 minutes. Treatment areas will be the same as en_línea, beginning with nutrition and exercise and a progressive incorporation of the other topics. Material to work at home and self-recording will be provided in paper.
干预措施: Group therapy (Behavioral)
Control group
Participants in the control group only will receive a biweekly newsletter by email without feedback. They will be provided with material and instructions to self-record their daily meals and exercise. The newsletter only will content basic information about nutrition and exercise.
结局指标
主要结局
Maintenance of weight loss 6 months follow-up
时间窗: 6 months follow-up
Maintenance of weight loss
Weight loss
时间窗: 4 months
5%-10% of weight loss respect the initial weight
Maintenance of weight loss 1 month follow-up
时间窗: 1 month follow-up
Maintenance of weight loss
Maintenance of weight loss 3 months follow-up
时间窗: 3 months follow-up
Maintenance of weight loss
Maintenance of weight loss 12 months follow-up
时间窗: 12 months follow-up
Maintenance of weight loss
次要结局
- Adherence(4 months)
- Drop out(4 months)
- Quality of life test measures(4 months)
研究者
Carmina Saldaña
PhD
University of Barcelona