An Internet-based Self-help Intervention for the Reduction of Consumption of Ultra-processed Products and Increase of Physical Activity in Mexican University Population: Study Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 176
- 主要终点
- Change in the Sedentary behavior questionnarie (SBQ-s)
研究概览
简要总结
This study evaluates the effectiveness of an online Multi-component psychological intervention, that is focused on reducing the consumption of ultra processed foods and increase the frequency of performing Physical Activity. At the same time to observe the effect on symptoms of anxiety, depression and stress.
详细描述
Ultra Processed Products are edible products made primarily or entirely from substances derived from food. Its manufacture is based on industrial processes such as hydrogenation, extrusion and molding, pre-processed for frying, and that cannot be done at home. A sedentary lifestyle or physical inactivity is associated with loss of muscle mass and weight gain. In contrast, physical activity acts as a protector against non-communicable diseases such as type 2 diabetes, cardiovascular diseases and some types of cancer. AF levels are determined through Units of Measurement of the Metabolic Rate. Also the consumption of Ultra Processed Products and sedentary behaviors have been associated with affectations on people's health; An example of this is the association that exists between them and has been associated with an increased risk of suffering from depression, anxiety, and stress.
Internet-based interventions had a large effect on cognitive dietary outcomes, a moderate effect on dietary intake and weight, and a small effect on physical activity outcomes. In concrete, self-applied interventions can be an option to arrive at a great number of participants. In such intervention the user receives the treatment solely through a web platform or an App. Such interventions are usually composed of videos, text and audios. Different reviews regarding self-administered treatments via the internet and computer-based treatments have been found them to be effective to achieve their goals.
The intervention will follow the principles of User Experience, with this ensuring that the design characteristics of the tool will meet the desired requirements to be perceived as easy to use, attractive and useful.
This study will be conducted through a randomized controlled clinical superiority trial with two independent groups. It will include intra subjects at five evaluation moments: 1) pretest, 2) middle of the intervention, 3) post-test, 4) follow up at three months and 5) follow up at 6 months.
Participants will be randomly assigned to one of two groups: experimental group, "UNISALUD", composed of 9 sessions and interactive elements such as videos, audios and infographics; control group, will be the waiting list group, the participants in this group will not receive the treatment immediately, it will be measured one time and then a second time 27 days later than the experimental group when it is calculated that the first group has carried out the 9 sessions.
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 (Participant)
盲法说明
The patients are not aware that there is an experimental group and a control group, the participants are not related and do not know each other. The conditions of the study are only known by the researcher, the therapists, and the Research Ethics Committee of the Universidad de Guadalajara.
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have a device (cell phone, computer or tablet) with internet access.
- •Have agreed to participate by giving tacit consent.
- •Be enrolled in any degree from a university in Mexico
排除标准
- •Be diagnosed with a psychiatric disorder.
- •Being diagnosed with an eating disorder.
- •Being under some nutritional food treatment.
- •Have a physical disability or injury that prevents you from engaging in mild to moderate physical activity.
- •Being under any pharmacological treatment for a medical condition.
- •Leaving the instruments unfinished.
研究组 & 干预措施
Behavioral: Online Intervention Unisalud
Participants in this group will receive 9 sessions of a multi-component intervention focused on the reduction of the consumption of ultra processed foods, symptoms of anxiety, depression and stress and the increase of physical activity.
干预措施: Unisalud (Behavioral)
No Intervention: Waiting List group
The participants in this group will not receive the treatment, just waiting list. They will be measured one time and then a second time 3 months after. Calculating when 3 months corresponding to 9 sessions will receive the intervention.
结局指标
主要结局
Change in the Sedentary behavior questionnarie (SBQ-s)
时间窗: 1 to 1.5 months, depending on the development of the patient and the completion of the 9 modules
The SBQ-s has 11 items that assess the time spent on sedentary behaviors (e.g., watching television, eating while sitting, resting while lying down, driving or traveling by car, bus, or subway). These activities are evaluated on both a typical weekday and a weekend day. The response options are: "none," "15 minutes or less," "30 minutes," "1 hour," "2 hours," "3 hours," "4 hours," "5 hours," and "more than 6 hours." The time dedicated to each activity is converted into hours.
Change in the Scale in Self- Efficacy Eating Consumption Scale (SEECS)
时间窗: 1 to 1.5 months, depending on the development of the patient and the completion of the 9 modules
Self-Efficacy Eating consumption Scale, consisted of 21 items with a response option ranging from 1 to 10, where 1 represents the absence of capacity and 10 represents being very capable of reducing the intake of caloric products or sweets and change the consumption of healthy foods. In addition, they were asked if they engaged in any type of physical activity. This scale shows reliability criteria of (α = 0.93).
Change in the Self-Efficacy for Exercise Questionnaire (SEEQ)
时间窗: 1 to 1.5 months, depending on the development of the patient and the completion of the 9 modules
The Self- Efficacy for Exercise Questionnaire assesses the degree of confidence that people perceive to be physically active. The full scale is composed of 5 items that assess negative affect, resistance to relapse, and giving oneself time to be physically active. It is Likert-type and its response options range from 1 (not at all confident) to 5 (extremely confident).
Change in the scores of the Frequency of Consumption
时间窗: 1 to 1.5 months, depending on the development of the patient and the completion of the 9 modules
To evaluate and monitor the consumption of PUs, a Consumption Frequency with emphasis on processing will be used, which was adapted from the Nova screener for the consumption of ultra-processed foods and the Consumption Frequency of foods of adolescents and adults (12 years or older), used in the National Health and Nutrition Survey, 2019, which shows the foods commonly consumed in Mexico. This is a qualitative instrument that evaluates the consumption of PUs in three categories: a) drinks (12 items); b) products that replace or accompany meals (26 items); and c) unhealthy snacks (12 items). Intake is reported on a previous day (yes or no) and in frequency of consumption per month (never, once a month, once every 15 days, and 1 to 7 times a week or more than once a day). The cut-off points were delimited based on previous studies: a) High consumption: 5 or more products per day, b) Medium consumption: between 2 and 4 products per day and c) Low one or non products
Change in time of the Physical Activity
时间窗: 1 to 1.5 months, depending on the development of the patient and the completion of the 9 modules
The short version of International Physical Activity questionnarie consists of 7 items and provides information about the time the person spends doing moderate and vigorous intensity activities, walking, and sitting in the last seven days. The questionnaire classifies the level of activity carried out into three categories: low, moderate and high
次要结局
- Change in the Generalized Anxiety Disorder Scale (GAD-7)(1 to 1.5 months, depending on the development of the patient and the completion of the 9 modules)
- Change in the Center for Epidemiological Studies Depression Scale (CES-D)(1 to 1.5 months, depending on the development of the patient and the completion of the 9 modules)
- Change in the Perceived Stress Scale(1 to 1.5 months, depending on the development of the patient and the completion of the 9 modules)