The System Fammeal Comprising an App With Tailored Recommendations and Gamification for Parents to Counteract Childhood Obesity, at Health Care Centers - Pilot Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Change from Baseline Perceptions and Attitudes regarding children's weight status at 4 weeks
研究概览
简要总结
The investigators aim to test an evidence-based intervention, allocated to a mobile app designed to parents and their children with 3 to 6 years old, identified by family doctors or nurses at well-child care visits as overweight or obese for age.
This intervention aims to improve parent's perceptions and attitudes regarding children's weight status and food intake, leading to better dietary intake and children's' eating behaviors through positive parental child-feeding practices. In this study, the investigators aim to assess the feasibility of the intervention and explore its impact on the beliefs and attitudes of parents.
详细描述
The investigators will enroll parents and their children with 3 to 6 years old, identified by family doctors or nurses at well-child care visits as overweight/obese for age.
Participant's eligibility will be assessed. Participants will be randomized to: 1) control group; 2) intervention group. The control group will receive treatment as usual. Parents in the intervention group will be provided with the app and invited to use it for 4 weeks. During the 4 weeks, the administrator monitors the app usage and call once to parents to improve it, if needed.
Both groups will perform a pre- and post-test, evaluating parent's perceptions and attitudes regarding children's weight status and food intake; eating behaviors and parental child-feeding practices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 36 Months 至 83 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with 36 to 83 months at the start of the intervention.
- •Children overweight or obese for age, according to World Health Organization criteria.
- •Parent/ caregiver with at least 18 years old.
- •Parent/caregiver involved in child feeding management (≥ 5 in a 0-10 rating scale, from 'Not at all' to 'Extremely involved').
- •Parent/ caregiver able to read, speak and understand Portuguese.
- •Parent/caregiver with an android device.
- •Parent/caregiver willing to participate in the research study, to participate in two face-to-face evaluations, to install and use the app and to receive weekly notifications and 1-3 calls, during 4 weeks.
排除标准
- •Children with any medical conditions that affect growth, intake or physical activity.
- •Children with any dietary professional advice, in the last 6 months.
研究组 & 干预措施
Control group
Treatment as usual for 4 weeks
Intervention group
Education through the app for 4 weeks
干预措施: Parenting education program (Behavioral)
结局指标
主要结局
Change from Baseline Perceptions and Attitudes regarding children's weight status at 4 weeks
时间窗: Baseline and 4 weeks
Parents recognize their children as overweight/obese (0-10 rating scale, ranging from 'too slim' to 'too heavy') and are concerned about it (0-10 rating scale, from 'Not concerned at all' to 'Extremely concerned').
Change from Baseline Perceptions and Attitudes regarding children's food intake at 4 weeks
时间窗: Baseline and 4 weeks
Parents are aware of dietary recommendations for children's age (Fruit and vegetables, sugar-sweetened beverages, energy-dense foods and water) and are concerned about their achievement (0-10 rating scale, from 'Not concerned at all' to 'extremely concerned').
Dietary Intake (in this pilot RCT only evaluated to test the randomization)
时间窗: Baseline
Increase fruit and vegetables and water intake per day and decrease sugar-sweetened beverages and energy-dense foods intake per week (evaluated by food frequency questionnaire).
Parental child-feeding practices (in this pilot RCT only evaluated to test the randomization)
时间窗: Baseline
Increase Availability and Accessibility of Healthy Foods; Attractive presentation of foods; Nutrition Education and decrease of Distractions (evaluated by HomeSTEAD Survey, adapted to Portuguese within this study).
Study population eligibility and interest
时间窗: Baseline
Proportion of all parents invited who meet eligibility and who accepted to enroll.
Participant engagement
时间窗: 4 weeks
Mean of points earned and app access per participant during intervention and proportion of recommended videos watched.
次要结局
- Eating Behaviors (in this pilot RCT only evaluated to test the randomization).(Baseline)