Ignite Creation Date:
2024-05-06 @ 1:41 PM
Last Modification Date:
2024-10-26 @ 1:18 PM
Study NCT ID:
NCT04099498
Status:
UNKNOWN
Last Update Posted:
2021-12-27
First Post:
2019-09-17
Brief Title:
In-person and Online Healthy Eating Promotion Through Self-regulation HEP-S
Sponsor:
University of Minho
Organization:
University of Minho
Study Overview
Official Title:
In-person and Online Healthy Eating Promotion Through Self-regulation HEP-S Assessing the Efficacy of a Narrative-based Intervention
Status:
UNKNOWN
Status Verified Date:
2021-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HEP-S
Brief Summary:
Obesity has more than doubled worldwide since 1980 The challenge with obesity as with many other modern diseases is that the solution may not rely on the medical side of the chain but rather on the individual via modifiable factors and behavioral changes such as eating habits and physical activity
The main goals of Healthy Eating Promotion with Self-regulation HEP-S are to design implement and evaluate the efficacy of an online intervention that promotes healthy eating among elementary school children using narratives involving self-regulation themes and skills Self-regulation SR refers to the processes that allow individuals to proactively control the personal behavioral and environmental influences that impact their behavior including eating The focus of this project is not on delivering knowledge per se about healthy eating but rather on promoting and developing a set of transversal skills and strategies on the healthy habits domain We chose this focus because we recognized that beliefs about healthy eating have a stronger influence on eating behavior than factual knowledge about food At the core of this intervention are the narratives an important educational tool that favors child development they allow readers to reflect on themselves and their behavior through the characters presented Narratives also instigate the debate and the uncovering of different perspectives on how to cope with daily dilemmas By using stories to initiate discussion and reflection it is expected that a change of beliefs will occur thus prompting a behavioral change
In todays world there is an increasing need to dematerialise procedures so interventions can reach more people at a lower cost Thus it is important to test the feasibility of the online version of the intervention
Overall it is expected that children taking part of the intervention will at the end of the intervention increase their use of SR strategies for healthy eating enhance their sense of self-efficacy for healthy eating and increase their consumption of healthy foods Additionally it is expected that their knowledge on the topic will increase that their food preferences become healthier and that they will display more positive perceptions and attitudes about the topic Lastly it is expected that participants enrolled in the enhanced-online-intervention group will be more engaged in the intervention than the online-intervention group
The main goals of Healthy Eating Promotion with Self-regulation HEP-S are to design implement and evaluate the efficacy of an online intervention that promotes healthy eating among elementary school children using narratives involving self-regulation themes and skills Self-regulation SR refers to the processes that allow individuals to proactively control the personal behavioral and environmental influences that impact their behavior including eating The focus of this project is not on delivering knowledge per se about healthy eating but rather on promoting and developing a set of transversal skills and strategies on the healthy habits domain We chose this focus because we recognized that beliefs about healthy eating have a stronger influence on eating behavior than factual knowledge about food At the core of this intervention are the narratives an important educational tool that favors child development they allow readers to reflect on themselves and their behavior through the characters presented Narratives also instigate the debate and the uncovering of different perspectives on how to cope with daily dilemmas By using stories to initiate discussion and reflection it is expected that a change of beliefs will occur thus prompting a behavioral change
In todays world there is an increasing need to dematerialise procedures so interventions can reach more people at a lower cost Thus it is important to test the feasibility of the online version of the intervention
Overall it is expected that children taking part of the intervention will at the end of the intervention increase their use of SR strategies for healthy eating enhance their sense of self-efficacy for healthy eating and increase their consumption of healthy foods Additionally it is expected that their knowledge on the topic will increase that their food preferences become healthier and that they will display more positive perceptions and attitudes about the topic Lastly it is expected that participants enrolled in the enhanced-online-intervention group will be more engaged in the intervention than the online-intervention group
Detailed Description:
HEP-S program is grounded on the Self-regulation SR approach which has several features that make it unique when it comes to health promotion Grounded on Social Cognitive Theory SR subsumes the processes that allow individuals to proactively control the personal behavioural and environmental influences that impact human behavior including eating These processes are intrinsically cyclic and interdependent open and dynamic and proceed through three main phases the preceding phase the performance or volitional control phase and the self-reflection phase or Planning Execution and Evaluation The SR process is under the influence of the individual and can therefore be taught and improved Thus the agent role of the individual throughout the process is key to become in control and autonomous
Although individuals may be influenced and regulated by external factors and agents exclusively relying on external regulation does not allow for the individual to develop adaptive competences and skills such as choosing a healthy snack Thus to self-regulate their behaviour and become increasingly autonomous individuals must progressively shift from external regulation to a model that supports and provides feedback SR can be essential in the processes of healthy eating as individuals who SR their behavior are likely to plan and systematically use a set of cognitive and metacognitive strategies to meet self-set goals Thus the effective use of SR strategies to achieve ones goal is part of a key process in maintaining an individuals motivation to reach a self-set goal such as eating healthily
In several studies researchers have successfully implemented self-management programs among individuals with various health conditions such as heart disease or obesity With the help of these programs individuals were able to manage their health conditions and improve their quality of life and wellbeing Still these programs focused on health promotion within a disease management context not on prevention and promotion of a healthy lifestyle Thus the current proposal will address this gap by focusing on healthy eating promotion among children
The HEP-S is a 20-week narrative-based intervention designed to promote healthy eating through the teaching and development of a set of transversal skills and strategies within that domain The program will be implemented online using the online tool Canvas Canvas is a learning management system that allows among other things to create modules of content attach files share materials create discussion forums and conduct videoconferences Each child will be provided with a unique login to the Canvas of the class The program has two main components i the weekly synchronous session which includes the reading of the chapter the discussion and reflection about the lessons conveyed in the chapter and the strengthening of learning through a consolidation activity and ii the weekly parental involvement activity which is conceived to consolidate learning of the SR processes and skills
At the core of this intervention are the narratives Narratives or story-tools are important educational tools that favor child development They allow readers to reflect on themselves and their own behaviour through the characters they instigate the debate and the uncovering of different perspectives of how to cope with every-day dilemmas Through the characters and plots these story-tools create opportunities from which the readers can experience and develop autonomous behaviors and promote SR in a given domain eg learning healthy eating Extensive extant research has examined and demonstrated the efficacy of using story-tools to promote SR strategies In this study excerpts of two narratives will be used as the prompt for and instigate discussion and reflection about healthy eating Specifically Yellows Trials and Tribulations and The Hill of the Bald Trees and Other Stories
There will be two intervention groups the online-intervention and enhanced-online-intervention What differentiates these groups is that the enhanced-online-intervention group counts with the inclusion of gamification strategies within the dynamic of the program Gamification consists in the use of game design elements in a non-game context Non-game contexts can be education health and business Examples of game design elements are the narrative context feedback reputation ranks levels competition relational support Considering the engaging nature of games it is expected that embedding some of their design and motivational features will contribute to the i creation of more engaging and fun contexts or environments ii enhancement of the degree and depth of participants engagement iii promotion of learning opportunities and iv motivate individuals to engage in the task at hand
Goals and expected outcomes
The main purpose of this study is to evaluate the efficacy of an online intervention designed to promote healthy eating by fostering the use of SR strategies among school-aged children Thus the major goals are to promote childrens use of SR strategies for healthy eating to strengthen their sense of self-efficacy regarding healthy eating to increase consumption and knowledge about healthy eating to contribute to healthier food preferences and contribute to more positive attitudes and perceptions about healthy eating Concomitantly we want to assess the feasibility of conducting an online intervention with this population and examine the advantages of embedding the program with gamification strategies
Overall it is expected that children taking part of the intervention will increase their use of SR strategies for healthy eating enhance their sense of self-efficacy for healthy eating and increase their consumption of healthy foods Additionally it is expected that their knowledge on the topic will increase and that they will display more positive perceptions and attitudes about the topic Lastly it is expected that participants enrolled in the enhanced-online-intervention group will be more engaged in the intervention than the online-intervention group
Participants
Children from the 5th and 6th grades will be recruited by first contacting Portuguese elementary and middle schools and inviting them to participate Orientation sessions will be held at schools for all parents of children in the target grades to explain the project and its rationale and to invite them to enroll their child The study will be introduced as a program to promote healthy lifestyles among school-aged children which aims to monitor relevant engagement variables and examine childrens parents and teachers perceptions of the utility and feasibility of these interventions
Retention and incentives for the participants
The following strategies will be undertaken to minimize attrition First prior to the intervention the researchers will organize orientation sessions with parents to present the project and explain its pertinence and rationale Second parents who agree to let their child participate in the program will sign a participation agreement detailing their responsibility as guarantors of their childs involvement in the program Third the registration e-mail for children to log in into the platform will be of their parents and reminder emails will be sent whenever there is an activity or task available in the platform Lastly check-up sessions with parents will be carried mid-through the program
Informed consent and randomization
During the orientation session parents who allow their child to participate in the program will complete the first assessment protocol in loco as well as complete the informed consent form In the informed consent the following aspects will be covered i description of the program accompanied by a timeline ii duties of the parents as guarantors of their childs involvement in the program and iii what it is expected from them in terms of their involvement with the program and its activities Genuine randomization at the individual level will not be possible as participants originating from the same class and school will have to be allocated to the same treatment condition to prevent between-group contamination To address this difficulty each school that accepts to enroll in the study will be randomly attributed a number associated with one of the conditions ie control intervention and enhanced-intervention in a 111 basis
Proposed sample size
Considering this longitudinal design the sample size was computed using GPower software In the calculation of the sample we considered a 02 effect size an alpha level of 005 a desired statistical power of 08 five measures three research groups ie control online-intervention enhanced-online-intervention and a 20 dropout rate This analysis suggested that a total of 150 participants will be recruited with 50 participants per group
Statistics
Descriptive analyses will be computed to describe all participants characteristics Specifically we will use chi-square tests and independent t-tests to compare groups on the distributions according to sex age group BMI classification and others To assess the effectiveness of the HEP-S intervention program we will develop linear mixed-effect models to specifically assess groups differences over time All analyses will be conducted using SPSS and p values below 05 will be considered statistically significant
Blinding and data access
The assessment protocol will be completed by children and will not be available for parents to consult or to the educational psychologist conducting the sessions Each child will be attributed a unique code Moreover data will be analyzed by an external statistician who will be blind to the treatment conditions of each data set Lastly only the principal investigator and the statistician will have access to the full data set
The standard procedure to conduct studies in the Portuguese school context requires an a priori evaluation and validation of the project by the Ministry of Education and by the Ethics Committee of the University of Minho before researchers can invite schools to participate Participation in the program is entirely voluntary and parents and children are informed that their involvement in the schools activities will not be affected by their decision on whether or not to participate Parents and children are informed they can withdraw from the program at any time We fully recognize our responsibilities for child protection so the project will ensure an environment where children feel secure feel free to either participate or leave the study at any time are encouraged to talk and are listened to In order to work with children researchers must present their criminal records during the job application This protocol will be held to meet high ethical standards
Lastly the procedures for personal data storage handling and protection will comply with the newest General Data Protection Regulation policies Particularly to ensure privacy and anonymity pseudonymisation will be carried out This is a process that transforms personal data into a data set that cannot be linked to a particular subject unless other piece of information is added eg decryption key Usually these data are stored in different locations
Although individuals may be influenced and regulated by external factors and agents exclusively relying on external regulation does not allow for the individual to develop adaptive competences and skills such as choosing a healthy snack Thus to self-regulate their behaviour and become increasingly autonomous individuals must progressively shift from external regulation to a model that supports and provides feedback SR can be essential in the processes of healthy eating as individuals who SR their behavior are likely to plan and systematically use a set of cognitive and metacognitive strategies to meet self-set goals Thus the effective use of SR strategies to achieve ones goal is part of a key process in maintaining an individuals motivation to reach a self-set goal such as eating healthily
In several studies researchers have successfully implemented self-management programs among individuals with various health conditions such as heart disease or obesity With the help of these programs individuals were able to manage their health conditions and improve their quality of life and wellbeing Still these programs focused on health promotion within a disease management context not on prevention and promotion of a healthy lifestyle Thus the current proposal will address this gap by focusing on healthy eating promotion among children
The HEP-S is a 20-week narrative-based intervention designed to promote healthy eating through the teaching and development of a set of transversal skills and strategies within that domain The program will be implemented online using the online tool Canvas Canvas is a learning management system that allows among other things to create modules of content attach files share materials create discussion forums and conduct videoconferences Each child will be provided with a unique login to the Canvas of the class The program has two main components i the weekly synchronous session which includes the reading of the chapter the discussion and reflection about the lessons conveyed in the chapter and the strengthening of learning through a consolidation activity and ii the weekly parental involvement activity which is conceived to consolidate learning of the SR processes and skills
At the core of this intervention are the narratives Narratives or story-tools are important educational tools that favor child development They allow readers to reflect on themselves and their own behaviour through the characters they instigate the debate and the uncovering of different perspectives of how to cope with every-day dilemmas Through the characters and plots these story-tools create opportunities from which the readers can experience and develop autonomous behaviors and promote SR in a given domain eg learning healthy eating Extensive extant research has examined and demonstrated the efficacy of using story-tools to promote SR strategies In this study excerpts of two narratives will be used as the prompt for and instigate discussion and reflection about healthy eating Specifically Yellows Trials and Tribulations and The Hill of the Bald Trees and Other Stories
There will be two intervention groups the online-intervention and enhanced-online-intervention What differentiates these groups is that the enhanced-online-intervention group counts with the inclusion of gamification strategies within the dynamic of the program Gamification consists in the use of game design elements in a non-game context Non-game contexts can be education health and business Examples of game design elements are the narrative context feedback reputation ranks levels competition relational support Considering the engaging nature of games it is expected that embedding some of their design and motivational features will contribute to the i creation of more engaging and fun contexts or environments ii enhancement of the degree and depth of participants engagement iii promotion of learning opportunities and iv motivate individuals to engage in the task at hand
Goals and expected outcomes
The main purpose of this study is to evaluate the efficacy of an online intervention designed to promote healthy eating by fostering the use of SR strategies among school-aged children Thus the major goals are to promote childrens use of SR strategies for healthy eating to strengthen their sense of self-efficacy regarding healthy eating to increase consumption and knowledge about healthy eating to contribute to healthier food preferences and contribute to more positive attitudes and perceptions about healthy eating Concomitantly we want to assess the feasibility of conducting an online intervention with this population and examine the advantages of embedding the program with gamification strategies
Overall it is expected that children taking part of the intervention will increase their use of SR strategies for healthy eating enhance their sense of self-efficacy for healthy eating and increase their consumption of healthy foods Additionally it is expected that their knowledge on the topic will increase and that they will display more positive perceptions and attitudes about the topic Lastly it is expected that participants enrolled in the enhanced-online-intervention group will be more engaged in the intervention than the online-intervention group
Participants
Children from the 5th and 6th grades will be recruited by first contacting Portuguese elementary and middle schools and inviting them to participate Orientation sessions will be held at schools for all parents of children in the target grades to explain the project and its rationale and to invite them to enroll their child The study will be introduced as a program to promote healthy lifestyles among school-aged children which aims to monitor relevant engagement variables and examine childrens parents and teachers perceptions of the utility and feasibility of these interventions
Retention and incentives for the participants
The following strategies will be undertaken to minimize attrition First prior to the intervention the researchers will organize orientation sessions with parents to present the project and explain its pertinence and rationale Second parents who agree to let their child participate in the program will sign a participation agreement detailing their responsibility as guarantors of their childs involvement in the program Third the registration e-mail for children to log in into the platform will be of their parents and reminder emails will be sent whenever there is an activity or task available in the platform Lastly check-up sessions with parents will be carried mid-through the program
Informed consent and randomization
During the orientation session parents who allow their child to participate in the program will complete the first assessment protocol in loco as well as complete the informed consent form In the informed consent the following aspects will be covered i description of the program accompanied by a timeline ii duties of the parents as guarantors of their childs involvement in the program and iii what it is expected from them in terms of their involvement with the program and its activities Genuine randomization at the individual level will not be possible as participants originating from the same class and school will have to be allocated to the same treatment condition to prevent between-group contamination To address this difficulty each school that accepts to enroll in the study will be randomly attributed a number associated with one of the conditions ie control intervention and enhanced-intervention in a 111 basis
Proposed sample size
Considering this longitudinal design the sample size was computed using GPower software In the calculation of the sample we considered a 02 effect size an alpha level of 005 a desired statistical power of 08 five measures three research groups ie control online-intervention enhanced-online-intervention and a 20 dropout rate This analysis suggested that a total of 150 participants will be recruited with 50 participants per group
Statistics
Descriptive analyses will be computed to describe all participants characteristics Specifically we will use chi-square tests and independent t-tests to compare groups on the distributions according to sex age group BMI classification and others To assess the effectiveness of the HEP-S intervention program we will develop linear mixed-effect models to specifically assess groups differences over time All analyses will be conducted using SPSS and p values below 05 will be considered statistically significant
Blinding and data access
The assessment protocol will be completed by children and will not be available for parents to consult or to the educational psychologist conducting the sessions Each child will be attributed a unique code Moreover data will be analyzed by an external statistician who will be blind to the treatment conditions of each data set Lastly only the principal investigator and the statistician will have access to the full data set
The standard procedure to conduct studies in the Portuguese school context requires an a priori evaluation and validation of the project by the Ministry of Education and by the Ethics Committee of the University of Minho before researchers can invite schools to participate Participation in the program is entirely voluntary and parents and children are informed that their involvement in the schools activities will not be affected by their decision on whether or not to participate Parents and children are informed they can withdraw from the program at any time We fully recognize our responsibilities for child protection so the project will ensure an environment where children feel secure feel free to either participate or leave the study at any time are encouraged to talk and are listened to In order to work with children researchers must present their criminal records during the job application This protocol will be held to meet high ethical standards
Lastly the procedures for personal data storage handling and protection will comply with the newest General Data Protection Regulation policies Particularly to ensure privacy and anonymity pseudonymisation will be carried out This is a process that transforms personal data into a data set that cannot be linked to a particular subject unless other piece of information is added eg decryption key Usually these data are stored in different locations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None