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In-person and Online Healthy Eating Promotion Through Self-regulation (HEP-S) (HEP-S)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04099498
Recruitment Status : Recruiting
First Posted : September 23, 2019
Last Update Posted : March 24, 2020
Sponsor:
Collaborator:
Fundação para a Ciência e a Tecnologia
Information provided by (Responsible Party):
Paula Cristina Soares de Magalhães da Silva Correia, University of Minho

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 today's 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.


Condition or disease Intervention/treatment Phase
Healthy Eating Behavioral: Online Program: Healthy Eating Promotion with Self-regulation Behavioral: Enhanced Online Program: Healthy Eating Promotion with Self-regulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A three-armed randomized controlled trial will be conducted and will include: a standard control group, with no intervention; an online-intervention group, with the program for 20-weeks; and an enhanced-online-intervention group, with the program for 20-weeks embedded with gamification strategies throughout.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: In-person and Online Healthy Eating Promotion Through Self-regulation (HEP-S): Assessing the Efficacy of a Narrative-based Intervention
Actual Study Start Date : January 27, 2020
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2021

Arm Intervention/treatment
No Intervention: Standard Control group
This group will not partake in the intervention but will be assessed with the same protocol at the same moments.
Experimental: Online-Intervention group
This group will take part of the 20-week long online intervention to promote healthy eating. The program will be developed to promote self-regulation skills and strategies about healthy eating among elementary school-aged children and each week will include: i) a narrative embedded with self-regulation skills and strategies; ii) a weekly parental involvement activity; and iii) a weekly group synchronous videoconference session with a trained educational psychologist serving as a mediator.
Behavioral: Online Program: Healthy Eating Promotion with Self-regulation
Online-Intervention group

Experimental: Enhanced-online-Intervention Group
This group will take part of the 20-week long online intervention to promote healthy eating. The program will be developed to promote self-regulation skills and strategies about healthy eating among elementary school-aged children and each week will include: i) a narrative embedded with self-regulation skills and strategies; ii) a weekly parental involvement activity; and iii) a weekly group synchronous videoconference session with a trained educational psychologist serving as a mediator. In addition, gamification strategies (e.g., points for each complete activity, feedback) will be implemented in order to promote engagement with the program and activities.
Behavioral: Enhanced Online Program: Healthy Eating Promotion with Self-regulation
Enhanced-online-Intervention Group




Primary Outcome Measures :
  1. Socio-demographic Questionnaire. [ Time Frame: baseline ]
    The participants will be asked about their gender, age and grade.

  2. Change of Self-Regulation Processes towards Healthy Eating at 20 weeks from baseline [ Time Frame: 20 weeks after baseline ]
    An adapted version of the Self-Regulation for Health Scale. (Mattos, et. al. 2018) was used to evaluate the self-regulation processes towards healthy eating that participants are guided by. The scale has nine statements regarding the participant's self-regulation towards healthy eating (e.g., I pay attention to information on healthy eating, I apply that knowledge on a daily basis). Responses are scored from 1 (never) to 5 (always) on a Likert-like scale and summed to create a composite score from nine to 45, with higher scores implying more self-regulation.

  3. Change of Self-Regulation Processes towards Healthy Eating at 3 months from the end of the intervention [ Time Frame: 3-months after end of the intervention ]
    An adapted version of the Self-Regulation for Health Scale. (Mattos, et. al. 2018) was used to evaluate the self-regulation processes towards healthy eating that participants are guided by. The scale has nine statements regarding the participant's self-regulation towards healthy eating (e.g., I pay attention to information on healthy eating, I apply that knowledge on a daily basis). Responses are scored from 1 (never) to 5 (always) on a Likert-like scale and summed to create a composite score from nine to 45, with higher scores implying more self-regulation.

  4. Change of Self-Regulation Processes towards Healthy Eating at 6-months after the last assessment [ Time Frame: 6-months after the last assessment ]
    An adapted version of the Self-Regulation for Health Scale. (Mattos, et. al. 2018) was used to evaluate the self-regulation processes towards healthy eating that participants are guided by. The scale has nine statements regarding the participant's self-regulation towards healthy eating (e.g., I pay attention to information on healthy eating, I apply that knowledge on a daily basis). Responses are scored from 1 (never) to 5 (always) on a Likert-like scale and summed to create a composite score from nine to 45, with higher scores implying more self-regulation.

  5. Change of Students' Attitudes and Perceptions on Healthy Eating at 20 weeks from the baseline [ Time Frame: 20 weeks after baseline ]
    An adaptation of the Students' Attitudes and Perceptions on the Health Instrument (Mattos et al., 2018) will be used. This instrument has 17 statements about student's attitudes and perceptions of the importance of healthy eating (e.g., Eating fruit and vegetables will help me growing up). Responses are scored as true or false, and the correct answers will be summed to create a composite score that ranged from 0 to 17, with higher scores implying more positive attitudes through healthy eating.

  6. Change of Students' Attitudes and Perceptions on Healthy Eatingat 3 months from the end of the intervention [ Time Frame: 3-months after end of the intervention ]
    An adaptation of the Students' Attitudes and Perceptions on the Health Instrument (Mattos et al., 2018) will be used. This instrument has 17 statements about student's attitudes and perceptions of the importance of healthy eating (e.g., Eating fruit and vegetables will help me growing up). Responses are scored as true or false, and the correct answers will be summed to create a composite score that ranged from 0 to 17, with higher scores implying more positive attitudes through healthy eating.

  7. Change of Students' Attitudes and Perceptions on Healthy Eating at 6-months after the last assessment [ Time Frame: 6-months after the last assessment ]
    An adaptation of the Students' Attitudes and Perceptions on the Health Instrument (Mattos et al., 2018) will be used. This instrument has 17 statements about student's attitudes and perceptions of the importance of healthy eating (e.g., Eating fruit and vegetables will help me growing up). Responses are scored as true or false, and the correct answers will be summed to create a composite score that ranged from 0 to 17, with higher scores implying more positive attitudes through healthy eating.

  8. Change of Knowledge of Healthy Eating at 20 weeks from the baseline [ Time Frame: 20 weeks from the baseline ]
    This questionnaire was developed to assess school-age children's (six to 17 years old) declarative knowledge about healthy eating (Pereira, et al. 2018). The questionnaire was built by a team comprised by several specialists (psychologists, teachers, medical doctors, and nurses) and the items were based on the directives by the Portuguese General Directorate for Health (DGS, 2017). The questionnaire consists of 15 statements and participants had to rate their agreement regarding each statement (e.g., "our meal should contain varied and colourful foods"; "going to school without having breakfast does not interfere with my school performance"). Responses to individual items were scored from one (totally disagree) to five (totally agree) in a Likert-like format. The alpha of Cronbach was .73. Responses of each participant were summed to create a composite score ranging from 15 to 75, with higher scores implying more knowledge of healthy eating.

  9. Change od Knowledge of Healthy Eating at 3 months from the end of the intervention [ Time Frame: 3-months after end of the intervention ]
    This questionnaire was developed to assess school-age children's (six to 17 years old) declarative knowledge about healthy eating (Pereira, et al. 2018). The questionnaire was built by a team comprised by several specialists (psychologists, teachers, medical doctors, and nurses) and the items were based on the directives by the Portuguese General Directorate for Health (DGS, 2017). The questionnaire consists of 15 statements and participants had to rate their agreement regarding each statement (e.g., "our meal should contain varied and colourful foods"; "going to school without having breakfast does not interfere with my school performance"). Responses to individual items were scored from one (totally disagree) to five (totally agree) in a Likert-like format. The alpha of Cronbach was .73. Responses of each participant were summed to create a composite score ranging from 15 to 75, with higher scores implying more knowledge of healthy eating.

  10. Change of Knowledge of Healthy Eating at 6-months after the last assessment [ Time Frame: 6-months after the last assessment ]
    This questionnaire was developed to assess school-age children's (six to 17 years old) declarative knowledge about healthy eating (Pereira, et al. 2018). The questionnaire was built by a team comprised by several specialists (psychologists, teachers, medical doctors, and nurses) and the items were based on the directives by the Portuguese General Directorate for Health (DGS, 2017). The questionnaire consists of 15 statements and participants had to rate their agreement regarding each statement (e.g., "our meal should contain varied and colourful foods"; "going to school without having breakfast does not interfere with my school performance"). Responses to individual items were scored from one (totally disagree) to five (totally agree) in a Likert-like format. The alpha of Cronbach was .73. Responses of each participant were summed to create a composite score ranging from 15 to 75, with higher scores implying more knowledge of healthy eating.

  11. Change of Self-Efficacy to Regulate Eating Habits for Children at 20 weeks from the baseline [ Time Frame: 20 weeks after baseline ]
    We will use an adaptation of the questionnaire "Self-Efficacy to Regulate Eating Habits" developed by Bandura (2005) in this project. The measure will assess the perceived capability to regulate and to adopt healthy eating habits in different daily situations (e.g., "While watching television"). This version consists in 15 adapted situations, in which participants will have to respond if they can choose healthy food choices or not in a Likert-like format, scored from one (not capable) to six (capable, for sure).

  12. Change of Self-Efficacy to Regulate Eating Habits for Children at 3 months from the end of the intervention [ Time Frame: 3-months after end of the intervention ]
    We will use an adaptation of the questionnaire "Self-Efficacy to Regulate Eating Habits" developed by Bandura (2005) in this project. The measure will assess the perceived capability to regulate and to adopt healthy eating habits in different daily situations (e.g., "While watching television"). This version consists in 15 adapted situations, in which participants will have to respond if they can choose healthy food choices or not in a Likert-like format, scored from one (not capable) to six (capable, for sure).

  13. Change of Self-Efficacy to Regulate Eating Habits for Children at 6 months after the end of the last assessment [ Time Frame: 6 months after the end of the last assessment ]
    We will use an adaptation of the questionnaire "Self-Efficacy to Regulate Eating Habits" developed by Bandura (2005) in this project. The measure will assess the perceived capability to regulate and to adopt healthy eating habits in different daily situations (e.g., "While watching television"). This version consists in 15 adapted situations, in which participants will have to respond if they can choose healthy food choices or not in a Likert-like format, scored from one (not capable) to six (capable, for sure).

  14. Change of Healthy Eating and Physical Activity Self-Efficacy in children at 20 weeks after baseline [ Time Frame: 20 weeks after baseline ]
    This measure was developed to assess self-efficacy related to enacting healthy eating and activity behaviours in children (Lassetter et al., 2017). An adapted version of the HEPASEQ-C was developed and consists of nine items with response options on a 6-point Likert-type scale, ranging from "There is no way I can do this" to "I believe I can do this". Seven items focus on self-efficacy related to healthy eating. For example, one item says, "I will eat healthy food even when my friends eat food that is not healthy."

  15. Change of Healthy Eating and Physical Activity Self-Efficacy in children at 3 months after the end of the intervention [ Time Frame: 3-months after end of the intervention ]
    This measure was developed to assess self-efficacy related to enacting healthy eating and activity behaviours in children (Lassetter et al., 2017). An adapted version of the HEPASEQ-C was developed and consists of nine items with response options on a 6-point Likert-type scale, ranging from "There is no way I can do this" to "I believe I can do this". Seven items focus on self-efficacy related to healthy eating. For example, one item says, "I will eat healthy food even when my friends eat food that is not healthy."

  16. Change of Healthy Eating and Physical Activity Self-Efficacy in children at 6 months after the end of the last assessment [ Time Frame: 6 months after end of the last assessment ]
    This measure was developed to assess self-efficacy related to enacting healthy eating and activity behaviours in children (Lassetter et al., 2017). An adapted version of the HEPASEQ-C was developed and consists of nine items with response options on a 6-point Likert-type scale, ranging from "There is no way I can do this" to "I believe I can do this". Seven items focus on self-efficacy related to healthy eating. For example, one item says, "I will eat healthy food even when my friends eat food that is not healthy."

  17. Change of the Healthy Eating and Physical Activity Behaviour Recall for Children at 20 weeks after baseline [ Time Frame: 20 weeks after baseline ]
    This measure was developed as a complement to the previous questionnaire and aimed to recall 'children's behaviors in terms of healthy eating and physical activity (Lassetter et al., 2017). The Portuguese version of this questionnaire consists of 9 items, two of which are in an open response format allowing children to write the actual foods they ate. For example, one of these two items states, "The last time I ate a snack at a friend's house, I ate __________." The other seven items include two yes/no items, and the remaining six items had response options that were presented using an ordinal scale.

  18. Change of Healthy Eating and Physical Activity Behaviour Recall for Children at 3-months after end of the intervention [ Time Frame: 3-months after end of the intervention ]
    This measure was developed as a complement to the previous questionnaire and aimed to recall 'children's behaviors in terms of healthy eating and physical activity (Lassetter et al., 2017). The Portuguese version of this questionnaire consists of 9 items, two of which are in an open response format allowing children to write the actual foods they ate. For example, one of these two items states, "The last time I ate a snack at a friend's house, I ate __________." The other seven items include two yes/no items, and the remaining six items had response options that were presented using an ordinal scale.

  19. Change of Healthy Eating and Physical Activity Behaviour Recall for Children at 6 months after end of the last assessment [ Time Frame: 6 months after end of the last assessment ]
    This measure was developed as a complement to the previous questionnaire and aimed to recall 'children's behaviors in terms of healthy eating and physical activity (Lassetter et al., 2017). The Portuguese version of this questionnaire consists of 9 items, two of which are in an open response format allowing children to write the actual foods they ate. For example, one of these two items states, "The last time I ate a snack at a friend's house, I ate __________." The other seven items include two yes/no items, and the remaining six items had response options that were presented using an ordinal scale.


Secondary Outcome Measures :
  1. Weekly Diary [ Time Frame: 20 weeks ]
    Each child will use a weekly diary to set goals, plan activities, and monitor his or her own performance. This will allow monitoring the individual progress of children in the program and, simultaneously, to create another moment to reflect about, and consolidate, the learning acquired in the program. Questions will invite children to reflect on what they have learn with the narrative, the synchronous session, and the parental involvement activity of that week. Additionally, questions regarding participants' engagement in the program that week will also be included. Lastly, concrete questions about their food intake will also be covered in the weekly journal.

  2. Satisfaction Questionnaire [ Time Frame: 20 Weeks after the baseline ]
    The research team will develop a satisfaction questionnaire based on previous satisfaction instruments used with this population. The questionnaire will address aspects of utility and feasibility of the program and perceived support by the educational psychologist from the students' perspective.

  3. Engagement Assessment [ Time Frame: 20 weeks ]
    Engagement in the program will be assessed through the analysis of the interactions of children in the online platform. Examples include number of activities completed, comments to peers' posts.



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Access to a computer equipped with camera and speakers at home;
  • Internet access at home;
  • Children have to read, speak and write Portuguese fluently;
  • Parents have to provide a written consent for their children to participate;
  • Children have to provide a written agreement of willingness to participate;
  • Parent have to sign the informed consent;
  • Parents have to be willing to participate in the parental involvement activities;
  • Parents have to have an e-mail account or be willing to create one;

Exclusion Criteria:

  • Any acute or chronic condition, or learning disabilities that would limit the ability of the patient to participate in the study
  • Refusal to give informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04099498


Contacts
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Contact: Paula Magalhaes, PhD 912546250 pcsmagalhaes@gmail.com
Contact: Pedro Rosário, PhD prosario@psi.uminho.pt

Locations
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Portugal
School of Psychology, University of Minho Recruiting
Braga, Portugal
Principal Investigator: Paula Magalhães, PhD         
Sponsors and Collaborators
University of Minho
Fundação para a Ciência e a Tecnologia
Investigators
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Principal Investigator: Paula Magalhaes, PhD Psychology Research Cente r (CIPsi) of University of Minho
Additional Information:
Publications:
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Responsible Party: Paula Cristina Soares de Magalhães da Silva Correia, Junior Researcher, University of Minho
ClinicalTrials.gov Identifier: NCT04099498    
Other Study ID Numbers: POCI-01-0145-FEDER-028302
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Paula Cristina Soares de Magalhães da Silva Correia, University of Minho:
Self-regulation
Healthy eating
Online
Promotion