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

NCT04099498 | Unknown

• 1 other identifier: POCI-01-0145-FEDER-028302
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Eating

Keywords

Self-regulation; Healthy eating; Online; Promotion

Outcome Measures

Primary Outcomes (19)

• Socio-demographic Questionnaire.

  The participants will be asked about their gender, age and grade.

  baseline

• Change of Self-Regulation Processes towards Healthy Eating at 20 weeks from 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.

  20 weeks after baseline

• Change of Self-Regulation Processes towards Healthy Eating at 3 months from the 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.

  3-months after end of the intervention

• Change of Self-Regulation Processes towards Healthy Eating at 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.

  6-months after the last assessment

• Change of Students' Attitudes and Perceptions on Healthy Eating at 20 weeks from the 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.

  20 weeks after baseline

• Change of Students' Attitudes and Perceptions on Healthy Eatingat 3 months from the 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.

  3-months after end of the intervention

• Change of Students' Attitudes and Perceptions on Healthy Eating at 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.

  6-months after the last assessment

• Change of Knowledge of Healthy Eating at 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.

  20 weeks from the baseline

• Change od Knowledge of Healthy Eating at 3 months from the 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.

  3-months after end of the intervention

• Change of Knowledge of Healthy Eating at 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.

  6-months after the last assessment

• Change of Self-Efficacy to Regulate Eating Habits for Children at 20 weeks from the 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).

  20 weeks after baseline

• Change of Self-Efficacy to Regulate Eating Habits for Children at 3 months from the 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).

  3-months after end of the intervention

• Change of Self-Efficacy to Regulate Eating Habits for Children at 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).

  6 months after the end of the last assessment

• Change of Healthy Eating and Physical Activity Self-Efficacy in children at 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."

  20 weeks after baseline

• Change of Healthy Eating and Physical Activity Self-Efficacy in children at 3 months after the 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."

  3-months after end of the intervention

• Change of Healthy Eating and Physical Activity Self-Efficacy in children at 6 months after the 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."

  6 months after end of the last assessment

• Change of the Healthy Eating and Physical Activity Behaviour Recall for Children at 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.

  20 weeks after baseline

• Change of Healthy Eating and Physical Activity Behaviour Recall for Children at 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.

  3-months after end of the intervention

• Change of Healthy Eating and Physical Activity Behaviour Recall for Children at 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.

  6 months after end of the last assessment

Secondary Outcomes (3)

• Weekly Diary

  20 weeks

• Satisfaction Questionnaire

  20 Weeks after the baseline

• Engagement Assessment

  20 weeks

Study Arms (3)

Standard Control group

NO INTERVENTION

This group will not partake in the intervention but will be assessed with the same protocol at the same moments.

Online-Intervention group

EXPERIMENTAL

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

Enhanced-online-Intervention Group

EXPERIMENTAL

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

Interventions

Online Program: Healthy Eating Promotion with Self-regulation BEHAVIORAL

Online-Intervention group

Online-Intervention group

Enhanced Online Program: Healthy Eating Promotion with Self-regulation BEHAVIORAL

Enhanced-online-Intervention Group

Enhanced-online-Intervention Group

Eligibility Criteria

• Age: 10 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minho: lead
• Fundação para a Ciência e a Tecnologia: collaborator

Study Sites (1)

School of Psychology, University of Minho

Braga, Portugal

RECRUITING

Related Publications (5)

• Bandura A. Health promotion by social cognitive means. Health Educ Behav. 2004 Apr;31(2):143-64. doi: 10.1177/1090198104263660.

  PMID: 15090118 BACKGROUND

• Zimmerman BJ. Self-Efficacy: An Essential Motive to Learn. Contemp Educ Psychol. 2000 Jan;25(1):82-91. doi: 10.1006/ceps.1999.1016.

  PMID: 10620383 BACKGROUND

• Clark NM, Zimmerman BJ. A social cognitive view of self-regulated learning about health. Health Educ Behav. 2014 Oct;41(5):485-91. doi: 10.1177/1090198114547512.

  PMID: 25270173 BACKGROUND

• Rosario P, Mourao R, Nunez JC, Gonzalez-Pienda J, Solano P, Valle A. [Evaluating the efficacy of a program to enhance college students' self-regulation learning processes and learning strategies]. Psicothema. 2007 Aug;19(3):422-7. Spanish.

  PMID: 17617980 BACKGROUND

• Magalhaes P, Silva C, Pereira B, Figueiredo G, Guimaraes A, Pereira A, Rosario P. An online-based intervention to promote healthy eating through self-regulation among children: study protocol for a randomized controlled trial. Trials. 2020 Sep 14;21(1):786. doi: 10.1186/s13063-020-04685-5.

  PMID: 32928277 DERIVED

MeSH Terms

Conditions

Self-Control

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• Paula Magalhaes, PhD

  Psychology Research Cente r (CIPsi) of University of Minho

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paula Magalhaes, PhD

CONTACT

912546250; pcsmagalhaes@gmail.com

Pedro Rosário, PhD

CONTACT

prosario@psi.uminho.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Junior Researcher

Model Details: 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.

Study Record Dates

• First Submitted: September 17, 2019
• First Posted: September 23, 2019
• Study Start: January 27, 2020
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: December 27, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)