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The System Fammeal With Tailored Recommendations and Gamification for Parents to Counteract Childhood Obesity (Fammeal)

Primary Purpose

Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Parenting education program
Sponsored by
Universidade do Porto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight and Obesity focused on measuring Childhood Obesity, Nutrition, mHealth, Parenting

Eligibility Criteria

36 Months - 83 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Children with any medical conditions that affect growth, intake or physical activity.
  • Children with any dietary professional advice, in the last 6 months.

Sites / Locations

  • Faculdade de Psicologia e de Ciências da Educação da Universidade do Porto

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Intervention group

Arm Description

Treatment as usual for 4 weeks

Education through the app for 4 weeks

Outcomes

Primary Outcome Measures

Change from Baseline Perceptions and Attitudes regarding children's weight status at 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
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)
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)
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
Proportion of all parents invited who meet eligibility and who accepted to enroll.
Participant engagement
Mean of points earned and app access per participant during intervention and proportion of recommended videos watched.

Secondary Outcome Measures

Eating Behaviors (in this pilot RCT only evaluated to test the randomization).
Increase Children's Satiety Responsiveness. This was evaluated by the mean score of 5 items of Children's Eating Behavior Questionnaire.Satiety Responsiveness reflects the ability to regulate the amount of food eaten, based on perceived fullness. Parents answered in a 5-point Likert scale (0 = never; 5 = always), with higher values reflecting higher punctuation in each subscale. A version of this questionnaire has been previously validated and adapted to Portuguese children aged 3-13 years (Viana, Sinde, & Saxton, 2008).

Full Information

First Posted
March 12, 2019
Last Updated
September 15, 2020
Sponsor
Universidade do Porto
Collaborators
Fundação para a Ciência e a Tecnologia, Administração Regional de Saúde do Norte, Portugal, Agrupamento de Centros de Saúde do Grande Porto III - Maia / Valongo, Portugal
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1. Study Identification

Unique Protocol Identification Number
NCT03881280
Brief Title
The System Fammeal With Tailored Recommendations and Gamification for Parents to Counteract Childhood Obesity
Acronym
Fammeal
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
February 6, 2019 (Actual)
Primary Completion Date
May 1, 2019 (Actual)
Study Completion Date
June 14, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidade do Porto
Collaborators
Fundação para a Ciência e a Tecnologia, Administração Regional de Saúde do Norte, Portugal, Agrupamento de Centros de Saúde do Grande Porto III - Maia / Valongo, Portugal

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
Childhood Obesity, Nutrition, mHealth, Parenting

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
Treatment as usual for 4 weeks
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Education through the app for 4 weeks
Intervention Type
Behavioral
Intervention Name(s)
Parenting education program
Intervention Description
Parenting education program through the app Fammeal. It includes educational content, tailored to parents and centered on positive parenting child-feeding practices. The app will also include a virtual-pet game for children, in order to help them self-regulate their intake. Through the app, parents will: Fill in a registration questionnaire, which will tailor recommendations. Receive information and video content recommendations. Set goals related to their child's lifestyle and tracking progress. Earn points by watching the contents. Invite children to play a serious game. Exchange messages with other users. The investigators created a support website that connects to the main server to get data gathered from the mobile app and game.
Primary Outcome Measure Information:
Title
Change from Baseline Perceptions and Attitudes regarding children's weight status at 4 weeks
Description
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').
Time Frame
Baseline and 4 weeks
Title
Change from Baseline Perceptions and Attitudes regarding children's food intake at 4 weeks
Description
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').
Time Frame
Baseline and 4 weeks
Title
Dietary Intake (in this pilot RCT only evaluated to test the randomization)
Description
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).
Time Frame
Baseline
Title
Parental child-feeding practices (in this pilot RCT only evaluated to test the randomization)
Description
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).
Time Frame
Baseline
Title
Study population eligibility and interest
Description
Proportion of all parents invited who meet eligibility and who accepted to enroll.
Time Frame
Baseline
Title
Participant engagement
Description
Mean of points earned and app access per participant during intervention and proportion of recommended videos watched.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Eating Behaviors (in this pilot RCT only evaluated to test the randomization).
Description
Increase Children's Satiety Responsiveness. This was evaluated by the mean score of 5 items of Children's Eating Behavior Questionnaire.Satiety Responsiveness reflects the ability to regulate the amount of food eaten, based on perceived fullness. Parents answered in a 5-point Likert scale (0 = never; 5 = always), with higher values reflecting higher punctuation in each subscale. A version of this questionnaire has been previously validated and adapted to Portuguese children aged 3-13 years (Viana, Sinde, & Saxton, 2008).
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
36 Months
Maximum Age & Unit of Time
83 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Children with any medical conditions that affect growth, intake or physical activity. Children with any dietary professional advice, in the last 6 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Afonso
Organizational Affiliation
Faculdade de Psicologia e de Ciências da Educação da Universidade do Porto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculdade de Psicologia e de Ciências da Educação da Universidade do Porto
City
Porto
State/Province
Porto, Portugal
ZIP/Postal Code
4200-135
Country
Portugal

12. IPD Sharing Statement

Citations:
Citation
Afonso L, Rodrigues R, Reis E, Miller KM, Castro J, Parente N, Teixeira C, Fraga A, Torres S. Fammeal: a gamified mobile application for parents and children to help health care centers treat childhood obesity. IEEE Transactions on Games. 2020. doi: 10.1109/TG.2020.3015804.
Results Reference
result
PubMed Identifier
34542511
Citation
Afonso L, Rodrigues R, Castro J, Parente N, Teixeira C, Fraga A, Torres S. A Mobile-Based Tailored Recommendation System for Parents of Children with Overweight or Obesity: A New Tool for Health Care Centers. Eur J Investig Health Psychol Educ. 2020 Aug 7;10(3):779-794. doi: 10.3390/ejihpe10030057.
Results Reference
result
Links:
URL
https://fammeal.up.pt/
Description
Website of the project

Learn more about this trial

The System Fammeal With Tailored Recommendations and Gamification for Parents to Counteract Childhood Obesity

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