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CompletedNCT03881280FammealUpdated Sep 17, 2020

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

An interventional study of Parenting education program in Overweight and Obesity, sponsored by Universidade do Porto. Completed at 1 site in Portugal. Open to participants aged 36 Months to 83 Months. Per ClinicalTrials.gov, last updated 2020-09-17.

Sponsored by Universidade do Porto · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
36 Months to 83 Months
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Overweight and Obesity

Keywords

  • Childhood Obesity
  • Nutrition
  • mHealth
  • Parenting
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 28 is below the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Universidade do Porto is the lead sponsor of 170 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
36 Months to 83 Months
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
28 participants (actual)

Study arms

  • No intervention
    Control group

    Treatment as usual for 4 weeks

  • Experimental
    Intervention group

    Education through the app for 4 weeks

    Behavioral: Parenting education program

Interventions

  • BehavioralParenting education program

    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.

06

What researchers measure

Primary outcomes

  1. 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').

    Time frame: Baseline and 4 weeks

  2. 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').

    Time frame: Baseline and 4 weeks

  3. 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).

    Time frame: Baseline

  4. 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).

    Time frame: Baseline

  5. Study population eligibility and interest

    Proportion of all parents invited who meet eligibility and who accepted to enroll.

    Time frame: Baseline

  6. Participant engagement

    Mean of points earned and app access per participant during intervention and proportion of recommended videos watched.

    Time frame: 4 weeks

Secondary outcomes

  1. 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).

    Time frame: Baseline

07

Study locations

1 site
  • Faculdade de Psicologia e de Ciências da Educação da Universidade do Porto
    Porto, Porto, Portugal 4200-135, Portugal
08

References and documents

Publications

  • 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.
  • 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. PubMed 34542511 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03881280
Lead 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
Responsible party
Sponsor
First posted
Mar 19, 2019
Start date
Feb 6, 2019
Primary completion
May 1, 2019
Completion
Jun 14, 2019
Last update
Sep 17, 2020

Study contacts

Lisa Afonso
principal investigator · Faculdade de Psicologia e de Ciências da Educação da Universidade do Porto

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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