AzTrials
AzTrials

Overweight and ObesityFammealNCT03881280

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

A study testing Parenting education program in people with Overweight and Obesity, run by Universidade do Porto at 1 site in Portugal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 36 to 83 months
Conditions the study is for
Overweight and Obesity
What is being tested?
Parenting education program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 sitePortugal
Study dates
6 Feb 2019to 14 Jun 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 36 to 83 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Portugal1 site

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

    Porto, Porto, Portugal, 4200-135

Other trials in Portugal

About this study

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

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.

Being tested
Parenting education program
Keywords
Childhood Obesity, Nutrition, mHealth, Parenting
Medical subject headings
Overweight, Obesity, Pediatric Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Parenting education programBehavioural

    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.

Study groups in NCT03881280
Study groupRoleWhat they receive
Control groupNo interventionTreatment as usual for 4 weeks
Intervention groupExperimentalEducation through the app for 4 weeks
Receives: Behavioral: Parenting education program

What is being measured

The primary outcome is the main question the study is designed to answer.

  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').

    Measured: 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').

    Measured: 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).

    Measured: 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).

    Measured: Baseline

  5. Study population eligibility and interest

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

    Measured: Baseline

  6. Participant engagement

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

    Measured: 4 weeks

Secondary outcomes (1)

  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).

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2019
  2. Study start6 Feb 2019
  3. Primary completion1 May 2019
  4. Study completion14 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03881280
Sponsor's protocol ID
FCT-PD/BD/128309/2017
Acronym
Fammeal
Status last verified
Aug 2019
First submitted
12 Mar 2019
Last updated
17 Sep 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Parenting education program in people with Overweight and Obesity, run by Universidade do Porto at 1 site in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline Perceptions and Attitudes regarding children's weight status at 4 weeks (time frame: Baseline and 4 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03881280, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in