Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03881280
Recruitment Status : Completed
First Posted : March 19, 2019
Last Update Posted : September 17, 2020
Sponsor:
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
Information provided by (Responsible Party):
Universidade do Porto

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.


Condition or disease Intervention/treatment Phase
Overweight and Obesity Behavioral: Parenting education program Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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
Actual Study Start Date : February 6, 2019
Actual Primary Completion Date : May 1, 2019
Actual Study Completion Date : June 14, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Parenting

Arm Intervention/treatment
No Intervention: Control group
Treatment as usual for 4 weeks
Experimental: Intervention group
Education through the app for 4 weeks
Behavioral: Parenting 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.





Primary Outcome Measures :
  1. Change from Baseline Perceptions and Attitudes regarding children's weight status at 4 weeks [ Time Frame: Baseline and 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').

  2. Change from Baseline Perceptions and Attitudes regarding children's food intake at 4 weeks [ Time Frame: Baseline and 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').

  3. Dietary Intake (in this pilot RCT only evaluated to test the randomization) [ Time Frame: Baseline ]
    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).

  4. Parental child-feeding practices (in this pilot RCT only evaluated to test the randomization) [ Time Frame: Baseline ]
    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).

  5. Study population eligibility and interest [ Time Frame: Baseline ]
    Proportion of all parents invited who meet eligibility and who accepted to enroll.

  6. Participant engagement [ Time Frame: 4 weeks ]
    Mean of points earned and app access per participant during intervention and proportion of recommended videos watched.


Secondary Outcome Measures :
  1. Eating Behaviors (in this pilot RCT only evaluated to test the randomization). [ Time Frame: Baseline ]
    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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   36 Months to 83 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT03881280


Locations
Layout table for location information
Portugal
Faculdade de Psicologia e de Ciências da Educação da Universidade do Porto
Porto, Porto, Portugal, Portugal, 4200-135
Sponsors and Collaborators
Universidade do Porto
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
Investigators
Layout table for investigator information
Principal Investigator: Lisa Afonso Faculdade de Psicologia e de Ciências da Educação da Universidade do Porto
Additional Information:
Publications of Results:
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, 10, 779-794. DOI: https://doi.org/10.3390/ejihpe10030057

Layout table for additonal information
Responsible Party: Universidade do Porto
ClinicalTrials.gov Identifier: NCT03881280    
Other Study ID Numbers: FCT-PD/BD/128309/2017
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: September 17, 2020
Last Verified: August 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universidade do Porto:
Childhood Obesity
Nutrition
mHealth
Parenting
Additional relevant MeSH terms:
Layout table for MeSH terms
Obesity
Pediatric Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight