The System Fammeal With Tailored Recommendations and Gamification for Parents to Counteract Childhood Obesity (Fammeal)
|ClinicalTrials.gov Identifier: NCT03881280|
Recruitment Status : Completed
First Posted : March 19, 2019
Last Update Posted : September 17, 2020
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Parallel Assignment|
|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|
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:
The investigators created a support website that connects to the main server to get data gathered from the mobile app and game.
- 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').
- 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').
- 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).
- 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).
- Study population eligibility and interest [ Time Frame: Baseline ]Proportion of all parents invited who meet eligibility and who accepted to enroll.
- Participant engagement [ Time Frame: 4 weeks ]Mean of points earned and app access per participant during intervention and proportion of recommended videos watched.
- 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03881280
|Faculdade de Psicologia e de Ciências da Educação da Universidade do Porto|
|Porto, Porto, Portugal, Portugal, 4200-135|
|Principal Investigator:||Lisa Afonso||Faculdade de Psicologia e de Ciências da Educação da Universidade do Porto|