Clinical trial NCT03881280: The System Fammeal With Tailored Recommendations and Gamification for Parents to Counteract Childhood Obesity
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
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Keywords: Childhood Obesity
Nutrition
mHealth
Parenting
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
Collaborators: name: Fundação para a Ciência e a Tecnologia
name: Administração Regional de Saúde do Norte, Portugal
name: Agrupamento de Centros de Saúde do Grande Porto III - Maia / Valongo, Portugal
First posted: 2019-03-19
Enrollment: 28
Sex: ALL
Minimum age (years): 36
Maximum age (years): 83
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Change from Baseline Perceptions and Attitudes regarding children's weight status at 4 weeks
timeFrame: Baseline and 4 weeks
measure: Change from Baseline Perceptions and Attitudes regarding children's food intake at 4 weeks
timeFrame: Baseline and 4 weeks
measure: Dietary Intake (in this pilot RCT only evaluated to test the randomization)
timeFrame: Baseline
measure: Parental child-feeding practices (in this pilot RCT only evaluated to test the randomization)
timeFrame: Baseline
measure: Study population eligibility and interest
timeFrame: Baseline
measure: Participant engagement
timeFrame: 4 weeks
Secondary outcomes:
measure: Eating Behaviors (in this pilot RCT only evaluated to test the randomization).
timeFrame: Baseline
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Faculdade de Psicologia e de Ciências da Educação da Universidade do Porto
state: Porto, Portugal
Study officials:
affiliation: Faculdade de Psicologia e de Ciências da Educação da Universidade do Porto
name: Lisa Afonso
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.