NCT03881280

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 6, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 12, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 19, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2019

Completed
Last Updated

September 17, 2020

Status Verified

August 1, 2019

Enrollment Period

3 months

First QC Date

March 12, 2019

Last Update Submit

September 15, 2020

Conditions

Keywords

Childhood ObesityNutritionmHealthParenting

Outcome Measures

Primary Outcomes (6)

  • 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').

    Baseline and 4 weeks

  • 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').

    Baseline and 4 weeks

  • 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).

    Baseline

  • 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).

    Baseline

  • Study population eligibility and interest

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

    Baseline

  • Participant engagement

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

    4 weeks

Secondary Outcomes (1)

  • Eating Behaviors (in this pilot RCT only evaluated to test the randomization).

    Baseline

Study Arms (2)

Control group

NO INTERVENTION

Treatment as usual for 4 weeks

Intervention group

EXPERIMENTAL

Education through the app for 4 weeks

Behavioral: Parenting education program

Interventions

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.

Intervention group

Eligibility Criteria

Age36 Months - 83 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Porto, Porto, Portugal, 4200-135, Portugal

Location

Related Publications (2)

  • 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.

    RESULT
  • 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.

Related Links

MeSH Terms

Conditions

OverweightObesityPediatric Obesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Lisa Afonso

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2019

First Posted

March 19, 2019

Study Start

February 6, 2019

Primary Completion

May 1, 2019

Study Completion

June 14, 2019

Last Updated

September 17, 2020

Record last verified: 2019-08

Locations