NCT04591496

Brief Summary

This research aims to develop and study the efficacy of a web-based brief intervention, Smart Feeding4Kids, to promote healthy dietary patterns in young children (2 to 6 years old) through changes in parents' feeding practices. The intervention is grounded on self-regulation and habit-formation models and combines the use of several effective behavioral methodologies. The multidisciplinary team integrates experienced researchers on parenting interventions, child nutrition, and the development of online applications to support personalized nutritional assessment and psychological interventions. The monitoring of the use of the platform and the knowledge about the predictors of efficacy, adherence, and involvement obtained in this project will offer professionals essential information to the development of future online interventions. The project will also contribute with knowledge concerning the most effective methodologies for changing parental feeding practices and collects unique information about the eating habits and practices of parents of Portuguese children. The main hypotheses of the study:

  1. 1.parents who enrolled in behavior change and social support interventions will report significantly higher use of effective feeding practices (child's self-regulation intake practices, food availability, and accessibility practices) and significantly lower use of ineffective feeding practices (food control, restriction, and permissiveness feeding practices);
  2. 2.children whose parents enrolled in behavior change and social support interventions will have a significantly more frequent intake of vegetables and fruits intake, and significantly less frequent intake of sugar-sweetened foods and beverages;
  3. 3.positive changes in parental feeding practices will mediate children's food intake, with increased vegetables and fruits and decreased sugar-sweetened foods and beverages intake.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
260

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

October 9, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

July 13, 2021

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

July 27, 2021

Status Verified

July 1, 2021

Enrollment Period

3.5 years

First QC Date

October 9, 2020

Last Update Submit

July 26, 2021

Conditions

Keywords

Preschool childInternet-based interventionParentingFeeding behaviorEating habitsHealth educationBehavior change techniquesRandom allocation

Outcome Measures

Primary Outcomes (2)

  • Changes from baseline in the child's dietary intake reported by parents

    Child's dietary intake reported by parents: Child's dietary intake is evaluated through a 24h food recall, completed during 3 days (two weekdays and one weekend day). Data regarding the mean number of portions of vegetables, fruit, and sugar-sweetened foods and beverages registered on three days will be extracted from the database and analyzed separately as primary outcomes.

    Baseline, immediately after the intervention, 3 months after the intervention, 6 months after the intervention

  • Changes from baseline in parental feeding practices

    Parental feeding practices: Parental feeding practices are evaluated through a self-reported questionnaire, Food Parenting Practices Questionnaire, with three subscales (Child's Intake Self-regulation Practices, Food Availability and Accessibility Practices, and Ineffective Control Practices) developed and adapted to the Portuguese population within this study. Parents answer to 40 items on a 5-point Likert scale (from Totally false to Totally true). Higher values on each subscale indicate a more frequent use of this type of parental feeding practices. The total mean score of each subscale ranged from 1 to 5.

    Baseline, immediately after the intervention, 3 months after the intervention, 6 months after the intervention

Secondary Outcomes (3)

  • Changes from baseline in parental perceived barriers related to food and feeding

    Baseline, immediately after the intervention, 3 months after the intervention, 6 months after the intervention

  • Changes from baseline in food parenting self-efficacy

    Baseline, immediately after the intervention, 3 months after the intervention, 6 months after the intervention

  • Changes from baseline in parental motivation to change

    Baseline, immediately after the intervention, 3 months after the intervention, 6 months after the intervention

Other Outcomes (6)

  • Perception of the child's weight

    Baseline

  • Concerns about the child's weight

    Baseline

  • Child's BMI and percentile

    Baseline, immediately after the intervention, 3 months after the intervention, 6 months after the intervention

  • +3 more other outcomes

Study Arms (2)

SmartFeeding4Kids

EXPERIMENTAL

SmartFeeding4Kids: information about children's healthy diet and effective parental feeding practices, with a behavioral intervention (5 sessions plus 2 brief booster sessions online intervention)

Behavioral: Behavioral change intervention;Behavioral: Health Education

SmartFeeding4Kids Health

ACTIVE COMPARATOR

Psychoeducational condition: information about children's healthy diet and effective parental feeding practices (5 sessions plus 2 brief booster sessions online intervention)

Behavioral: Health Education

Interventions

Behavioral change intervention: goal setting, regarding child's diet and parental feeding practices; self-monitoring, with observation and recording of the child's food intake and parental feeding practices; individualized feedback, based on preceding week monitoring and according to the defined objectives, regarding child's and parent's behaviors; modeling and direct suggestions by tailored parent figures; positive reinforcement associated to parents' accomplishment of the objectives; prompts, to remember the defined objectives and the main messages of the intervention.

SmartFeeding4Kids

Health education: provision of information about preschool children's nutrition guidelines, effective parental feeding practices, strategies to overcome food and feeding-related barriers, and steps to form healthy habits.

SmartFeeding4KidsSmartFeeding4Kids Health

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Parent/caregiver of a 2 to 6 years old child, at baseline (if the parent has two children in the same age interval, the parent must choose the child that raises more concerns about their health habits, as reference)
  • Have access to a mobile phone or computer/tablet with internet
  • Be fluent in Portuguese
  • Agree to participate in the study to accomplish the intervention in which they are allocated, the evaluation protocols, and the tasks required in each condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculdade de Psicologia, Universidade de Lisboa

Lisbon, 1649-013, Portugal

RECRUITING

Related Publications (2)

  • Charneca S, Gomes AI, Branco D, Guerreiro T, Barros L, Sousa J. Intake of added sugar, fruits, vegetables, and legumes of Portuguese preschool children: Baseline data from SmartFeeding4Kids randomized controlled trial participants. Front Nutr. 2023 Mar 29;10:1150627. doi: 10.3389/fnut.2023.1150627. eCollection 2023.

  • Gomes AI, Pereira AI, Guerreiro T, Branco D, Roberto MS, Pires A, Sousa J, Baranowski T, Barros L. SmartFeeding4Kids, an online self-guided parenting intervention to promote positive feeding practices and healthy diet in young children: study protocol for a randomized controlled trial. Trials. 2021 Dec 18;22(1):930. doi: 10.1186/s13063-021-05897-z.

MeSH Terms

Conditions

Feeding BehaviorHealth Education

Condition Hierarchy (Ancestors)

Behavior, AnimalBehaviorAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth Behavior

Study Officials

  • Luisa Barros

    University of Lisbon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants are assigned to one of three groups in parallel for the duration of the study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor

Study Record Dates

First Submitted

October 9, 2020

First Posted

October 19, 2020

Study Start

July 13, 2021

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

July 27, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations