Evaluation of the Efficacy of an App for Parents to Promote Healthy Life-styles in Children: the CoSIE Trial

NCT04915092 | Completed

• 1 other identifier: ID:360 - CoSIE app
• Study Type: interventional
• Target: 327
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to evaluate the effectiveness of the app in terms of changing lifestyles both related to nutrition and physical activity. The study is also aimed at evaluating the usability and the degree of acceptance of the app among parents. The primary objective will be assessed in terms of the change in the consumption of sugary drinks and high-calorie food and in terms of time spent in front of a screen. The secondary objectives are the evaluation of BMI (percentile and z-score) and waist circumference and the evaluation of the usability of the app. STUDY DESIGN The study is a randomized control trial. Both parents and children are recruited.

• Family paediatricians during the health balance of 3 or 5 years old (children between 3 and 6.5 years old)
• Sport medicine during the visits for sport ability (children between 7 and 11 years old)
• Pediatric Endocrinology and Diabetology of the Santa Maria Hospital during routine visits (children between 5 and 11 years old) When the study is presented to families, few clinical information are collected on the electronic platform designed for enrollment and randomization:
• Child weight and height
• Child waist circumference More information about children and parents are collected (through questionnaire). The families (both treatment and control ) are contacted after 12 month and after 24 months from the recruitment to answer to a questionnaire on lifestyle habits (food and physical activity) of the child and app utilization During this visit also child weight, height and waist circumference will be collected. Intervention group The app is explained and installed during the recruitment to the family in the intervention group. Some families in this group will be selected to take part to the qualitative research. Control group Every months during the first year of study a newsletter is sent only to the members of the control group.

Conditions

Childhood Obesity

Keywords

mhealth; app; obesity; prevention

Outcome Measures

Primary Outcomes (6)

• Change in consumption of sugar - sweetened beverages and juice, first year

  Endpoint: number per week Outcome: Delta 12m-baseline Test/analysis: Difference between groups Source: Questionnaire in FU visits

  12 months

• Change in consumption of sugar - sweetened beverages and juice, second year

  Endpoint: number per week Outcome: Delta 24m - baseline Test/analysis: Difference between groups Source: Questionnaire in FU visits

  24 months

• Change in consumption of hypercaloric foods like fried food, salty snacks and sweet snacks/candies, first year

  Endpoint: number per week Outcome: Delta 12m-baseline Test/analysis: Difference between groups Source: Questionnaire in FU visits

  12 months

• Change of consumption of hypercaloric foods like fried food, salty snacks and sweet snacks/candies, second year

  Endpoint: number per week Outcome: Delta 24m-baseline Test/analysis: Difference between groups Source: Questionnaire in FU visits

  24 months

• Change in screen time spent by children, first year

  Endpoint: Minutes of screen time per day Outcome: Delta 12m-baseline Test/analysis: Difference between groups Source: Questionnaire in FU visits

  12 months

• Change in screen time spent by children, second year

  Endpoint: Minutes of screen time per day Outcome: Delta 24m-baseline Test/analysis: Difference between groups Source: Questionnaire in FU visits

  24 months

Secondary Outcomes (4)

• BMI centile of children after the first year

  12 months

• BMI centile of children after the second year

  24 months

• Acceptability

  after at 12 months of app utilization

• Usability

  after at 12 months of app utilization

Study Arms (2)

Intervention group

EXPERIMENTAL

The app is explained and installed during the recruitment to the family in the intervention group. Some families in this group will be selected to take part to the qualitative research.

Device: CoSIE app

Control group

NO INTERVENTION

Every months during the first year of study a newsletter is sent only to the members of the control group.

Interventions

CoSIE app DEVICE

The app is a mobile phone application compatible with both iOS and Android operating system. Parents are able to register their children and to keep track of their weight status and activities. The app include five themes: child development, physical activity, healthy food, critical situations, BMI. Push notification on healthy behaviours, on important event taking place in the province of Reggio Emilia, on food advices based on seasonality and on party tips are constantly delivered by the app.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• parents of children aged 3 to 11 presneting for a new well child visit or for a sport medicin visit or presenting for a childhood obesity visit at the AUSL Reggio Emilia clinics, including family pediatricians clinics.

You may not qualify if:

• Families resident outside the Province of Reggio Emilia
• Parents with no comprehension of the Italian language
• Children inside a program for obesity cure or prevention. The program are:
• the GET program (a program coordinated by the hospital pediatric unit in which obese children follow a group intervention),
• the BMInforma program (in which overweight girls from 5 to 7 years old follow a counselling proposed by the family paediatrician),
• the second level medical clinic in which obese children with pathologic condition are cured
• Children with severe obesity previously diagnosed

Sponsors & Collaborators

• Azienda USL Reggio Emilia - IRCCS: lead

Study Sites (1)

Azienda USL-IRCCS Reggio Emilia

Reggio Emilia, Reggio Emilia, 42123, Italy

Location

Related Publications (1)

• Giorgi Rossi P, Ferrari F, Amarri S, Bassi A, Bonvicini L, Dall'Aglio L, Della Giustina C, Fabbri A, Ferrari AM, Ferrari E, Fontana M, Foracchia M, Gallelli T, Ganugi G, Ilari B, Lo Scocco S, Maestri G, Moretti V, Panza C, Pinotti M, Prandini R, Storani S, Street ME, Tamelli M, Trowbridge H, Venturelli F, Volta A, Davoli AM; Childhood Obesity Prevention Working Group. Describing the Process and Tools Adopted to Cocreate a Smartphone App for Obesity Prevention in Childhood: Mixed Method Study. JMIR Mhealth Uhealth. 2020 Jun 8;8(6):e16165. doi: 10.2196/16165.

  PMID: 32357123 BACKGROUND

MeSH Terms

Conditions

Pediatric Obesity; Alzheimer Disease; Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Paolo Giorgi Rossi, phd

  Azienda USL-IRCCS Reggio Emilia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Families in the control arm will receive a newsletter
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Families in the intervention arm will receive the app

Study Record Dates

• First Submitted: November 16, 2020
• First Posted: June 7, 2021
• Study Start: June 14, 2021
• Primary Completion: January 15, 2024
• Study Completion: January 15, 2024
• Last Updated: June 25, 2025

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)