Effectiveness of a Mobile Health Intervention for the Prevention of Overweight and Obesity in Adolescents

NCT05329753 | Completed

• 1 other identifier: PI-77.18 EIESOJTIC18
• Study Type: interventional
• Target: 305
• Locations: 1 country
• Sites: 1

Brief Summary

The prevention of overweight and obesity in adolescents is a public health priority given the impact of obesity on both short- and long-term health. Scientific evidence has shown that interventions in diet and physical exercise can reduce the risk of obesity in children and young people since adolescence is an ideal stage for educating on a healthy lifestyle and correcting the habits that may have been acquired in childhood. Smartphone applications (apps) can provide a useful alternative to overweight and obesity prevention measures. The objective of this study was to evaluate, through a randomized controlled clinical trial, the effect of an intervention based on a mobile health application (m-Health) on improving the degree of sport and nutrition knowledge, eating habits, and level of physical activity of adolescents. The sample consists of 305 adolescents, 154 in the intervention group and 151 in the control group that are evaluated at the beginning and 6 months later regarding sociodemographic, eating habits, food knowledge, level of physical activity, body mass index, and waist circumference. The educational intervention was carried out using an m-Health tool, a mobile phone application. The outcomes were changes in the mentioned variables to a six-month follow-up between the two groups.

Conditions

Adolescent Obesity

Keywords

mobile application; eating habits; physical activity; overweight; nutrition knowledge

Outcome Measures

Primary Outcomes (3)

• Eating habits

  KidMed: A 16-item Questionnaire of Mediterranean diet adherence (unit of measure: points. Each item is scored 0 or 1. The total Mediterranean diet score ranges from 0 to 12 points. The higher the score, the higher the degree of adherence to the Mediterranean Diet).

  6 months

• Nutrition knowledge

  General and Sport Nutrition knowledge Questionnaire: A questionnaire with 62 items (unit of measure: points. The higher the score, the higher the knowledge level)

  6 months

• Level of physical activity

  Physical Activity Questionnaire for adolescents (PAQ-A) (The overall result of the test is a score from 1 to 5 points that allows to establish a graduation in the level of physical activity made by each adolescent. Do higher values represent a better outcome)

  6 months

Secondary Outcomes (2)

• Body mass index

  6 months

• Waist circumference

  6 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Mobile application

Device: Mobile health application

Control group

NO INTERVENTION

Usual education

Interventions

Mobile health application DEVICE

Health intervention through a smartphone application that favors the process of learning

Intervention group

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Adolescents who were studying the 1st to 3rd grades of secondary education in public institutes
• Have a smartphone or tablet with an Android operating system and internet access

You may not qualify if:

• Adolescents with barriers that prevented them from understanding the characteristics of the study: Comprehension, visual or auditory problems
• Adolescents with disease or treatment that affect the variables studied (diagnosed diseases that affect body weight such as liver or kidney disease or regular treatment with drugs such as corticosteroids)

Sponsors & Collaborators

• University of Cadiz: lead

Study Sites (1)

University of Cádiz

Cadiz, 11009, Spain

Location

MeSH Terms

Conditions

Pediatric Obesity; Feeding Behavior; Motor Activity; Overweight

Condition Hierarchy (Ancestors)

Obesity; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior

Study Officials

• M J Santi, MD

  University of Cádiz

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 8, 2022
• First Posted: April 15, 2022
• Study Start: September 15, 2019
• Primary Completion: May 5, 2020
• Study Completion: June 30, 2021
• Last Updated: April 15, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)