Digital Intervention to Improve Physical Activity Behaviour In Overweight and Obese Adolescents

NCT05764291 | Completed

• 1 other identifier: FF-2021-414
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 2

Brief Summary

This is a study protocol to test the feasibility of a digital intervention aiming to increase physical activity in overweight and obese adolescents. This study will be conducted in the state of Selangor, Malaysia. The intervention will be provided in two public schools. Another two public schools, which will be matched on the basis of similar socioeconomic background of attending students and curriculum structure, will act as control group. Additional schools may be recruited to fulfil required sample size. A digital behaviour change intervention (FIT-TEENS) will be delivered to overweight and obese adolescents (aged 13-18 years) using an online learning platform (EdApp) over 10 weeks to provide information on physical activity and the behaviour change aspects towards physical activity. The participants who received the intervention will be compared with the control group, where no intervention will be delivered, who will be requested to continue their usual physical activities. To determine the feasibility of the intervention, the researchers will obtain views and overall satisfaction from participants on the intervention and trial, and determine the proportion of participants who completed all intervention modules and outcome measures. In addition to feasibility measures, participants' physical activity behaviour, self-efficacy and social support, as well as body weight and composition will be compared between the two groups. This study will establish whether FIT-TEENS intervention is feasible and acceptable to overweight and obese adolescents in increasing their physical activity behaviour.

Conditions

Adolescent Behavior; Adolescent Obesity; Adolescent Overweight

Keywords

physical activity; behaviour change; digital intervention; adolescent; obesity; feasibility; acceptability; pilot trial

Outcome Measures

Primary Outcomes (2)

• Change in Physical Activity Behaviour as assessed by PAQ-A Questionnaire

  Self-reported physical activity behaviour will be measured using the Malay version of the Physical Activity Questionnaire for Adolescents (PAQ-A), which consists of 8 items measuring physical activity behaviour in the last seven days. The range of scores is between 5-40, with higher mean PAQ-A scores indicates higher activity

  10 weeks

• Change in Physical activity behaviour (Daily step count) as assessed by Pedometer

  Physical activity behaviour will be measured objectively using an Omron pedometer, in both intervention and control groups. Daily step counts will be recorded for a week (seven consecutive days) at baseline and for seven consecutive days after receiving the intervention.

  10 weeks

Secondary Outcomes (4)

• Change of Body Mass Index (BMI) as assessed by standardized anthropometric measurement using SECA weight and height scale

  10 weeks

• Level of Physical Activity Self-Efficacy as measured by the Self-Efficacy for Physical Activity Scale

  10 weeks

• Level of Social support for Physical Activity as measured by the Social Support for Exercise Scale

  10 weeks

• Level of Physical Activity Motivation to Exercise as measured by BREQ-3

  10 weeks

Study Arms (2)

FIT-TEENS

EXPERIMENTAL

Participants in the intervention group will receive access to a digital behaviour change intervention (FIT-TEENS). Participants will need to complete 10 self-paced online modules and activities over a period of 10 weeks.

Behavioral: FIT-TEENS

Wait-list control

NO INTERVENTION

Participants in the waitlist-control group will be required to continue their usual physical activities. At the end of 10 weeks, they will also receive access to FIT-TEENS intervention.

Interventions

FIT-TEENS BEHAVIORAL

FIT-TEENS is a digital behaviour change intervention which provides information on physical activity and behaviour change support towards physical activity, presented in multimedia format through an online learning platform (EdApp). The contents is developed in Malay language and consist of 10 self-paced modules and activities. The objectives of FIT-TEENS are for the participants to be able to 1) review the definitions and health benefits of physical activity 2) provide an overview of physical activity guidelines 3) write a SMART goal about physical activity 4) be aware of barriers to physical activity and how to overcome them.

Also known as: Digital Behaviour Change Intervention

FIT-TEENS

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Secondary school students (aged 13-18 years)
• Overweight or obese based on CDC criteria (BMI \> 85th centile) calculated based on their age, gender, height and weight using the CDC calculator
• Has access to internet using computer, tablet or smartphone/mobile device.
• Able to read and understand Malay language.

You may not qualify if:

• Currently involved in any other weight management programs.
• Physically disabled/ have any medical conditions that limit physical activity

Sponsors & Collaborators

• National University of Malaysia: lead
• Universiti Putra Malaysia: collaborator
• University of Roehampton: collaborator

Study Sites (2)

SMK Seri Indah

Seri Kembangan, Selangor, 43300, Malaysia

Location

SMK Taman Desaminium

Seri Kembangan, Selangor, 43300, Malaysia

Location

Related Publications (2)

• Sallis JF, Grossman RM, Pinski RB, Patterson TL, Nader PR. The development of scales to measure social support for diet and exercise behaviors. Prev Med. 1987 Nov;16(6):825-36. doi: 10.1016/0091-7435(87)90022-3.

  PMID: 3432232 BACKGROUND

• Motl RW, Dishman RK, Trost SG, Saunders RP, Dowda M, Felton G, Ward DS, Pate RR. Factorial validity and invariance of questionnaires measuring social-cognitive determinants of physical activity among adolescent girls. Prev Med. 2000 Nov;31(5):584-94. doi: 10.1006/pmed.2000.0735.

  PMID: 11071840 BACKGROUND

MeSH Terms

Conditions

Adolescent Behavior; Pediatric Obesity; Motor Activity; Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Noor Azimah Muhammad

  National University of Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants for both the intervention and control arms will be recruited simultaneously using cluster design to minimise contamination between intervention and control group participants. At the end of the 10-week intervention period, participants in the waitlist control arm will receive access to the intervention.

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: March 10, 2023
• Study Start: April 1, 2023
• Primary Completion: June 30, 2023
• Study Completion: August 31, 2023
• Last Updated: March 26, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

MY (2)