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

Adolescent Behavior Clinical Trial

Official title:

Feasibility Study of a Digital Behaviour Change Intervention (FIT-TEENS) to Increase Physical Activity Levels in Overweight and Obese Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05764291
• Other study ID #: FF-2021-414
• Status: Completed
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: August 31, 2023

Study information

• Verified date: March 2024
• Source: National University of Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is the study protocol of a cluster randomised controlled trial to evaluate the feasibility of a digital behaviour change intervention (DBCI) aimed at increasing physical activity, which will be delivered via an online learning platform to Malaysian overweight and obese adolescents (aged 13-18 years). The study will be conducted in four public secondary schools in Selangor, Malaysia. Additional schools may be recruited to fulfil required sample size. Study participants will include adolescents who are either overweight or obese (BMI > 85the or >95th percentile respectively). The intervention group will receive access to a digital intervention (FIT-TEENS) over 10 weeks, which provides information on physical activity and behaviour change support towards physical activity in the local Malay language. Briefly, this DBCI is based on the Behaviour Change Wheel and Theoretical Domains Framework. FIT-TEENS contains 10 online modules, delivered via simple, interactive, user-friendly digital platform (EdApp). The modules consist of the following topics: 1) Introduction to Physical Activity 2) Physical Activity Intensity Levels 3) Benefits of Physical Activity 4) Health-Related Fitness 5) Assessing Fitness Level 6) Setting SMART Goal 7) Motivation to Change 8) Choosing the "Right" Physical Activity 9) Overcoming Barriers 10) Other healthy lifestyle aspects: Nutrition and Stress Management. No intervention will be delivered in the control group, and participants will be requested to continue their usual physical activities. However, at the end of 10 weeks, the control group participants will also receive access to the intervention. The primary outcome of this trial is the feasibility of a digital behaviour change intervention (FIT-TEENS) at increasing physical activity compared with wait-list control in overweight and obese adolescents. More specifically, the primary objectives are to determine 1) the recruitment, retention and adherence rates, including length of time required to complete participant recruitment, 2) the acceptability of the intervention and level of overall satisfaction in participants, and 3) to conduct a qualitative process evaluation with participants to explore potential mediators of behaviour change, as well as the participants' views of the intervention and trial, including barriers and facilitators to completion of the intervention. The secondary outcomes are to estimate the variability in clinical markers to inform the design of future trial, by calculating interval estimates of the mean difference over time for physical activity behaviour, self-efficacy and social support as well as body mass index (BMI) and waist circumference of participants. This will enable the statistical power calculations for future cluster-RCT to assess the effectiveness of the intervention as part of routine clinical care.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: August 31, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Currently involved in any other weight management programs.

• Physically disabled/ have any medical conditions that limit physical activity

Related Conditions & MeSH terms

• Adolescent Behavior
• Adolescent Obesity
• Adolescent Overweight
• Overweight
• Pediatric Obesity

Intervention

Behavioral:
• FIT-TEENS
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.

Locations

Country	Name	City	State
Malaysia	SMK Seri Indah	Seri Kembangan	Selangor
Malaysia	SMK Taman Desaminium	Seri Kembangan	Selangor

Sponsors (3)

Lead Sponsor	Collaborator
National University of Malaysia	Universiti Putra Malaysia, University of Roehampton

Country where clinical trial is conducted

Malaysia, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change of Body Mass Index (BMI) as assessed by standardized anthropometric measurement using SECA weight and height scale	Weight (in kg) and height (in cm) will be measured using standardized procedure and then be used to calculate the body mass index (BMI) based on their age, gender, height and weight using the CDC calculator.	10 weeks
Secondary	Level of Physical Activity Self-Efficacy as measured by the Self-Efficacy for Physical Activity Scale	Physical Activity self-efficacy will be measured using Self-Efficacy for Physical Activity Scale to assess the confidence in participants' ability to do physical activities (PA), which is an 8-item 5-point Likert scale to measure PA self-efficacy which were adapted from a previously validated instrument (Moth et al. 2000). The range of scores is between 5 to 40, with higher scores indicates higher PA self-efficacy	10 weeks
Secondary	Level of Social support for Physical Activity as measured by the Social Support for Exercise Scale	Ten items adapted from the Social Support for Exercise Scale (Sallis et al. 1987) will be used to measure social support for physical activity. Participants will rate how often they receive PA related social support (e.g "During the past three motnsh, my family and friends discussed PA with me') on a 5-point scale (1=none to 5= very often). The range of scores is between 5 to 50, with higher scores indicates higher social support for PA.	10 weeks
Secondary	Level of Physical Activity Motivation to Exercise as measured by BREQ-3	Physical activity (PA) motivation will be assessed via the validated Malay version of the Behavioural Regulation in Exercise Questionnaire (BREQ-3), which contains 20 items on a 5-point Likert scale, with higher mean scores indicates higher motivation for PA.	10 weeks