Adolescent BehaviorNCT05764291
Digital Intervention to Improve Physical Activity Behaviour In Overweight and Obese Adolescents
A study testing FIT-TEENS in people with Adolescent Behavior and Adolescent Obesity, run by National University of Malaysia at 2 sites in Malaysia.
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. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Adolescent Behavior, Adolescent Obesity, Adolescent Overweight
- What is being tested?
- FIT-TEENS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 2 sitesMalaysia
- Study dates
- 1 Apr 2023to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Currently involved in any other weight management programs.
- Physically disabled/ have any medical conditions that limit physical activity
Trial locations and contacts
2 sites in 1 country.
Malaysia2 sites
SMK Seri Indah
Seri Kembangan, Selangor, 43300
SMK Taman Desaminium
Seri Kembangan, Selangor, 43300
About this study
Official title: Feasibility Study of a Digital Behaviour Change Intervention (FIT-TEENS) to Increase Physical Activity Levels in Overweight and Obese Adolescents
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.
Read the detailed 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.
- Being tested
- FIT-TEENS
- Keywords
- physical activity, behaviour change, digital intervention, adolescent, obesity, feasibility, acceptability, pilot trial
- Medical subject headings
- Adolescent Behavior, Pediatric Obesity, Motor Activity, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FIT-TEENSBehavioural
Also called Digital Behaviour Change Intervention
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 10 weeks
Secondary outcomes (4)
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.
Measured: 10 weeks
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
Measured: 10 weeks
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.
Measured: 10 weeks
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.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start1 Apr 2023
- Primary completion30 Jun 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Adolescent BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Universiti Putra Malaysia, University of Roehampton
- Responsible party
- Principal investigator, Dr. Noor Azimah Muhammad, National University of Malaysia
- Investigators
- Noor Azimah Muhammad, Principal investigator, National University of Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05764291
- Sponsor's protocol ID
- FF-2021-414
- Status last verified
- Mar 2024
- First submitted
- 6 Sep 2022
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to requirements of the respective ethical committees, individual participant data will not be made available to other researchers. However, reasonable request for de-identified patient data may be considered by the principal investigator on case-to-case basis
Publications
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.
PubMed 3432232Motl 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.
PubMed 11071840
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of a Digital Behaviour Change Intervention (FIT-TEENS) to Increase Physical Activity Levels in Overweight and Obese Adolescents
- ClinicalTrials.gov ID
- NCT05764291
- Acronym / sponsor ID
- FF-2021-414
- Keywords
- physical activity, behaviour change, digital intervention, adolescent, obesity, feasibility, acceptability, pilot trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Collaborators
- Universiti Putra Malaysia, University of Roehampton
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 10 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| FIT-TEENS | Experimental | Behavioral: FIT-TEENSParticipants 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. |
| 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. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Currently involved in any other weight management programs.
- Physically disabled/ have any medical conditions that limit physical activity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FIT-TEENSAlso: Digital Behaviour Change InterventionFIT-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. | Behavioural | FIT-TEENS |
Primary outcome
Change in Physical Activity Behaviour as assessed by PAQ-A Questionnaire
Time frame: 10 weeks
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
Change in Physical activity behaviour (Daily step count) as assessed by Pedometer
Time frame: 10 weeks
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.
4 secondary outcomes
Change of Body Mass Index (BMI) as assessed by standardized anthropometric measurement using SECA weight and height scale
Time frame: 10 weeks
Level of Physical Activity Self-Efficacy as measured by the Self-Efficacy for Physical Activity Scale
Time frame: 10 weeks
Level of Social support for Physical Activity as measured by the Social Support for Exercise Scale
Time frame: 10 weeks
Level of Physical Activity Motivation to Exercise as measured by BREQ-3
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Background: PubMed 3432232Sallis 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.
- Background: PubMed 11071840Motl 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.
- Individual participant dataSharing planned: No. Due to requirements of the respective ethical committees, individual participant data will not be made available to other researchers. However, reasonable request for de-identified patient data may be considered by the principal investigator on case-to-case basis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noor Azimah Muhammad principal investigator
National University of Malaysia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FIT-TEENS in people with Adolescent Behavior and Adolescent Obesity, run by National University of Malaysia at 2 sites in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Physical Activity Behaviour as assessed by PAQ-A Questionnaire (time frame: 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05764291, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024; AzTrials last refreshed its copy on 1 Nov 2026.