Clinical trial NCT05764291: Digital Intervention to Improve Physical Activity Behaviour In Overweight and Obese Adolescents
Official title: Feasibility Study of a Digital Behaviour Change Intervention (FIT-TEENS) to Increase Physical Activity Levels in Overweight and Obese Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Behavior
Adolescent Obesity
Adolescent Overweight
Keywords: physical activity
behaviour change
digital intervention
adolescent
obesity
feasibility
acceptability
pilot trial
Lead sponsor: National University of Malaysia
Sponsor class: OTHER
Collaborators: name: Universiti Putra Malaysia
name: University of Roehampton
First posted: 2023-03-10
Enrollment: 49
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Physical Activity Behaviour as assessed by PAQ-A Questionnaire
timeFrame: 10 weeks
measure: Change in Physical activity behaviour (Daily step count) as assessed by Pedometer
timeFrame: 10 weeks
Secondary outcomes:
measure: Change of Body Mass Index (BMI) as assessed by standardized anthropometric measurement using SECA weight and height scale
timeFrame: 10 weeks
measure: Level of Physical Activity Self-Efficacy as measured by the Self-Efficacy for Physical Activity Scale
timeFrame: 10 weeks
measure: Level of Social support for Physical Activity as measured by the Social Support for Exercise Scale
timeFrame: 10 weeks
measure: Level of Physical Activity Motivation to Exercise as measured by BREQ-3
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Seri Kembangan
country: Malaysia
facility: SMK Seri Indah
state: Selangor
city: Seri Kembangan
country: Malaysia
facility: SMK Taman Desaminium
state: Selangor
Study officials:
affiliation: National University of Malaysia
name: Noor Azimah Muhammad
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.