APOLO-Teens, a Web-based Intervention For Adolescents With Overweight/Obesity

Pediatric Obesity Clinical Trial

Official title:

APOLO-Teens, a Web-based Intervention For Treatment-seeking Adolescents With Overweight/Obesity: A Multicenter Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04642222
• Other study ID #: SECVS 142/2015
• Secondary ID: POCI-01- 0145-FE
• Status: Completed
• Phase: N/A
• Start date: October 1, 2015
• Est. completion date: March 2022

Study information

• Verified date: May 2023
• Source: University of Minho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

With the demand for weight-loss interventions likely to continue its upward trend over the next decades, the question remains on how to continuously monitor and support overweight and obese adolescents, particularly in the long-term. Moreover, as the burden of the obesity rates increases in health care centers, the development of alternative delivering strategies gains attention. In an environment of limited resources, the development of new-technology based programs seems a promising area to deliver cost-effective interventions to a wide number of individuals. However, the existing studies present several limitations and a challenging aspect of treating obesity in adolescents is the presence of high rates of disordered eating behaviors.

The objective of this study is to develop and test the effectiveness of a web-based Cognitive Behavioral Therapy intervention, for adolescents with overweight/obesity. A Randomized Controlled Trial will compare a control group receiving medical treatment as usual (TAU), and an intervention group receiving TAU plus a psychological/behavioral intervention delivered via the internet.

Description:

This research project intends to examine the effectiveness of a Cognitive Behavioral Therapy and psychoeducational based program for adolescents with overweight and obesity delivered as a web-based intervention: APOLO-Teens. Therefore, a randomized controlled trial will compare a control group receiving medical treatment as usual for pediatric obesity in public health care centers in Portugal, and an intervention group receiving TAU plus the APOLO-Teens web-based intervention.

The APOLO-Teens web-based intervention was designed to optimize treatment as usual for pediatric obesity, promoting the adoption of healthy eating habits and lifestyle behaviors. Particularly it aims to promote higher consumption of fruits and vegetables, increase physical activity levels, reduce sedentary time, enhance psychological well-being, and facilitating weight loss.

All participants will be assessed at baseline, 3 months after the beginning of the research protocol/intervention, end of the web-based intervention, and at 6 and 12 months follow-up. All the assessments will be conducted in Qualtrics: Online Survey Software. Repeated Paired Samples T-test will explore differences between the two groups across the assessment times. Multiple linear regression analysis will be applied to explore predictors of weight loss and weight regain, and survival analyses to identify participants with the highest probability to regain weight. Additionally, 3-Level Hierarchical Linear Models will be conducted to explore the temporal occurrence and patterns of change of eating-related variables, physical activity, and BMI z-score in participants from the two groups.

It is expected that the intervention group participants will present a higher frequency of healthy food consumption (fruit/vegetables) and increased physical activity levels at the end of the web-based intervention when compared with TAU group participants. We further expect, differences between the groups regarding eating behavior-related variables, as well as in the psychological features assessed throughout the different assessment points, and ultimately in weight maintenance or regain, with the intervention group presenting lower scores/weight.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: March 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

Inclusion Criteria:

• Participants with overweight or obesity (BMI z-score = 1/BMI percentile = 85th);

• Enrolled in ambulatory treatment for overweight/obesity in a public Portuguese health care center;

• Having a Facebook® account;

• Having access to the Internet at least three times per week.

Exclusion Criteria:

• Medical conditions that affect weight;

• Intellectual disabilities (Specific learning difficulties that prevented adolescents from reading and understanding written text);

• Ambulatory movement limitations (e.g., use of the walking stick, morpho-functional alterations as lower limb amputation, etc.);

• Not being under other interventions for weight loss at the time of enrollment.

Related Conditions & MeSH terms

• Obesity
• Overweight
• Pediatric Obesity

Intervention

Behavioral:
• APOLO-Teens web-based intervention
The APOLO-Teens web-based intervention is a 6-month cognitive-behavioral lifestyle program developed to optimize treatment as usual for pediatric obesity in public portuguese hospitals.

Other:
• Treatment as Usual for Pediatric Obesity
Treatment as Usual for pediatric obesity in portuguese public hospitals.

Locations

Country	Name	City	State
Portugal	Centro Hospitalar Universitário de São João	Porto
Portugal	Centro Hospitalar Universitário do Porto (Centro Materno Infantil do Norte)	Porto

Sponsors (1)

Lead Sponsor	Collaborator
University of Minho

Country where clinical trial is conducted

Portugal, 

References & Publications (1)

Ramalho S, Saint-Maurice PF, Silva D, Mansilha HF, Silva C, Goncalves S, Machado P, Conceicao E. APOLO-Teens, a web-based intervention for treatment-seeking adolescents with overweight or obesity: study protocol and baseline characterization of a Portuguese sample. Eat Weight Disord. 2020 Apr;25(2):453-463. doi: 10.1007/s40519-018-0623-x. Epub 2018 Dec 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Foods/beverages intake	Food/beverages frequency questionnaire, which assesses the frequency of soup, fruit, vegetables on the plate, sweetened beverages drinks and pastries/sweets intake in the previous week.	Change from baseline, to 3 months after the begging if the intervention, end of intervention (after 6-months of baseline assessment), 6 and 12 months follow-up. Specific duration of time over which participant change is assessed: 18 months.
Primary	Minutes of moderate-to-vigorous physical activity per week at school	Youth Activity Profile (YAP): This is a 15 items questionnaire to evaluate psychical activity and sedentary behaviors in youth on the previous seven days.	Change from baseline, to 3 months after the begging if the intervention, end of intervention (after 6-months of baseline assessment), 6 and 12 months follow-up. Specific duration of time over which participant change is assessed: 18 months.
Primary	Minutes per week spent in sedentary behaviors	Youth Activity Profile (YAP): This is a 15 items questionnaire to evaluate psychical activity and sedentary behaviors in youth on the previous seven days.	Change from baseline, to 3 months after the begging if the intervention, end of intervention (after 6-months of baseline assessment), 6 and 12 months follow-up. Specific duration of time over which participant change is assessed: 18 months.
Primary	Minutes of moderate-to-vigorous physical activity out-of-school per week	Youth Activity Profile (YAP): This is a 15 items questionnaire to evaluate psychical activity and sedentary behaviors in youth on the previous seven days.	Change from baseline, to 3 months after the begging if the intervention, end of intervention (after 6-months of baseline assessment), 6 and 12 months follow-up. Specific duration of time over which participant change is assessed: 18 months.
Secondary	Eating disturbance	Children's Eating Attitudes Test (ChEAT). Higher scores indicate more eating disturbance.	Baseline (before the intervention), 3 months after the begging if the intervention, end of intervention (after 6-months of baseline assessment), 6 and 12 months follow-up. Specific duration of time over which participant is assessed: 18 months.
Secondary	Grazing eating pattern	Repetitive Eating Questionnaire (Rep(eat)-Q). Higher scores indicate the existence of a grazing-type eating pattern.	Baseline (before the intervention), 3 months after the begging if the intervention, end of intervention (after 6-months of baseline assessment), 6 and 12 months follow-up. Specific duration of time over which participant is assessed: 18 months.
Secondary	Psychological Distress (depression, anxiety and stress)	Depression Anxiety Stress Scales (DASS-21). Higher scores indicating more anxiety, stress and depressive symptomatology.	Baseline (before the intervention), 3 months after the begging if the intervention, end of intervention (after 6-months of baseline assessment), 6 and 12 months follow-up. Specific duration of time over which participant is assessed: 18 months.
Secondary	Health-related quality of life	Pediatric Quality of Life Inventory. Higher scores indicate more health-related quality of life.	Baseline (before the intervention), 3 months after the begging if the intervention, end of intervention (after 6-months of baseline assessment), 6 and 12 months follow-up. Specific duration of time over which participant is assessed: 18 months.
Secondary	BMI z-score	Calculated by WHO Anthroplus software 3.2.2. version	Baseline (before the intervention), 3 months after the begging if the intervention, end of intervention (after 6-months of baseline assessment), 6 and 12 months follow-up. Specific duration of time over which participant is assessed: 18 months.