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

NCT ID: NCT04642222

Last Updated: 2023-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-01
• Study Completion Date: 2022-03-31

Brief 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.

Detailed 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.

Conditions

Pediatric Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

APOLO-Teens Intervention Group (APOLO-Teens group)

In addition to the Treatment As Usual for pediatric obesity offered in Portuguese public hospitals, participants in this group receive the APOLO-Teens web-based intervention. It comprises three key components: 1) a manualized psychoeducational intervention implemented via Facebook® private groups, including cognitive-behavioral therapy strategies; 2) A weekly self-monitoring system (the APOLO-Teens web application) with automatic feedback messages assessing hours of physical activity, sedentary time, and consumption of fruits and vegetables; and 3) Monthly chat sessions.

Group Type: EXPERIMENTAL

APOLO-Teens web-based intervention

Intervention Type: BEHAVIORAL

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.

Treatment As Usual (TAU) Control Group (TAU control group)

Treatment As Usual control group receives the standard intervention for pediatric obesity offered in Portuguese public hospitals. It comprises pediatric or/and nutritional appointments, usually a 30-minute appointment every 3 months. These appointments usually include a physical examination (weight, height) and personalized dietary/lifestyle recommendations. The Treatment As Usual intervention is common to the APOLO-Teens group and TAU control groups.

Group Type: ACTIVE_COMPARATOR

Treatment as Usual for Pediatric Obesity

Intervention Type: OTHER

Treatment as Usual for pediatric obesity in portuguese public hospitals.

Interventions

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.

Intervention Type: BEHAVIORAL

Treatment as Usual for Pediatric Obesity

Treatment as Usual for pediatric obesity in portuguese public hospitals.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minho

OTHER

Sponsor Role: lead

Responsible Party

Eva Conceição

Research Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eva M Conceição, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Minho, School of Psychology

Locations

Centro Hospitalar Universitário do Porto (Centro Materno Infantil do Norte)

Porto, , Portugal

Centro Hospitalar Universitário de São João

Porto, , Portugal

Countries

Portugal

References

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.

Reference Type: BACKGROUND

PMID: 30519810 (View on PubMed)

Other Identifiers

POCI-01- 0145-FEDER-028209

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

SECVS 142/2015

Identifier Type: -

Identifier Source: org_study_id