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

NCT04642222 | Completed

• 2 other identifiers: SECVS 142/2015POCI-01- 0145-FEDER-028209
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 2

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.

Conditions

Pediatric Obesity

Keywords

Adolescent; Web-based intervention; Health promotion; Eating Behaviors

Outcome Measures

Primary Outcomes (4)

• 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.

• 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.

• 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.

• 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 Outcomes (5)

• 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.

• Grazing 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.

• Psychological Distress (depression, anxiety and stress)

  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.

• 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.

• BMI z-score

  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.

Study Arms (2)

APOLO-Teens Intervention Group (APOLO-Teens group)

EXPERIMENTAL

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.

Behavioral: APOLO-Teens web-based intervention

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

ACTIVE COMPARATOR

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.

Other: Treatment as Usual for Pediatric Obesity

Interventions

APOLO-Teens web-based intervention 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.

APOLO-Teens Intervention Group (APOLO-Teens group)

Treatment as Usual for Pediatric Obesity OTHER

Treatment as Usual for pediatric obesity in portuguese public hospitals.

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

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minho: lead

Study Sites (2)

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

Porto, 4050-651, Portugal

Location

Centro Hospitalar Universitário de São João

Porto, 4200-319, Portugal

Location

Related 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.

  PMID: 30519810 BACKGROUND

MeSH Terms

Conditions

Pediatric Obesity; Feeding Behavior

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior

Study Officials

• Eva M Conceição, Ph.D.

  University of Minho, School of Psychology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Randomization is performed by a researcher not involved in data management. The researcher who evaluates the outcomes of interest is masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Fellow

Model Details: This is a randomized control trial with two groups: the Treatment As Usual control group (TAU group) and the APOLO-Teens web-based intervention group (APOLO-Teens group). Adolescents attending a medical appointment scheduled for any multidisciplinary obesity appointment at a public Portuguese health facility will be invited to participate. The criteria for inclusion/exclusion will be given to the healthcare professionals conducting these medical appointments, to screen for potential participants. After completing the baseline assessment participants will be consecutively randomized to the Treatment As Usual control group (TAU group) or the APOLO-Teens web-based intervention group (APOLO-Teens group). Participants in the APOLO-Teens group received the APOLO-Teens web-based intervention in addition to their treatment as usual (TAU).

Study Record Dates

• First Submitted: November 17, 2020
• First Posted: November 24, 2020
• Study Start: October 1, 2015
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: May 25, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

PT (2)