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Completed

NCT Number: NCT04642222

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

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.

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Key information

Conditions

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

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Hospitalar Universitário de São João, Porto, Portugal

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Treatment as Usual for Pediatric Obesity

Other

Treatment as Usual for pediatric obesity in portuguese public hospitals.

Primary outcomes

  1. Foods/beverages intake

    Time frame: 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.

    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.

  2. Minutes of moderate-to-vigorous physical activity per week at school

    Time frame: 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.

    Youth Activity Profile (YAP): This is a 15 items questionnaire to evaluate psychical activity and sedentary behaviors in youth on the previous seven days.

  3. Minutes per week spent in sedentary behaviors

    Time frame: 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.

    Youth Activity Profile (YAP): This is a 15 items questionnaire to evaluate psychical activity and sedentary behaviors in youth on the previous seven days.

  4. Minutes of moderate-to-vigorous physical activity out-of-school per week

    Time frame: 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.

    Youth Activity Profile (YAP): This is a 15 items questionnaire to evaluate psychical activity and sedentary behaviors in youth on the previous seven days.

Secondary outcomes

  1. Eating disturbance

    Time frame: 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.

    Children's Eating Attitudes Test (ChEAT). Higher scores indicate more eating disturbance.

  2. Grazing eating pattern

    Time frame: 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.

    Repetitive Eating Questionnaire (Rep(eat)-Q). Higher scores indicate the existence of a grazing-type eating pattern.

  3. Psychological Distress (depression, anxiety and stress)

    Time frame: 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.

    Depression Anxiety Stress Scales (DASS-21). Higher scores indicating more anxiety, stress and depressive symptomatology.

  4. Health-related quality of life

    Time frame: 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.

    Pediatric Quality of Life Inventory. Higher scores indicate more health-related quality of life.

  5. BMI z-score

    Time frame: 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.

    Calculated by WHO Anthroplus software 3.2.2. version

Sponsors and collaborators

Lead sponsor

University of Minho

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2022
Study completion
2022
First posted
Nov 24, 2020
Registry last updated
May 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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