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

Primary Purpose

Pediatric Obesity

Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
APOLO-Teens web-based intervention
Treatment as Usual for Pediatric Obesity
Sponsored by
University of Minho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediatric Obesity focused on measuring Adolescent, Web-based intervention, Health promotion, Eating Behaviors

Eligibility Criteria

13 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centro Hospitalar Universitário do Porto (Centro Materno Infantil do Norte)
  • Centro Hospitalar Universitário de São João

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

APOLO-Teens Intervention Group (APOLO-Teens group)

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

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Eating disturbance
Children's Eating Attitudes Test (ChEAT). Higher scores indicate more eating disturbance.
Grazing eating pattern
Repetitive Eating Questionnaire (Rep(eat)-Q). Higher scores indicate the existence of a grazing-type eating pattern.
Psychological Distress (depression, anxiety and stress)
Depression Anxiety Stress Scales (DASS-21). Higher scores indicating more anxiety, stress and depressive symptomatology.
Health-related quality of life
Pediatric Quality of Life Inventory. Higher scores indicate more health-related quality of life.
BMI z-score
Calculated by WHO Anthroplus software 3.2.2. version

Full Information

First Posted
November 17, 2020
Last Updated
May 24, 2023
Sponsor
University of Minho
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1. Study Identification

Unique Protocol Identification Number
NCT04642222
Brief Title
APOLO-Teens, a Web-based Intervention For Adolescents With Overweight/Obesity
Official Title
APOLO-Teens, a Web-based Intervention For Treatment-seeking Adolescents With Overweight/Obesity: A Multicenter Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2015 (Actual)
Primary Completion Date
March 2022 (Actual)
Study Completion Date
March 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Minho

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obesity
Keywords
Adolescent, Web-based intervention, Health promotion, Eating Behaviors

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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).
Masking
Outcomes Assessor
Masking Description
Randomization is performed by a researcher not involved in data management. The researcher who evaluates the outcomes of interest is masked.
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
APOLO-Teens Intervention Group (APOLO-Teens group)
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment As Usual (TAU) Control Group (TAU control group)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
APOLO-Teens web-based intervention
Intervention Description
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
Other
Intervention Name(s)
Treatment as Usual for Pediatric Obesity
Intervention Description
Treatment as Usual for pediatric obesity in portuguese public hospitals.
Primary Outcome Measure Information:
Title
Foods/beverages intake
Description
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.
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.
Title
Minutes of moderate-to-vigorous physical activity per week at school
Description
Youth Activity Profile (YAP): This is a 15 items questionnaire to evaluate psychical activity and sedentary behaviors in youth on the previous seven days.
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.
Title
Minutes per week spent in sedentary behaviors
Description
Youth Activity Profile (YAP): This is a 15 items questionnaire to evaluate psychical activity and sedentary behaviors in youth on the previous seven days.
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.
Title
Minutes of moderate-to-vigorous physical activity out-of-school per week
Description
Youth Activity Profile (YAP): This is a 15 items questionnaire to evaluate psychical activity and sedentary behaviors in youth on the previous seven days.
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.
Secondary Outcome Measure Information:
Title
Eating disturbance
Description
Children's Eating Attitudes Test (ChEAT). Higher scores indicate more 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.
Title
Grazing eating pattern
Description
Repetitive Eating Questionnaire (Rep(eat)-Q). Higher scores indicate the existence of a grazing-type 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.
Title
Psychological Distress (depression, anxiety and stress)
Description
Depression Anxiety Stress Scales (DASS-21). Higher scores indicating more anxiety, stress and depressive symptomatology.
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.
Title
Health-related quality of life
Description
Pediatric Quality of Life Inventory. Higher scores indicate more 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.
Title
BMI z-score
Description
Calculated by WHO Anthroplus software 3.2.2. version
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva M Conceição, Ph.D.
Organizational Affiliation
University of Minho, School of Psychology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro Hospitalar Universitário do Porto (Centro Materno Infantil do Norte)
City
Porto
ZIP/Postal Code
4050-651
Country
Portugal
Facility Name
Centro Hospitalar Universitário de São João
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The type of data to collect include sensitive and personal health information protected by the Portuguese Law.
Citations:
PubMed Identifier
30519810
Citation
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.
Results Reference
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APOLO-Teens, a Web-based Intervention For Adolescents With Overweight/Obesity

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