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E-therapeutic Program for Obese Adolescents

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Next.Step - e-therapeutic intervention program
Standard treatment protocol
Sponsored by
Hospital de Santa Maria, Portugal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Obesity focused on measuring obesity, overweight, technology, internet, intervention, adolescents

Eligibility Criteria

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

Inclusion Criteria:

  • patients from POC/HSM
  • aged between 12 and 18 years
  • BMI percentile ≥ 95th
  • internet access at least once a week

Exclusion Criteria:

  • presence of severe psychopathology
  • inability to communicate in writing
  • pregnancy
  • having been proposed for bariatric surgery

Sites / Locations

  • Instituto Politécnico de Leiria
  • Hospital de Santa Maria

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Next.Step

Standard protocol

Arm Description

Experimental group participants, in addition to the standard treatment program are invited to get restricted access to the e-therapeutic platform (Next.Step), which includes a diverse set of resources, such as: educational resources (videos, brochures, menus, weekly tips, access to other links), self-monitoring (food, weight and physical activity records), social support (chats, discussion forums and personalized messages), interactive training modules (self-assessment quizzes, making their own diets) and motivational tools (personal goals planning, treatment progression registry, positive reinforcement). Intervention length will be 36 weeks (24 weeks of direct intervention with a follow-up of 12 weeks), being based on case management methodology.

The control group will follow the POC/HSM standard treatment protocol, which includes a baseline evaluation session with a paediatrician for initial screening, followed by appointments with the nutritionist and exercise physiologist. The second set of appointments will take place one month after for adjustments. After this, the adolescent will have appointments at 3, 6, 9 and 12 months. These adolescents will join a waiting list and nine months (36 weeks) after having started the standard treatment, they will receive the personal codes for accessing Next.Step.

Outcomes

Primary Outcome Measures

Change in Body mass index percentile
Change in BMI percentile from baseline to 24 weeks. Height and weight will be used to calculate BMI percentile, adjusted for age and gender.

Secondary Outcome Measures

Change in physical activity
Change in physical activity from baseline to 24 weeks, measure in self-reported hours/week
Change in sedentary lifestyle
Change in physical activity from baseline to 24 weeks, measure in self-reported hours/week of screen time
Change in body image
Change in body image silhouette perception from baseline to 24 weeks
Next.Step Usability
Perception of usability of the Next.Step platform measure with a self-reported instrument (NSUQ - Next.Step Usability Questionnaire)
Change in weight specific quality of life
Change in weight specific quality of life from baseline to 24 weeks, evaluated with a self-report instrument (IWQOL - Impact of Weight on Quality of Life)
Change in adherence to weight control
Change in adherence to weight control from baseline to 24 weeks, evaluated with a self-report instrument (AWCQ - Adherence to Weight Control Questionnaire)
Change in Lifestyle Profile
Change in Lifestyle Profile from baseline to 24 weeks, evaluated with a self-report instrument (ALP - Adolescent Lifestyle Profile).

Full Information

First Posted
July 9, 2013
Last Updated
November 16, 2015
Sponsor
Hospital de Santa Maria, Portugal
Collaborators
Instituto Politécnico de Leiria
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1. Study Identification

Unique Protocol Identification Number
NCT01904474
Brief Title
E-therapeutic Program for Obese Adolescents
Official Title
Internet Based Intervention Program for Obese Adolescents and Their Families(NEXT.STEP)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital de Santa Maria, Portugal
Collaborators
Instituto Politécnico de Leiria

4. Oversight

5. Study Description

Brief Summary
This study aims to: I. Determine the e-therapeutic intervention program effectiveness compared with the standard treatment protocol, on both the behavioural change (treatment adherence and promotion of healthy lifestyles) and health impact (weight control and quality of life), based on a population of adolescents followed at Paediatric Obesity Clinic (POC) of Hospital de Santa Maria (HSM), Lisbon (Portugal). II. Evaluate the health profile, treatment adherence, lifestyle and impact of weight on quality of life of this population. III. Test the usability of an e-therapeutic platform for obese adolescents and their families.
Detailed Description
Information and Communications Technology (ICT) have been identified as important tools, allowing for health gains and reducing costs. They have been associated with positive results in terms of efficiency, effectiveness, equity, accessibility and quality of the provided care/services (Alcañiz et al., 2009; Baulch et al., 2008; Cottrell, 2005; Grohol, 1999). The existence of accurate, reliable, structured and relevant information, available when and where is needed, enables professionals and consumers to make informed and timely decisions (High Commissioner for Health, 2010; Organization for Economic Cooperation and Development, 2010). This project was designed according to the national guidelines (Direção-Geral da Saúde, 2005), and has the potential to become a relevant educational and intervention instrument. Its content may be adapted to the needs and expectations of target groups. Strategies as problem solving reinforced by the e-therapeutic programme may enable participants to overcome barriers to adherence and thereby enhance treatment-induced weight losses (Murawski et al., 2009). Moreover, this project will allow to: a) Obtain relevant information about patients and their progress, enabling health professionals to interpret the inputs and send feedback in real time, b) Tailor therapeutic strategies to individual responses, c) Monitor individual progress. This study is designed as a randomized clinical trial. The experimental group will follow the standard treatment protocol and, additionally, receive free access to the e-therapeutic platform (Next.Step) for 24 weeks. The control group participants will follow the standard treatment protocol and join a waiting list for entering the Next.Step. Based on the literature review and on the contribution of the Nola Pender's Health Promotion reference model (Pender et al., 2010), investigators will look for empirical evidence for the general investigation hypothesis: treatment adherence, healthy lifestyles, quality of life and weight control of obese adolescents are positively influenced by this intervention program.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
obesity, overweight, technology, internet, intervention, adolescents

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Next.Step
Arm Type
Experimental
Arm Description
Experimental group participants, in addition to the standard treatment program are invited to get restricted access to the e-therapeutic platform (Next.Step), which includes a diverse set of resources, such as: educational resources (videos, brochures, menus, weekly tips, access to other links), self-monitoring (food, weight and physical activity records), social support (chats, discussion forums and personalized messages), interactive training modules (self-assessment quizzes, making their own diets) and motivational tools (personal goals planning, treatment progression registry, positive reinforcement). Intervention length will be 36 weeks (24 weeks of direct intervention with a follow-up of 12 weeks), being based on case management methodology.
Arm Title
Standard protocol
Arm Type
Active Comparator
Arm Description
The control group will follow the POC/HSM standard treatment protocol, which includes a baseline evaluation session with a paediatrician for initial screening, followed by appointments with the nutritionist and exercise physiologist. The second set of appointments will take place one month after for adjustments. After this, the adolescent will have appointments at 3, 6, 9 and 12 months. These adolescents will join a waiting list and nine months (36 weeks) after having started the standard treatment, they will receive the personal codes for accessing Next.Step.
Intervention Type
Other
Intervention Name(s)
Next.Step - e-therapeutic intervention program
Intervention Type
Other
Intervention Name(s)
Standard treatment protocol
Primary Outcome Measure Information:
Title
Change in Body mass index percentile
Description
Change in BMI percentile from baseline to 24 weeks. Height and weight will be used to calculate BMI percentile, adjusted for age and gender.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Change in physical activity
Description
Change in physical activity from baseline to 24 weeks, measure in self-reported hours/week
Time Frame
24 weeks
Title
Change in sedentary lifestyle
Description
Change in physical activity from baseline to 24 weeks, measure in self-reported hours/week of screen time
Time Frame
24 weeks
Title
Change in body image
Description
Change in body image silhouette perception from baseline to 24 weeks
Time Frame
24 weeks
Title
Next.Step Usability
Description
Perception of usability of the Next.Step platform measure with a self-reported instrument (NSUQ - Next.Step Usability Questionnaire)
Time Frame
24 weeks
Title
Change in weight specific quality of life
Description
Change in weight specific quality of life from baseline to 24 weeks, evaluated with a self-report instrument (IWQOL - Impact of Weight on Quality of Life)
Time Frame
24 weeks
Title
Change in adherence to weight control
Description
Change in adherence to weight control from baseline to 24 weeks, evaluated with a self-report instrument (AWCQ - Adherence to Weight Control Questionnaire)
Time Frame
24 weeks
Title
Change in Lifestyle Profile
Description
Change in Lifestyle Profile from baseline to 24 weeks, evaluated with a self-report instrument (ALP - Adolescent Lifestyle Profile).
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients from POC/HSM aged between 12 and 18 years BMI percentile ≥ 95th internet access at least once a week Exclusion Criteria: presence of severe psychopathology inability to communicate in writing pregnancy having been proposed for bariatric surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pedro M Sousa, Msc
Organizational Affiliation
Instituto Politécnico de Leiria
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Helena R Fonseca, PhD
Organizational Affiliation
Hospital de Santa Maria, Portugal
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pedro J Gaspar, PhD
Organizational Affiliation
Instituto Politécnico de Leiria
Official's Role
Study Chair
Facility Information:
Facility Name
Instituto Politécnico de Leiria
City
Leiria
ZIP/Postal Code
2411-901
Country
Portugal
Facility Name
Hospital de Santa Maria
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal

12. IPD Sharing Statement

Citations:
Citation
Alcañiz M, Botella C, Baños R, Zaragoza I, Guixeres J. The Intelligent e-Therapy system: a new paradigm for telepsychology and cybertherapy. British Journal of Guidance & Counselling 37(3): 287-296, 2009.
Results Reference
background
Citation
Baulch J, Chester A, Brennan L. Treatment Alternatives for Overweight and Obesity: The Role of Online Interventions. Behaviour Change 25(1): 1-14, 2008.
Results Reference
background
Citation
Cottrell S. E-therapy: the future? Healthcare Counselling & Psychotherapy Journal 5(1): 18-21, 2005.
Results Reference
background
Citation
Direção-Geral da Saúde. Programa Nacional de Combate à Obesidade. Circular Normativa nº 03/DGCG de 17/03/2005.
Results Reference
background
Citation
Grohol JH. Best practices in e-therapy: Definition & Scope of e-therapy. 1999. Available at: www.psychcentral.com/best/best3.htm (accessed 12 Feb 2012).
Results Reference
background
Citation
High Commissioner for Health [Alto Comissariado da Saúde]. Plano Nacional de Saúde 2011-2016: Tecnologias de Informação e Comunicação, 2010. Available at: www.acs.min-saude.pt/pns2011-2016/files/2010/07/TIC4.pdf (accessed 12 Fev 2012).
Results Reference
background
PubMed Identifier
19665096
Citation
Murawski ME, Milsom VA, Ross KM, Rickel KA, DeBraganza N, Gibbons LM, Perri MG. Problem solving, treatment adherence, and weight-loss outcome among women participating in lifestyle treatment for obesity. Eat Behav. 2009 Aug;10(3):146-51. doi: 10.1016/j.eatbeh.2009.03.005. Epub 2009 Mar 29.
Results Reference
background
Citation
Organization for Economic Cooperation and Development. Improving health sector efficiency - The role of information and communication technologies. Paris: OECD Health Policy Studie, 2010.
Results Reference
background
Citation
Pender N, Murdaugh C, Parsons M. Health Promotion in Nursing Practice (6th ed.). Upper Saddle River, NJ: Pearson/Prentice-Hall.
Results Reference
background
PubMed Identifier
26966545
Citation
Fonseca H, Prioste A, Sousa P, Gaspar P, Machado Mdo C. Effectiveness analysis of an internet-based intervention for overweight adolescents: next steps for researchers and clinicians. BMC Obes. 2016 Mar 9;3:15. doi: 10.1186/s40608-016-0094-4. eCollection 2016.
Results Reference
derived
PubMed Identifier
25772743
Citation
Sousa P, Fonseca H, Gaspar P, Gaspar F. Controlled trial of an Internet-based intervention for overweight teens (Next.Step): effectiveness analysis. Eur J Pediatr. 2015 Sep;174(9):1143-57. doi: 10.1007/s00431-015-2502-z. Epub 2015 Mar 14.
Results Reference
derived

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E-therapeutic Program for Obese Adolescents

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