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Young, Fit and Happy. A Web-based Intervention to Prevent Obesity in Adolescents. (YFH)
| Tracking Information | ||||
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| First Received Date ICMJE | October 2, 2012 | |||
| Last Updated Date | April 14, 2015 | |||
| Start Date ICMJE | January 2012 | |||
| Primary Completion Date | May 2014 (Final data collection date for primary outcome measure) | |||
| Current Primary Outcome Measures ICMJE |
Fitness [ Time Frame: One year ] It Hypothesised that weekly individual web-counseling will motivate overweight and obese adolescents to increased physical activity. Further we assume that increased physical activity will improve the adolescents' fitness. Fitness is measured with a maximal multistage 20 m shuttle run test (Leger et al., 1988) |
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| Original Primary Outcome Measures ICMJE | Same as current | |||
| Change History | Complete list of historical versions of study NCT01700309 on ClinicalTrials.gov Archive Site | |||
| Current Secondary Outcome Measures ICMJE |
Quality of Life [ Time Frame: one year ] It is our assumption that weekly individual web-counseling, based on theories of coping and motivation, will motivate overweight and obese adolescents to increased physical activity. Further we assume that increased physical activity will improve the adolescents' fitness (health) and their quality of life. Measured with Kidscreen 52. |
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| Original Secondary Outcome Measures ICMJE | Same as current | |||
| Current Other Outcome Measures ICMJE |
Motivation for Physical activity and exercise, BMI, Self-efficacy [ Time Frame: One Year ] Motivation for Physical activity and exercise measured by the Behavioural Regulation In Exercise Questionnaire (BREQ2). BMI is calculated based on objective measures of height and weight. Self-efficacy is measured with Schwarzer 8 item questionaire. |
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| Original Other Outcome Measures ICMJE |
Motivation for Physical activity and exercise, BMI, Self-efficacy [ Time Frame: One Year ] Motivation for Physical activity and exercise measured by the Behavioural Regulation In Exercise Questionnaire (BREQ2). BMI is calculated based on objective measures of height and weight. Self-efficacy is mesured with Schwarzer 8 item questionaire. |
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| Descriptive Information | ||||
| Brief Title ICMJE | Young, Fit and Happy. A Web-based Intervention to Prevent Obesity in Adolescents. | |||
| Official Title ICMJE | Young Fit and Happy - Meaningful Physical Activity as Means to Improve Quality of Life and Prevent Weight Gain in Over-weight and Obese Adolescents. A Web-based Intervention. | |||
| Brief Summary | The prevalence of overweight and obesity is increasing throughout the world. Obesity is seen as one of the most important public health threats because of the significant impact of chronic conditions associated with obesity. Obesity during adolescence is a strong precursor of obesity and related morbidity in adulthood. Interventions aimed directly at reducing weight or preventing increase in weight shows limited results on long term effects and it is shown that increase in activity has more impact on health outcome than on weight-loss. Further, weight-loss does not seem to be an appropriate measure of therapeutic interventions for growing children. The hypothesis of this study is that focusing on increasing meaningful physical activity through individual tailored counselling will have positive effects on the adolescents' fitness (health) and quality of life. Thus, the overall purpose of the study is to examine the extent to which a web-based intervention influences physical activity, fitness and quality of life in over-weight and obese adolescents Further, the aim is to explore and describe how adolescents experience being over-weight and obese, what they perceive as meaningful physical activity and finally how adolescents experience lifestyle changes as demanded in the intervention study. |
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| Detailed Description | The target group is overweight adolescents, meaning their BMI is over or equal to the 95th percentile (BMI>25) and they should not have severe health problems as a result of their overweight. For adults, BMI (Body Mass Index; weight in kilograms divided by the square of height in meters) values at or above 25 indicate overweight and a BMI at or above 30 defines obesity. No such generally accepted definitions exist for children and adolescents. However, international standardized cut points have been proposed, among others by Cole et al (2000) and experts support the use of BMI cutoff points for children. The cut points proposed by Cole et al (2000) are widely used and take age, gender and sex into consideration in the estimation. The focus is primarily to prevent a negative development, and the aim is that the school health service in the future might implement a modified version of this strategy for working with overweight adolescents. The design of the study is a complex intervention study with a multi-method design, consisting of a quasi-experimental trial and a qualitative study. The sample will be drawn from schools in Oslo. Overweight adolescents will be selected and placed in the intervention group or control group respectively. The sampling will be based on objective measures of weight and height and using Cole's index to define overweight and obesity. Weight and height will be measured by the school nurse and will be coordinated with her regular meetings with the adolescents in 8th grade.. The study group will receive the web-based intervention and the control group will receive standard care. At baseline, 3 months and 1 year both the experimental group and the control group will be measured at relevant variables. In the qualitative part of the study, in depth interviews with the adolescents in the intervention group will be performed and they will write daily unstructured blogs on the web. The sampling procedure for the qualitative part of the study will follow the sampling procedure of the intervention study. From the intervention group, a strategic or purposive sample of adolescents will be asked to participate in the qualitative part (Gerrish and Lacey 2006). A sample of maximum variation according to gender and sosio-demographic variables is intended. Sampling continues until saturation is reached and the adolescents will be interviewed in depth before the intervention starts, further at 3 and 12 months after the intervention is ended. |
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| Study Type ICMJE | Interventional | |||
| Study Phase | Not Provided | |||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | Overweight and Obesity | |||
| Intervention ICMJE | Behavioral: Young and Active
The intervention will consist of three meetings between the adolescent, the parents and the researchers, and weekly web-based health-counselling. The adolescents will set goals and make an individual activity plan on the web-page. During the study period all activity will be registered by the adolescents. The researchers will perform weekly counseling based on Selfdetermination Theory and Motivational Interviewing. The webiste also allows for the adolescents to communicate with eacother and with the counsler through a blog. |
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| Study Arms |
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| Publications * | Riiser K, Løndal K, Ommundsen Y, Småstuen MC, Misvær N, Helseth S. The outcomes of a 12-week Internet intervention aimed at improving fitness and health-related quality of life in overweight adolescents: the Young & Active controlled trial. PLoS One. 2014 Dec 5;9(12):e114732. doi: 10.1371/journal.pone.0114732. eCollection 2014. | |||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Enrollment ICMJE | 120 | |||
| Completion Date | December 2014 | |||
| Primary Completion Date | May 2014 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion criteria
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| Sex/Gender |
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| Ages | 12 Years to 14 Years (Child) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Norway | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT01700309 | |||
| Other Study ID Numbers ICMJE | 2010/2978 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Sølvi Helseth, Oslo and Akershus University College of Applied Sciences | |||
| Study Sponsor ICMJE | Oslo and Akershus University College of Applied Sciences | |||
| Collaborators ICMJE | Norwegian School of Sport Sciences | |||
| Investigators ICMJE |
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| PRS Account | Oslo and Akershus University College of Applied Sciences | |||
| Verification Date | April 2015 | |||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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