Clinical trial NCT01700309: Young, Fit and Happy. A Web-based Intervention to Prevent Obesity in Adolescents.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Keywords: Obesity prevention; Adolescent; Physical activity; Health counselling
Lead sponsor: Oslo Metropolitan University
Sponsor class: OTHER
Collaborators: name: Norwegian School of Sport Sciences
First posted: 2012-10-04
Enrollment: 120
Sex: ALL
Minimum age (years): 12
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: Inclusion Criteria:

* overweight/obese adolescents in 8th grade
* BMI is over or equal to the 95th percentile (BMI\>25 according to Cole's index)(height and weight measured by the school nurse)
* school population

Exclusion criteria

* not have severe health problems as a result of their overweight
* not be in another treatment program

Primary outcomes:
measure: Fitness
timeFrame: One year
Secondary outcomes:
measure: Quality of Life
timeFrame: one year
Other outcomes:
measure: Motivation for Physical activity and exercise, BMI, Self-efficacy
timeFrame: One Year
Locations:
city: Oslo
country: Norway
facility: Oslo and Akershus University College
city: Oslo
country: Norway
facility: Norwegian School of Sport Sciences
Study officials:
affiliation: Oslo Metropolitan University
name: Sølvi Helseth, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sundar TKB, Londal K, Lagerlov P, Glavin K, Helseth S. Overweight adolescents' views on physical activity - experiences of participants in an internet-based intervention: a qualitative study. BMC Public Health. 2018 Apr 4;18(1):448. doi: 10.1186/s12889-018-5324-x.
citation: Riiser K, Londal K, Ommundsen Y, Smastuen MC, Misvaer 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.