Young, Fit and Happy. A Web-based Intervention to Prevent Obesity in Adolescents. (YFH)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Oslo University College
Sponsor:
Collaborator:
Norwegian School of Sport Sciences
Information provided by (Responsible Party):
Inger Johanne Flatland, Oslo University College
ClinicalTrials.gov Identifier:
NCT01700309
First received: October 2, 2012
Last updated: May 28, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Overweight and Obesity
Behavioral: Young and Active

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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.

Resource links provided by NLM:


Further study details as provided by Oslo University College:

Primary Outcome Measures:
  • Fitness [ Time Frame: One year ] [ Designated as safety issue: No ]

    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)



Secondary Outcome Measures:
  • Quality of Life [ Time Frame: one year ] [ Designated as safety issue: No ]

    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.



Other Outcome Measures:
  • Motivation for Physical activity and exercise, BMI, Self-efficacy [ Time Frame: One Year ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 140
Study Start Date: January 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control group
Treatment as usual
Experimental: Young and Active
This arm will recieve web-based health counselling through the web-site Young and Active.
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.

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

Ages Eligible for Study:   12 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01700309

Contacts
Contact: Sølvi Helseth, PhD solvi.helseth@hioa.no
Contact: Knut Løndal, PhD knut.londal@hioa.no

Locations
Norway
Oslo and Akershus University College Recruiting
Oslo, Norway, 0130
Principal Investigator: Sølvi Helseth, PhD, RN         
Sub-Investigator: Knut Løndal, PhD         
Norwegian School of Sport Sciences Recruiting
Oslo, Norway, 0806
Sub-Investigator: Yngvar Ommundsen, PhD         
Sponsors and Collaborators
Oslo University College
Norwegian School of Sport Sciences
Investigators
Study Director: Nina Waaler, PhD Dean og Faculty of Health, Oslo and Akershus University College
  More Information

No publications provided

Responsible Party: Inger Johanne Flatland, Rearch advisor, Oslo University College
ClinicalTrials.gov Identifier: NCT01700309     History of Changes
Other Study ID Numbers: HR2008/2/0248
Study First Received: October 2, 2012
Last Updated: May 28, 2013
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Oslo University College:
Obesity prevention; Adolescent; Physical activity; Health counselling

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014