Overweight and ObesityYFHNCT01700309
Young, Fit and Happy. A Web-based Intervention to Prevent Obesity in Adolescents.
A study testing Young and Active in people with Overweight and Obesity, run by Oslo Metropolitan University at 2 sites in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 14 years
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Young and Active
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesNorway
- Study dates
- Jan 2012to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- not have severe health problems as a result of their overweight
- not be in another treatment program
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Oslo and Akershus University College
Oslo, 0130
Norwegian School of Sport Sciences
Oslo, 0806
About this study
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.
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.
Read the 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.
- Conditions
- Overweight and Obesity
- Being tested
- Young and Active
- Keywords
- Obesity prevention; Adolescent; Physical activity; Health counselling
- Medical subject headings
- Overweight, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Young and ActiveBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Treatment as usual |
| Young and Active | Experimental | This arm will recieve web-based health counselling through the web-site Young and Active. Receives: Behavioral: Young and Active |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fitness
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)
Measured: One year
Secondary outcomes (1)
Quality of Life
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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2012 (estimated)
- Study startJan 2012
- Primary completionMay 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian School of Sport Sciences
- Responsible party
- Principal investigator, Sølvi Helseth, Oslo Metropolitan University
- Investigators
- Sølvi Helseth, PhD, Principal investigator, Oslo Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01700309
- Sponsor's protocol ID
- 2010/2978
- Acronym
- YFH
- Status last verified
- Apr 2015
- First submitted
- 2 Oct 2012
- Last updated
- 15 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29618327Riiser 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.
PubMed 25478791
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01700309
- Acronym / sponsor ID
- YFH / 2010/2978
- Conditions
- Overweight and Obesity
- Keywords
- Obesity prevention; Adolescent; Physical activity; Health counselling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Oslo Metropolitan UniversityUniversity, hospital or other
- Collaborators
- Norwegian School of Sport Sciences
- Study start
- Jan 2012
- Primary completion
- May 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 4 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Treatment as usual |
| Young and Active | Experimental | Behavioral: Young and ActiveThis arm will recieve web-based health counselling through the web-site Young and Active. |
Who may qualify
- Ages
- 12 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- not have severe health problems as a result of their overweight
- not be in another treatment program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Young and ActiveThe 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. | Behavioural | Young and Active |
Primary outcome
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)
1 secondary outcome
Quality of Life
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2015.
- Derived from this study: PubMed 29618327Sundar 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.
- Derived from this study: PubMed 25478791Riiser 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sølvi Helseth, PhD principal investigator
Oslo Metropolitan University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Young and Active in people with Overweight and Obesity, run by Oslo Metropolitan University at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fitness (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01700309, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2015.