ObesityNCT02295761
Promoting Overweight Adolescents Physical Activity
A study testing Lifestyle counseling (Fb) and Lifestyle counseling + activity monitor (Fb+Act) in people with Obesity, run by Heidi Ruotsalainen at 1 site in Finland.
Trial summary
Objectives: Aim of this study is to evaluate the effectiveness of Facebook-delivered lifestyle counseling intervention on overweight and obese adolescent's physical activity, BMI and adherence to healthy lifestyles. Design: A 12-week, randomized controlled trial with three, 24 and 36 month follow-up. Read more about this study
- Who is it for?
- Ages 13 to 16 years
- Conditions the study is for
- Obesity
- What is being tested?
- Lifestyle counseling (Fb) and Lifestyle counseling + activity monitor (Fb+Act)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2012to Dec 2015
- 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 13 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 13-16 years old,
- overweight or obese (weight for height >20% over normality)
Who cannot join
- mental health problems, long term illnesses.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Promoting Overweight Adolescents Physical Activity and Adherence to Healthy Lifestyles: a Randomized Controlled Trial
Objectives: Aim of this study is to evaluate the effectiveness of Facebook-delivered lifestyle counseling intervention on overweight and obese adolescent's physical activity, BMI and adherence to healthy lifestyles.
Design: A 12-week, randomized controlled trial with three, 24 and 36 month follow-up.
Read more
Settings: One of the Northern Finland healthcare districts school health care units.
Participants: all overweight or obese 13-16 years old adolescent and their parents were invited to study.
Methods: Adolescents were stratified by gender, age, and self-reported physical activity and they were randomized into three groups. Two experimental groups, where those both got Facebook-delivered lifestyle counseling and one of the experimental groups got activity monitor which showed the daily activity. One group served as a control group. Parents were allocated to intervention groups according which group their adolescent were randomized.
Outcomes: physical activity,body mass index (BMI) adherence to healthy lifestyles. Baseline measurements have been done and assessment to adherence to healthy lifestyles have been measured. Follow-up measures have been conducted three months after baseline. Adherence to healthy lifestyles measurement follow-up is at 24 and 36 months after intervention.
Read the detailed description
Adolescents inclusion criteria: weight-fof-height over 20% over normality (finnish recommendations), age 13-16 years old Exclusion criteria: mental health problems, or long term illness.
Adolescents outcome measures:
- Change from baseline physical activity at 12 weeks using a blinded Polar Activity activity monitor. Primary outcome is measuder using continuous scale and measurement unit is one minute. For each subject the minutes per day is calculated (minimum value is 0). It is a wrist worn uni-axial accelerometer designed to determine physical activity of children and adolescents. Polar activity monitor records activity in every 30 seconds bouts and the device records steps when user takes >70 steps per minute. Activity measurements were done for 21 days at baseline and three months follow-up measurements. A wear-time shows valid days in this study, and one valid day required at least 500 minutes / day and users had to have at least eight valid days from weekdays and also one from weekend. The device integrates the total amount of acceleration in one dimension and counts physical activity quantity and quality, amount of steps and total energy expenditure in calories (Kcal). Physical activity is defined by metabolic equivalent of tasks (MET), which are divided in five areas of activity; very light (1-2 MET), light (2-3.5 MET), moderate (3.6-5 MET), vigorous (5.1-8 MET) and vigorous plus (>8 MET).
- Change from baseline body mass index (BMI) at 12 weeks BMI was calculated from weight (kg) and height (cm) that were measured by heath care professionals. Formula BMI= weight (kg)/(height (m))2 were using calculating BMI. Scale is continuous.
- Change from baseline adherence to healthy lifestyles at 12 weeks, 24 months and 36 months. The Adherence to healthy lifestyle is measured using Likert scale with 5 point. The range were from 1 to 5, where 1=strong disagree - 5=strong agree. The adherence to healthy lifestyle questionnaires validity and reliability have been tested before (Kyngäs et al. 2000. The development of an instrument to measure the compliance of adolescents with a chronic diseases. Journal of advanced nursing 32 (6):1499-1506.
Parents outcomes:
- Change from baseline adherence to healthy lifestyles at 12 weeks, 24 months and 36 months. The Adherence to healthy lifestyle is measured using Likert scale with 5 point. The range were from 1 to 5, where 1=strong disagree - 5=strong agree. The adherence to healthy lifestyle questionnaires validity and reliability have been tested before (Kyngäs et al. 2000. The development of an instrument to measure the compliance of adolescents with a chronic diseases. Journal of advanced nursing 32 (6):1499-1506.
Data analysis: Across-group comparison of baseline physical activity, BMI, gender and age were conducted for evaluable participants using ANOVA (Kruskal-Wallis test) for continuous variables and for categorical variables (eg. sex) we used Fischer´s exact test.
- Conditions
- Obesity
- Being tested
- Lifestyle counseling (Fb), Lifestyle counseling + activity monitor (Fb+Act)
- Keywords
- motor activity, obesity, overweight, intervention study, health promotion, lifestyle counseling, adherence
- Medical subject headings
- Obesity, Motor Activity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle counseling (Fb)Behavioural
Facebook-delivered lifestyle counseling
Lifestyle counseling + activity monitor (Fb+Act)Behavioural
Facebook-delivered lifestyle counseling and self-monitoring physical activity using Polar activity monitor
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle counseling | Active comparator | 12-weeks Receives: Behavioral: Lifestyle counseling (Fb) |
| Lifestyle counseling + activity watch | Active comparator | 12-weeks Receives: Behavioral: Lifestyle counseling + activity monitor (Fb+Act) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline physical activity at 12 weeks
Adolescent primary outcome is measuder using continuous scale and measurement unit is one minute.
It is a wrist worn uni-axial accelerometer designed to determine physical activity of children and adolescents. Polar activity monitor records activity in every 30 seconds bouts and the device records steps when user takes >70 steps per minute. Activity measurements were done for 21 days at baseline and three months follow-up measurements. A wear-time shows valid days in this study, and one valid day required at least 500 minutes / day and users had to have at least eight valid days from weekdays and also one from weekend.
Measured: 12 weeks
Secondary outcomes (2)
Change from baseline adherence to healthy lifestyle at 12 weeks, 24 and 36 months
adolescent secondary outcome, parents primary outcome. The Adherence to healthy lifestyle is measured using Likert scale with 5 point. The range were from 1 to 5, where 1=strong disagree - 5=strong agree. The adherence to healthy lifestyle questionnaires validity and reliability have been tested before (Kyngäs et al. 2000. The development of an instrument to measure the compliance of adolescents with a chronic diseases. Journal of advanced nursing 32 (6):1499-1506.
Measured: 12 weeks, 24 and 36 months
Change from baselin BMI at 12 weeks
adolescent secondary outcome BMI is calculated from weight (kg) and height (cm) that were measured by heath care professionals. Formula BMI= weight (kg)/(height (m))2 were using calculating BMI. Scale is continuous.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study startJan 2012
- Primary completionJun 2012
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidi Ruotsalainen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Heidi Ruotsalainen, University of Oulu
- Investigators
- Heidi M Ruotsalainen, MHS, Principal investigator, University of Oulu, institute of Health sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02295761
- Sponsor's protocol ID
- 100/2011
- Status last verified
- Nov 2015
- First submitted
- 18 Feb 2014
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Ruotsalainen H, Kyngas H, Tammelin T, Heikkinen H, Kaariainen M. Effectiveness of Facebook-Delivered Lifestyle Counselling and Physical Activity Self-Monitoring on Physical Activity and Body Mass Index in Overweight and Obese Adolescents: A Randomized Controlled Trial. Nurs Res Pract. 2015;2015:159205. doi: 10.1155/2015/159205. Epub 2015 Dec 1.
PubMed 26697218
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Overweight Adolescents Physical Activity and Adherence to Healthy Lifestyles: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02295761
- Acronym / sponsor ID
- 100/2011
- Conditions
- Obesity
- Keywords
- motor activity, obesity, overweight, intervention study, health promotion, lifestyle counseling, adherence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Heidi RuotsalainenUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Dec 2015 (estimated)
- First posted
- 20 Nov 2014 (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.
Objectives: Aim of this study is to evaluate the effectiveness of Facebook-delivered lifestyle counseling intervention on overweight and obese adolescent's physical activity, BMI and adherence to healthy lifestyles.
Design: A 12-week, randomized controlled trial with three, 24 and 36 month follow-up.
Settings: One of the Northern Finland healthcare districts school health care units.
Participants: all overweight or obese 13-16 years old adolescent and their parents were invited to study.
Methods: Adolescents were stratified by gender, age, and self-reported physical activity and they were randomized into three groups. Two experimental groups, where those both got Facebook-delivered lifestyle counseling and one of the experimental groups got activity monitor which showed the daily activity. One group served as a control group. Parents were allocated to intervention groups according which group their adolescent were randomized.
Outcomes: physical activity,body mass index (BMI) adherence to healthy lifestyles. Baseline measurements have been done and assessment to adherence to healthy lifestyles have been measured. Follow-up measures have been conducted three months after baseline. Adherence to healthy lifestyles measurement follow-up is at 24 and 36 months after intervention.
Detailed description
Adolescents inclusion criteria: weight-fof-height over 20% over normality (finnish recommendations), age 13-16 years old Exclusion criteria: mental health problems, or long term illness.
Adolescents outcome measures:
- Change from baseline physical activity at 12 weeks using a blinded Polar Activity activity monitor. Primary outcome is measuder using continuous scale and measurement unit is one minute. For each subject the minutes per day is calculated (minimum value is 0). It is a wrist worn uni-axial accelerometer designed to determine physical activity of children and adolescents. Polar activity monitor records activity in every 30 seconds bouts and the device records steps when user takes >70 steps per minute. Activity measurements were done for 21 days at baseline and three months follow-up measurements. A wear-time shows valid days in this study, and one valid day required at least 500 minutes / day and users had to have at least eight valid days from weekdays and also one from weekend. The device integrates the total amount of acceleration in one dimension and counts physical activity quantity and quality, amount of steps and total energy expenditure in calories (Kcal). Physical activity is defined by metabolic equivalent of tasks (MET), which are divided in five areas of activity; very light (1-2 MET), light (2-3.5 MET), moderate (3.6-5 MET), vigorous (5.1-8 MET) and vigorous plus (>8 MET).
- Change from baseline body mass index (BMI) at 12 weeks BMI was calculated from weight (kg) and height (cm) that were measured by heath care professionals. Formula BMI= weight (kg)/(height (m))2 were using calculating BMI. Scale is continuous.
- Change from baseline adherence to healthy lifestyles at 12 weeks, 24 months and 36 months. The Adherence to healthy lifestyle is measured using Likert scale with 5 point. The range were from 1 to 5, where 1=strong disagree - 5=strong agree. The adherence to healthy lifestyle questionnaires validity and reliability have been tested before (Kyngäs et al. 2000. The development of an instrument to measure the compliance of adolescents with a chronic diseases. Journal of advanced nursing 32 (6):1499-1506.
Parents outcomes:
- Change from baseline adherence to healthy lifestyles at 12 weeks, 24 months and 36 months. The Adherence to healthy lifestyle is measured using Likert scale with 5 point. The range were from 1 to 5, where 1=strong disagree - 5=strong agree. The adherence to healthy lifestyle questionnaires validity and reliability have been tested before (Kyngäs et al. 2000. The development of an instrument to measure the compliance of adolescents with a chronic diseases. Journal of advanced nursing 32 (6):1499-1506.
Data analysis: Across-group comparison of baseline physical activity, BMI, gender and age were conducted for evaluable participants using ANOVA (Kruskal-Wallis test) for continuous variables and for categorical variables (eg. sex) we used Fischer´s exact test.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counseling | Active comparator | Behavioral: Lifestyle counseling (Fb)12-weeks |
| Lifestyle counseling + activity watch | Active comparator | Behavioral: Lifestyle counseling + activity monitor (Fb+Act)12-weeks |
Who may qualify
- Ages
- 13 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 13-16 years old,
- overweight or obese (weight for height >20% over normality)
Key exclusion criteria (1 listed)
- mental health problems, long term illnesses.
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 |
|---|---|---|
| Lifestyle counseling (Fb)Facebook-delivered lifestyle counseling | Behavioural | Lifestyle counseling |
| Lifestyle counseling + activity monitor (Fb+Act)Facebook-delivered lifestyle counseling and self-monitoring physical activity using Polar activity monitor | Behavioural | Lifestyle counseling + activity watch |
Primary outcome
Change from baseline physical activity at 12 weeks
Time frame: 12 weeks
Adolescent primary outcome is measuder using continuous scale and measurement unit is one minute. It is a wrist worn uni-axial accelerometer designed to determine physical activity of children and adolescents. Polar activity monitor records activity in every 30 seconds bouts and the device records steps when user takes >70 steps per minute. Activity measurements were done for 21 days at baseline and three months follow-up measurements. A wear-time shows valid days in this study, and one valid day required at least 500 minutes / day and users had to have at least eight valid days from weekdays and also one from weekend.
2 secondary outcomes
Change from baseline adherence to healthy lifestyle at 12 weeks, 24 and 36 months
Time frame: 12 weeks, 24 and 36 months
Change from baselin BMI at 12 weeks
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
- Derived from this study: PubMed 26697218Ruotsalainen H, Kyngas H, Tammelin T, Heikkinen H, Kaariainen M. Effectiveness of Facebook-Delivered Lifestyle Counselling and Physical Activity Self-Monitoring on Physical Activity and Body Mass Index in Overweight and Obese Adolescents: A Randomized Controlled Trial. Nurs Res Pract. 2015;2015:159205. doi: 10.1155/2015/159205. Epub 2015 Dec 1.
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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.
Heidi M Ruotsalainen, MHS principal investigator
University of Oulu, institute of Health sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle counseling (Fb) and Lifestyle counseling + activity monitor (Fb+Act) in people with Obesity, run by Heidi Ruotsalainen at 1 site in Finland.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. 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?
Results are not available in the source record.
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?
Change from baseline physical activity at 12 weeks (time frame: 12 weeks). 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 NCT02295761, which also lists 1 linked publication.
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 2 Dec 2015.