Promoting Overweight Adolescents Physical Activity
Primary Purpose
Obesity
Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Lifestyle counseling (Fb)
Lifestyle counseling + activity monitor (Fb+Act)
Sponsored by
About this trial
This is an interventional prevention trial for Obesity focused on measuring motor activity, obesity, overweight, intervention study, health promotion, lifestyle counseling, adherence
Eligibility Criteria
Inclusion Criteria:
- 13-16 years old,
- overweight or obese (weight for height >20% over normality)
Exclusion Criteria:
- mental health problems, long term illnesses.
Sites / Locations
- University of Oulu, institute of health sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Lifestyle counseling
Lifestyle counseling + activity watch
Arm Description
12-weeks
12-weeks
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT02295761
First Posted
February 18, 2014
Last Updated
November 30, 2015
Sponsor
Heidi Ruotsalainen
1. Study Identification
Unique Protocol Identification Number
NCT02295761
Brief Title
Promoting Overweight Adolescents Physical Activity
Official Title
Promoting Overweight Adolescents Physical Activity and Adherence to Healthy Lifestyles: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Heidi Ruotsalainen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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:
1) 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
motor activity, obesity, overweight, intervention study, health promotion, lifestyle counseling, adherence
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lifestyle counseling
Arm Type
Active Comparator
Arm Description
12-weeks
Arm Title
Lifestyle counseling + activity watch
Arm Type
Active Comparator
Arm Description
12-weeks
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle counseling (Fb)
Intervention Description
Facebook-delivered lifestyle counseling
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle counseling + activity monitor (Fb+Act)
Intervention Description
Facebook-delivered lifestyle counseling and self-monitoring physical activity using Polar activity monitor
Primary Outcome Measure Information:
Title
Change from baseline physical activity at 12 weeks
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change from baseline adherence to healthy lifestyle at 12 weeks, 24 and 36 months
Description
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.
Time Frame
12 weeks, 24 and 36 months
Title
Change from baselin BMI at 12 weeks
Description
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.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
13-16 years old,
overweight or obese (weight for height >20% over normality)
Exclusion Criteria:
mental health problems, long term illnesses.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heidi M Ruotsalainen, MHS
Organizational Affiliation
University of Oulu, institute of Health sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Oulu, institute of health sciences
City
Oulu
Country
Finland
12. IPD Sharing Statement
Citations:
PubMed Identifier
26697218
Citation
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.
Results Reference
derived
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Promoting Overweight Adolescents Physical Activity
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