Promoting Overweight Adolescents Physical Activity

November 30, 2015 updated by: Heidi Ruotsalainen

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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:

  1. 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).

  2. 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.
  3. 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.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Oulu, Finland
        • University of Oulu, institute of health sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 13-16 years old,
  • overweight or obese (weight for height >20% over normality)

Exclusion Criteria:

  • mental health problems, long term illnesses.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Lifestyle counseling
12-weeks
Behavioral: Lifestyle counseling (Fb)
Facebook-delivered lifestyle counseling
Active Comparator: Lifestyle counseling + activity watch
12-weeks
Behavioral: Lifestyle counseling + activity monitor (Fb+Act)
Facebook-delivered lifestyle counseling and self-monitoring physical activity using Polar activity monitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline adherence to healthy lifestyle at 12 weeks, 24 and 36 months
Time Frame: 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.
12 weeks, 24 and 36 months
Change from baselin BMI at 12 weeks
Time Frame: 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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heidi Ruotsalainen

Investigators

  • Principal Investigator: Heidi M Ruotsalainen, MHS, University of Oulu, institute of health sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

June 1, 2012

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

February 18, 2014

First Submitted That Met QC Criteria

November 17, 2014

First Posted (Estimate)

November 20, 2014

Study Record Updates

Last Update Posted (Estimate)

December 2, 2015

Last Update Submitted That Met QC Criteria

November 30, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 100/2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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