NCT02295761

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 18, 2014

Completed
9 months until next milestone

First Posted

Study publicly available on registry

November 20, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 2, 2015

Status Verified

November 1, 2015

Enrollment Period

5 months

First QC Date

February 18, 2014

Last Update Submit

November 30, 2015

Conditions

Keywords

motor activityobesityoverweightintervention studyhealth promotionlifestyle counselingadherence

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 weeks

Secondary Outcomes (2)

  • Change from baseline adherence to healthy lifestyle at 12 weeks, 24 and 36 months

    12 weeks, 24 and 36 months

  • Change from baselin BMI at 12 weeks

    12 weeks

Study Arms (2)

Lifestyle counseling

ACTIVE COMPARATOR

12-weeks

Behavioral: Lifestyle counseling (Fb)

Lifestyle counseling + activity watch

ACTIVE COMPARATOR

12-weeks

Behavioral: Lifestyle counseling + activity monitor (Fb+Act)

Interventions

Facebook-delivered lifestyle counseling

Lifestyle counseling

Facebook-delivered lifestyle counseling and self-monitoring physical activity using Polar activity monitor

Lifestyle counseling + activity watch

Eligibility Criteria

Age13 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • mental health problems, long term illnesses.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oulu, institute of health sciences

Oulu, Finland

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

ObesityMotor ActivityOverweight

Interventions

Fitness Trackers

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Diagnostic EquipmentEquipment and SuppliesWearable Electronic DevicesElectrical Equipment and Supplies

Study Officials

  • Heidi M Ruotsalainen, MHS

    University of Oulu, institute of Health sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
researcher

Study Record Dates

First Submitted

February 18, 2014

First Posted

November 20, 2014

Study Start

January 1, 2012

Primary Completion

June 1, 2012

Study Completion

December 1, 2015

Last Updated

December 2, 2015

Record last verified: 2015-11

Locations