Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

TWOgether - From Sport Zero to Sport Hero (TWOgether)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03575559
Recruitment Status : Recruiting
First Posted : July 2, 2018
Last Update Posted : October 31, 2018
Sponsor:
Collaborators:
Swiss National Science Foundation
SWPS University of Social Sciences and Humanities, Wroclaw
University of Southern Queensland
Information provided by (Responsible Party):
University of Zurich

Brief Summary:

BACKGROUND: The physiological and psychological benefits of regular physical activity (PA) and reduced sedentary behavior are well documented. Nevertheless, the majority of adolescents in western countries, e.g., Switzerland, do not meet the recommendations for moderate to vigorous PA of at least one hour per day. Planning interventions, defined as the creation of plans when, where and how to engage in a behavior change, have been proposed as an effective way of translating intentions into action. AIM: The project aims at closing the empirical gap of the question whether or not planning interventions of PA in adolescents are successful and which planning intervention is the most effective one.

In detail, it is aimed for to examine changes in (daily) moderate to vigorous physical activity in adolescents' friendship dyads following (a) an individual planning intervention, (b) a collaborative planning intervention or (c) one of the two no-planning control conditions. Changes in (daily) physical activity will be examined over a period of 6-months. By investigating the intervention effect systematically by means of daily diaries, long-term follow-ups and objective measurements this project will provide a novel knowledge about individual self-regulating mechanism and social exchange processes as the mediating mechanism of the effectiveness of individual and collaborative planning for health behavior change in adolescents. DESIGN: Single-blind four-arm parallel-group cluster-randomized controlled trial with longitudinal design. The assessment of the main and secondary outcomes is conducted at the baseline, at 1 week after the first intervention session, and at 1-, and 6-month follow-ups. The intervention consists of one planning session and one booster session after 1-month. PARTICIPANTS: The sample will consist of 400 friendship dyads between 14 and 18 years of age. A cluster-randomization will assign participants to one of the two planning groups (collaborative or individual) or one of the two control groups. Both partners of the friendship dyad will complete all questionnaires. OUTCOMES: Physical activity constitutes the main outcome, whereas self-regulatory strategies like planning, self-efficacy, as well as social exchange processes like social support are secondary outcomes.


Condition or disease Intervention/treatment Phase
Physical Activity Adolescent Behavior Health Behavior Behavioral: Individual planning Behavioral: Collaborative planning Behavioral: Education and motivation treatment Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: Friendship dyads are assigned to the 4 conditions without being informed that 4 conditions exist.
Primary Purpose: Prevention
Official Title: What Friends Are for: Comparing the Effectiveness of an Individual Planning Intervention With Collaborative Planning
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : April 1, 2022

Arm Intervention/treatment
Experimental: Individual planning
An education and general motivational treatment is provided to each participant. Afterwards, participants are filling in the planning forms, referring to their individual physical activity. Both members of the dyad form up to three own individual plans. They are not allowed to speak to each other. The following behavior change techniques (BCT) are included in the planning intervention protocol: action planning, barrier identification, problem solving (coping planning). Interventions: Behavioral: Individual planning. Behavioral: Education and motivation. Active Comparator: No planning intervention, individual distraction task.
Behavioral: Individual planning
Each participant forms up to three action and up to three coping plans individually, without consulting the participating friend, but discussing the plans with the experimenter. CONTENT: The planning materials and forms have the following sections: (a) information on the importance of planning (b) instructions of what should be included in a good plan (the when, where, and how components), (c) formulating action and coping plans based on the if-then structure. Action plans (referring to when, when, and how the individual will act) as well as coping plans (referring to how to overcome potential difficulties, risky situations or temptations to not engage in physical activity).

Behavioral: Education and motivation treatment
Adolescents will watch a movie from the Federal Office of Public Health Switzerland including the guidelines of physical activity (PA) for adolescents. All adolescents respond to a quiz afterwards. After the quiz, the experimenter repeats the guidelines for PA based on a brochure that all adolescents can take home with them. In addition, the experimenter asks for barriers and benefits of PA the adolescents perceive. Next to it, the experimenter explains that a weight gain might be possible due to PA in the beginning. Furthermore, the experimenter presents how the data of the accelerometer should look like if one is sufficiently physical active. As a last part self-efficacy as an important aspect of goal success is mentioned. The materials exclude any planning statements.

Experimental: Collaborative planning
An education and general motivational treatment is provided to each participant. Afterwards, participants are filling in the planning forms together, referring to their joint physical activity. The friendship dyad forms up to three joint plans about engaging in PA together. The following behavior change techniques (BCT) are included in the planning intervention protocol: action planning, barrier identification, problem solving (coping planning). Interventions: Behavioral: Collaborative planning. Behavioral: Education and motivation. Active Comparator: No planning intervention, collaborative distraction task.
Behavioral: Collaborative planning
Both friends together create up to three if-then plans on when, where, and how both will implement PA together. In addition, up to three coping plans will be formed together. This jointly developed plan is discussed with the experimenter. CONTENT: The planning materials and forms have the following sections: (a) information on the importance of planning (b) instructions of what should be included in a good plan (the when, where, and how components), (c) formulating action and coping plans based on the if-then structure. Action plans refers to when, when, and how the individual will act) as well as coping plans (referring to how to overcome potential difficulties, risky situations or temptations to not engage in PA). All materials are formulated using the plural.

Behavioral: Education and motivation treatment
Adolescents will watch a movie from the Federal Office of Public Health Switzerland including the guidelines of physical activity (PA) for adolescents. All adolescents respond to a quiz afterwards. After the quiz, the experimenter repeats the guidelines for PA based on a brochure that all adolescents can take home with them. In addition, the experimenter asks for barriers and benefits of PA the adolescents perceive. Next to it, the experimenter explains that a weight gain might be possible due to PA in the beginning. Furthermore, the experimenter presents how the data of the accelerometer should look like if one is sufficiently physical active. As a last part self-efficacy as an important aspect of goal success is mentioned. The materials exclude any planning statements.

Active Comparator: Individual distraction task
An education and general motivational treatment is provided to each participant. Afterwards, participants have to interpret a short video showing scenes of two different superhero movies. Several questions will be asked about characteristics of the two super heroes in the movie and whether these heroes are comparable. Each participant watches the movie alone and answers all questions by him/herself. Both members of the dyad are not allowed to speak to each other.
Behavioral: Education and motivation treatment
Adolescents will watch a movie from the Federal Office of Public Health Switzerland including the guidelines of physical activity (PA) for adolescents. All adolescents respond to a quiz afterwards. After the quiz, the experimenter repeats the guidelines for PA based on a brochure that all adolescents can take home with them. In addition, the experimenter asks for barriers and benefits of PA the adolescents perceive. Next to it, the experimenter explains that a weight gain might be possible due to PA in the beginning. Furthermore, the experimenter presents how the data of the accelerometer should look like if one is sufficiently physical active. As a last part self-efficacy as an important aspect of goal success is mentioned. The materials exclude any planning statements.

Active Comparator: Collaborative distraction task
An education and general motivational treatment is provided to each participant. Afterwards, participants have to interpret a short video showing scenes of two different superhero movies together. Several questions ask about the characteristics of the two super heroes in the movie and whether these heroes are comparable. Both members of the dyad watch the movie together and answer the questions conjointly.
Behavioral: Education and motivation treatment
Adolescents will watch a movie from the Federal Office of Public Health Switzerland including the guidelines of physical activity (PA) for adolescents. All adolescents respond to a quiz afterwards. After the quiz, the experimenter repeats the guidelines for PA based on a brochure that all adolescents can take home with them. In addition, the experimenter asks for barriers and benefits of PA the adolescents perceive. Next to it, the experimenter explains that a weight gain might be possible due to PA in the beginning. Furthermore, the experimenter presents how the data of the accelerometer should look like if one is sufficiently physical active. As a last part self-efficacy as an important aspect of goal success is mentioned. The materials exclude any planning statements.




Primary Outcome Measures :
  1. Objective measurement of physical activity [ Time Frame: 4 daily diary phases of one week each over a period of 6 month ]
    Physical activity will be assessed by an accelerometer device ActiGraph (model wGT3X-BT). At each assessment, accelerometer devices will be worn for 7 days (8 days for the first assessment). Accelerometers will be worn by both members of the dyad.

  2. Subjective measurement of daily physical activity [ Time Frame: 4 daily diary phases of one week each over a period of 6 month ]
    Self-reported daily physical activity of all participants is assessed including detailed information on time spent on physical activities, the intensity of each PA and how long each activity has been done together with the friend.

  3. Subjective measurement of physical activity during the past 7 days [ Time Frame: Time point one (T1, Month 1) to Time point four (T4; 6 month follow-up) ]
    Self-reported physical activity of all participants is assessed including detailed information on time spent on physical activities during the past 7 days, the intensity of each PA and how long each activity has been done together with the friend.


Secondary Outcome Measures :
  1. Subjective measurement of daily self-efficacy [ Time Frame: 4 daily diary phases of one week each over a period of 6 month ]
    Self-reported daily self-efficacy will be assessed in all adolescents.

  2. Subjective measurement of daily planning [ Time Frame: 4 daily diary phases of one week each over a period of 6 month ]
    Self-reported daily planning of physical activity will be assessed for all adolescents.

  3. Subjective measurement of self-efficacy [ Time Frame: Time point one (T1, Month 1) to Time point four (T4; 6 month follow-up) ]
    Self-reported self-efficacy will be assessed in all adolescents.

  4. Subjective measurement of planning [ Time Frame: Time point one (T1, Month 1) to Time point four (T4; 6 month follow-up) ]
    Self-reported planning of physical activity will be assessed for all adolescents.


Other Outcome Measures:
  1. Body mass index [ Time Frame: Time point one (T1, Month 1) to Time point four (T4; 6 month follow-up) ]
    Body mass index (BMI). Certified and standardized body weight scales (OMRON BF 214; measurement error < 5%) and measuring rods will be used. BMI will be calculated as body weight (in kilograms) divided by a square height (in meters).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   14 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adolescents (age 14-18)
  • Same sex of the adolescents of each friendship dyad
  • Access to internet (smartphone or at home)
  • Adolescents less active than 1 hour of moderate to vigorous physically active per day
  • Adolescents with the intention to be more physically active
  • Parental consent at the baseline for adolescents under the age of 16
  • Adolescents consent at the baseline

Exclusion Criteria:

  • Restrictions on being physically active as assessed by a risk-check form modelled after the Physical Activity Readiness Questionnaire
  • Romantic relationship with participating friend
  • A BMI below 17
  • Insufficient comprehension of the German language
  • Pregnancy
  • Participating in other intervention programmes targeting physical activity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03575559


Contacts
Layout table for location contacts
Contact: Theda Radtke, PhD +41 44 635 72 55 Theda.Radtke@uzh.ch
Contact: Konstantin Schenkel +41 44 635 72 14 Konstantin.Schenkel@uzh.ch

Locations
Layout table for location information
Switzerland
University of Zurich Recruiting
Zürich, Zurich, Switzerland, 8050
Contact: Theda Radtke, Dr.    0041 44 635 72 55    Theda.Radtke@uzh.ch   
Contact: Konstantin Schenkel, MSc    0041 44 635 72 14    Konstantin.Schenkel@uzh.ch   
Sponsors and Collaborators
University of Zurich
Swiss National Science Foundation
SWPS University of Social Sciences and Humanities, Wroclaw
University of Southern Queensland
Investigators
Layout table for investigator information
Principal Investigator: Theda Radtke, PhD University of Zurich

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT03575559     History of Changes
Other Study ID Numbers: 100019_169781/1
First Posted: July 2, 2018    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: In line with the recommendations of the Swiss National Science Foundation the data underlying publications will be shared (anonymised) to make the published results reproducible.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: The study protocol will be published before the end of the study. In line with the recommendations of the Swiss National Science Foundation the data underlying publications will be shared to make the published results reproducible after submission of the papers.
Access Criteria: Upon reasonable request.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No