NCT03575559

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.

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
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 2, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

September 18, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

November 4, 2020

Status Verified

November 1, 2020

Enrollment Period

2.7 years

First QC Date

June 18, 2018

Last Update Submit

November 3, 2020

Conditions

Outcome Measures

Primary Outcomes (3)

  • Objective measurement of physical activity

    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.

    4 daily diary phases of one week each over a period of 6 month

  • Subjective measurement of daily physical activity

    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.

    4 daily diary phases of one week each over a period of 6 month

  • Subjective measurement of physical activity during the past 7 days

    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.

    Time point one (T1, Month 1) to Time point four (T4; 6 month follow-up)

Secondary Outcomes (4)

  • Subjective measurement of daily self-efficacy

    4 daily diary phases of one week each over a period of 6 month

  • Subjective measurement of daily planning

    4 daily diary phases of one week each over a period of 6 month

  • Subjective measurement of self-efficacy

    Time point one (T1, Month 1) to Time point four (T4; 6 month follow-up)

  • Subjective measurement of planning

    Time point one (T1, Month 1) to Time point four (T4; 6 month follow-up)

Other Outcomes (1)

  • Body mass index

    Time point one (T1, Month 1) to Time point four (T4; 6 month follow-up)

Study Arms (4)

Individual planning

EXPERIMENTAL

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 planningBehavioral: Education and motivation treatment

Collaborative planning

EXPERIMENTAL

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 planningBehavioral: Education and motivation treatment

Individual distraction task

ACTIVE COMPARATOR

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

Collaborative distraction task

ACTIVE COMPARATOR

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

Interventions

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).

Individual 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.

Collaborative planning

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.

Collaborative distraction taskCollaborative planningIndividual distraction taskIndividual planning

Eligibility Criteria

Age14 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Zurich

Zurich, Canton of Zurich, 8050, Switzerland

RECRUITING

Related Publications (1)

  • Radtke T, Luszczynska A, Schenkel K, Biddle S, Scholz U. A cluster randomized controlled trial comparing the effectiveness of an individual planning intervention with collaborative planning in adolescent friendship dyads to enhance physical activity (TWOgether). BMC Public Health. 2018 Jul 24;18(1):911. doi: 10.1186/s12889-018-5818-6.

Related Links

MeSH Terms

Conditions

Motor ActivityAdolescent BehaviorHealth Behavior

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Theda Radtke, PhD

    University of Zurich

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Friendship dyads are assigned to the 4 conditions without being informed that 4 conditions exist.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2018

First Posted

July 2, 2018

Study Start

September 18, 2018

Primary Completion

June 1, 2021

Study Completion

June 1, 2022

Last Updated

November 4, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, 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.

Locations