NCT02689973

Brief Summary

This longitudinal experimental study tested the effects of three brief interventions: (1) prompting the formation of plans (or implementation intentions), (2) prompting self-efficacy beliefs, and (3) prompting planning + self-efficacy in adolescents aged 14-18 years relative to an active 'education only' control group. It was hypothesized that participants assigned to the interventions would exhibit a smaller increase in body fat at 14-month follow-up compared to controls. The study also investigated whether the combined planning + self-efficacy intervention would have larger effects on the main outcome (body fat) than single-component interventions. Second, it was hypothesized that the effects of the intervention conditions on body fat at 14-month follow-up would be mediated by their respective psychological and behavioral constructs: self-efficacy and planning at T2 (Mediator 1), and by moderate-to-vigorous physical activity (MVPA) at T3 (Mediator 2). It was expected that the effects of the interventions including the planning component (i.e., planning intervention and self-efficacy + planning intervention) would be mediated by respective cognitions, i.e. planning, whereas the effects of the interventions including self-efficacy component (i.e., self-efficacy intervention and self-efficacy + planning intervention) would be mediated by self-efficacy. Finally, it was explored whether the effects of the intervention (both direct and indirect effects, via their respective psychological variables and MVPA) on body fat would be moderated by the presence of built PA facilities, located in the proximity of schools.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,217

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 2009

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 24, 2016

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

July 30, 2018

Completed
Last Updated

September 4, 2018

Status Verified

August 1, 2018

Enrollment Period

6.1 years

First QC Date

February 19, 2016

Results QC Date

January 3, 2017

Last Update Submit

August 2, 2018

Conditions

Keywords

adolescencebody fatphysical activitypsychosocial interventionself-efficacyplanning

Outcome Measures

Primary Outcomes (1)

  • Body Fat Tissue

    bioimpedance (BIA) method (Kyle et al., 2004), which determines the electrical impedance of an electric current through body tissues. Fat tissue was estimated with Schaefer equation for BIA which is considered a reliable index of body fat in adolescent from primarily white backgrounds (Cleary et al., 2008).

    Baseline to 14-month follow-up

Secondary Outcomes (3)

  • Moderate-to-vigorous Physical Activity (MVPA)

    Baseline to 14-month follow-up

  • The Use of Physical Activity Planning (the Use of Planning)

    Baseline to 2-month follow-up

  • Physical Activity Self-efficacy (PA Self-efficacy)

    Baseline to 2-month follow-up

Study Arms (4)

Self-efficacy

EXPERIMENTAL

The self-efficacy intervention protocol included following behavior change techniques (BCT; Michie et al., 2011): barrier identification, prompting focus on past success, and prompting self-talk. Applications of all BCT included references to self-efficacy beliefs. The intervention was integrated into health promotion-nutrition education program (8h). The intervention was applied twice (the baseline and 2-month follow-up).

Behavioral: Self-EfficacyBehavioral: Education

Planning

EXPERIMENTAL

The following BCT were included in the planning intervention protocol: action planning, barrier identification, prompting self-talk, relapse prevention/coping planning. Applications of all BCT included references to planning. The intervention was integrated into health promotion-nutrition education program (8h). The intervention was applied twice (the baseline and 2-month follow-up).

Behavioral: PlanningBehavioral: Education

Combined planning+self-efficacy

EXPERIMENTAL

This condition included all BCT applied in the planning and self-efficacy arms. The intervention was integrated into health promotion-nutrition education program. The intervention was applied twice (the baseline and 2-month follow-up).

Behavioral: Self-EfficacyBehavioral: PlanningBehavioral: Education

Education

ACTIVE COMPARATOR

The education group received extended physical activity education program. The physical activity education was integrated into health promotion-nutrition education program.The education program was applied twice (the baseline and 2-month follow-up).

Behavioral: Education

Interventions

Self-EfficacyBEHAVIORAL

The introductory part included an abbreviated version of the education materials used in the control group. The self-efficacy materials and forms had four sections: (a) definitions of self-efficacy beliefs, (b) information on the importance of self-efficacy for goal pursuit, (c) recollecting a mastery experience, (d) persuasive statements evoking self-persuasive statements about self-efficacy beliefs. The materials ended with instructions for the following 7 days to recollect self-efficacy enhancing statements every morning. The procedures are based on a self-efficacy intervention by Luszczynska, Tryburcy et al. (2007). Group and individual components were included. Setting: secondary and high schools.

Also known as: Physical Activity Self-Efficacy Enhancement
Combined planning+self-efficacySelf-efficacy
PlanningBEHAVIORAL

The introductory part included an abbreviated version of the education materials used in the control group. The planning materials and forms had four sections: (a) information on the importance of planning, including examples of how planning works and what it affects, (b) instructions of what should be included in a good plan (the when, where, and how components), (c) formulating action and coping plans. The materials ended with instructions for the following 7 days to recollect/redo plans every morning.The procedures are based on a planning intervention by Luszczynska, Sobczyk, et al. (2007). Group and individual components were included. Setting: secondary and high schools.

Also known as: Physical Activity Planning Enhancement
Combined planning+self-efficacyPlanning
EducationBEHAVIORAL

Participants received a set of educational materials about types of physical activity (PA), PA intensity, exercise calorie expenditure, myths about PA, strength and endurance training, stretching, and general healthy nutrition guidelines. The materials excluded planning and self-efficacy statements. The materials ended with instructions for the following 7 days to recollect forms of MVPA every morning. Group and individual components were included. Setting: secondary and high schools.

Also known as: Physical Activity Education
Combined planning+self-efficacyEducationPlanningSelf-efficacy

Eligibility Criteria

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

You may qualify if:

  • Healthy adolescents
  • Adolescents with chronic conditions but without contraindications for moderate-to-vigorous physical activity

You may not qualify if:

  • Adolescents who were younger than 14 years old
  • Adolescents who declared plans for changing schools during the following year (e.g., due to graduation or moving to another region)
  • No parental consent at the baseline
  • Existing diseases with contraindications for moderate-to-vigorous physical activity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Social Sciences and Humanities

Warsaw, 03-815, Poland

Location

Related Publications (10)

  • Luszczynska A, Schwarzer R, Lippke S, Mazurkiewicz M. Self-efficacy as a moderator of the planning-behaviour relationship in interventions designed to promote physical activity. Psychol Health. 2011 Feb;26(2):151-66. doi: 10.1080/08870446.2011.531571.

    PMID: 21318927BACKGROUND
  • Michie S, Ashford S, Sniehotta FF, Dombrowski SU, Bishop A, French DP. A refined taxonomy of behaviour change techniques to help people change their physical activity and healthy eating behaviours: the CALO-RE taxonomy. Psychol Health. 2011 Nov;26(11):1479-98. doi: 10.1080/08870446.2010.540664. Epub 2011 Jun 28.

    PMID: 21678185BACKGROUND
  • Godin G, Shephard RJ. A simple method to assess exercise behavior in the community. Can J Appl Sport Sci. 1985 Sep;10(3):141-6.

    PMID: 4053261BACKGROUND
  • Cleary J, Daniells S, Okely AD, Batterham M, Nicholls J. Predictive validity of four bioelectrical impedance equations in determining percent fat mass in overweight and obese children. J Am Diet Assoc. 2008 Jan;108(1):136-9. doi: 10.1016/j.jada.2007.10.004.

    PMID: 18156000BACKGROUND
  • Kyle UG, Bosaeus I, De Lorenzo AD, Deurenberg P, Elia M, Gomez JM, Heitmann BL, Kent-Smith L, Melchior JC, Pirlich M, Scharfetter H, Schols AM, Pichard C; Composition of the ESPEN Working Group. Bioelectrical impedance analysis--part I: review of principles and methods. Clin Nutr. 2004 Oct;23(5):1226-43. doi: 10.1016/j.clnu.2004.06.004.

    PMID: 15380917BACKGROUND
  • Schwarzer R, Luszczynska A, Ziegelmann JP, Scholz U, Lippke S. Social-cognitive predictors of physical exercise adherence: three longitudinal studies in rehabilitation. Health Psychol. 2008 Jan;27(1S):S54-63. doi: 10.1037/0278-6133.27.1(Suppl.).S54.

    PMID: 18248106BACKGROUND
  • Luszczynska A, Horodyska K, Zarychta K, Liszewska N, Knoll N, Scholz U. Planning and self-efficacy interventions encouraging replacing energy-dense foods intake with fruit and vegetable: A longitudinal experimental study. Psychol Health. 2016;31(1):40-64. doi: 10.1080/08870446.2015.1070156. Epub 2015 Aug 6.

    PMID: 26160226BACKGROUND
  • Luszczynska A, Tryburcy M, Schwarzer R. Improving fruit and vegetable consumption: a self-efficacy intervention compared with a combined self-efficacy and planning intervention. Health Educ Res. 2007 Oct;22(5):630-8. doi: 10.1093/her/cyl133. Epub 2006 Oct 23.

    PMID: 17060349BACKGROUND
  • Luszczynska A, Sobczyk A, Abraham C. Planning to lose weight: randomized controlled trial of an implementation intention prompt to enhance weight reduction among overweight and obese women. Health Psychol. 2007 Jul;26(4):507-12. doi: 10.1037/0278-6133.26.4.507.

    PMID: 17605571BACKGROUND
  • Luszczynska A, Hagger MS, Banik A, Horodyska K, Knoll N, Scholz U. Self-Efficacy, Planning, or a Combination of Both? A Longitudinal Experimental Study Comparing Effects of Three Interventions on Adolescents' Body Fat. PLoS One. 2016 Jul 13;11(7):e0159125. doi: 10.1371/journal.pone.0159125. eCollection 2016.

MeSH Terms

Conditions

Adolescent BehaviorMotor Activity

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Results Point of Contact

Title
Dr Aleksandra Luszczynska, Principal Investigator
Organization
SWPS University of Social Sciences and Humanities

Study Officials

  • Aleksandra Luszczynska, PhD

    University of Social Sciences and Humanities

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2016

First Posted

February 24, 2016

Study Start

May 1, 2009

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

September 4, 2018

Results First Posted

July 30, 2018

Record last verified: 2018-08

Locations