Adolescent BehaviorNCT02689973
Effects of Self-efficacy, Planning, and Self-efficacy+Planning Interventions on Body Fat Among Adolescents
A study testing Self-Efficacy, Planning and Education in people with Adolescent Behavior, run by University of Social Sciences and Humanities, Warsaw at 1 site in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Behavior
- What is being tested?
- Self-Efficacy, Planning and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,217 participants
- Where
- 1 sitePoland
- Study dates
- May 2009to Jun 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy adolescents
- Adolescents with chronic conditions but without contraindications for moderate-to-vigorous physical activity
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Synergistic Effects of Implementation Intention and Self-efficacy on Behavior Change and Body Fat: a Randomized Controlled Trial of Interventions Promoting Physical Activity
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.
Read the detailed description
The experimental procedures were integrated into a health promotion and education program.
Pre-manipulation education: Across the study groups, participants received a common healthy lifestyle education program, focusing on nutrition and physical activity, which was a part of the school curriculum. The combination of nutrition and PA interventions is in line with best practice guidelines for interventions promoting healthy body weight. The education program was delivered by teachers and a group format was used. The groups discussed food composition, safe food handling, food labeling, nutrient needs for age and gender groups, dietary guidelines, and clinical nutrition issues. The program did not include behavior change techniques and was not accompanied by changes in policies.
The intervention conditions were delivered via a combination of printed forms with paper-and-pencil exercises and face-to-face sessions. All experimental conditions included an initial session (completing the forms individually in the groups + face-to-face component) and sets of handouts for three following weeks. The face-to-face component was delivered within three days of completing the initial forms. The initial session was followed by a booster session (group + face-to-face components), delivered at 2-month follow-up. Across the groups, completing the forms (individual component) took approximately 30 minutes and was conducted in classrooms. The face-to-face components took 45-60 minutes and were conducted in the offices of school nurses or school psychologists.
Group intervention component. At the baseline participants completed the intervention materials individually, using self-copy paper; the copies were collected for fidelity analysis and originals were left for participants. The paper-and-pencil materials followed a similar format in four groups in terms of word count, visual format, and the number and length of sections requiring participants filling in the blanks.
Face-to-face intervention component. During the face-to-face component (at the baseline and during the booster sessions) all participants received feedback on their body weight, information regarding their physical activity levels and energy expenditure based on participant's age, gender, body weight, followed by moderate-to-vigorous physical activity recommendations (body mass and body fat measured during the booster session was not recorded). Next, all participants and experimenters jointly reviewed the forms completed during the group component. Adolescents reported included plans and were prompted to provide even more detailed responses to questions included in the forms. Experimenters asked participants to read the content of the form loudly; looked for sections which were incomplete and encouraged adolescents to complete these sections; prompted participants to provide detailed responses.
- Conditions
- Adolescent Behavior
- Being tested
- Self-Efficacy, Planning, Education
- Keywords
- adolescence, body fat, physical activity, psychosocial intervention, self-efficacy, planning
- Medical subject headings
- Adolescent Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-EfficacyBehavioural
Also called Physical Activity Self-Efficacy Enhancement
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.
PlanningBehavioural
Also called Physical Activity Planning Enhancement
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.
EducationBehavioural
Also called Physical Activity Education
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Self-Efficacy; Behavioral: 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). Receives: Behavioral: Planning; Behavioral: 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). Receives: Behavioral: Self-Efficacy; Behavioral: Planning; Behavioral: 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). Receives: Behavioral: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline to 14-month follow-up
Secondary outcomes (3)
Moderate-to-vigorous Physical Activity (MVPA)
Items from Godin and Shephard's (1985) Leisure-Time Exercise Questionnaire (e.g., 'Considering a 7-day period [a week], how many times on the average do you do the following kinds of exercise for more than 15 minutes during your free time: strenuous exercise [heart beats rapidly], i.e. running, jogging, hockey, soccer, basketball, cross-country skiing, vigorous swimming, vigorous long distance bicycling').
Number of Items: 2
Response format: open ended, the participant indicated the number of 15 min blocks of physical activity.
Scoring: the total (sum) score of 2 items
Scoring formula: the sum score for the number of minutes of MVPA per week, i.e. individual score = {response to item #1 x 15} + {response to item # 2 x 15})
The range for the score (i.e. the sum score of 2 items): minimum = 0, maximum = 42
Interpretation: Higher scores indicate better results (more minutes of MVPA per week)
Measured: Baseline to 14-month follow-up
The Use of Physical Activity Planning (the Use of Planning)
Use of physical activity planning was measured with four items (e.g., 'I have my own plan regarding when to engage in exercise of moderate-to-vigorous intensity'; Schwarzer et al., 2008).
Number of Items: 4
Response format: Responses ranged from 1 ('definitely not') to 4 ('exactly true').
Scoring: the total score of 4 items
Scoring formula: the sum score for the 4 items divided by 4, i.e. {item #1 + item #2 + item #3 + item #4} : 4
The range for the score (i.e. the sum score of 4 items divided by 4): minimum = 1, maximum = 4
Interpretation: Higher scores indicate better results (the more frequent use of planning)
Measured: Baseline to 2-month follow-up
Physical Activity Self-efficacy (PA Self-efficacy)
Physical activity self-efficacy (T1 and T2) was measured with 9 items (e.g., 'I am able to maintain regular MVPA even if I would have to reorganize my daily life'; Luszczynska et al., 2011).
Number of Items: 9
Response format: Responses ranged from 1 ('definitely not') to 4 ('exactly true').
Scoring: the total score of 9 items divided by 9
Scoring formula: the sum score for the 9 items divided by 9, i.e. {item #1 + item #2 + item #3 + item #4+ item #5 + item #6 + item #7 + item #8 + item #9} : 9
The range for score (i.e. the sum score of 9 items divided by 4): minimum = 1, maximum = 4
Interpretation: Higher scores indicate better results (the higher levels of PA self-efficacy)
Measured: Baseline to 2-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2016 (estimated)
- Study startMay 2009
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Adolescent BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,217 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Social Sciences and Humanities, Warsaw
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zurich, Free University of Berlin, Curtin University
- Responsible party
- Sponsor
- Investigators
- Aleksandra Luszczynska, PhD, Principal investigator, University of Social Sciences and Humanities
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02689973
- Sponsor's protocol ID
- N106 036 32/2487
- Status last verified
- Aug 2018
- First submitted
- 19 Feb 2016
- Last updated
- 4 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 21318927Michie 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.
PubMed 21678185Godin G, Shephard RJ. A simple method to assess exercise behavior in the community. Can J Appl Sport Sci. 1985 Sep;10(3):141-6.
PubMed 4053261Cleary 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.
PubMed 18156000Kyle 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.
PubMed 15380917Schwarzer 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.
PubMed 18248106Luszczynska 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.
PubMed 26160226Luszczynska 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.
PubMed 17060349Luszczynska 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.
PubMed 17605571Luszczynska 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.
PubMed 27410961
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synergistic Effects of Implementation Intention and Self-efficacy on Behavior Change and Body Fat: a Randomized Controlled Trial of Interventions Promoting Physical Activity
- ClinicalTrials.gov ID
- NCT02689973
- Acronym / sponsor ID
- N106 036 32/2487
- Conditions
- Adolescent Behavior
- Keywords
- adolescence, body fat, physical activity, psychosocial intervention, self-efficacy, planning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,217 participants (actual)
- Lead sponsor
- University of Social Sciences and Humanities, WarsawUniversity, hospital or other
- Collaborators
- University of Zurich, Free University of Berlin, Curtin University
- Study start
- May 2009
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 24 Feb 2016 (estimated)
- Results
- Posted 30 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The experimental procedures were integrated into a health promotion and education program.
Pre-manipulation education: Across the study groups, participants received a common healthy lifestyle education program, focusing on nutrition and physical activity, which was a part of the school curriculum. The combination of nutrition and PA interventions is in line with best practice guidelines for interventions promoting healthy body weight. The education program was delivered by teachers and a group format was used. The groups discussed food composition, safe food handling, food labeling, nutrient needs for age and gender groups, dietary guidelines, and clinical nutrition issues. The program did not include behavior change techniques and was not accompanied by changes in policies.
The intervention conditions were delivered via a combination of printed forms with paper-and-pencil exercises and face-to-face sessions. All experimental conditions included an initial session (completing the forms individually in the groups + face-to-face component) and sets of handouts for three following weeks. The face-to-face component was delivered within three days of completing the initial forms. The initial session was followed by a booster session (group + face-to-face components), delivered at 2-month follow-up. Across the groups, completing the forms (individual component) took approximately 30 minutes and was conducted in classrooms. The face-to-face components took 45-60 minutes and were conducted in the offices of school nurses or school psychologists.
Group intervention component. At the baseline participants completed the intervention materials individually, using self-copy paper; the copies were collected for fidelity analysis and originals were left for participants. The paper-and-pencil materials followed a similar format in four groups in terms of word count, visual format, and the number and length of sections requiring participants filling in the blanks.
Face-to-face intervention component. During the face-to-face component (at the baseline and during the booster sessions) all participants received feedback on their body weight, information regarding their physical activity levels and energy expenditure based on participant's age, gender, body weight, followed by moderate-to-vigorous physical activity recommendations (body mass and body fat measured during the booster session was not recorded). Next, all participants and experimenters jointly reviewed the forms completed during the group component. Adolescents reported included plans and were prompted to provide even more detailed responses to questions included in the forms. Experimenters asked participants to read the content of the form loudly; looked for sections which were incomplete and encouraged adolescents to complete these sections; prompted participants to provide detailed responses.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Self-efficacy | Experimental | Behavioral: Self-Efficacy, Behavioral: EducationThe 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). |
| Planning | Experimental | Behavioral: Planning, Behavioral: EducationThe 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). |
| Combined planning+self-efficacy | Experimental | Behavioral: Self-Efficacy, Behavioral: Planning, Behavioral: EducationThis 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). |
| Education | Active comparator | Behavioral: EducationThe 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). |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Healthy adolescents
- Adolescents with chronic conditions but without contraindications for moderate-to-vigorous physical activity
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-EfficacyAlso: Physical Activity Self-Efficacy EnhancementThe 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. | Behavioural | Combined planning+self-efficacy, Self-efficacy |
| PlanningAlso: Physical Activity Planning EnhancementThe 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. | Behavioural | Combined planning+self-efficacy, Planning |
| EducationAlso: Physical Activity EducationParticipants 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. | Behavioural | Combined planning+self-efficacy, Education, Planning, Self-efficacy |
Primary outcome
Body Fat Tissue
Time frame: Baseline to 14-month follow-up
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).
3 secondary outcomes
Moderate-to-vigorous Physical Activity (MVPA)
Time frame: Baseline to 14-month follow-up
The Use of Physical Activity Planning (the Use of Planning)
Time frame: Baseline to 2-month follow-up
Physical Activity Self-efficacy (PA Self-efficacy)
Time frame: Baseline to 2-month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21318927Luszczynska 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.
- Background: PubMed 21678185Michie 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.
- Background: PubMed 4053261Godin G, Shephard RJ. A simple method to assess exercise behavior in the community. Can J Appl Sport Sci. 1985 Sep;10(3):141-6.
- Background: PubMed 18156000Cleary 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.
- Background: PubMed 15380917Kyle 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.
- Background: PubMed 18248106Schwarzer 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.
- Background: PubMed 26160226Luszczynska 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.
- Background: PubMed 17060349Luszczynska 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.
- Background: PubMed 17605571Luszczynska 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.
- Results publication: PubMed 27410961Luszczynska 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aleksandra Luszczynska, PhD principal investigator
University of Social Sciences and Humanities
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Efficacy, Planning and Education in people with Adolescent Behavior, run by University of Social Sciences and Humanities, Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Fat Tissue (time frame: Baseline to 14-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02689973, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2018.