Effects of Self-efficacy, Planning, and Self-efficacy+Planning Interventions on Body Fat Among Adolescents

Adolescent Behavior Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02689973
• Other study ID #: N106 036 32/2487
• Status: Completed
• Phase: N/A
• Start date: May 2009
• Est. completion date: June 2015

Study information

• Verified date: August 2018
• Source: University of Social Sciences and Humanities, Warsaw
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1217
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 18 Years

Eligibility

Inclusion Criteria:

• Healthy adolescents

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Adolescent Behavior

Intervention

Behavioral:
• Self-Efficacy
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.
• Planning
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.
• 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.

Locations

Country	Name	City	State
Poland	University of Social Sciences and Humanities	Warsaw

Sponsors (4)

Lead Sponsor	Collaborator
University of Social Sciences and Humanities, Warsaw	Curtin University, Free University of Berlin, University of Zurich

Country where clinical trial is conducted

Poland, 

References & Publications (10)

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. — View Citation

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. — View Citation

Kyle UG, Bosaeus I, De Lorenzo AD, Deurenberg P, Elia M, Gómez 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. Review. — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2006 Oct 23. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	Baseline to 14-month follow-up
Secondary	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)	Baseline to 2-month follow-up
Secondary	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)	Baseline to 2-month follow-up