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Clinical Trials/NCT02689973
NCT02689973
Completed
Not Applicable

Synergistic Effects of Implementation Intention and Self-efficacy on Behavior Change and Body Fat: a Randomized Controlled Trial of Interventions Promoting Physical Activity

University of Social Sciences and Humanities, Warsaw1 site in 1 country1,217 target enrollmentMay 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Adolescent Behavior
Sponsor
University of Social Sciences and Humanities, Warsaw
Enrollment
1217
Locations
1
Primary Endpoint
Body Fat Tissue
Status
Completed
Last Updated
7 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
May 2009
End Date
June 2015
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Social Sciences and Humanities, Warsaw
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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).

Secondary Outcomes

  • Physical Activity Self-efficacy (PA Self-efficacy)(Baseline to 2-month follow-up)
  • The Use of Physical Activity Planning (the Use of Planning)(Baseline to 2-month follow-up)
  • Moderate-to-vigorous Physical Activity (MVPA)(Baseline to 14-month follow-up)

Study Sites (1)

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