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临床试验/NCT02689973
NCT02689973已完成不适用

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, Warsaw2 个研究点 分布在 1 个国家目标入组 1,217 人开始时间: 2009年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,217
试验地点
2
主要终点
Body Fat Tissue

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
14 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

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).

干预措施: Self-Efficacy (Behavioral)

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).

干预措施: Education (Behavioral)

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).

干预措施: Education (Behavioral)

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).

干预措施: Planning (Behavioral)

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).

干预措施: Self-Efficacy (Behavioral)

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).

干预措施: Planning (Behavioral)

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).

干预措施: Education (Behavioral)

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).

干预措施: Education (Behavioral)

结局指标

主要结局

Body Fat Tissue

时间窗: 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).

次要结局

  • 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)

研究者

发起方
University of Social Sciences and Humanities, Warsaw
申办方类型
Other
责任方
Sponsor

研究点 (2)

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