A feasibility randomized trial of an identity-based physical activity intervention among university students.
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ABSTRACT: Introduction
Exercise identity has considerable evidence as a correlate of physical activity (PA), but almost no research has focused on intervention. Theory suggests identity may be formed through indirect means of motivated behaviour change over time or through direct targeting of identity related antecedents. Using a parallel, single blind design, the purpose of this study was to explore the feasibility (recruitment, retention, and satisfaction) of these two types of interventions (indirect, direct) to increase exercise identity and subsequent PA.Methods
Participants between the ages of 18-25 who were not meeting PA guidelines were recruited from the University of Victoria, and randomized at a 1:1 ratio to an indirect or direct intervention group. The indirect intervention group received information on the benefits of PA and behaviour change techniques such as planning. The direct intervention group received the same information, with the addition of identity-specific information. Intervention materials were delivered bi-weekly for 6 weeks. Feasibility and participant satisfaction at the study end-point were assessed using mixed methods, and both PA change and exercise identity change were assessed via self-report.Results
Twenty participants were randomized to the direct or indirect intervention group (10 each), with 18 participants completing full study protocol. The recruitment rate was 26% and retention was 90%. Mean scores from the satisfaction survey (five-point scale) were high for both groups (indirect M = 2.69, SD = 0.62; direct M = 2.83, SD = 0.40). Both intervention groups increased their PA (η2 = 0.25), and exercise identity levels (η2 = 0.43) across six weeks.Discussion
High feasibility ratings, both through retention, and survey and interview data show that the study could be extended to a full-scale RCT. Modifications to recruitment including oversampling to account for low recruitment rates may be useful. No adverse events were reported.
SUBMITTER: Husband CJ
PROVIDER: S-EPMC8114372 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundAmple evidence demonstrates that university students are at high risk for sedentary behaviors and inadequate fruit and vegetable intake (FVI). Internet-based interventions for multiple health behavior appear to be promising in changing such unhealthy habits. Limited randomized controlled trials have tested this assumption among Chinese university students.ObjectiveOur objective was to test the efficacy of an 8-week Web-based intervention compared with a control group condition to improve physical activity (PA) and FVI in Chinese university students. The intervention content was based on the health action process approach, and developed on the basis of previous evidence from the Western hemisphere. We evaluated self-reported data including PA and FVI, stages of change for PA and FVI, and motivational (risk perception, outcome expectancies, self-efficacy), volitional (action planning, coping planning, social support), and distal (intention, habit) indicators for PA and FVI, as well as perceived mental health outcomes (quality of life, depression).MethodsIn a randomized controlled trial, we recruited 566 university students from one university in the central region of China during their general physical education class. After random allocation and exclusion of unsuitable participants, we assigned 493 students to 1 of 2 groups: (1) intervention group: first 4 weeks on PA and subsequent 4 weeks on FVI, (2) control group. We conducted 3 Web-based assessments: at the beginning of the intervention (T1, n=493), at the end of the 8-week intervention (T2, n=337), and at a 1-month follow-up after the intervention (T3, n=142). The entire study was conducted throughout the fall semester of 2015.ResultsSignificant time ⨯ group interactions revealed superior intervention effects on FVI; motivational, volitional, and distal indicators of FVI; and PA behavior changes, with an effect size (η2) ranging from .08 to .20. In addition, the overall intervention effects were significant for stage progression to the action group from T1 to T2 in PA (χ21=11.75, P=.001) and FVI (χ21=15.64, P=.03). Furthermore, the intervention effect was seen in the improvement of quality of life (F3,492=1.23, η2=.03, P=.02).ConclusionsThis study provides evidence for the efficacy of a Web-based multiple health behavior intervention among Chinese university students tested with different outcome variables. Future research should address the high dropout rate and optimize the most effective components of this intervention.Trial registrationClinicaltrials.gov NCT01909349; https://clinicaltrials.gov/ct2/show/NCT01909349 (Archived by WebCite at http://www.webcitation.org/6pHV1A0G1).
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Project description:BackgroundTreatment rates for social anxiety, a prevalent and potentially debilitating condition, remain among the lowest of all major mental disorders today. Although computer-delivered interventions are well poised to surmount key barriers to the treatment of social anxiety, most are only marginally effective when delivered as stand-alone treatments. A new, Web-based cognitive behavioral therapy (CBT) intervention called Overcome Social Anxiety was recently created to address the limitations of prior computer-delivered interventions. Users of Overcome Social Anxiety are self-directed through various CBT modules incorporating cognitive restructuring and behavioral experiments. The intervention is personalized to each user's symptoms, and automatic email reminders and time limits are used to encourage adherence.ObjectiveThe purpose of this study was to conduct a randomized controlled trial to investigate the effectiveness of Overcome Social Anxiety in reducing social anxiety symptoms in a nonclinical sample of university students. As a secondary aim, we also investigated whether Overcome Social Anxiety would increase life satisfaction in this sample.MethodsFollowing eligibility screening, participants were randomly assigned to a treatment condition or a wait-list control condition. Only those assigned to the treatment condition were given access to Overcome Social Anxiety; they were asked to complete the program within 4 months. The social interaction anxiety scale (SIAS), the fear of negative evaluation scale (FNE), and the quality of life enjoyment and satisfaction questionnaire-short form (Q-LES-Q-SF) were administered to participants from both conditions during baseline and 4-month follow-up lab visits.ResultsOver the course of the study, participants assigned to the treatment condition experienced a significant reduction in social anxiety (SIAS: P<.001, Cohen d=0.72; FNE: P<.001, Cohen d=0.82), whereas those assigned to the control condition did not (SIAS: P=.13, Cohen d=0.26; FNE: P=.40, Cohen d=0.14). Additionally, a direct comparison of the average change in social anxiety in the 2 conditions over the course of the study showed that those assigned to the treatment condition experienced significantly more improvement than those assigned to the control condition (SIAS: P=.03, Cohen d=0.56; FNE: P=.001, Cohen d=0.97). Although participants assigned to the treatment condition experienced a slight increase in life satisfaction, as measured by Q-LES-Q-SF scores, and those assigned to the control condition experienced a slight decrease, these changes were not statistically significant (treatment: P=.35, Cohen d=-0.18; control: P=.30, Cohen d=0.18).ConclusionsOur findings indicate that Overcome Social Anxiety is an effective intervention for treating symptoms of social anxiety and that it may have further utility in serving as a model for the development of new interventions. Additionally, our findings provide evidence that contemporary Web-based interventions can be sophisticated enough to benefit users even when delivered as stand-alone treatments, suggesting that further opportunities likely exist for the development of other Web-based mental health interventions.Trial registrationClinicalTrials.gov NCT02792127; https://clinicaltrials.gov/ct2/show/record/NCT02792127 (Archived by WebCite at http://www.webcitation.org/6xGSRh7MG).
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Project description:Young adult university students are a priority population for nutrition intervention. This study assessed the feasibility and preliminary efficacy of the EATS (Eating Advice to Students) brief (i.e., single use) web-based nutrition intervention for young adult university students. A 3-month pilot randomized controlled trial (RCT) was conducted with 124 students aged 17-35 from the University of Newcastle, Australia. Participants were randomized to EATS (n = 62) or attention control (n = 62). EATS aimed to improve four target eating behaviors (vegetables, fruit, discretionary foods, breakfast). Primary outcomes were feasibility (recruitment, retention, usage, program acceptability). Recruitment and retention numbers were recorded, the program acceptability was assessed by a process evaluation survey and the website usage was objectively tracked. Preliminary efficacy was assessed via changes in diet quality (primary), fruit, vegetables, discretionary foods and breakfast intake, measured using Food Frequency Questionnaire. Recruitment was completed in five weeks. Retention was 73% (90/124) at 3-months. Intervention participants used EATS 1.5 ± 1.0 times. Satisfaction with EATS was rated at 4.04 ± 0.74 (maximum five). Intervention participants significantly decreased the percentage energy/day from discretionary foods compared with control (-4.8%, 95%CI -8.6, -1.1, p = 0.012, d = -0.34). No significant between-group differences were observed for diet quality, fruit, vegetable or breakfast intakes. EATS demonstrated high feasibility, particularly for reach and acceptability. The university setting and a brief web-based intervention show promise in engaging young adults to improve their eating behaviors.
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Project description:BackgroundUrban elementary schools in minority communities with high obesity prevalence may have limited resources for physical education (PE) to achieve daily activity recommendations. Little is known whether integrating physical activity (PA) into classrooms can increase activity levels of students attending such schools.MethodsWe conducted a cluster randomized, controlled trial among kindergarten and first-grade students from four Bronx, New York, schools to determine feasibility and impact of a classroom-based intervention on students' PA levels. Students in two intervention schools received the Children's Hospital at Montefiore Joining Academics and Movement (CHAM JAM), an audio CD consisting of 10-minute, education-focused aerobic activities led by teachers three times a day. PA was objectively measured by pedometer. Each subject wore a sealed pedometer during the 6-hour school day for 5 consecutive days at baseline (Time 1) and 8 weeks postintervention (Time 2). Hierarchical linear models were fit to evaluate differences in mean number of steps between the two groups.ResultsA total of 988 students participated (intervention group, n=500; control group, n=488). There was no significant difference at baseline between the two groups on mean number of steps (2581 [standard deviation (SD), 1284] vs. 2476 [SD, 1180]; P=0.71). Eight weeks post-CHAM JAM, intervention group students took significantly greater mean number of steps than controls (2839 [SD, 1262] vs. 2545 [SD, 1153]; P=0.0048) after adjusting for baseline number of steps and other covariates (grade, gender, recess, and PE class). CHAM JAM was equally effective in gender, grade level, and BMI subgroups.ConclusionsCHAM JAM significantly increased school-based PA among kindergarten and first-grade students in inner-city schools. This approach holds promise as a cost-effective means to integrate the physical and cognitive benefits of PA into high-risk schools.
| S-EPMC4485880 | biostudies-literature
Project description:BackgroundSince the beginning of the COVID-19 pandemic, sanitary context and e-learning have greatly modified student lifestyles and led to deteriorations in their mental health. An increase in anxiety and depressive symptoms and sedentary behaviors, reduction in physical activity, and a stronger tendency to move toward unhealthy diet have been demonstrated. This finding highlights the need for innovative interventions to promote healthy lifestyle among students.ObjectiveThis research protocol aims to evaluate the effects of an intervention program on the lifestyle and psychological state of students.MethodsStudents from University of Nîmes were recruited and randomly assigned to 1 of 2 following conditions: an intervention group and a control group. Participants in the intervention group were engaged in an 8-week physical activity program. Prior to the start of the program, design-based innovative workshops were conducted with participants to ensure that the program was co-constructed by the users and met their specific needs. Students in the control group did not receive any intervention. For each group, measures of physical activity, sedentary time, anthropometric data, sleep, physical condition, and psychological variables (eg, anxiety, depression, motivation, body appreciation, perceived control, well-being) were conducted at baseline and 9 weeks later.ResultsA total of 110 participants were initially included. Reporting of the results is projected for the spring of 2022.ConclusionsIt is anticipated that this innovative intervention co-constructed by pairs will promote a healthier lifestyle and psychological health in students. There is every reason to believe that a mobilized co-construction approach is a promising strategy to limit unhealthy habits and promote physical activity while increasing motivation. The development and evaluation of interventions to address the specific needs of university students is essential and could be transferred to other vulnerable populations such as people with chronic diseases or older people.Trial registrationClinicalTrials.gov NCT05019482; https://clinicaltrials.gov/ct2/show/NCT05019482.International registered report identifier (irrid)DERR1-10.2196/36429.
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Project description:Direct-to-consumer mHealth devices are a potential asset to behavioral research but rarely tested as intervention tools. This trial examined the accelerometer-based Fitbit tracker and website as a low-touch physical activity intervention. The purpose of this study is to evaluate, within an RCT, the feasibility and preliminary efficacy of integrating the Fitbit tracker and website into a physical activity intervention for postmenopausal women.Fifty-one inactive, postmenopausal women with BMI ?25.0 were randomized to a 16-week web-based self-monitoring intervention (n=25) or comparison group (n=26). The Web-Based Tracking Group received a Fitbit, instructional session, and follow-up call at 4 weeks. The comparison group received a standard pedometer. All were asked to perform 150 minutes/week of moderate to vigorous physical activity (MVPA). Physical activity outcomes were measured by the ActiGraph GT3X+ accelerometer.Data were collected and analyzed in 2013-2014. Participants were aged 60 (SD=7) years with BMI of 29.2 (3.5) kg/m(2). Relative to baseline, the Web-Based Tracking Group increased MVPA by 62 (108) minutes/week (p<0.01); 10-minute MVPA bouts by 38 (83) minutes/week (p=0.008); and steps by 789 (1,979) (p=0.01), compared to non-significant increases in the Pedometer Group (between-group p=0.11, 0.28, and 0.30, respectively). The Web-Based Tracking Group wore the tracker on 95% of intervention days; 96% reported liking the website and 100% liked the tracker.The Fitbit was well accepted in this sample of women and associated with increased physical activity at 16 weeks. Leveraging direct-to-consumer mHealth technologies aligned with behavior change theories can strengthen physical activity interventions.
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Project description:BackgroundOnline social networks, such as Facebook™, have extensive reach, and they use technology that could enhance social support, an established determinant of physical activity. This combination of reach and functionality makes online social networks a promising intervention platform for increasing physical activity.PurposeTo test the efficacy of a physical activity intervention that combined education, physical activity monitoring, and online social networking to increase social support for physical activity compared to an education-only control.DesignRCT. Students (n=134) were randomized to two groups: education-only controls receiving access to a physical activity-focused website (n=67) and intervention participants receiving access to the same website with physical activity self-monitoring and enrollment in a Facebook group (n=67). Recruitment and data collection occurred in 2010 and 2011; data analyses were performed in 2011.Setting/participantsFemale undergraduate students at a large southeastern public university.InterventionIntervention participants were encouraged through e-mails, website instructions, and moderator communications to solicit and provide social support related to increasing physical activity through a physical activity-themed Facebook group. Participants received access to a dedicated website with educational materials and a physical activity self-monitoring tool.Main outcome measuresThe primary outcome was perceived social support for physical activity; secondary outcomes included self-reported physical activity.ResultsParticipants experienced increases in social support and physical activity over time but there were no differences in perceived social support or physical activity between groups over time. Facebook participants posted 259 times to the group. Two thirds (66%) of intervention participants completing a post-study survey indicated that they would recommend the program to friends.ConclusionsUse of an online social networking group plus self-monitoring did not produce greater perceptions of social support or physical activity as compared to education-only controls. Given their promising features and potential reach, efforts to further understand how online social networks can be used in health promotion should be pursued.Trial registrationThis study is registered at clinicaltrials.govNCT01421758.
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Project description:Excessive drinking among university students is a global challenge, leading to significant health risks. However, heavy drinking among students is widely accepted and socially normalized. Mobile phone interventions have attempted to reach students who engage in excessive drinking. A growing number of studies suggest that text message-based interventions could potentially reach many students and, if effective, such an intervention might help reduce heavy drinking in the student community.The objective of this study was to test the effectiveness of a behavior change theory-based 6-week text message intervention among university students.This study was a two-arm, randomized controlled trial with an intervention group receiving a 6-week text message intervention and a control group that was referred to treatment as usual at the local student health care center. Outcome measures were collected at baseline and at 3 months after the initial invitation to participate in the intervention. The primary outcome was total weekly alcohol consumption. Secondary outcomes were frequency of heavy episodic drinking, highest estimated blood alcohol concentration, and number of negative consequences attributable to excessive drinking.A total of 896 students were randomized to either the intervention or control group. The primary outcome analysis included 92.0% of the participants in the intervention group and 90.1% of the control group. At follow-up, total weekly alcohol consumption decreased in both groups, but no significant between-group difference was seen. Data on the secondary outcomes included 49.1% of the participants in the intervention group and 41.3% of the control group. No significant between-group difference was seen for any of the secondary outcomes.The present study was under-powered, which could partly explain the lack of significance. However, the intervention, although theory-based, needs to be re-assessed and refined to better support the target group. Apart from establishing which content forms an effective intervention, the optimal length of an alcohol intervention targeting students also needs to be addressed in future studies.International Standard Randomised Controlled Trial Number ISRCTN95054707; http://www.isrctn.com/ISRCTN95054707 (Archived by WebCite at http://www.webcitation.org/70Ax4vXhd).
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Project description:Smoking is globally the most important preventable cause of ill health and death. Mobile telephone interventions and, in particular, short message service (SMS) text messaging, have the potential to overcome access barriers to traditional health services, not least among young people.To determine the effectiveness of a text-based smoking cessation intervention among young people.A single-blind, 2-arm, randomized clinical trial (Nicotine Exit [NEXit]) was conducted from October 23, 2014, to April 17, 2015; data analysis was performed from April 23, 2014, to May 22, 2015. Participants included daily or weekly smokers willing to set a quit date within 1 month of enrollment. The study used email to invite all college and university students throughout Sweden to participate.The NEXit core program is initiated with a 1- to 4-week motivational phase during which participants can choose to set a stop date. The intervention group then received 157 text messages based on components of effective smoking cessation interventions for 12 weeks. The control group received 1 text every 2 weeks thanking them for participating in the study, with delayed access to the intervention.The primary outcomes were self-reported prolonged abstinence (not having smoked >5 cigarettes over the past 8 weeks) and 4-week point prevalence of complete smoking cessation shortly after the completion of the intervention (approximately 4 months after the quit date).A total of 1590 participants, mainly between 21 and 30 years of age, were randomized into the study; 827 (573 [69.3%] women) were allocated to the intervention group and 763 (522 [68.4%] women) were included in the control group. Primary outcome data were available for 783 (94.7%) of the intervention group and 719 (94.2%) of the control group. At baseline, participants were smoking a median (range) of 63 (1-238) and 70 (2-280) cigarettes per week, respectively. Eight-week prolonged abstinence was reported by 203 participants (25.9%) in the intervention group and 105 (14.6%) in the control group; 4-week point prevalence of complete cessation was reported by 161 (20.6%) and 102 (14.2%) participants, respectively, a mean (SD) of 3.9 (0.37) months after the quit date. The adjusted odds ratios (95% CIs) for these findings were 2.05 (1.57-2.67) and 1.56 (1.19-2.05), respectively.With the limitation of assessing only the short-term effect of the intervention, the effects observed in this trial are comparable with those for traditional smoking cessation interventions. The simple NEXit intervention has the potential to improve the uptake of effective smoking cessation interventions.isrctn.org Identifier: ISRCTN75766527.
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Project description:BackgroundLatino men in the United States report low physical activity (PA) levels and related health conditions (eg, diabetes and obesity). Engaging in regular PA can reduce the risk of chronic diseases and yield many health benefits; however, there is a paucity of interventions developed exclusively for Latino men.ObjectiveTo address the need for culturally relevant PA interventions, this study aims to develop and evaluate Hombres Saludables, a 6-month theory-based, tailored web- and text message-based PA intervention in Spanish for Latino men. This protocol paper describes the study design, intervention, and evaluation methods for Hombres Saludables.MethodsLatino men aged 18-65 years were randomized to either the individually tailored PA internet intervention arm or the nutrition and wellness internet control arm. The PA intervention included 2 check-in phone calls; automated SMS text messages; a pedometer; a 6-month gym membership; access to a private Facebook group; and an interactive website with PA tracking, goal setting, and individually tailored PA content. The primary outcomes were feasibility, acceptability, and efficacy (minutes per week of total moderate-to-vigorous PA assessed via the ActiGraph GT3X+ accelerometer worn at the waist and 7-day physical activity recall at baseline and 6 months). Secondary outcomes examined potential moderators (eg, demographics, acculturation, and environmental variables) and mediators (eg, self-efficacy and cognitive and behavioral processes of change) of treatment effects at 6 months post randomization.ResultsThis study was funded in September 2016. Initial institutional review board approval was received in February 2017, and focus groups and intervention development were conducted from April 2017 to January 2018. Recruitment for the clinical trial was carried out from February 2018 to July 2019. Baseline data collection was carried out from February 2018 to October 2019, with a total of 43 participants randomized. Follow-up data were collected through April 2020. Data cleaning and analysis are ongoing.ConclusionsWe developed and tested protocols for a highly accessible, culturally and linguistically relevant, theory-driven PA intervention for Latino men. Hombres Saludables used an innovative, interactive, web- and text message-based intervention for improving PA among Latino men, an underserved population at risk of low PA and related chronic disease. If the intervention demonstrates feasibility, acceptability, and preliminary efficacy, we will refine and evaluate it in a larger randomized control trial.Trial registrationClinicaltrials.gov: NCT03196570; https://clinicaltrials.gov/ct2/show/NCT03196570.International registered report identifier (irrid)DERR1-10.2196/23690.
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