Targeting self-control as a behavior change mechanism to increase physical activity: Study protocol of a randomized controlled trial.
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SUBMITTER: Stieger M
PROVIDER: S-EPMC7887092 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundLower-limb amputation (LLA) due to non-traumatic vascular etiology is linked to extremely low physical activity and high disability.ObjectiveTo test the feasibility of a biobehavioral intervention designed to promote physical activity.DesignA randomized, single-blind feasibility trial with a crossover design.SettingVeterans Administration Medical Center.ParticipantsMilitary veterans (age: 65.7 [7.8] years; mean [standard deviation]) with nontraumatic lower-limb amputation (LLA), randomized to two groups: GROUP1 (n = 16) and GROUP2 (n = 15). Both groups had similar baseline amputation characteristics (level of amputation and time since amputation).InterventionsTwelve weekly, 30-minute telehealth sessions of physical activity behavior-change intervention, with GROUP1 participating in weeks 1-12 and GROUP2 in weeks 13-24. GROUP1 noncontact phase in weeks 13-24 and GROUP2 attention control telehealth phase in weeks 1-12.Main outcome measuresFeasibility (participant retention, dose goal attainment, intervention acceptability [Intrinsic Motivation Inventory [IMI] Interest and Enjoyment scale], safety) and signal of efficacy (free-living physical activity [accelerometer-based average daily step count], Late Life Function and Disability Index - Disability Scale [LLFDI-DS]).ResultsParticipant retention rate was high (90%), with three participants lost to follow-up during the intervention period. Dose goal attainment was low, with only 10% of participants achieving an a priori walking dose goal. Intervention was rated as acceptable, with mean IMI Interest and Enjoyment score (5.8) statistically higher than the null value of 5.0 (P = .002). There were no between-group differences in adverse event rates (falls: P = .19, lower extremity wounds: P = .60). There was no signal of efficacy for change in average daily step count (d = -0.15) or LLFDI-DS (d = -0.22 and 0.17 for frequency and limitations scales, respectively).ConclusionsTelehealth delivered biobehavioral intervention resulted in acceptable participant retention, low dose goal attainment, high participant acceptability, and low safety risk, while having no signal of efficacy (physical activity, disability) for people with nontraumatic LLA.
| S-EPMC8229675 | biostudies-literature
Project description:ObjectiveTo determine preliminary efficacy of a home-based behavior-change intervention designed to promote exercise, walking activity, and disease self-management.DesignA single-blind, randomized controlled pilot trial.SettingOne Veterans Administration and 2 regional medical centers.ParticipantsA total of 38 participants randomized to behavior-change intervention (n=19) or attention control (CTL; n=19) group.InterventionsWeekly 30-minute telephone sessions for 12 weeks with intervention group sessions focused on health behavior change and CTL group sessions focused on health status monitoring.Main outcome measuresPhysical function, walking activity (steps/d averaged over 10d), and disability were measured at baseline, 12 weeks (intervention end), and 24 weeks after baseline with the Timed Up and Go (TUG) test as the primary outcome measure.ResultsThe TUG test was not changed from baseline in either group and was not different between groups after 12 or 24 weeks. Several exploratory outcomes were assessed, including daily step count, which increased 1135 steps per day in the intervention group compared to 144 steps per day in the CTL group after 12 weeks (P=.03). Only the intervention group had within-group increase in steps per day from baseline to 12 (P<.001) and 24 (P=.03) weeks and spent significantly less time in sedentary activity (4.8% decrease) than the CTL group (0.2% decrease) at 24 weeks (P=.04). There were no other between-group differences in physical function or disability change over time.ConclusionThe behavior-change intervention demonstrates promise for increasing walking activity for people with dysvascular transtibial amputation (TTA). The efficacy of implementing such intervention in the scope of conventional TTA rehabilitation should be further studied.
| S-EPMC6215727 | biostudies-literature
Project description:BackgroundBeing physically active is critical to successful aging, but most middle-aged and older adults do not move enough. Research has shown that even small increases in activity can have a significant impact on risk reduction and improve quality of life. Some behavior change techniques (BCTs) can increase activity, but prior studies on their effectiveness have primarily tested them in between-subjects trials and in aggregate. These design approaches, while robust, fail to identify those BCTs most influential for a given individual. In contrast, a personalized, or N-of-1, trial design can assess a person's response to each specific intervention.ObjectiveThis study is designed to test the feasibility, acceptability, and preliminary effectiveness of a remotely delivered personalized behavioral intervention to increase low-intensity physical activity (ie, walking) in adults aged 45 to 75 years.MethodsThe intervention will be administered over 10 weeks, starting with a 2-week baseline period followed by 4 BCTs (goal-setting, self-monitoring, feedback, and action planning) delivered one at a time, each for 2 weeks. In total, 60 participants will be randomized post baseline to 1 of 24 intervention sequences. Physical activity will be continuously measured by a wearable activity tracker, and intervention components and outcome measures will be delivered and collected by email, SMS text messages, and surveys. The effect of the overall intervention on step counts relative to baseline will be examined using generalized linear mixed models with an autoregressive model that accounts for possible autocorrelation and linear trends for daily steps across time. Participant satisfaction with the study components and attitudes and opinions toward personalized trials will be measured at the intervention's conclusion.ResultsPooled change in daily step count will be reported between baseline and individual BCTs and baseline versus overall intervention. Self-efficacy scores will be compared between baseline and individual BCTs and between baseline and the overall intervention. Mean and SD will be reported for survey measures (participant satisfaction with study components and attitudes and opinions toward personalized trials).ConclusionsAssessing the feasibility and acceptability of delivering a personalized, remote physical activity intervention for middle-aged and older adults will inform what steps will be needed to scale up to a fully powered and within-subjects experimental design remotely. Examining the effect of each BCT in isolation will allow for their unique impact to be assessed and support design of future behavioral interventions. In using a personalized trial design, the heterogeneity of individual responses for each BCT can be quantified and inform later National Institutes of Health stages of intervention development trials.Trial registrationclinicaltrials.gov NCT04967313; https://clinicaltrials.gov/ct2/show/NCT04967313.International registered report identifier (irrid)RR1-10.2196/43418.
| S-EPMC10337349 | biostudies-literature
Project description:BackgroundIncreasing physical activity is important in the promotion of better health. Computer-tailored behavior change programs have shown promise in changing lifestyle risk factors.PurposeTo provide a narrative systematic review describing the range of evidence on 'second' and 'third' generation computer-tailored primary prevention interventions for physical activity, to determine their effectiveness and key characteristics of success. Unlike previous reviews, this review used specific criteria to measure the external validity of studies, was exclusive to primary prevention interventions in which tailoring was generated through an expert system, and excluded first generation computer-tailored interventions.MethodsComputer-tailored intervention studies published from January 1996-2008 were identified through a search of five databases: Medline; Embase; PsycINFO; CINAHL; and All EBM Reviews and by examining reference lists of relevant articles.ResultsSeventeen articles were included, describing the evaluation of 16 interventions, ten of which found significant positive effects of the computer-tailored interventions on physical activity or weight reduction outcomes.ConclusionThe evidence of effectiveness for computer-tailored physical activity interventions is inconclusive. They have potential to reach large groups of people however there is uncertainty whether reported effects are generalizable and sustained.
| S-EPMC2700068 | biostudies-literature
Project description:BackgroundBehavior change interventions have been the focus of recent studies, and the COVID-19 pandemic highlighted the importance of online interventions. However, no previous studies have investigated behavior change techniques to improve physical activity in adults with asthma through online intervention.MethodsThis double-blind clinical trial will investigate the effectiveness of an online behavior change intervention in increasing physical activity and reducing sedentary behavior in adults with asthma, as well as in improving other clinical outcomes in short and medium terms. Patients with clinically stable moderate to severe asthma, who are physically inactive and do not have cardiovascular and/or osteoneuromuscular impairments will be randomized into control or intervention groups (23 in each). Both groups will carry out an online educational program (1 h). Additionally, the intervention group will receive weekly individual online sessions for 12 weeks of motivation-based behavior change intervention to promote an increase in physical activity and reduce sedentary behavior based on both self-determination theory and transtheoretical model. The intervention group will also receive an activity monitor with specific strategies related to it. Both groups will be reassessed immediately after the intervention and 6 months after that. The primary outcomes are physical activity and sedentary behavior, which will be objectively assessed by a triaxial accelerometer (Actigraph wGT3X-BT). Secondary outcomes are Asthma Control Questionnaire, Incremental Step Test, Sit-To-Stand, Timed Up-and-Go, 4-Metre Gait Speed, Asthma Quality of Life Questionnaire, Pittsburgh Sleep Quality Index, Epworth Sleepiness Scale, Actiwatch 2, and the Hospital Anxiety and Depression Scale.DiscussionThe intervention is unprecedented and was carefully developed to joint most characteristics and techniques of both behavioral strategies (transtheoretical model and self-determination theory). Therefore, this intervention has the potential to improve physical activity levels and asthma management and reduce sedentary behavior. As a consequence, this novel intervention will improve global health in this population and support its use in clinical practice. The intervention will be carried out online with direct weekly contact with the therapist. Consequently, it has low implementation costs, might improve patient's attendance, and has the potential to be largely offered elsewhere.Trial registrationClinicalTrials.gov NCT05241223 . Registered on January 22, 2022.
| S-EPMC9727857 | biostudies-literature
Project description:OBJECTIVE:With the growing recognition that, for some, significant changes in drinking occur before the first treatment session (i.e., pretreatment change), researchers have called for the careful assessment of when change occurs and its potential impact on mechanism of behavior change (MOBC) research. Using a commonly hypothesized MOBC variable, alcohol abstinence self-efficacy, the primary aim of this study was to examine the effect of pretreatment change on the study of MOBCs. METHOD:Sixty-three individuals diagnosed with alcohol dependence were recruited to participate in a 12-week cognitive-behavioral treatment. Participants completed weekly assessments of self-efficacy and drinking behaviors. RESULTS:Multilevel time-lagged regression models indicated that pretreatment change significantly moderated the effect of self-efficacy on the number of drinking days, such that among those higher on pretreatment change, higher self-efficacy ratings predicted lower rates of drinking days in the week until the next treatment session. In contrast, pretreatment change did not moderate the effect of self-efficacy on the rate of heavy drinking days. CONCLUSIONS:Results from the current study add to a small but growing body of research highlighting the importance of pretreatment change when studying MOBCs. Further, these results provide important insights into the conditions in which self-efficacy may play an important role in treatment outcomes.
| S-EPMC6019774 | biostudies-literature
Project description:ObjectiveThis pilot randomized controlled trial (RCT) aimed at evaluating the feasibility and potential efficacy of a motivational interviewing (MI) intervention to increase physical activity (PA) behavior in cancer patients.MethodsParticipants were randomly assigned to an experimental group with standard care plus 12 MI sessions within 12 weeks or a control group with standard care only. The number of recruited participants and the modality of recruitment were recorded to describe the reach of the study. The acceptability of the study was estimated using the attrition rate during the intervention phase. The potential efficacy of the intervention was evaluated by analyzing the PA behavior.ResultsTwenty-five participants were recruited within the 16-month recruitment period (1.6 participants per month). Five participants (38.5%) from the experimental group (n = 13) and one participant (8.3%) from the control group (n = 12) dropped out of the study before the end of the intervention phase. No group by time interaction effect for PA behavior was observed at the end of the intervention.ConclusionDue to the low recruitment rate and compliance, no conclusion can be drawn regarding the efficacy of MI to increase PA behavior in cancer patients. Moreover, the current literature cannot provide any evidence on the effectiveness of MI to increase PA in cancer survivors. Future RCTs should consider that the percentage of uninterested patients to join the study may be as high as 60%. Overrecruitment (30% to 40%) is also recommended to accommodate the elevated attrition rate.
| S-EPMC7092651 | biostudies-literature
Project description:The goal of this study was to test the effects of a 7-week digital self-control intervention to increase physical activity using a two-arm randomized controlled trial. The self-control treatment group showed greater increases in self-reported physical activity (MET's) than the comparison group. Both groups significantly increased their daily steps and self-control. Participants with higher initial levels of conscientiousness were better able to increase their daily steps during the intervention and participants who increased more in self-control showed greater increases in MET's. These moderation effects were more pronounced in the self-control treatment group as compared to the comparison group. This study shows that the effects of physical activity interventions may depend on personality characteristics and outcomes may be improved when individual differences are considered and targeted.
| S-EPMC10466994 | biostudies-literature
Project description:BackgroundA better understanding of how multicomponent school-based interventions work and their effects on health and education outcomes are needed. This paper described the methods of the Movimente Program, a school-based intervention that aims to increase physical activity (PA) and decrease sedentary behavior (SB) among Brazilian students.MethodsThis is a cluster randomized controlled trial with adolescents from 7th to 9th grade in public schools from Florianopolis, Southern Brazil. After agreement, 6 schools were randomly selected to intervention or control groups (3 schools each), and all eligible students were invited to the study. The Movimente intervention program was performed during a school year and included 3 main components: Teacher training (including face-to-face meeting, social media platform, and handbook with lesson plans); improvements in the PA environment in school; and educational strategies. Control schools continued with their traditional schedule. Baseline (March/April 2017), postintervention (November/December 2017), and maintenance (June/July 2018) evaluations included PA and SB as primary outcomes (assessed by self-report and accelerometry). Secondary outcomes included psychosocial factors related to PA and SB (e.g., social support and self-efficacy), as well as health (e.g., quality of life and nutritional status) and education (e.g., academic achievement) outcomes. A program evaluation was performed based on the RE-AIM framework. Participants, intervention staffs, and evaluators were not blinded to group assignment, but a standardized evaluation protocol was applied independently of the trial allocation.ResultsStatistical analyses will include a multilevel approach for repeated measurements and mediation analysis. Any side effects of the intervention will be recorded. The sample size close to that expected (n = 1090) was reached (n = 999). The results of this trial will involve valuable information about the effect and the evaluation of a multicomponent intervention carried out in a middle-income country.ConclusionBy creating opportunities for adolescents to be active at school using multicomponent strategies, the Movimente program has the potential to enhance students health and academic performance which may encourage the school community (e.g., teachers, principals) to adopt the program. Also, this trial will provide evidence for practitioners, policy makers, and researchers on how multicomponent program may be implemented in a school setting.Trial registrationThe trial is registered at the Clinical Trial Registry (Trial ID: NCT02944318; date of registration: 18 October 2016).
| S-EPMC7402733 | biostudies-literature
Project description:BackgroundChronic diseases are the principal cause of morbidity and mortality worldwide. An increased consumption of vegetables and fruit reduces the risk of hypertension, coronary heart disease, stroke, and cancer. An increased fruit and vegetable (FV) intake may also prevent body weight gain, and therefore indirectly affect type 2 diabetes mellitus. Insufficient physical activity (PA) has been identified as the fourth leading risk factor for global mortality. Consequently, effective interventions that promote PA and FV intake in a large number of people are required.ObjectiveTo describe the systematic development of an eHealth intervention, MyPlan 1.0, for increasing FV intake and PA.MethodsThe intervention was developed following the six steps of the intervention mapping (IM) protocol. Decisions during steps were based upon available literature, focus group interviews, and pilot studies.ResultsBased on needs assessment (Step 1), it was decided to focus on fruit and vegetable intake and physical activity levels of adults. Based on self-regulation and the health action process approach model, motivational (eg, risk awareness) and volitional (eg, action planning) determinants were selected and crossed with performance objectives into a matrix with change objectives (Step 2). Behavioral change strategies (eg, goal setting, problem solving, and implementation intentions) were selected (Step 3). Tablet computers were chosen for delivery of the eHealth program in general practice (Step 4). To facilitate implementation of the intervention in general practice, GPs were involved in focus group interviews (Step 5). Finally, the planning of the evaluation of the intervention (Step 6) is briefly described.ConclusionsUsing the IM protocol ensures that a theory- and evidence-based intervention protocol is developed. If the intervention is found to be effective, a dynamic eHealth program for the promotion of healthy lifestyles could be available for use in general practice.
| S-EPMC4704890 | biostudies-literature