Dataset Information

The Walking Interventions Through Texting (WalkIT) Trial: Rationale, Design, and Protocol for a Factorial Randomized Controlled Trial of Adaptive Interventions for Overweight and Obese, Inactive Adults.

ABSTRACT: BACKGROUND:Walking is a widely accepted and frequently targeted health promotion approach to increase physical activity (PA). Interventions to increase PA have produced only small improvements. Stronger and more potent behavioral intervention components are needed to increase time spent in PA, improve cardiometabolic risk markers, and optimize health. OBJECTIVE:Our aim is to present the rationale and methods from the WalkIT Trial, a 4-month factorial randomized controlled trial (RCT) in inactive, overweight/obese adults. The main purpose of the study was to evaluate whether intensive adaptive components result in greater improvements to adults' PA compared to the static intervention components. METHODS:Participants enrolled in a 2x2 factorial RCT and were assigned to one of four semi-automated, text message-based walking interventions. Experimental components included adaptive versus static steps/day goals, and immediate versus delayed reinforcement. Principles of percentile shaping and behavioral economics were used to operationalize experimental components. A Fitbit Zip measured the main outcome: participants' daily physical activity (steps and cadence) over the 4-month duration of the study. Secondary outcomes included self-reported PA, psychosocial outcomes, aerobic fitness, and cardiorespiratory risk factors assessed pre/post in a laboratory setting. Participants were recruited through email listservs and websites affiliated with the university campus, community businesses and local government, social groups, and social media advertising. RESULTS:This study has completed data collection as of December 2014, but data cleaning and preliminary analyses are still in progress. We expect to complete analysis of the main outcomes in late 2015 to early 2016. CONCLUSIONS:The Walking Interventions through Texting (WalkIT) Trial will further the understanding of theory-based intervention components to increase the PA of men and women who are healthy, insufficiently active and are overweight or obese. WalkIT is one of the first studies focusing on the individual components of combined goal setting and reward structures in a factorial design to increase walking. The trial is expected to produce results useful to future research interventions and perhaps industry initiatives, primarily focused on mHealth, goal setting, and those looking to promote behavior change through performance-based incentives. TRIAL REGISTRATION:ClinicalTrials.gov NCT02053259; https://clinicaltrials.gov/ct2/show/NCT02053259 (Archived by WebCite at http://www.webcitation.org/6b65xLvmg).

SUBMITTER: Hurley JC

PROVIDER: S-EPMC4704955 | biostudies-literature | 2015 Sep

REPOSITORIES: biostudies-literature

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The Walking Interventions Through Texting (WalkIT) Trial: Rationale, Design, and Protocol for a Factorial Randomized Controlled Trial of Adaptive Interventions for Overweight and Obese, Inactive Adults.

Hurley Jane C JC Hollingshead Kevin E KE Todd Michael M Jarrett Catherine L CL Tucker Wesley J WJ Angadi Siddhartha S SS Adams Marc A MA

JMIR research protocols 20150911 3

<h4>Background</h4>Walking is a widely accepted and frequently targeted health promotion approach to increase physical activity (PA). Interventions to increase PA have produced only small improvements. Stronger and more potent behavioral intervention components are needed to increase time spent in PA, improve cardiometabolic risk markers, and optimize health.<h4>Objective</h4>Our aim is to present the rationale and methods from the WalkIT Trial, a 4-month factorial randomized controlled trial (R ...[more]

PMID: 26362511

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Project description:Little change over the decades has been seen in adults meeting moderate-to-vigorous physical activity (MVPA) guidelines. Numerous individual-level interventions to increase MVPA have been designed, mostly static interventions without consideration for neighborhood context. Recent technologies make adaptive interventions for MVPA feasible. Unlike static interventions, adaptive intervention components (e.g., goal setting) adjust frequently to an individual's performance. Such technologies also allow for more precise delivery of "smaller, sooner incentives" that may result in greater MVPA than "larger, later incentives". Combined, these factors could enhance MVPA adoption. Additionally, a central tenet of ecological models is that MVPA is sensitive to neighborhood environment design; lower-walkable neighborhoods constrain MVPA adoption and maintenance, limiting the effects of individual-level interventions. Higher-walkable neighborhoods are hypothesized to enhance MVPA interventions. Few prospective studies have addressed this premise. This report describes the rationale, design, intervention components, and baseline sample of a study testing individual-level adaptive goal-setting and incentive interventions for MVPA adoption and maintenance over 2 years among adults from neighborhoods known to vary in neighborhood walkability. We scaled these evidenced-based interventions and tested them against static-goal-setting and delayed-incentive comparisons in a 2 × 2 factorial randomized trial to increase MVPA among 512 healthy insufficiently-active adults. Participants (64.3% female, M age = 45.5 ± 9.1 years, M BMI = 33.9 ± 7.3 kg/m2, 18.8% Hispanic, 84.0% White) were recruited from May 2016 to May 2018 from block groups ranked on GIS-measured neighborhood walkability and socioeconomic status (SES) and classified into four neighborhood types: "high walkable/high SES," "high walkable/low SES," "low walkable/high SES," and "low walkable/low SES." Results from this ongoing study will provide evidence for some of the central research questions of ecological models.

Project description:BackgroundFor infertile women with overweight/obesity and insulin resistance (IR), it is uncertain whether intervention before infertility treatment can improve live birth rate (LBR). We implemented a factorial-design study to explore the effectiveness of lifestyle and metformin interventions. This pilot study aimed to evaluate the feasibility of a definitive study.MethodsWe randomised 80 women without polycystic ovarian syndrome (PCOS) who planned to start their first or second IVF/ICSI treatment with a body mass index ≥ 25 kg/m2 and IR. Participants were randomised (1:1:1:1) into four groups: (A) lifestyle intervention, (B) metformin intervention, (C) lifestyle + metformin intervention, or (D) no intervention. All interventions were performed before IVF/ICSI treatment.ResultsDuring 10 months, 114 women were screened and eligible; 80 were randomised, and 72 received the assigned treatment. The recruitment rate was 70.18% (80/114, 95% CI 61.65%-78.70%). An average of 10 participants were randomised each month. None of the participants crossed over from one group to another. Approximately 93.15% (68/73) of the participants achieved good intervention compliance. Only 77.78% (56/72) of the recruited participants started infertility treatment after achieving the goal of the intervention. All randomised participants completed the follow-up. Mild adverse events after metformin administration were reported in 43.24% (16/37) of the cases, although no serious adverse events related to the interventions occurred. The LBR for groups A + C and B + D were 33.33% (12/36) and 33.33% (12/36) (RR = 1.00, 95%CI:0.52-1.92) (lifestyle intervention effect). The LBR for groups B + C and A + D were 43.24% (16/37) and 22.86% (8/35) (RR = 1.89, 95% CI:0.93-3.86) (metformin intervention effect). There was no evidence for an intervention interaction between lifestyle and metformin. We cannot yet confirm the effects of lifestyle, metformin, or their interaction owing to the insufficient sample size in this pilot study.ConclusionsInstituting a 2 × 2 factorial design randomized controlled trial (RCT) is feasible, as the pilot study showed a high recruitment rate and compliance. There is no evidence that lifestyle or metformin improves live birth, and adequately powered clinical trials are required.Trial registrationclinicaltrials.gov NCT03898037. Registered: April 1, 2019.

Project description:BackgroundWalkIT Arizona was a 2×2 factorial trial examining the effects of goal type (adaptive versus static) and reinforcement type (immediate versus delayed) to increase moderate to vigorous physical activity (MVPA) among insufficiently active adults. The 12-month intervention combined mobile health (mHealth) technology with behavioral strategies to test scalable population-health approaches to increasing MVPA. Self-reported physical activity provided domain-specific information to help contextualize the intervention effects.ObjectiveThe aim of this study was to report on the secondary outcomes of self-reported walking for transportation and leisure over the course of the 12-month WalkIT intervention.MethodsA total of 512 participants aged 19 to 60 years (n=330 [64.5%] women; n=425 [83%] Caucasian/white, n=96 [18.8%] Hispanic/Latinx) were randomized into interventions based on type of goals and reinforcements. The International Physical Activity Questionnaire-long form assessed walking for transportation and leisure at baseline, and at 6 months and 12 months of the intervention. Negative binomial hurdle models were used to examine the effects of goal and reinforcement type on (1) odds of reporting any (versus no) walking/week and (2) total reported minutes of walking/week, adjusted for neighborhood walkability and socioeconomic status. Separate analyses were conducted for transportation and leisure walking, using complete cases and multiple imputation.ResultsAll intervention groups reported increased walking at 12 months relative to baseline. Effects of the intervention differed by domain: a significant three-way goal by reinforcement by time interaction was observed for total minutes of leisure walking/week, whereas time was the only significant factor that contributed to transportation walking. A sensitivity analysis indicated minimal differences between complete case analysis and multiple imputation.ConclusionsThis study is the first to report differential effects of adaptive versus static goals for self-reported walking by domain. Results support the premise that individual-level PA interventions are domain- and context-specific and may be helpful in guiding further intervention refinement.Trial registrationPreregistered at clinicaltrials.gov: (NCT02717663) https://clinicaltrials.gov/ct2/show/NCT02717663.International registered report identifier (irrid)RR2-10.1016/j.cct.2019.05.001.

Project description:ObjectivesMobile phone texting is a common daily occurrence with a paucity of research examining corresponding gait characteristics. To date, most studies have participants walk in a straight line vs. overcoming barriers and obstacles that occur during regular walking. The aim of our study is to examine the effect of mobile phone texting during periods of cognitive distraction while walking and negotiating barriers synonymous with pedestrian traffic.MethodsThirty participants (18-50 y) completed three randomized, counter-balanced walking tasks over a course during: (1) normal walking (control), (2) texting and walking, and (3) texting and walking whilst being cognitively distraction via a standard mathematical test performed while negotiating the obstacle course. We analyzed gait characteristics during course negotiation using a 3-dimensional motion analysis system and a general linear model and Dunnet-Hsu post-hoc procedure the normal walking condition to assess gait characteristic differences. Primary outcomes included the overall time to complete the course time and barrier contact. Secondary outcomes included obstacle clearance height, step frequency, step time, double support phase and lateral deviation.ResultsParticipants took significantly longer (mean ± SD) to complete the course while texting (24.96 ± 4.20 sec) and during cognitive distraction COG (24.09 ± 3.36 sec) vs. normal walking (19.32 ± 2.28 sec; all, P<0.001). No significant differences were noted for barrier contacts (P = 0.28). Step frequency, step time, double support phase and lateral deviation all increased in duration during the texting and cognitive distraction trial. Texting and being cognitively distracted also increased obstacle clearance versus the walking condition (all, P<0.02).ConclusionsTexting while walking and/or being cognitively distracted significantly affect gait characteristics concordant to mobile phone usage resulting in a more cautious gate pattern. Future research should also examine a similar study in older participants who may be at a greater risk of tripping with such walking deviations.

Project description:This randomized controlled trial investigated the effects of a 5-month high-intensity hybrid-type neuromuscular training program with nontraditional implements on cardiometabolic health, redox status, and cardiovascular disease (CVD) risk in inactive overweight and obese women. Forty-nine inactive female participants with overweight and obesity (age: 36.4 ± 4.4 years; BMI: 29.1 ± 2.9 kg/m2) were randomly assigned to either a control (C, n = 21) or a training group (TR, n = 28). TR followed a 20-week supervised, progressive, time-efficient (3 days/week; 6-15 min net exercise time) program implementing loaded fundamental movement patterns with prescribed work-to-rest time intervals (20-40 s, 1:2, 1:1, 2:1) in a circuit fashion (2-3 rounds). Cardiometabolic risk factors were measured at baseline and post-training as secondary outcomes of a larger randomized controlled trial. At post-intervention, TR demonstrated favorable changes in resting heart rate (-7%, p = 0.043), high-density lipoprotein (+18.1%, p = 0.029), atherogenic index (-17%, p = 0.045), mean arterial pressure (-4.5%, p = 0.03), waist circumference (-6.2%, p = 0.005), waist-to-hip ratio (-4.6%; p = 0.015), metabolic syndrome severity score (-222%, p = 0.024), full 30-year CVD risk (-15.8%, p = 0.002) and hard 30-year CVD risk (-17.6%, p = 0.01), vascular age (-7.8%, p = 0.002), protein carbonyls (-45.7%, p = 0.001), catalase activity (+15.2%, p = 0.023), and total antioxidant capacity (+11.4%, p = 0.002) relative to C. Additionally, TR induced beneficial changes in fasting glucose (-3.4%, p = 0.002), homeostatic model assessment for insulin resistance (-15.7%, p < 0.001), diastolic blood pressure (-5.6%, p < 0.001), reduced glutathione (+39.8%, p < 0.001), 10-year CVD risk (-17.4%, p = 0.011), and total bilirubin (-21.7%, p < 0.001) compared to baseline. These results suggest that hybrid-type neuromuscular training may improve aspects of cardiometabolic health and antioxidant status in inactive overweight and obese women providing a time-efficient (~100 min/week) exercise approach in a real-world gym setting.

Project description:It is often assumed that some individuals reliably increase energy intake (EI) post-exercise ('compensators') and some do not ('non-compensators'), leading researchers to examine the characteristics that distinguish these two groups. However, it is unclear whether EI post-exercise is stable over time. The present study examined whether compensatory eating responses to a single exercise bout are consistent within individuals across three pairs of trials. Physically inactive, overweight/obese women (n 28, BMI 30·3 (SD 2·9) kg/m²) participated in three pairs of testing sessions, with each pair consisting of an exercise (30 min of moderate-intensity walking) and resting testing day. EI was measured using a buffet meal 1 h post-exercise/rest. For each pair, the difference in EI (EIdiff = EIex - EIrest) was calculated, where EIex is the EI of the exercise session and EIrest is the EI of the resting session, and women were classified as a 'compensator' (EIex > EIrest) or 'non-compensator' (EIex ? EIrest). The average EI on exercise days (3328·0 (SD 1686·2) kJ) was similar to those on resting days (3269·4 (SD 1582·4) kJ) (P= 0·67). Although EI was reliable within individuals across the three resting days (intraclass correlation coefficient (ICC) 0·75, 95 % CI 0·60, 0·87; P< 0·001) and three exercise days (ICC 0·83, 95 % CI 0·70, 0·91; P< 0·001), the ICC for EIdiff across the three pairs of trials was low (ICC 0·20, 95 % CI -0·02, 0·45; P= 0·04), suggesting that compensatory eating post-exercise is not a stable construct. Moreover, the classification of 'compensators'/'non-compensators' was not reliable (? = -0·048; P= 0·66). The results were unaltered when 'relative' EI was used, which considers the energy expenditure of the exercise/resting sessions. Acute compensatory EI following an exercise bout is not reliable in overweight women. Seeking to understand what distinguishes 'compensators' from 'non-compensators' based on a single eating episode post-exercise is not justified.

Dataset Information

The Walking Interventions Through Texting (WalkIT) Trial: Rationale, Design, and Protocol for a Factorial Randomized Controlled Trial of Adaptive Interventions for Overweight and Obese, Inactive Adults.

Publications

The Walking Interventions Through Texting (WalkIT) Trial: Rationale, Design, and Protocol for a Factorial Randomized Controlled Trial of Adaptive Interventions for Overweight and Obese, Inactive Adults.

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