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Increasing Physical Activity in Empty Nest and Retired Populations Online: A Randomized Feasibility Trial Protocol.

ABSTRACT: Despite the extensive evidence on the benefits of physical activity (PA) in older adults, including reduced risk of disease, mortality, falls, and cognitive and functional decline, most do not attain sufficient PA levels. Theoretical work suggests that behavioral change interventions are most effective during life transitions, and as such, a theory-based, online intervention tailored for recently retired and empty nest individuals could lend support for increasing levels of PA. The aim of this study is to examine the feasibility of the intervention and study procedures for a future controlled trial. This study has a randomized controlled trial design with an embedded qualitative and quantitative process evaluation. Participants are randomized at 1:1 between the intervention and waitlist controls. Potential participants are within six months of their final child leaving the familial home or within six months of retiring (self-defined), currently not meeting the Canadian PA guidelines, have no serious contraindications to exercise, and are residing in Victoria, British Columbia, Canada. Participants are recruited by online and print flyers as well as in-person at community events. The study aims to recruit 40 empty nest and 40 retired participants; half of each group received the intervention during the study period. The internet-delivered intervention is delivered over a 10-week period, comprising 10 modules addressing behavior change techniques associated with PA. Primary outcomes relate to recruitment, attrition, data collection, intervention delivery, and acceptability. Secondary behavioral outcomes are measured at baseline and post-treatment (10 weeks). Intervention-selected participants are invited to an optional qualitative exit interview. The results of this feasibility study will inform the planning of a randomized effectiveness trial, that will examine the behavior change, health-related fitness, and well-being outcomes by exploring how reflexive processes of habit and identity may bridge adoption and maintenance in behavioral adherence.

SUBMITTER: Cox A

PROVIDER: S-EPMC7277598 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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Increasing Physical Activity in Empty Nest and Retired Populations Online: A Randomized Feasibility Trial Protocol.

Cox Amy A Rhodes Ryan R

International journal of environmental research and public health 20200519 10

Despite the extensive evidence on the benefits of physical activity (PA) in older adults, including reduced risk of disease, mortality, falls, and cognitive and functional decline, most do not attain sufficient PA levels. Theoretical work suggests that behavioral change interventions are most effective during life transitions, and as such, a theory-based, online intervention tailored for recently retired and empty nest individuals could lend support for increasing levels of PA. The aim of this s ...[more]

PMID: 32438600

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Project description:Background:Fun For Wellness (FFW) is an online behavioral intervention designed to promote growth in well-being and physical activity by providing capability-enhancing learning opportunities to participants. The conceptual framework for the FFW intervention is guided by self-efficacy theory. Evidence has been provided for the efficacy of FFW to promote self-reported free-living physical well-being actions in adults who comply with the intervention. The objective of this manuscript is to describe the protocol for a feasibility study designed to address uncertainties regarding the inclusion of accelerometer-based assessment of free-living physical activity within the FFW online intervention among adults with obesity in the United States of America (USA). Method:The study design is a prospective, double-blind, parallel group randomized pilot trial. Thirty participants will be randomly assigned to the FFW or usual care (UC) group to achieve a 1:1 group (i.e., FFW:UC) assignment. Recruitment of participants is scheduled to begin on 29 April 2019 at a local bariatric services center within a major healthcare organization in the Midwest of the USA. There are five eligibility criteria for participation in this study: (1) between 18 and 64?years old, (2) a body mass index ??25.00?kg/m2, (3) ability to access the online intervention, (4) the absence of simultaneous enrollment in another intervention program promoting physical activity, and (5) willingness to comply with instructions for physical activity monitoring. Eligibility verification and data collection will be conducted online. Three waves of data will be collected over a 13-week period. Instruments designed to measure demographic information, anthropometric characteristics, acceptability and feasibility of accelerometer-based assessment of physical activity, self-efficacy, and well-being will be included in the study. Data will be analyzed using descriptive statistics (e.g., recruitment rates), Pearson's correlation coefficient, Bland-Altman analyses, and inferential statistical models under both an intent to treat approach and a complier average causal effect approach. Discussion:Results are intended to inform the preparation of a future definitive randomized controlled trial. Trial registration:ClinicalTrials.gov, NCT03906942, registered 8 April 2019. Trial funding:The Erwin and Barbara Mautner Charitable Foundation and the Michigan State University College of Education.

Project description:Increasing moderate to vigorous physical activity among urban girls of low socioeconomic status is both a challenge and a public health priority. Physical activity interventions targeting exclusively girls remain limited, and maintenance of moderate to vigorous physical activity during the post-intervention period has been difficult to maintain. The main aim of the 5-year "Girls on the Move" group randomized trial is to evaluate the efficacy of a comprehensive school-based intervention in increasing girls' minutes of moderate to vigorous physical activity and improving cardiovascular fitness, body mass index, and percent body fat immediately post-intervention (after 17 weeks) and at 9-month post-intervention follow-up (9 months after end of intervention).A total of 24 urban middle schools in the Midwestern U.S. will be randomized to either receive the intervention or serve as a control (N = 1200 girls). The intervention, based on the Health Promotion Model and Self-Determination Theory, will include: (1) two face-to-face motivational, individually tailored counseling sessions with a registered nurse, one at the beginning and the other at the end of the intervention period; (2) an interactive Internet-based session during which each girl receives individually tailored motivational and feedback messages via iPad at 11 weeks (shortly after midpoint of intervention); and (3) a 90-minute after-school physical activity club. Racially diverse, low-active, 10- to 14-year-old 5th to 8th-grade girls will complete questionnaires and physical measures at baseline and post-intervention (n = 50 per school). Minutes of moderate to vigorous physical activity will be assessed with accelerometers. Cardiovascular fitness will be assessed by estimating VO2 max with PACER (Progressive Aerobic Cardiovascular Endurance Run) scores. Height and weight will be assessed to calculate body mass index. Percent body fat will be estimated with a foot-to-foot bioelectric impedance scale. Linear mixed effects regression analyses will be performed to assess intervention effects.This multi-component approach is expected to improve girls' moderate to vigorous physical activity and related physical outcomes.ClinicalTrials.gov Identifier NCT01503333.

Project description:BackgroundHigh attrition following initial enrollment in evidence-based weight loss programs is a common, challenging, and under-studied issue. A behavioral economics approach consisting of modest monetary incentives may help to engage participants beyond enrollment to close the initial attrition gap.PurposeTo describe the methods and design of a pragmatic, online randomized controlled trial (RCT) of an incentivized, technology-facilitated weight loss program through an innovative research-practice partnership involving primary care, health promotion researchers, and a small business.MethodsThis study is a four-arm (1:1:1:1) RCT that compares the efficacy of outcome-based (weight loss), process-based (weighing in), a combination of outcome- and process-based, or choice-based incentives on sustaining program reach after initial enrollment for an evidence-based weight loss program. The multicomponent weight loss program includes a website, social cognitive theory-based daily health coaching, tailored messaging delivered via email and text messaging, access to online health coaches, and objective weight assessment through a community kiosk. The study will enroll 400 individuals aged 19 and older who have a body mass index ≥25 kg/m2, and have reliable access to the Internet or a smart phone. Participants will be followed for 3, 6, 9, and 12 months to assess program reach and representativeness, and continued participation after enrollment. The secondary outcomes include weight loss and program implementation costs. We will conduct participant focus groups to understand the barriers and facilitators of participation and key informant interviews focusing on clinic managers and care providers to explore the potential for future adoption and implementation of the evidence-based program.DiscussionThis study possesses the potential to close the attrition gap after initial enrollment in a web-based digital weight loss intervention in the primary care and community settings. Clinicaltrials.gov registration: NCT04225234.

Project description:BackgroundMost adults are not achieving recommended levels of physical activity (150 minutes/week, moderate-to-vigorous intensity). Inadequate activity levels are associated with numerous poor health outcomes, and clinical recommendations endorse physical activity in the front-line treatment of obesity, diabetes, dyslipidemia, and hypertension. A framework for physical activity prescription and referral has been developed, but has not been widely implemented. This may be due, in part, to the lack of feasible and effective physical activity intervention programs designed to coordinate with clinical care delivery.ObjectiveThis manuscript describes the protocol for a pilot randomized controlled trial (RCT) that tests the efficacy of a 13-week online intervention for increasing physical activity in adult primary care patients (aged 21-70 years) reporting inadequate activity levels. The feasibility of implementing specific components of a physical activity clinical referral program, including screening for low activity levels and reporting patient program success to referring physicians, will also be examined. Analyses will include participant perspectives on maintaining physical activity.MethodsThis pilot study includes a 3-month wait-listed control RCT (1:1 ratio within age strata 21-54 and 55-70 years). After the RCT primary end point at 3 months, wait-listed participants are offered the full intervention and all participants are followed to 6 months after starting the intervention program. Primary RCT outcomes include differences across randomized groups in average step count, moderate-to-vigorous physical activity, and sedentary behavior (minutes/day) derived from accelerometers. Maintenance of physical activity changes will be examined for all participants at 6 months after the intervention start.ResultsRecruitment took place between October 2018 and May 2019 (79 participants were randomized). Data collection was completed in February 2020. Primary data analyses are ongoing.ConclusionsThe results of this study will inform the development of a clinical referral program for physical activity improvement that combines an online intervention with clinical screening for low activity levels, support for postintervention behavior maintenance, and feedback to the referring physician.Trial registrationClinicalTrials.gov NCT03695016; https://clinicaltrials.gov/ct2/show/NCT03695016.International registered report identifier (irrid)DERR1-10.2196/18891.

Project description:BackgroundMajor depressive disorder (MDD) is a prevalent and debilitating mental health disorder. Among different therapeutic approaches (eg, medication and psychotherapy), psychotherapy in the form of cognitive behavioral therapy (CBT) is considered the gold standard treatment for MDD. However, although efficacious, CBT is not readily accessible to many patients in need because of hurdles such as stigma, long wait times, high cost, the large time commitment for health care providers, and cultural or geographic barriers. Electronically delivered cognitive behavioral therapy (e-CBT) can effectively address many of these accessibility barriers.ObjectiveThis study aims to investigate the efficacy and feasibility of implementing an e-CBT program compared with in-person treatment for MDD. It is hypothesized that the e-CBT program will offer results comparable with those of the in-person treatment program, regarding symptom reduction and quality of life improvement.MethodsThis nonrandomized controlled trial intervention will provide e-CBT for MDD through the Online Psychotherapy Tool, a secure, cloud-based, digital mental health platform. Participants (aged 18-65 years) will be offered 12 weekly sessions of an e-CBT program tailored to MDD to address their depressive symptoms. Participants (n=55) will complete predesigned modules and homework assignments while receiving personalized feedback and interacting with a therapist through the platform. Using clinically validated symptomology questionnaires, the efficacy of the e-CBT program will be compared with that of a group (n=55) receiving in-person CBT. Questionnaires will be completed at baseline, at week 6 and week 12, and at a 6-month follow-up. Focus groups will be conducted to investigate personal, cultural, and social factors impacting the accessibility and feasibility of implementing a web-based psychotherapy tool from a patient and care provider perspective. Inclusion criteria include diagnosis of MDD, competence to consent to participate, ability to speak and read English, and consistent and reliable access to the internet. Exclusion criteria include active psychosis, acute mania, severe alcohol or substance use disorder, and active suicidal or homicidal ideation.ResultsEthics approval was obtained in January 2019, and recruitment of participants began in June 2019. Recruitment has been conducted via social media, web-based communities, and physician referrals. To date, 52 participants have been recruited to the e-CBT group, and 48 patients have been recruited to the in-person CBT group. Data collection is expected to be completed by March 2021, and analyses are expected to be completed by June 2021, as linear regression (for continuous outcomes) and binomial regression analysis (for categorical outcomes) are still being conducted.ConclusionsThe results of this study can provide valuable information for the development of more accessible and scalable mental health interventions with increased care capacity for MDD, without sacrificing the quality of care.Trial registrationClinicalTrials.gov NCT04478058; http://clinicaltrials.gov/ct2/show/NCT04478058.International registered report identifier (irrid)DERR1-10.2196/27489.

Project description:BackgroundIn the veteran community, chronic pain is particularly prevalent and often debilitating. Until recently, veterans with chronic pain were offered primarily pharmacological intervention options, which rarely suffice and can also have negative health consequences. To better address chronic pain in veterans, the Veterans Health Administration has invested in novel, nonpharmacological behavior interventions that target both pain management and chronic pain-related functional issues. One approach, acceptance and commitment therapy (ACT) for chronic pain, is supported by decades of efficacy evidence for improving pain outcomes; however, ACT can be difficult to obtain owing to issues such as a lack of trained therapists or veterans having difficulty committing to the time and resources needed for the full clinician-led ACT protocol. Given the strong ACT evidence base combined with access limitations, we set out to develop and evaluate Veteran ACT for Chronic Pain (VACT-CP), an online program guided by an embodied conversational agent to improve pain management and functioning.ObjectiveThe aims of this study are to develop, iteratively refine, and then conduct a pilot feasibility randomized controlled trial (RCT) of a VACT-CP group (n=20) versus a waitlist and treatment-as-usual control group (n=20).MethodsThis research project includes 3 phases. In phase 1, our research team consulted with pain and virtual care experts, developed the preliminary VACT-CP online program, and conducted interviews with providers to obtain their feedback on the intervention. In phase 2, we incorporated feedback from phase 1 into the VACT-CP program and completed initial usability testing with veterans with chronic pain. In phase 3, we are conducting a small pilot feasibility RCT, with the primary outcome being assessment of usability of the VACT-CP system.ResultsThis study is currently in phase 3; recruitment for the RCT began in April 2022 and is expected to continue through April 2023. Data collection is expected to be completed by October 2023, with full data analysis completed by late 2023.ConclusionsThe findings from this research project will provide information on the usability of the VACT-CP intervention, as well as secondary outcomes related to treatment satisfaction, pain outcomes (pain-related daily functioning and pain severity), ACT processes (pain acceptance, behavioral avoidance, and valued living), and mental and physical functioning.Trial registrationClinicalTrials.gov NCT03655132; https://clinicaltrials.gov/ct2/show/NCT03655132.International registered report identifier (irrid)DERR1-10.2196/45887.

Dataset Information

Increasing Physical Activity in Empty Nest and Retired Populations Online: A Randomized Feasibility Trial Protocol.

Publications

Increasing Physical Activity in Empty Nest and Retired Populations Online: A Randomized Feasibility Trial Protocol.

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