Dataset Information

C-A1-01: Changes in Physical Activity and Nutrition in a Behavioral Intervention Pilot Study - Passport to Brain Wellness.

ABSTRACT: Background/Aims: Increasing concerns about cognitive decline and dementia in the aging populations of most westernized countries suggests the need for interventions that can preserve cognitive function, are cost-effective, and feasibly implemented on a large scale. Empirical evidence is accumulating that points to the potential beneficial effects of cardiovascular fitness, healthy diet, social integration and participation in cognitively stimulating activities in the maintenance of cognitive function. We have developed and pilot tested ?Passport,? a multi-component, cognitive-behavioral, phone and mail based intervention to promote such lifestyle changes in older adults.Methods: Cognitively intact (TICS ? 31), sedentary (<90 min physical activity[PA] per week) adults aged 61?80 years were recruited from among HealthPartners? members. Baseline assessments included cognitive function, biomarkers, lifestyle factors, and physical traits. In the first phase, 21 participants were recruited and all assigned (non-randomized) to receive a course book, pedometer, tool kit and 7 bi-weekly phone coaching calls. In the second phase, 42 participants were recruited and randomized to either the Guided Intervention (n=22) or a Self-Directed (n=20) group, who received the study materials but no coaching. We completed 6 month follow-up measures with 58 (92%) subjects, and report here on their PA and nutritional outcomes.Results: The 63 enrolled subjects were female (60%), 70 years old, highly educated (73% college or more), predominantly retired (81%), non-Hispanic White (71%;) and married (65%). On average, they were overweight, BMI M=29.8, normotensive, systolic BP M=122.8, and normocholesterolemic, total serum cholesterol M=189.3. Mixed-model analyses indicated a time*treatment group effect on objectively monitored MVPA (p<.05), with a significant increase in the guided group (7.3 to 16.5mins/day, p<.05). We observed a significant effect of time on saturated fat intake (p<.05), with a significant pre-post reduction among Guided participants (26.1 to 23.4 grams, p<.05). Similar patterns of effects were observed for intake of fruits, vegetables and dietary fiber. Finally, we observed a time effect on intake of fish high in omega-3 fatty acids, driven by an increase in the non-randomized group (p<.05).Conclusions: Passport shows promise for improving aspects of lifestyle behaviors hypothesized to be important for the primary prevention of cognitive decline in older adults.

SUBMITTER: Hanson LR

PROVIDER: S-EPMC3006554 | biostudies-other | 2010 Dec

REPOSITORIES: biostudies-other

ACCESS DATA

Similar Datasets

Project description:BackgroundFun 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).MethodThe 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.DiscussionResults are intended to inform the preparation of a future definitive randomized controlled trial.Trial registrationClinicalTrials.gov, NCT03906942, registered 8 April 2019.Trial fundingThe Erwin and Barbara Mautner Charitable Foundation and the Michigan State University College of Education.

Project description:BackgroundFun For Wellness (FFW) is an online behavioral intervention developed to encourage growth in well-being by providing capability-enhancing learning opportunities to participants. Self-efficacy theory guides the conceptual model underlying the FFW intervention. Some initial evidence has been provided for the efficacy of FFW to promote: well-being self-efficacy; interpersonal, community, psychological and economic subjective well-being; and, interpersonal and physical well-being actions. The purpose of this paper is to describe the protocol for a new randomized controlled trial (RCT) designed to provide the first investigation of the effectiveness of FFW to increase well-being and physical activity in adults with obesity in the United States of America.MethodsThe study design is a large-scale, prospective, parallel group RCT. Approximately 9 hundred participants will be randomly assigned to the FFW or Usual Care (UC) group to achieve a 1:1 group (i.e., ffwUC) assignment. Participants will be recruited through an online panel recruitment company. Data collection, including determination of eligibility, will be conducted online and enrollment is scheduled to begin on 8 August 2018. Data collection will occur at baseline, 30 days and 60 days after baseline. Instruments to measure demographic information, anthropometric characteristics, self-efficacy, physical activity and well-being will be included in the battery. Data will be modeled under an intent to treat approach and/or a complier average causal effect approach depending on the level of observed engagement with the intervention.DiscussionThe effectiveness trial described in this paper builds upon the 2015 FFW efficacy trial and has the potential to be important for at least three reasons. The first reason is based upon a general scientific approach that the potential utility of interventions should be evaluated under both ideal (e.g., more controlled) and real-world (e.g., less controlled) conditions. The second reason is based upon the global need for readily scalable online behavioral interventions that effectively promote physical activity in adults. The third reason is based upon the troubling global trend toward obesity along with evidence for obesity as a risk factor for several major non-communicable diseases.Trial registrationClinicalTrials.gov, identifier: NCT03194854 , registered 21 June 2017.

Project description:BACKGROUND:Insufficient physical activity in the adult population is a global pandemic. Fun for Wellness (FFW) is a self-efficacy theory- and Web-based behavioral intervention developed to promote growth in well-being and physical activity by providing capability-enhancing opportunities to participants. OBJECTIVE:This study aimed to evaluate the effectiveness of FFW to increase physical activity in adults with obesity in the United States in a relatively uncontrolled setting. METHODS:This was a large-scale, prospective, double-blind, parallel-group randomized controlled trial. Participants were recruited through an online panel recruitment company. Adults with overweight were also eligible to participate, consistent with many physical activity-promoting interventions for adults with obesity. Also consistent with much of the relevant literature the intended population as simply adults with obesity. Eligible participants were randomly assigned to the intervention (ie, FFW) or the usual care (ie, UC) group via software code that was written to accomplish equal allocations to the FFW and UC groups. Data collection was Web based, fully automated, and occurred at three time points: baseline, 30 days after baseline (T2), and 60 days after baseline (T3). Participants (N=461) who were assigned to the FFW group (nFFW=219) were provided with 30 days of 24-hour access to the Web-based intervention. A path model was fit to the data consistent with the FFW conceptual model for the promotion of physical activity. RESULTS:There was evidence for a positive direct effect of FFW on transport-related physical activity self-efficacy (beta=.22, P=.02; d=0.23), domestic-related physical activity self-efficacy (beta=.22, P=.03; d=0.22), and self-efficacy to regulate physical activity (beta=.16, P=.01; d=0.25) at T2. Furthermore, there was evidence for a positive indirect effect of FFW on physical activity at T3 through self-efficacy to regulate physical activity at T2 (beta=.42, 95% CI 0.06 to 1.14). Finally, there was evidence for a null direct effect of FFW on physical activity (beta=1.04, P=.47; d=0.07) at T3. CONCLUSIONS:This study provides some initial evidence for both the effectiveness (eg, a positive indirect effect of FFW on physical activity through self-efficacy to regulate physical activity) and the ineffectiveness (eg, a null direct effect of FFW on physical activity) of the FFW Web-based behavioral intervention to increase physical activity in adults with obesity in the United States. More broadly, FFW is a scalable Web-based behavioral intervention that may effectively, although indirectly, promote physical activity in adults with obesity and therefore may be useful in responding to the global pandemic of insufficient physical activity in this at-risk population. Self-efficacy to regulate physical activity appears to be a mechanism by which FFW may indirectly promote physical activity in adults with obesity. TRIAL REGISTRATION:ClinicalTrials.gov, identifier: NCT03194854; https://clinicaltrials.gov/ct2/show/NCT03194854.

Project description:BackgroundUntreated heterozygous familial hypercholesterolaemia (FH) causes high low-density lipoprotein cholesterol (LDL-C) levels and increased cardiovascular disease (CVD) risk. Despite pharmacological treatment, many treated individuals remain at higher CVD risk than non-affected individuals. This may be due to LDL-C targets not being met and presence of other CVD risk factors. Adhering to dietary and physical activity (PA) recommendations developed for individuals with FH may further reduce CVD risk. However, there is insufficient research to support the efficacy of adhering to these guidelines on LDL-C and other CVD risk factors. The need for studies to investigate the effectiveness of nutrition and PA interventions in the FH population has been widely recognised and recommended. This paper describes the protocol of a pilot, randomised controlled trial designed to evaluate the feasibility and acceptability of a specifically developed nutrition and PA intervention aimed at improving the dietary intakes and PA levels of families with FH.MethodsA two-arm randomised waitlist-controlled pilot trial will be conducted across three National Health Service (NHS) sites in England, UK. Twenty-four young people with FH, aged 10-18 years, and their affected parent, will be recruited and randomly assigned to the intervention or waitlist and usual care control. The primary aim is to provide evidence for the feasibility and acceptability of delivering the intervention, explored quantitatively (rates of recruitment, retention and outcome measure completeness) and qualitatively (qualitative interviews). The secondary aim is to provide evidence for the potential efficacy of the intervention on dietary intake, PA, sedentary time, body composition, CVD risk factors and quality of life determined at baseline and endpoint assessments. The intervention will involve an hour-long consultation with a dietitian at baseline and four follow-up contacts across the 12-week intervention. It has been specifically developed for use with individuals with FH and incorporates behavioural change techniques to target identified enablers and barriers to adherence in this population.DiscussionThis trial will estimate the feasibility and acceptability of the nutrition and PA intervention delivered to young people and parents with FH. If appropriate, this study can be used to inform the design of an adequately powered definitive trial.Trial registrationISRCTN, ISRCTN24880714. Registered 07/06/2018, http://www.isrctn.com/ISRCTN24880714.

Dataset Information

C-A1-01: Changes in Physical Activity and Nutrition in a Behavioral Intervention Pilot Study - Passport to Brain Wellness.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets