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The Italian Diabetes and Exercise Study 2 (IDES-2): a long-term behavioral intervention for adoption and maintenance of a physically active lifestyle.

ABSTRACT: Physical activity (PA)/exercise have become an integral part of the management of type 2 diabetes mellitus (T2DM). However, current guidelines are difficult to put into action in this population due to a number of barriers, especially the lack of acceptable, feasible, and validated behavioral intervention strategies. The present manuscript reports the rationale, study design and methods, and design considerations of the Italian Diabetes and Exercise Study (IDES)-2, a randomized controlled trial testing the efficacy of a behavior change strategy in increasing total daily PA and reducing sedentary time (SED-time) in patients with T2DM.Starting 7 January 2014, the IDES_2 began enrolling 300 patients with known T2DM of at least 1-year duration in three tertiary referral outpatient Diabetes Clinics in Rome. Additional requirements are age 40 to 80 years, body mass index 27 to 40 kg/m(2), sedentary lifestyle, and physically inactive for at least 6 months, ability to walk 1.6 km without assistance, and eligibility after cardiovascular evaluation. Patients are randomized by center and within each center, by age and type of diabetes treatment to either the intervention or the control group. Patients in the intervention (INT) group (n?=?150) receive theoretical and practical exercise counseling consisting of aggregated behavior change techniques (one individual theoretical counseling session plus eight twice-a-week individual theoretical and practical exercise counseling sessions) once a year for 3 years. Patients in the control (CON) group (n?=?150), receive standard care, including general physician recommendations for daily PA. The primary outcomes are total daily PA and SED-time, as measured objectively by the use of an accelerometer. Secondary outcomes include physical fitness, modifiable cardiovascular risk factors, musculoskeletal disturbances, well-being/depression, and health-related quality of life.The behavioral intervention strategy tested in the IDES_2 is based on solid theoretical grounds and uses several behavioral change techniques, two factors which were found to improve effectiveness of behavioral intervention. In addition, physicians and exercise specialists have been specifically trained for counselling/prescribing and supervising PA/exercise, respectively, in subjects suffering from metabolic disorders. Finally, the large sample size, the long study duration, and the objective measurement of PA allow statistically significant and scientifically robust conclusions to be drawn on the feasibility and efficacy of this intervention in T2DM patients.ClinicalTrials.gov; NCT01600937 ; 10 October 2012.

SUBMITTER: Balducci S

PROVIDER: S-EPMC4676117 | biostudies-literature | 2015 Dec

REPOSITORIES: biostudies-literature

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The Italian Diabetes and Exercise Study 2 (IDES-2): a long-term behavioral intervention for adoption and maintenance of a physically active lifestyle.

Balducci Stefano S Sacchetti Massimo M Haxhi Jonida J Orlando Giorgio G Zanuso Silvano S Cardelli Patrizia P Cavallo Stefano S D'Errico Valeria V Ribaudo Maria Cristina MC Di Biase Nicolina N Salvi Laura L Vitale Martina M Bollanti Lucilla L Conti Francesco G FG Nicolucci Antonio A Pugliese Giuseppe G

Trials 20151211

<h4>Background</h4>Physical activity (PA)/exercise have become an integral part of the management of type 2 diabetes mellitus (T2DM). However, current guidelines are difficult to put into action in this population due to a number of barriers, especially the lack of acceptable, feasible, and validated behavioral intervention strategies. The present manuscript reports the rationale, study design and methods, and design considerations of the Italian Diabetes and Exercise Study (IDES)-2, a randomize ...[more]

PMID: 26651484

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Project description:BackgroundPsychological well-being and quality of life (QoL) are important outcomes of lifestyle interventions, as a positive impact may favour long-term maintenance of behaviour change.ObjectiveThis study investigated the effect of a behavioural intervention for adopting and maintaining an active lifestyle on psychological well-being and health-related QoL in individuals with type 2 diabetes.MethodsThree hundred physically inactive and sedentary patients were randomized 1:1 to receive 1 month's theoretical and practical counselling once a year (intervention group, INT) or standard care (control group, CON) for 3 years. Psychological well-being and QoL, assessed using the World Health Organization (WHO)-5 and the 36-Item Short Form (SF-36) questionnaire, respectively, were pre-specified secondary endpoints. The primary endpoint was sustained behaviour change, as assessed by accelerometer-based measurement of physical activity (PA) and sedentary time.ResultsWHO-5 and SF-36 physical and mental component summary (PCS and MCS) scores increased progressively in the INT group and decreased in the CON group, resulting in significant between-group differences (WHO-5: mean difference 7.35 (95% confidence interval (CI) 3.15-11.55), P = 0.0007; PCS 4.20 (95% CI 2.25-6.15), P < 0.0001; MCS 3.04 (95% CI 1.09-4.99), P = 0.0025). Percentage of participants with likely depression decreased in the INT group and increased in the CON group. PA volume changes were independently associated with WHO-5 changes, which were significantly higher in participants who accumulated > 150 min·wk-1 of moderate-to-vigorous intensity PA versus those who did not (13.06 (95% CI 7.51-18.61), P < 0.0001), whereas no relationship was detected for QoL.ConclusionA counselling intervention that was effective in promoting a sustained change in PA and sedentary behaviour significantly improved psychological well-being and QoL.Trial registrationClinicalTrials.gov; NCT01600937; 10 October 2012.

Project description:Background:Physical inactivity contributes to disability and falls in older adults. Falls prevention exercise (FaME) programmes improve physical activity and physical function and reduce falling rates. Improvements in physical function are reduced, and falls rates increase, if physical activity is not maintained. This research investigated the feasibility and acceptability of an intervention that aimed to maintain physical activity in older adults exiting FaME. Methods:The Keeping Adults Physically Active (KAPA) intervention comprised of six group sessions of motivational interviewing, delivered monthly by trained and mentor-supported postural stability instructor's after the FaME programme ceased. The KAPA intervention included participant manuals, illustrated exercise books, physical activity diaries and pedometers. A feasibility study was conducted in 8 FaME classes. The study design was a two-arm, cluster randomised, multi-site feasibility study comparing the KAPA intervention with usual care. A sample of 50 community-dwelling adults aged 65?years old or older were recruited. Recruitment, retention and attendance rates, self-reported physical activity and participant interviews were used to examine the feasibility and acceptability of the KAPA intervention. Results:Fifty of the sixty-seven (74.6%) participants invited into the study agreed to take part, 94.2% of the available KAPA sessions were attended and 92.3% of the recruited participants provided outcome data. The KAPA participants expressed positive views about the venues and postural stability instructors and reported enjoying the group interactions. Intervention participants discussed increasing their physical activity in response to the peer-support, illustrated home exercise booklet, physical activity diaries and pedometers. Most discussed the written tasks to be the least enjoyable element of the KAPA intervention. The proportion of participants reporting at least 150?minutes of moderate to vigorous physical activity per week rose from 56.3 to 62.5% in the intervention arm and from 41.4 to 52.0% in the usual care arm. Conclusions:The participants found the KAPA intervention acceptable. Participants reported the exercise booklet, peer support and the physical activity monitoring tools encouraged them to keep active. A full-scale trial is needed to assess whether physical activity can be significantly maintained in response to the KAPA intervention. Trial registration:Retrospectively registered on ClinicalTrials.gov (NCT03824015).

Project description:The physical activity-related health competence (PAHCO) model assumes that individuals require movement competence, control competence, and self-regulation competence to lead a healthy, physically active lifestyle. Although previous research has already established some measurement factors (n = 8) of the three dimensions, no attempts have so far been made to statistically aggregate them on the sub-competence level. Therefore, the goal of the present study was to test two additional factors for PAHCO and subsequently model the second-order structure with two samples from the fields of rehabilitation and prevention. We conducted two questionnaire surveys with persons with multiple sclerosis (n = 475) and teaching students undergoing a basic qualification course in physical education (n = 502). After performing exploratory items analysis, we used second-order confirmatory factor analysis (CFA) and multidimensional scaling to investigate whether the scales could be bundled in accordance with the PAHCO model. The CFAs with 10 factors (42 items) demonstrated a good model fit. In contrast, the second-order analysis with a simple loading structure on the three sub-competencies revealed an unacceptable model fit. Instead, a second-order model variant was preferred [comparative fit index (CFI) = 0.926, root mean square error of approximation (RMSEA) = 0.048, standardized root mean square residual (SRMR) = 0.065] in which body awareness and self-efficacy had theory-conform cross-loadings. The results of multidimensional scaling (two-dimensional solution) were in line with the extracted second-order structure. The present results suggested that the extension of the measurement instrument to 10 first-order factors was psychometrically justified for the two populations. The results from the second-order analyses provided the basis for the creation of sum scores, representing manifest indicators of movement competence, control competence, and self-regulation competence. Future studies are needed that cross-validate the extended measurement model with other populations and that relate the sub-competencies of PAHCO to indicators of health-enhancing physical activity.

Project description:BACKGROUND:Technology-based lifestyle behavioral interventions (i.e., telehealth, mHealth, eHealth, and/or digital health) are becoming an alternative standard of care and possess several advantages over traditional clinical settings such as convenience, cost, and the ability to tailor plans and feedback to a participant's individual needs. These technology-based interventions also present unique challenges to intervention fidelity due to extra elements involved in executing the intervention. Intervention fidelity monitoring is essential to ensure internal and external validity, yet the development and utilization of fidelity protocols is under-reported in the literature. The purpose of this paper is to describe the intervention fidelity protocol for the 24-START study, a behavior change intervention delivered through telephone and internet. This paper also discusses the results of a pilot audit conducted to determine the feasibility of monitoring adherence to the fidelity protocol. METHODS:The 24-START fidelity protocol was developed in accordance with the five fidelity areas outlined by the NIH Behavior Change Consortium (NIH BCC) including: design of study, provider training, delivery of treatment, receipt of treatment, and enactment of treatment. The fidelity strategies provided by the NIH BCC in each area were tailored to fit the specific design of the 24-START study. Twenty-six total fidelity strategies were developed in accordance with the five areas and a corresponding fidelity monitoring plan was created. Because these strategies are only beneficial if implemented, the fidelity monitoring plan was developed to ensure the fidelity strategies are consistently implemented over the course of the intervention. RESULTS:A pilot audit of nine participant files was conducted to test the feasibility of the fidelity protocol developed. Out of the nine participant files reviewed, 89% of scheduled phone calls between a telehealth coach and participant were successfully completed. Of the completed calls, telehealth coaches delivered the intervention as intended 85.3% of the time, and 74% of planned secondary contacts made through the internet were delivered successfully. Additionally, between treatment group dosing was found to be equal. Several weak areas in the fidelity protocol were identified for improvement. The results were satisfactory and the audit was deemed feasible for ongoing use. CONCLUSIONS:The NIH BCC provides a valuable framework for telehealth interventions to develop fidelity protocols ultimately contributing to improved internal and external validity, better translation of results, increased transparency, and increased opportunities for replication within the field. The 24-START pilot audit found the fidelity protocol efficacious and feasible while also identifying areas of weakness in need of revision. The refined protocol will continue to be utilized throughout the data collection phase. Future telehealth interventions should develop and disclose fidelity protocols to improve the overall quality and standard of telehealth interventions.

Project description:BackgroundPolicy frameworks focusing on policy implementation may vary in terms of their scope, included constructs, relationships between the constructs, and context factors. Although multiple policy implementation frameworks exist, the overarching synthesis characterizing differences between the frameworks is missing. This study investigated frameworks guiding implementation of policies aiming at healthy nutrition, physical activity promotion, and a reduction of sedentary behavior. In particular, we aimed at examining the scope of the frameworks and the content of included constructs (e.g., referring to implementation processes, determinants, or implementation evaluation), the level at which these constructs operate (e.g., the individual level, the organizational/community level), relationships between the constructs, and the inclusion of equity factors.MethodsA systematic review (the PROSPERO registration no. CRD42019133251) was conducted using 9 databases and 8 stakeholder websites. The content of 38 policy implementation frameworks was coded and analyzed.ResultsAcross the frameworks, 47.4% (18 in 38) addressed three aims: description of the process, determinants, and the evaluation of implementation. The majority of frameworks (65.8%; 25 in 38) accounted for constructs from three levels: individual, organizational/community, and the system level. System-level constructs were included less often (76.3%; 29 in 38) than individual-level or organizational/community-level constructs (86.8% [33 in 38 frameworks] and 94.7% [36 in 38 frameworks] respectively). The majority of frameworks (84.2%, 32 in 38) included at least some sections that were solely of descriptive character (a list of unassociated constructs); 50.0% (19 in 38) included sections of prescriptive character (general steps of implementation); 60.5% (23 in 38) accounted for explanatory sections (assuming bi- or uni-directorial associations). The complex system approach was accounted for only in 21.1% (8 in 38) of frameworks. More than half (55.3%; 21 in 38) of frameworks did not account for any equity constructs (e.g., socioeconomic status, culture).ConclusionsThe majority of policy implementation frameworks have two or three aims (combining processes, determinants and/or the evaluation of implementation), include multi-level constructs (although the system-level determinants are less frequently included than those from the individual- or organizational/community-level), combine sections of purely descriptive character with sections accounting for prescriptive and/or explanatory associations, and are likely to include a little or no equity constructs.RegistrationPROSPERO, #CRD42019133251.

Project description:Alterations in hippocampal function have been shown in older adults, which are expressed as changes in hippocampal activity and connectivity. While hippocampal activation during memory demands has been demonstrated to decrease with age, some older individuals present increased activity, or hyperactivity, of the hippocampus which is associated with increased neuropathology and poor memory function. In addition, lower functional coherence between the hippocampus and core hubs of the default mode network (DMN), namely, the posteromedial and medial prefrontal cortices, as well as increased local intrahippocampal connectivity, were also demonstrated in cognitively intact older adults. Aerobic exercise has been shown to elicit neuroprotective effects on hippocampal structure and vasculature in aging, and improvements in cardiorespiratory fitness have been suggested to mediate these exercise-related effects. However, how these lifestyle factors relate to hippocampal function is not clear. Fifty-two cognitively intact older adults (aged 65-80 years) have been recruited and divided into physically active (n = 29) or non-active (n = 23) groups based on their aerobic activity lifestyle habits. Participants underwent resting-state and task-based fMRI experiments which included an associative memory encoding paradigm followed by a post-scan memory recognition test. In addition, 44 participants also performed cardiopulmonary exercise tests to evaluate cardiorespiratory fitness by measuring peak oxygen consumption (Vo2peak). While both groups demonstrated increased anterior hippocampal activation during memory encoding, a physically active lifestyle was associated with significantly lower activity level and higher memory performance in the recognition task. In addition, the physically active group also demonstrated higher functional connectivity of the anterior and posterior hippocampi with the core hubs of the DMN and lower local intra-hippocampal connectivity within and between hemispheres. Vo2peak was negatively associated with the hippocampal activation level and demonstrated a positive correlation with hippocampal-DMN connectivity. According to these findings, an aerobically active lifestyle may be associated with attenuation of hippocampal dysfunction in cognitively intact older adults.

Project description:BACKGROUND:The high prevalence of physical inactivity has led to a search for novel and feasible interventions that will enhance physical activity, especially among the least physically active individuals. This randomized controlled trial aimed to determine the effectiveness of a value-based intervention to promote a physically more active lifestyle among physically inactive adults. The framework of the study was based on Acceptance and Commitment Therapy (ACT). METHODS:Physically inactive participants aged 30 to 50 years (n?=?138) were randomly allocated to a feedback (FB, n?=?69) or an acceptance- and commitment-based group (ACT?+?FB, n?=?69). Both groups received written feedback about their objectively measured physical activity and were offered a body composition analysis. In addition, the participants in the ACT?+?FB group attended six group sessions and were given a pedometer for self-monitoring their physical activity during the nine-week intervention. The primary outcome was physical activity. In addition, participants' cognitions related to exercise and physical activity were evaluated at baseline and at three- and six-month follow-ups. The changes in mean physical activity level were analysed using multilevel random regression and rank order stability, using the structural equation model. RESULTS:Participants in both groups increased their objectively measured and self-reported physical activity with high individual differences. No difference was observed in the change of physical activity level between the FB and ACT?+?FB groups over time. However, the cognitions related to physical activity and exercise improved more in the ACT?+?FB group than in the FB group. In addition, after re-analyzing the data among the non-depressive participants, higher stability was observed in objectively measured physical activity at the individual level between the three- and six-month follow-ups in the ACT?+?FB group as compared to FB group. CONCLUSIONS:Acceptance- and commitment-based group intervention, combined with the self-monitoring of physical activity, was beneficial in supporting the cognition related to exercise and physical activity, and brought more stability to the individual level physical activity behaviour change, especially among the non-depressive participants. TRIAL REGISTRATION:ClinicalTrials.gov, number NCT01796990. Registered in February 2013.

Dataset Information

The Italian Diabetes and Exercise Study 2 (IDES-2): a long-term behavioral intervention for adoption and maintenance of a physically active lifestyle.

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The Italian Diabetes and Exercise Study 2 (IDES-2): a long-term behavioral intervention for adoption and maintenance of a physically active lifestyle.

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