Dataset Information

A positive psychology-motivational interviewing program to promote physical activity in type 2 diabetes: The BEHOLD-16 pilot randomized trial.

ABSTRACT:

Background

The majority of persons with type 2 diabetes (T2D) do not meet recommended levels of physical activity, despite clear links between physical activity and superior medical outcomes in this population. The objective of this trial was to assess the feasibility and impact of a novel 16-week combined positive psychology-motivational interviewing (PP-MI) program to promote physical activity among inactive persons with T2D.

Methods

This pilot randomized trial compared the 16-week, phone-delivered PP-MI intervention to an attention-matched diabetes counseling condition among 70 persons with T2D and low levels of baseline moderate to vigorous physical activity (MVPA; <150 min/week). The primary study outcomes were feasibility (assessed via rates of session completion) and acceptability (assessed via mean participant ratings [0-10] of the ease and utility of weekly sessions). Key secondary outcomes included between-group differences in improvement in positive affect, other psychological outcomes, and accelerometer-measured physical activity, assessed using mixed effects regression models, at 16 and 24 weeks.

Results

Participants completed a mean 11.0 (SD 4.4; 79%) of 14 PP-MI phone sessions, and composite mean ratings of ease/utility were 8.6/10, above our a priori benchmarks for feasibility/acceptability (70% session completion; 7.0/10 mean ratings). PP-MI participants had small to medium effect size (ES) difference improvements in MVPA (ES difference = 0.34) and steps/day (ES difference = 0.76) at 16 weeks, with sustained but smaller effects at 24 weeks (ES difference = 0.22-0.33).

Conclusions

Next-step studies of this PP-MI program in T2D patients can more rigorously explore the intervention's effects on physical activity and clinical outcomes.

SUBMITTER: Huffman JC

PROVIDER: S-EPMC8307449 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:BackgroundPhysical activity among those with type 2 diabetes (T2D) is independently associated with superior medical outcomes, but existing behavioral interventions have not led to widespread increases in activity in this population. A remotely delivered intervention that targets well-being constructs associated with greater activity and assists in the creation of specific physical activity goals has the potential to improve activity and outcomes in T2D.ObjectiveTo outline the rationale and methods of two studies designed to assess the impact and optimal duration of a combined positive psychology-motivational interviewing (PP-MI) intervention for inactive persons with T2D.MethodsWe conducted trials studying 8-week (BEHOLD-8;) and 16-week (BEHOLD-16;) phone-delivered interventions, compared to attention-matched control conditions. In a two-step randomization design, participants were allocated randomly first to study (BEHOLD-8 or BEHOLD-16), then to study condition within study. The primary aims in both trials were feasibility (rates of session completion) and acceptability (participant session ratings), with additional aims examining intervention effects on accelerometer-measured physical activity, psychological measures, and health-related metrics (e.g. vital signs). Main analyses, currently being conducted, will utilize mixed effects models between study conditions, and secondary analyses will utilize the same models to compare the 8- and 16-week PP-MI interventions on feasibility and impact.ResultsEnrollment and data collection have been completed for both trials (BEHOLD-8: N = 60; BEHOLD-16: N = 70), and data analysis is ongoing to assess feasibility and acceptability within study, as well as the relative feasibility and acceptability of the PP-MI interventions across the two studies. We will also explore impact on clinical outcomes between groups.ConclusionsThis design will address how intervention content (i.e. PP elements vs. no PP elements) and intervention duration (8 weeks vs. 16 weeks) affect feasibility, acceptability, and impact, allowing intervention optimization before a next-step larger clinical trial.Trial registrationClinicalTrials.gov identifier: NCT03150199; NCT03001999.

Project description:BackgroundPhysical activity is critical for preventing and treating Type 2 diabetes (T2D). It is important to identify different profiles of physical activity change among those participating in behavioral interventions to optimize intervention-person fit.MethodsThis study analyzes longitudinal trajectories of change in moderate-to-vigorous physical activity (MVPA) in a positive psychology (PP) and motivational interviewing (MI) intervention for T2D, using latent growth curve modeling (LGCM). Objective measures of MVPA were collected using accelerometers at three time points: pre-intervention, immediately post-intervention, and eight weeks post-intervention. LGCM analyses identified subpopulations of participants who responded similarly to the intervention and examined if sociodemographic, medical and psychosocial characteristics were associated with MVPA trajectories.ResultsAnalyses included 47 participants with complete follow-ups: 49% male, 81% non-Hispanic white, average age 66.1 (SD = 10.1). Overall, 36% of the participants increased MVPA while 57% did not. LGCM identified three profiles with distinct MVPA trajectories. Profile 1 ('Started Low, No Change'; 65.8% of participants) with a starting mean of 4.54 min of MVPA/day and decreased by -3.36 min. Profile 2 ('Moderate-High Start, Minimal Change,' 27.4% of participants) and had a starting mean of 22.86 min/day of MVPA with an average increase of 1.03 min. Profile 3 ('Moderate Start, Ended High'; 6.8% of participants), had a starting mean of 7.33 min MVPA/day, and increased by 28.4 min. Being male, younger, having fewer medical and psychiatric comorbidities were associated with increases in MVPA.ConclusionsThis secondary analysis detected three distinct physical activity profiles during and after a PP-MI intervention. Future interventions can target individuals with characteristics that showed the greatest benefit and add additional supports to people in groups that did not increase physical activity as much. These findings show a need for targeted and sustained behavior change strategies during and after physical activity interventions. Trial registration: ClinicalTrials.gov; identifier: NCT03001999.

Project description:Background: Training programs must be evaluated to understand whether the training was successful at enabling staff to implement a program with fidelity. This is especially important when the training has been translated to a new context. The aim of this community case study was to evaluate the effectiveness of the in-person Small Steps for Big Changes training for fitness facility staff using the 4-level Kirkpatrick training evaluation model. Methods: Eight staff were trained to deliver the motivational interviewing-informed Small Steps for Big Changes program for individuals at risk of developing type 2 diabetes. Between August 2019 and March 2020, 32 clients enrolled in the program and were allocated to one of the eight staff. The Kirkpatrick 4-level training evaluation model was used to guide this research. Level one assessed staff satisfaction to the training on a 5-point scale. Level two assessed staff program knowledge and motivational interviewing knowledge/skills. Level three assessed staff behaviors by examining their use of motivational interviewing with each client. Level four assessed training outcomes using clients' perceived satisfaction with their staff and basic psychological needs support both on 7-point scales. Results: Staff were satisfied with the training (M = 4.43; SD = 0.45; range = 3.86-4.71). All learning measures demonstrated high post-training scores that were retained at implementation follow-up. Staff used motivational interviewing skills in practice and delivered the program at a client-centered level (≥6; M = 6.34; SD = 0.83; range = 3.75-7.80). Overall, clients perceived staff supported their basic psychological needs (M = 6.55; SD = 0.64; range = 6.17-6.72) and reported high staff satisfaction scores (M = 6.88; SD = 0.33; range = 6-7). Conclusion: The Small Steps for Big Changes training was successful and fitness facility staff delivered a motivational interviewing-informed program. While not all staff operated at a client-centered level, clients perceived their basic psychological needs to be supported. Findings support the training for future scale-up sites. Community fitness staff represent a feasible resource through which to run evidence-based counseling programs.

Project description:Background:Diabetes and prediabetes are chronic conditions that affect over 40% of the US adult population combined. Regular physical activity can benefit people with diabetes through improved glucose control and can reduce the conversion of prediabetes to diabetes. Studies are needed in settings where people with these conditions can be identified and provided the skills and support to increase physical activity. The primary care setting meets this need, but there are insufficient high-quality trials to recommend this approach be broadly implemented. Methods:We conducted a randomized, 24-week pilot study in Southern California to assess the feasibility of using information technology systems available in primary care for identifying potential participants, test methods for obtaining physical activity clearance, conducting mail-based assessments, and delivering telephone-based motivational interviewing to increase physical activity. Eligibility criteria included age between 18 and 74?years, diabetes or prediabetes, and physically inactive based on a clinical assessment tool. At baseline and follow-up, physical activity was assessed by a 7-day accelerometry, cardiometabolic risk factors were collected from electronic medical records, and psychosocial factors were assessed from validated questionnaires administered through a mail survey. Participants were block randomized into intervention or usual care. Staff collecting outcome data were blinded to group assignment. Analysis of covariance was used to assess the difference at follow-up between the intervention and usual care, adjusting for baseline. Results:A total of 67 participants were randomized. Follow-up mail assessments were completed by 53 participants. Of 224 potential intervention calls, 194 were completed (87%). Psychosocial measures significantly improved in four of the five factors for physical activity motivation relative to participants in the usual care arm. The more internally focused factors for exercise self-regulation and outcome expectancies scores were significantly greater for participants in intervention compared with usual care. Moderate to vigorous physical activity improved in intervention participants relative to usual care, but the difference was not statistically significant. No adverse events were noted. Conclusions:The objectives of this pilot study were met. If a fully powered trial is successful, primary care settings with "behind-the-scenes" information technology support may be appropriate to increase physical activity among patients with prediabetes and diabetes. Trial registration:Exercise Promotion in Primary Care (EPPC), NCT03429088, registered on February 5, 2018.

Project description:AimsPatients suffering from heart failure with preserved ejection fraction (HFpEF) report similar symptoms and reduction in quality of life to those with reduced ejection fraction but remain largely untreated. We conducted a preliminary evaluation of the acceptance, feasibility, and efficacy of a motivational interviewing (MI) intervention to support elderly patients suffering from HFpEF in maintaining or starting physical activity.Methods and resultsAt the conclusion of the exercise training in diastolic heart failure parent trial that examined the effects of supervised exercise, patients with HFpEF were offered participation in a two-group pilot study. Based on their preference, consenting patients were assigned to either a 6 month MI intervention group (n = 19) or their physicians' usual care (n = 20). To support participants in increasing and/or maintaining their physical activity, counsellors delivered a mean of 6.5 MI sessions (face to face and via telephone) and also provided a physical activity diary as self-management tool. At baseline and 6 months, we assessed participants' physical activity motivation (Sportbezogene Selbstkonkordanz Scale) and their physical improvements with the 6 min walk test and a cardiopulmonary exercise test. Of the entire sample (N = 39), 46% were female, their mean age was 73, 90% were in New York Heart Association Class II, and the mean ejection fraction was 61.4%. The majority of MI participants rated the intervention as acceptable, 90% perceived MI as helpful in setting specific exercise goals and overcoming barriers concerning physical activity, and 58% considered the physical activity diary as very helpful. Three-quarters of MI participants (79%) reported an increase in their physical activity compared with the previous year. Intervention participants showed a greater increase in median peak VO2 from baseline to 6 months (baseline: 18.4 mL/kg/min; 6 months: 20.4 mL/kg/min) compared with the control group (baseline: 20.0 mL/kg/min; 6 months: 19.2 mL/kg/min; P = 0.015). There was no significant change in motivation on the Sportbezogene Selbstkonkordanz Scale for either group (MI: 1.7 vs. 3, P = 0.55; control: 4.7 vs. 4, P = 0.26) nor did patients show any significant improvements in the 6 min walk test (MI: 549 vs. 540 m, P = 0.80; control: 572 vs. 580 m, P = 0.37). Counsellors rated the implementation of the MI intervention as feasible.ConclusionsThe results from this pilot study suggest that our MI intervention was well accepted by participants and deemed feasible. It also appears to be an effective treatment to increase and maintain physical activity and exercise capacity in patients suffering from HFpEF. Our findings need to be confirmed in a randomized clinical trial with larger and unselected patient cohorts.

Project description:BackgroundObesity is a chronic disease and is an established risk factor for other chronic diseases and mortality. Young adulthood is a period when people may be highly amenable to healthy behavior change, develop lifelong healthy behaviors, and when primary prevention of obesity may be feasible. Interventions in early adulthood have the potential for primary or primordial prevention (i.e., preventing risk factors before disease onset). The primary objective of this study is to determine the feasibility of a 6-month behavioral and educational intervention to promote healthy behaviors for obesity prevention among young adults.MethodsThis is the study protocol for a pilot randomized controlled trial. Young adults (age 18-29) attending McMaster University, Hamilton, Canada, will be recruited and randomized to either the intervention or control. The intervention will include individual motivational interviewing sessions (online or in-person) with a trained interviewer plus educational materials (based on Canada's food guide and physical activity recommendations). The control group will receive educational materials only. The primary feasibility outcomes that will be evaluated as part of this pilot study include enrollment, retention (≥ 80%), data completion (≥ 80% of weights measured, and surveys completed), and participant satisfaction. Secondary clinical outcomes will include body mass index (BMI) change from baseline to 6 months, physical activity, nutrition risk, health-related quality of life mental health, and economic outcomes. Outcomes will be measured remotely using activity trackers, and online questionnaires at baseline and every 2 months. Risk stratification will be applied at baseline to identify participants at high risk of obesity (e.g., due to family or personal history). Exit questionnaires will collect data on how participants felt about the study and cost analysis will be conducted.DiscussionOur pilot randomized controlled trial will evaluate the feasibility of an obesity prevention intervention in early adulthood and will inform future larger studies for obesity prevention. The results of this study have the potential to directly contribute to the primary prevention of several types of cancer by testing an intervention that could be scalable to public health, post-secondary education, or primary care settings.Trial registrationhttps://clinicaltrials.gov/ct2/show/NCT05264740 . Registered on March 3, 2022.