E-PROOF: E-intervention for protein intake and resistance training to optimize function: A study protocol.

BACKGROUND: Accounting for more than 60% of cancer survivors, older (≥65 years) cancer survivors have a 2- to 5-fold risk of physical function impairment, compared to cancer-free peers. One strategy to improve physical function is dietary and resistance training interventions, which improve muscle strength and mass by stimulating muscle protein synthesis. The E-PROOF (E-intervention for Protein Intake and Resistance Training to Optimize Function) study will examine the feasibility, acceptability, and preliminary efficacy of a 12-week randomized controlled trial of an online, tailored nutritional and resistance training education and counseling intervention to improve physical function and associated health outcomes (muscle strength, health-related quality of life (HRQoL), self-efficacy, and weight management). METHODS: In this study, 70 older cancer survivors will be randomized to one of two groups: experimental (receiving remote behavioral counseling and evidence-based education and resources), and control (general survivorship education). We will examine the intervention effects on physical function, muscle strength, HRQoL, self-efficacy, weight, and waist circumference during a 12-week period between the experimental and control groups. Three months following the end of the intervention, we will conduct a follow-up assessment to measure physical function, muscle strength, and HRQoL. SIGNIFICANCE AND IMPACT: This study is the first synchronous, online protein-focused diet and resistance training intervention among older cancer survivors. This novel study advances science by promoting independent health behaviors among older cancer survivors to improve health outcomes, and provide foundational knowledge to further address this growing problem on a wider scale through online platforms.

Effect of a Telephone-Based Lifestyle Intervention on Weight, Body Composition, and Metabolic Biomarkers in Rural Ohio: Results from a Randomized Pilot Study.

Rural residents experience higher rates of obesity, obesity-related chronic diseases, and poorer lifestyle. Promoting physical activity and healthy eating are critical for rural residents; however, lack of resources and access barriers limit the feasibility of in-person lifestyle interventions. There is a need to design and deliver remotely accessible lifestyle interventions in this population. This pilot study examined the effect of a telephone-based lifestyle intervention on weight, body composition, lipids, and inflammatory biomarkers among rural Ohio residents. Rural Ohio adults with overweight/obesity (n = 40) were 2:1 randomized to a 15-week telephone-based lifestyle intervention (n = 27) or control group (n = 13). The lifestyle intervention group received weekly telephone counseling sessions emphasizing healthy eating and increasing physical activity. The control group received educational brochures describing physical activity and dietary recommendations. Weight, body composition, fasting blood lipids, and inflammatory biomarkers were objectively measured at baseline and 15 weeks at local community centers (trial registration#: NCT05040152 at ClinicalTrial.gov). Linear mixed models were used to examine change over time by group. Participants were mostly female, with an average age of 49 years. Over the 15-week trial, the lifestyle intervention showed superior improvements in total cholesterol (∆ = -18.7 ± 7.8 mg/dL, p = 0.02) and LDL (∆ = -17.1 ± 8.1 mg/dL, p = 0.04) vs. control, whereas no significant between-group differences in weight, body composition, or inflammation were observed. Our findings suggest that a 15-week telephone-based lifestyle intervention may offer metabolic benefits that reduce disease risk in rural adults with obesity. Future large-scale studies are needed to determine the efficacy of remotely accessible lifestyle interventions in rural populations, with the goal of reducing obesity-related disparities.

Design and methods of a translational, community-based, lifestyle weight management pilot intervention trial in breast cancer survivors with overweight or obesity.

Background: Breast cancer survivors (BCS) with overweight or obesity are at heightened risk of cancer recurrence, cardiometabolic disease, and compromised quality of life. Given the prevalence of significant weight gain during and following breast cancer treatment, there is growing recognition of the need to develop efficacious, widely-accessible, weight management programs for BCS. Unfortunately, access to evidence-based weight management resources for BCS remains limited and little is known of the optimal theoretical basis, program components, and mode of delivery for community-based interventions. The primary aim of the Healthy New Albany Breast Cancer (HNABC) pilot trial was to determine the safety, feasibility, and preliminary efficacy of delivering a translational, evidence-based, and theory-driven lifestyle weight management intervention to BCS with overweight or obesity in the community setting. Methods: HNABC was a single-arm, pilot trial evaluating a 24-week, multi-component intervention leveraging exercise, dietary modification, and group-mediated cognitive behavioral (GMCB) counseling components designed to facilitate lifestyle behavior change and promote sustained independent adherence. Assessments of various objectively-determined and patient-reported outcomes and theory-derived determinants of behavioral adoption and maintenance were obtained at baseline, 3- and 6-month follow-up. Measures of trial feasibility were calculated prospectively throughout the study. Conclusion: Findings from the HNABC pilot trial will provide evidence demonstrating the feasibility and preliminary efficacy of a multi-component, community-based, GMCB lifestyle weight management intervention for BCS. Results will inform the design of a future, large-scale, randomized controlled efficacy trial. If successful, this approach could offer a widely accessible, community-based intervention model for weight management programs in BCS.

The feasibility of a telephone-based weight loss intervention in rural Ohio: A pilot study.

BACKGROUND: Weight loss through lifestyle modification can produce health benefits and may reduce cancer risk. The goal of this study was to examine the feasibility of and adherence to a 15-week telephone-based weight loss intervention in rural Ohio, an area with high rates of obesity. METHODS: This pilot 2-arm randomized controlled study was designed for rural Ohio residents who were overweight or obese. Eligible participants were 2:1 randomly assigned to either a 15-week weight loss intervention group or active control group. The weight loss intervention group received weekly telephone sessions to improve healthy diet and increase physical activity. The active control group received education brochures with information on physical activity and dietary guidelines. Feasibility was defined as at least 80% of participants completing the follow-up surveys, and acceptable adherence was defined as the percentage of participants in the weight loss group who attend ≥75% of weekly telephone sessions. RESULTS: A total of 423 individuals entered the online screening survey, 215 (50.8%) completed the survey, and 98 (45.6%) of those were eligible. Forty eligible individuals were enrolled and randomly assigned to the weight loss group (n = 27) or active control group (n = 13). The average age of the weight loss group was 49 (SD = 10) years, and 89% were female. The average age of the active control group was 51 (SD = 9) years, and 92% were female. Feasibility was demonstrated: 90% of participants completed the online follow-up surveys at 15-weeks. Among participants in the weight loss group, 22 out of 27 (81.5%) completed the 15-week intervention, the average number of sessions attended was 9.7 (64.9%). Adherence to the intervention was rated as acceptable among almost half of the group (48.1%). CONCLUSIONS: Feasibility of a 15-week telephone-based weight loss study among rural residents with overweight/obesity were determined. A future study will test this intervention for weight loss efficacy.

The Collaborative Lifestyle Intervention Program in Knee Osteoarthritis Patients (CLIP-OA) trial: Design and methods.

Being overweight or obese is a primary modifiable risk factor that exacerbates disease progression and mobility disability in older knee osteoarthritis (OA) patients. Lifestyle interventions combining exercise with dietary weight loss (EX+DWL) yield meaningful improvements in mobility and weight loss that are superior to EX or DWL alone. Unfortunately, community access to practical, sustainable weight management interventions remains limited and places knee OA patients at increased risk of mobility disability. The Collaborative Lifestyle Intervention Program in Knee Osteoarthritis patients (CLIP-OA), was a two-arm, 18 month randomized-controlled, comparative effectiveness trial designed to contrast the effects of an evidence-based, theory-driven EX+DWL intervention, personalized to patient needs and delivered by our community partners, with those of the Arthritis Foundation's Walk With Ease (WWE) standard of care self-management program in the treatment of knee OA patients with overweight or obesity. The primary outcome of the CLIP-OA trial was mobility performance assessed using the 400-m walk test (400MWT). Secondary outcomes included weight loss, pain, select quality of life and social cognitive variables, and cost-effectiveness of intervention delivery. Findings from the CLIP-OA trial will determine the comparative and cost-effectiveness of the EX+DWL and WWE interventions on key clinical outcomes and has the potential to offer a sustainable medium for intervention delivery that can promote widely accessible weight management among knee OA patients with overweight or obesity. Trial Registration: NCT02835326.

Social cognitive outcomes are associated with improvements in mobility performance following lifestyle intervention in prostate cancer patients undergoing androgen deprivation therapy.

OBJECTIVE: To compare the effects of an exercise and dietary intervention with those of standard-of-care management upon change in lift and carry performance and mobility-related self-efficacy beliefs and explore associations in prostate cancer patients undergoing androgen deprivation therapy. METHODS: 32 prostate cancer patients (M age = 66.2 years; SD = 7.8) undergoing androgen deprivation therapy were randomly assigned to a 3-month exercise and dietary lifestyle intervention (n = 16) or standard-of-care management (n = 16). Outcome assessments were obtained at baseline, 2- and 3-month follow-up. RESULTS: The lifestyle intervention resulted in significantly greater improvements in lift and carry performance (p = 0.01) at 2 Months (d = 1.01; p < 0.01) and 3 Months (d = 0.95; p < 0.01) and superior improvements in mobility-related self-efficacy at 2 Months (d = 0.38) and 3 Months (d = 0.58) relative to standard-of-care. Mobility-related self-efficacy (r = -.66; p = 0.006) and satisfaction with function (r = -.63; p = 0.01) were significantly correlated with lift and carry performance at 3 Months. CONCLUSIONS: The exercise and dietary lifestyle intervention yielded superior improvements in lift and carry performance and mobility-related self-efficacy relative to standard-of-care and key social cognitive outcomes were associated with more favorable mobility performance.

Effects of a lifestyle intervention on body composition in prostate cancer patients on androgen deprivation therapy.

Background: Exercise and dietary (EX+D) interventions could represent an optimal treatment for attenuating or reversing adverse effects of androgen deprivation therapy (ADT) in prostate cancer (PCa) patients. The Individualized Diet and Exercise Adherence-Pilot (IDEA-P) trial compared the effects of an EX+D intervention relative to standard-of-care (SC) treatment among PCa patients undergoing ADT. The present study evaluated the effects of the EX+D intervention on body composition (BC) obtained via dual-energy X-ray absorptiometry (DXA) in a subsample of IDEA-P patients. A secondary objective was to explore the association of adiposity and lean mass with mobility performance and strength. Methods: Complete DXA data were acquired from a subsample of 22 PCa patients (EX+D: n = 13; SC: n = 9) at baseline and 3 month follow-up. Intention-to-treat analysis included data from 30 participants (M age = 66.28; SD = 7.79) with baseline DXA assessments. Results: Intention-to-treat analysis revealed EX+D resulted in significant improvements in fat mass (P = 0.022), per cent fat mass (P = 0.028), trunk fat mass (P = 0.017), fat mass/lean mass (P = 0.040), and per cent lean mass (P = 0.026) vs. SC. EX+D also resulted in more favourable changes in appendicular lean mass/body mass (d = 0.59). Select BC outcomes were also significantly correlated with mobility performance and strength (P < 0.05) at 3 month follow-up. Conclusions: Findings suggest the EX+D intervention resulted in superior preservation of lean tissue and improvement in adiposity relative to SC treatment. Results underscore the utility of implementing EX+D interventions for preserving muscle mass and reducing adiposity in PCa patients undergoing ADT.

Effects of a Group-Mediated Cognitive Behavioral Lifestyle Intervention on Select Social Cognitive Outcomes in Prostate Cancer Patients Undergoing Androgen Deprivation Therapy.

Objective. To compare the effects of a group-mediated cognitive behavioral (GMCB) exercise and dietary (EX+D) intervention with those of standard-of-care (SC) treatment on select social cognitive outcomes in prostate cancer (PCa) patients undergoing androgen deprivation therapy (ADT). Methods. In the single-blind, 2-arm, randomized controlled Individualized Diet and Exercise Adherence-Pilot (IDEA-P) trial, 32 PCa patients (mean age = 66.2 years; SD = 7.8) undergoing ADT were randomly assigned to a 12-week EX+D intervention (n = 16) or SC treatment (n = 16). The exercise component of the personalized EX+D intervention integrated a combination of supervised resistance and aerobic exercise performed twice per week. The dietary component involved counseling and education to modify dietary intake and composition. Blinded assessments of social cognitive outcomes were obtained at baseline and 2-month and 3-month follow-up. Results. Intent-to-treat analysis of covariance demonstrated that the EX+D intervention resulted in significantly greater improvements in scheduling (P < .05), coping (P < .01), and exercise self-efficacy (P < .05), and satisfaction with function (P < .01) at 3 months relative to SC. Results of partial correlation analysis also demonstrated that select social cognitive outcomes were significantly correlated with primary trial outcomes of mobility performance and exercise participation (P < .05) at 3-month follow-up. Conclusions: The GMCB lifestyle intervention yielded more favorable improvements in relevant social cognitive outcomes relative to SC among PCa patients undergoing ADT. Additionally, more favorable social cognitive outcomes were associated with superior mobility performance and exercise participation following the independent maintenance phase of the EX+D intervention.