Lifestyle Improvement Program Research Articles

Construct validity of the 12-item Short Form Health Survey (SF-12) version 2 and the impact of lifestyle modifications on the health-related quality of life among Indian adults with prediabetes: results from the D-CLIP trial.

This study aimed to validate the factor structure of the 12-item Short-Form (SF-12) health-related quality of life (HRQOL) survey for Indian adults and assess the impact of lifestyle modification on the SF-12 of Indian adults with prediabetes. To validate the context-specific construct of the SF-12, two-factor confirmatory factor analysis (CFA) was performed using data from 1285 adults residing in Chennai, India, who screened for the Diabetes Community Lifestyle Improvement Program (D-CLIP). D-CLIP was a randomized controlled trial of 578 participants with prediabetes (283 treatment, 293 control), focusing on the effect of lifestyle modifications on the prevention of diabetes. Physical and mental component scores (PCS and MCS) were computed by using CFA standardized factor loadings. Multiple linear regression was subsequently conducted to estimate the effect of lifestyle modification on post-study changes of PCS and MCS among D-CLIP participants. Cronbach's alpha and CFA fit indices demonstrated acceptable reliability and model fit of the SF-12 for Indian adults. The intervention group showed greater mean change in PCS after study participation compared to the controls (1.63 ± 0.82, p = 0.046); no significant difference was observed for MCS between two groups (1.00 ± 0.85, p = 0.242). The study confirmed that the SF-12 is suitable for assessing the physical and mental health dimensions of HRQOL for Indian adults. Our findings suggest that the benefits of diabetes prevention lifestyle modification strategies may primarily enhance the physical well-being of adults with prediabetes. Further studies validating the SF-12 in a broader Asian Indian population are needed. Clinicaltrials.gov, NCT01283308.

Perceived stress and progression of cardiometabolic risk factors among South Asians with prediabetes in a lifestyle intervention trial

AimsTo examine associations between perceived stress and cardiometabolic risk factors in South Asians with prediabetes and assess whether a diabetes prevention program mitigates the impact of stress on cardiometabolic health. MethodsWe conducted a secondary analysis of the Diabetes Community Lifestyle Improvement Program, a lifestyle modification trial for diabetes prevention in India (n = 564). Indicators for cardiometabolic health (weight, waist circumference, blood pressure, glucose, HbA1c, and lipids) were measured at each visit while perceived stress was assessed via questionnaire at baseline. Multivariable linear regression assessed associations between stress and cardiometabolic parameters at baseline and 3-year follow up. ResultsAt baseline, perceived stress was associated with higher weight (b=0.16; 95% CI: 0.04, 0.29) and waist circumference (b=0.11; 95% CI: 0.01, 0.21) but lower 30-minute postload glucose (b=−0.44; 95% CI: −0.76, −0.14) and LDL cholesterol (b=−0.40; 95% CI: −0.76, −0.03). Over the study period, perceived stress was associated with weight gain (b=0.20; 95% CI: 0.07, 0.33) and increased waist circumference (b=0.14; 95% CI: 0.04, 0.24). Additionally, higher perceived stress was associated with lower HDL cholesterol among the control arm (pinteraction = 0.02). ConclusionsBaseline stress was associated with negative cardiometabolic risk factor outcomes over time in those with prediabetes.

Management Of Improving Reproductive Healthy Lifestyle In Students' Environment Subang District Junior High School

The Maternal Mortality Rate in Indonesia is still high, the number of cases of maternal mortality in Subang Regency is also still far from the achievement target. One of the causes of maternal death in Subang Regency is in the adolescent phase. Lack of knowledge of adolescents about reproductive health becomes an important point and has a widespread impact on women's health conditions in the future. This study aims to determine and analyze how the management of improving reproductive healthy lifestyles at SMPN 1 Subang, SMPN 2 Subang and SMPN 4 Subang. This research uses a qualitative approach with a case study method, the sample is determined purposively with key informants the principal, vice principal of curriculum, science subject teachers, PMR coaches and students. The research location is at SMPN 1 Subang, SMPN 2 Subang and SMPN 4 Subang. Data were obtained from in-depth interviews, document materials, and participant observation. The findings of this study are: 1) Goals and Programs for Improving Reproductive Healthy Lifestyles among students in 3 locations of SMP Negeri Subang, starting with the science education curriculum for grade IX students; 2) Implementation of the Reproductive Healthy Lifestyle Improvement Program in 3 SMP N Subang in the form of implementing learning activities in science subjects. In its implementation, the program to improve reproductive health is carried out through science learning, in collaboration with local health centers for the program of giving blood-added tablets, in collaboration with the health office in providing reproductive health counseling; 3) Problems in implementing the program to improve reproductive healthy lifestyles are teaching materials that are less relevant to the goal of reducing maternal mortality, consumption of blood-added tablets is not monitored properly, health education is not routinely given. 4) Solutions to problems in implementing programs to improve reproductive healthy lifestyles: adding teaching materials, monitoring and evaluating adherence to consuming blood-added tablets, and increasing reproductive health counseling activities. The product of this research is the adolescent reproductive health module for junior high school students.

An AI-Based Medical Chatbot Model for Infectious Disease Prediction

The purpose of this paper is to show concisely how we can promote chatbots in the medical sector and cure infectious diseases. We can create awareness through the users and the users can get proper medical solutions to prevent disease. We created a preliminary training model and a study report to improve human interaction in databases in 2021. Through natural language processing, we describe the human behaviors and characteristics of the chatbot. In this paper, we propose an AI Chatbot interaction and prediction model using a deep feedforward multilayer perceptron. Our analysis discovered a gap in knowledge about theoretical guidelines and practical recommendations for creating AI chatbots for lifestyle improvement programs. A brief comparison of our proposed model concerning the time complexity and accuracy of testing is also discussed in this paper. In our work, the loss is a minimum of 0.1232 and the highest accuracy is 94.32%. This study describes the functionalities and possible applications of medical chatbots and explores the accompanying challenges posed by the use of these emerging technologies during such health crises mainly posed by pandemics. We believe that our findings will help researchers get a better understanding of the layout and applications of these revolutionary technologies, which will be required for continuous improvement in medical chatbot functionality and will be useful in avoiding COVID-19.

Assessment of a Clinical Case for A Female Patient with Type 2 Diabetes Using the 2021 Consensus Report on Type 2 Diabetes Remission Discussions Sponsored by American Diabetes Association Based on GH-Method: math-physical medicine (No. 506)

This 73-year-old female patient has suffered from type 2 diabetes (T2D), hypertension, and hyperlipidemua for over 20 years. She started taking Metformin in 1999 and ceased taking it on 1/7/2019. As of 4/3/2019, her HbA1C level was at 6.6%. Since 4/4/2019, she implemented a lifestyle management program which not only focuses on diet and exercise but also factors in sleep, stress, life routines and habits, as well as environmental factors. In this article, the author applies the final conclusions from the American Diabetes Association (ADA) 2021 consensus report regarding “T2D Remission”. For this clinical case, he analyzes the patient’s present conditions to determine if she satisfies the criteria of “T2D remission” or not. The defined criteria of “remission” include timespan of at least one year, HbA1C level less than 6.5%, fasting plasma glucose (FPG) level less than 126 mg/dL, and estimated HbA1C (eA1C) values based on the mean continuous glucose monitoring (CGM) glucose data less than 6.5%. In conclusion, according to the ADA 2021 consensus report, this female patient is in “remission” for T2D. In summary, over the past year from 9/5/2020 to 9/5/2021, her average lab-A1C is 6.3%, mean CGM FPG value is 102 mg/dL, and CGM eAG is 5.7%. First, the selected one year satisfies the timespan requirement cited in the 2021 consensus report. Her set of glucose data has been collected over ~3 years, after post-Metformin (started on 1/7/2019) and her initiation of lifestyle management program that began on 4/4/2019. Second, all of her A1C values, both lab-tested and CGM eA1C, are less than 6.5% and her mean CGM FPG level is less than 126 mg/dL. Finally, she keeps a regular routine with quarterly medical examinations to monitor various diabetes complications, including macrovascular, micro- vascular, neural, and hormonal systems. The author understands and agrees with the consensus report that diabetes is non-curable and at most is “controllable” or “partially reversible”. Nevertheless, this female patient has also adopted a similar lifestyle improvement program as the author in order to deal with the root causes of her multiple metabolic disorders, particularly T2D, instead of suppressing the external symptoms of diabetes through medication intervention.

Comprehensive Lifestyle Improvement Program for Prostate Cancer (CLIPP) is associated with improvement in weight and components of metabolic syndrome in men exposed to androgen deprivation therapy for prostate cancer.

Androgen deprivation therapy (ADT) for prostate cancer is associated with adverse effects, such as obesity and metabolic syndrome, which increase cardiovascular risk, the most common cause of non-cancer mortality in men diagnosed with prostate cancer. The Comprehensive Lifestyle Improvement Program for Prostate Cancer (CLIPP) was created to determine the feasibility of conducing a comprehensive lifestyle modification intervention in men on ADT for prostate cancer and determine its early efficacy in reducing obesity and metabolic syndrome. A single-arm, open-label clinical trial was conducted by recruiting 31 men diagnosed with prostate cancer and exposed to ADT within the last 5 years. A multicomponent lifestyle modification program was delivered weekly for 16 weeks by a trained health coach. This was followed by 8 weeks of passive follow-up resulting in a total trial duration of 24 weeks. Feasibility was determined by calculating study recruitment, retention, and adherence rates. Weight and components of metabolic syndrome (waist circumference, triglycerides (TG), high-density lipoprotein (HDL), serum glucose, and blood pressure (BP)) were measured at baseline, 12, and 24 weeks. Recruitment, retention, and adherence rates were 47.1%, 90.3%, and 100%, respectively. Statistically significant improvements were noted between baseline and end of study measurements for weight (206.3 vs. 191.3 lbs, p < 0.001), waist (41.3 vs. 38.8 inches, p < 0.001), systolic BP (144.1 vs. 133.4 mm of Hg, p = 0.014), diastolic BP (83.3 vs. 76.2 mm of Hg, p = 0.0056), TG (146.0 vs. 113.8 mg/dl, p = 0.022), HDL (51.1 vs. 55.0 mg/dl, p = 0.012), and serum glucose (114.0 vs. 103.2 mg/dl, p = 0.013). CLIPP demonstrates feasibility and early efficacy of a multicomponent lifestyle modification intervention toward addressing obesity as well as components of metabolic syndrome in men on ADT for prostate cancer. This study provides strong preliminary data to develop future clinical trials in this population.

Moderate-to-vigorous physical activity changes in a diabetes prevention intervention randomized trial among South Asians with prediabetes – The D-CLIP trial

AimsThe Diabetes Community Lifestyle Improvement Program (D-CLIP) was a lifestyle education program to prevent diabetes in South Asians with prediabetes. This paper examines the impact of the D-CLIP intervention on moderate-to-vigorous intensity physical activity (MVPA). MethodsThis randomized controlled trial to prevent diabetes included 573 individuals with prediabetes from Chennai, India. The intervention was designed to increase MVPA to ≥150 minutes per week. MVPA was measured by questionnaire at baseline, six, 12, 18, 24, 30 and 36 months of follow-up. Random effects models were used to examine the relationship between treatment group and odds of reporting ≥150 weekly minutes of MVPA and to examine the impact of the intervention on weekly MVPA. ResultsWith the exception of the proportion of respondents at baseline with a high waist circumference, selected sample characteristics did not differ at baseline between the intervention and control groups. The intervention significantly (p < 0.05) increased the proportion of respondents who reported ≥150 weekly minutes of MVPA by 28.5%, 13.6% and 14.0% at six, 12 and 18 months respectively. Mean minutes of weekly MVPA significantly (p < 0.05) increased by an additional 56.7, 34.3, 23.6 and 24.3 minutes/week at six, 12, 18, and 24 months, respectively. ConclusionThe D-CLIP intervention significantly increased MVPA at six, 12 and 18 months of follow-up. Interventions to prevent diabetes in South Asians with prediabetes can significantly increase MVPA in this population.

Protocol for a feasibility and early efficacy study of the Comprehensive Lifestyle Improvement Program for Prostate Cancer-2 (CLIPP2)

BackgroundAlthough androgen deprivation therapy (ADT) for prostate cancer demonstrates improved overall and disease-free survival, it is associated with adverse effects such as obesity and metabolic syndrome that increase risk of cardiometabolic disease and diabetes type 2. ADT also leads to fatigue, depression and erectile dysfunction, which reduce quality of life (QoL). Lifestyle modification has shown promise in reducing obesity, metabolic syndrome and diabetes type 2 in other disease types. However, there is a paucity of data regarding the utility of lifestyle modification in men receiving ADT for prostate cancer. MethodsThe primary aim of the Comprehensive Lifestyle Improvement Program for Prostate Cancer-2 (CLIPP2) is to test the feasibility of conducting a 24-week lifestyle modification intervention in men on ADT for prostate cancer. Additionally, it will also determine the effect of this intervention on weight loss, cardiometabolic markers (secondary aim and markers of interest: serum glucose, insulin resistance, hemoglobin A1C and lipid panel), and QoL (tertiary aim). The intervention will be delivered weekly via telephone for the first 10 weeks and bi-weekly for the remaining 14 weeks. Questionnaires and serum samples will be collected at baseline, week 12, and week 24. Anthropometric measurements will be collected at baseline, week 6, week 12, week 18 and week 24. ResultsWe hypothesize that the CLIPP2 intervention will produce a 7% weight loss that will result in improved markers associated with cardiometabolic disease and type 2 diabetes in the study population. ConclusionResults will provide insight into the role of lifestyle modification in addressing ADT adverse effects as well as provide preliminary data to inform the development of future lifestyle interventions in this area. Trial registrationNCT04228055 Clinicaltrials. gov.

Risk Factors of Metabolic Syndrome in Community-Dwelling People with Schizophrenia.

This study investigated the prevalence and risk factors of metabolic syndrome in 100 community-dwelling people with schizophrenia registered in mental health facilities in Seoul, Korea. This study was conducted between 12 September and 15 November 2019. This study used a cross-sectional descriptive design. The data included were general and disease-related characteristics, diagnostic tests for metabolic syndrome, lifestyles, depression, and social support. The analysis of collected data was done by using the SPSS 24.0 program. The prevalence of metabolic syndrome was 42.0%. Higher body mass index (odds ratio [OR] = 1.60, 95% CI = 1.16–2.18, p = 0.004), and depression (OR = 1.22, 95% CI = 1.06–1.42, p = 0.008) were associated with higher risks of metabolic syndrome, while physical activity and weight control (OR = 0.71, 95% CI = 0.54–0.94, p = 0.018), dietary habits (OR = 0.72, 95% CI = 0.54–0.93, p = 0.011), and medication and health management (OR = 0.52, 95% CI = 0.31–0.86, p = 0.012) were associated with lower risks. Mental health care nurses need to recognize the high prevalence of metabolic syndrome in people with schizophrenia in the community and provide differentiated, customized lifestyle improvement programs based on the body mass index and depression status of each person with schizophrenia. Furthermore, comprehensive lifestyle improvement programs and health examination services that people with schizophrenia can easily adhere to should be developed.

Cost-effectiveness of a Stepwise Approach vs Standard Care for Diabetes Prevention in India

A stepwise approach that includes screening and lifestyle modification followed by the addition of metformin for individuals with high risk of diabetes is recommended to delay progression to diabetes; however, there is scant evidence regarding whether this approach is cost-effective. To estimate the cost-effectiveness of a stepwise approach in the Diabetes Community Lifestyle Improvement Program. This economic evaluation study included 578 adults with impaired glucose tolerance, impaired fasting glucose, or both. Participants were enrolled in the Diabetes Community Lifestyle Improvement Program, a randomized clinical trial with 3-year follow-up conducted at a diabetes care and research center in Chennai, India. The intervention group underwent a 6-month lifestyle modification curriculum plus stepwise addition of metformin; the control group received standard lifestyle advice. Cost, health benefits, and incremental cost-effectiveness ratios (ICERs) were estimated from multipayer (including direct medical costs) and societal (including direct medical and nonmedical costs) perspectives. Costs and ICERs were reported in 2019 Indian rupees (INR) and purchasing power parity-adjusted international dollars (INT $). The mean (SD) age of the 578 participants was 44.4 (9.3) years, and 364 (63.2%) were men. Mean (SD) body mass index was 27.9 (3.7), and the mean (SD) glycated hemoglobin level was 6.0% (0.5). Implementing lifestyle modification and metformin was associated with INR 10 549 (95% CI, INR 10 134-10 964) (INT $803 [95% CI, INT $771-834]) higher direct costs; INR 5194 (95% CI, INR 3187-INR 7201) (INT $395; 95% CI, INT $65-147) higher direct nonmedical costs, an absolute diabetes risk reduction of 10.2% (95% CI, 1.9% to 18.5%), and an incremental gain of 0.099 (95% CI, 0.018 to 0.179) quality-adjusted life-years per participant. From a multipayer perspective (including screening costs), mean ICERs were INR 1912 (INT $145) per 1 percentage point diabetes risk reduction, INR 191 090 (INT $14 539) per diabetes case prevented and/or delayed, and INR 196 960 (INT $14 986) per quality-adjusted life-year gained. In the scenario of a 50% increase or decrease in screening and intervention costs, the mean ICERs varied from INR 855 (INT $65) to INR 2968 (INT $226) per 1 percentage point diabetes risk reduction, from INR 85 495 (INT $6505) to INR 296 681 (INT $22 574) per diabetes case prevented, and from INR 88 121 (INT $6705) to INR 305 798 (INT $23 267) per quality-adjusted life-year gained. The findings of this study suggest that a stepwise approach for diabetes prevention is likely to be cost-effective, even if screening costs for identifying high-risk individuals are added.

PDB69 FACTORS ASSOCIATED WITH PRE-DIABETES IN THE U.S ‘DIABETES-BELT’ REGION POPULATION

To determine the factors associated with pre-diabetes in the U.S ‘diabetes-belt’ region population. - Data from the Behavioral Risk Factor Surveillance System (BRFSS) 2017, survey of U. S. adults by CDC was used for this project. Respondents of the pre-diabetes survey module were included in the analysis. The primary outcome of interest was pre-diabetes diagnosis. Behavioral risk factors such as smoking status, high cholesterol, high blood pressure, employment status, marital status, BMI status were assessed as predictors in the model. Multivariate logistic regression was conducted to examine the associations between the independent risk factors and the diagnosis of pre-diabetes (self-reported). The study analysis included 46,460 participants of which overall, 12.63% of adults reported pre-diabetes condition. After adjusting for covariates, individuals falling under the Obese category, those that are insufficiently physically active had ORs 3.036, (95%CI 2.547-3.618), 1.331, (95%CI 1.085-1.633), statistically significantly increased odds of pre-diabetes. Having high blood pressure 1.763 (95% CI: 1.521- 2.044), high cholesterol 2.146 (95% CI: 1.858- 2.479) and arthritis 1.585 (95% CI: 1.367- 1.838) showed higher odds of pre-diabetes diagnosis. Our findings indicate that sub-groups of patients (e.g. Obese category, comorbidities like high cholesterol, high blood pressure and arthritis might particularly benefit from targeted interventions and additional support such as lifestyle improvement programs. The findings therefore call for action by health care professionals to plan about prevention and management of pre-diabetes in the ‘diabetes belt’ region.

Abstract 19: Cost-effectiveness of the Stepwise Approach to Diabetes Prevention in India

Introduction: Expert guidelines recommend a stepwise approach (lifestyle modification followed by addition of metformin in those not meeting goals) in high-risk people to delay progression to diabetes. However, there is scant evidence on the cost-effectiveness of implementing stepwise diabetes prevention. We estimated the 3-year within trial cost-effectiveness of a stepwise diabetes prevention approach in the Diabetes Community Lifestyle Improvement Program (D-CLIP) study in Chennai, India. Hypothesis: We assessed the cost-effectiveness of a stepwise diabetes prevention approach in India. Methods: The D-CLIP study was a randomized, controlled, translation trial in 578 overweight/obese Asian Indian adults with isolated impaired glucose tolerance (IGT) and/or isolated impaired fasting glucose (IFG), comparing a 6-month lifestyle modification curriculum and stepwise addition of metformin vs. standard lifestyle advice. We assessed direct medical costs including costs to deliver the intervention, general health care utilization, and direct non-medical costs. We also calculated costs for screening which included identifying and recruiting eligible individuals with IGT and/or IFG. Health effects were measured as absolute reductions in cumulative diabetes risk and in quality adjusted life years (QALYs) gained. Generalized linear regressions models adjusted for age, sex and baseline levels were fitted to estimate incremental costs and health effects. Bootstrapping was applied to describe the uncertainty around incremental cost-effectiveness ratios (ICER). Results: Over 3 years, the intervention resulted in incremental direct medical costs of 211 USD; incremental direct non-medical costs of 34 USD, an absolute diabetes risk reduction of 10.2%, and incremental QALYs gained of 0.098 per person. The absolute diabetes risk reduction in people with IFG was 6.4%, with IGT was 9% and with both IFG and IGT was 8.1%. ICERs from a multi-payer perspective (including the screening costs) averaged 4,275 USD per diabetes case prevented/delayed. That figure was 5,220 USD in people with IFG, 2,627 USD with IGT and 3,312 USD with both IFG and IGT. ICERs from a multi-payer perspective (including the screening costs) averaged 4,472 USD per QALY gained. That figure was 4,589 USD in people with IFG, 4,270 USD with IGT and 4,335 USD with both IFG and IGT. ICERs from a societal perspective were slightly higher. In the sensitivity analysis, with the scenario of a 50% increase/decrease in screening and intervention costs, from a multi-payer perspective, the average of ICERs varied 1,907 to 6,420 USD per diabetes case prevented, from 1,995 to 6,715 USD per QALY gained. Conclusions: In conclusion, a stepwise approach for diabetes prevention is likely to be cost-effective over a three-year time horizon.

National Cancer Control Program of Thailand.

Since 2000 cancer has been the leading cause of death in Thailand. In response to this challenge, the National Cancer Institute of Thailand (NCI), in collaboration with other bodies, has developed and promoted the National Cancer Control Program (NCCP) to provide appropriate policies and practice for the prevention, early detection and treatment of cancer, with optimal supportive care. With plans strongly supported by the Ministry of Public Health, the NCCP envisages integration into the health care system in 6 strategic areas: (1) cancer informatics; (2) primary prevention; (3) early detection; (4) treatment; (5) palliative care; and (6) cancer control research. For this purpose 7 regional cancer hospitals have been established to aid the NCI in conducting the NCCP. Cancer registration is a high priority, with 31.2% of the population now covered by quality registries. In primary prevention, there is a focus on awareness, lifestyle improvement, anti-smoking and alcohol control programs, vaccination, and Opisthorchis viverrini (OV) control. Screening programs for cervical, breast and colorectal cancer are underway to increase early detection. Priority is being given to facilities for chemotherapy and radiotherapy, as well as palliative care. Cancer control research encompasses international cooperation and participation in training programs, especially for development of cancer registration and other aspects of cancer control programs in South-East Asia, not least as an IARC Collaborating Center.

Clinical utility of 30-min plasma glucose for prediction of type 2 diabetes among people with prediabetes: Ancillary analysis of the diabetes community lifestyle improvement program

AimsTo examine the clinical utility of 30-min plasma glucose (30-min-PG) measurement during an oral glucose tolerance (OGTT) in predicting type 2 diabetes (T2DM). Research design and methodsData from a 3-year, randomized, controlled, primary prevention trial among 548 Asian Indians with prediabetes were analyzed. Participants underwent OGTT with PG measurements at fasting, 30-min, and 2-h at baseline and annually until the end of the study. Multivariable Cox regression models were constructed to calculate the risk of developing diabetes based on 30-min-PG levels. Improvement in prediction performance gained by adding an elevated level of 30-min-PG over prediabetic categories was calculated using the area-under-curve (AUC), net-reclassification (NRI), and integrated discrimination improvement (IDI) statistics. ResultsAt the end of follow-up, 30.4% of individuals had been diagnosed with T2DM by ADA criteria. Based on the maximally selected log-rank statistics, the optimal 30-min-PG cut point for predicting incident T2DM was >182 mg/dl. Multivariable-adjusted Cox regression models showed an independent association between elevated 30-min-PG (>182 mg/dl) and incident diabetes (hazard ratio (95% CI): 1.85 [1.32, 2.59]; Dxy = 0.353, c-statistic = 0.676). The addition of an elevated 30-min-PG (>182 mg/dl) model significantly improved the prediction of diabetes (Δdeviance: −15.4; ΔAUC: 0.11; NRIcontinuous: 0.51; IDI: 0.08) compared with IFG model alone) in individuals with prediabetes. ConclusionIn prediabetic individuals, baseline 30-min-PG independently predicted T2DM and significantly improved reclassification and discrimination. Therefore, 30-min-PG should be considered as part of the routine testing in addition to FPG and 2-h-PG for better risk stratification.

Comprehensive Lifestyle Improvement Program for Me With Prostate Cancer 2 (CLIPP2)

Comprehensive Lifestyle Improvement Program for Me With Prostate Cancer 2 (CLIPP2)

Comprehensive Lifestyle Improvement Program for Men With Prostate Cancer

Comprehensive Lifestyle Improvement Program for Men With Prostate Cancer

Comprehensive Lifestyle Improvement Program for Prostate Cancer (CLIPP): Protocol for a Feasibility and Exploratory Efficacy Study in Men on Androgen Deprivation Therapy.

BackgroundAndrogen deprivation therapy (ADT) for prostate cancer is associated with adverse cardiometabolic effects such as reduced libido, hot flashes, metabolic syndrome, diabetes, myocardial infarction, and stroke. This reduces quality of life and potentially increases mortality. Several large clinical trials have demonstrated improvements in cardiometabolic risk with comprehensive multimodality lifestyle modification. However, there is a lack of data for such interventions in men on ADT for prostate cancer, and existing studies have used non-standardized interventions or lacked data on metabolic risk factors.ObjectiveThe Comprehensive Lifestyle Improvement Project for Prostate Cancer (CLIPP) is designed to address these gaps by using an intervention modeled on the Diabetes Prevention Program, a standardized multicomponent intervention with demonstrated effectiveness in reducing cardiometabolic risk factors that has been successfully adapted for multiple disease types including breast cancer.MethodsA single-arm unblinded clinical trial will be conducted to determine the feasibility of conducting a 24-week comprehensive lifestyle modification intervention that targets weight loss and increased physical activity modeled on the Diabetes Prevention Program in 30 men on ADT for prostate cancer. Secondary aims are to determine the effect of the intervention on cardiometabolic markers and quality of life. The tertiary aim is to determine the effect of the intervention on markers of inflammation and angiogenesis, important mechanisms for prostate cancer progression. Participants will be recruited from the University of Arizona Cancer Center and the surrounding community. The intervention will be delivered weekly in person and over the phone for 16 weeks. For Weeks 16-24, participants receive weekly phone calls from the study health coach to motivate them to continue their lifestyle modification. Questionnaire and biological data are collected at baseline, 12 weeks, and 24 weeks. Body composition using dual-energy x-ray absorptiometry scans will be performed at baseline and end of study.ResultsBased on a sample size of 30, the two-sided 95% confidence interval will not be wider than 0.373 standard deviations for the adherence rate and will not be wider than 0.374 for the retention rate. In addition, the study will have a power of 80% to detect a change of 0.47 standard deviations from baseline for each of the markers investigated in the secondary and tertiary aims assuming a within-subject correlation of 0.20 at a significance level of 5%. The recruitment period is from October 2018 to April 2019.ConclusionsThe aim of CLIPP is to determine the feasibility of conducting a Diabetes Prevention Program–style comprehensive lifestyle modification intervention in men with ADT for prostate cancer and its effects on cardiometabolic adverse effects, quality of life, as well as markers of inflammation and angiogenesis. Results will inform the development of future clinical trials in this population.International Registered Report Identifier (IRRID)DERR1-10.2196/12579

An Evaluation of Lifestyle Health Coaching Programs Using Trained Health Coaches and Evidence-Based Curricula at 6 Months Over 6 Years.

Describe health plan member-level participation, completion, and 6-month outcomes for 5 lifestyle health coaching programs offered by an integrated delivery and financing system (IDFS) over 6 years. Case series study of 5 lifestyle programs with 180-day follow-up. Large Western PA integrated delivery and financing system (IDFS) deployed multiple coaching modalities for diverse insurance-member enrolled population. A total of 14 591 health plan members choosing a lifestyle health coaching program. Evidence- and curriculum-based lifestyle health coaching programs delivered by 1 of 4 interactive modalities. A single metric was used as an overall indicator of clinical success for each program. Success measures include a ≥5% reduction of self-reported baseline weight, meeting physical activity guidelines, and 7-day point prevalence abstinence from tobacco. For stress and nutrition, where no single target measure exists, a metric was created that represented a net improvement across all key outcomes measured. The proportion of members meeting target outcomes were calculated and described across all time points and modalities. At 180 days, 77% of enrolled members reported reduced stress, 7% quit tobacco, 50.5% met physical activity guidelines, 65.2% improved nutrition, and 44.2% lost 5% or more of baseline weight. This evaluation describes the real-world effectiveness of evidence- and curriculum-based lifestyle improvement programs delivered by trained health coaches to a diverse health plan member population.

Addressing health disparities in survivors of breast cancer through lifestyle modifications and group support.

177 Background: Obesity and inactivity have been shown to adversely affect outcomes in survivors of breast cancer. These factors may contribute to poorer outcomes in women of black and Hispanic populations, and those from lower socioeconomic backgrounds. We sought to improve overall well-being and limit weight gain in patients from these underserved populations through a group lifestyle intervention in a public hospital setting. Methods: 46 women were recruited and gave informed consent after completion of adjuvant chemotherapy for stage I-III breast cancer to participate in this feasibility pilot program. Blood work, body measurements, diet, two-minute walk tests, and PHQ9 depression scores were collected at the first and last of six monthly sessions. The group classes were led by a registered dietician and included diet and light exercise instruction at each visit. Results: Patient demographics and results are in the table below. Trends for non-completers included younger age, ethnicity, no hormonal therapy, lower baseline weight, lower HOMA IR, and dropout after two sessions. Among the 40% who completed all six sessions, there was a trend toward greater well-being (lower PHQ) with slight weight gain and increased insulin resistance. Completers tended to start in the same cohort and were more likely to complete if they attended more than two visits. Conclusions: Greater well-being may be an important outcome for group lifestyle improvement programs in populations with disparities. Motivations for better attendance may include group bonding. Participants will continue to be followed to obtain information on long-term weight change and cancer recurrence.[Table: see text]

Dietary changes in a diabetes prevention intervention among people with prediabetes: the Diabetes Community Lifestyle Improvement Program trial.

Diabetes prevention interventions have been less successful in Asian Indians compared to other populations, which may be due in part to dietary differences. The objective of this study was to determine the impact of a diabetes prevention intervention on diet and risk of diabetes in Asian Indians at high risk. Data were included from the Diabetes Community Lifestyle Improvement Program (D-CLIP), a randomized control trial to prevent diabetes in overweight/obese Asian Indian adults (20-65years) with prediabetes. Respondents received standard treatment (control; n = 283) or a 6-month intervention (n = 295) that included education and support to reduce intakes of fat and total calories (kilocalories; kcal). Diet was ascertained using a food frequency questionnaire, and incident diabetes was determined from annual 2-h plasma glucose post-oral glucose tolerance test or biannual fasting plasma glucose. There were 485 (control 240; intervention 245) respondents with complete diet data at baseline. At 6months, the intervention was associated with decreased intake of total energy (- 185.6kcal/day; 95% CI - 353.6, - 17.5kcal/day) and refined cereals (- 7.2g/1000kcal; 95% CI - 12.7, - 1.7g/1000kcal), and increased intakes of fruits and vegetables (33.4g/1000kcal; 95% CI 16.0, 50.8g/1000kcal). The intervention group was half (HR 0.49; 95% CI 0.25, 0.94) as likely to develop diabetes at 1year, and the hazard was significantly attenuated (12.2%; P = 0.015) with adjustment for fruits and vegetable intake. The D-CLIP decreased the total energy intake and increased the intakes of fruits and vegetables, and reduced the 1-year incidence of diabetes by half. Clinicaltrails.gov # NCT01283308.