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Intervention Fidelity Focusing on Interaction between Participants and Facilitators in a Telephone-Delivered Health Coaching Intervention for the Prevention and Management of Type 2 Diabetes.
Timm, L, Karlsson, I, Sidney Annerstedt, K, Absetz, P, Forsberg, BC, Daivadanam, M, Mølsted Alvesson, H
Nutrients. 2021;(11)
Abstract
Self-management support and lifestyle interventions with an empowerment approach have been found to be effective strategies for health improvement among people at risk for or living with type 2 diabetes. Telephone coaching seems particularly efficient for individuals with low socioeconomic status and culturally and linguistically diverse backgrounds. In this mixed methods study, we investigate a telephone-delivered health coaching intervention provided by the diabetes project SMART2D (Self-Management Approach and Reciprocal learning for Type 2 Diabetes) implemented in socioeconomically disadvantaged areas in Stockholm, Sweden. We focus on the interaction between participants and facilitators as part of intervention fidelity. Recorded coaching sessions were scored using an interaction tool and analyzed by exploratory factor analysis and recorded supervisory discussions with facilitators analyzed using thematic analysis. The quantitative analysis showed that the intervention components were delivered as intended; however, differences between facilitators were found. The qualitative data highlighted differences between facilitators in the delivery, especially in relation to dietary and physical activity goalsetting. The level of language skills hindered the delivery flow and the tailoring of sessions to participants' needs led to different delivery styles. The interaction between facilitators and participants is an important aspect of intervention implementation. Tailoring of interventions is necessary, and language-skilled facilitators are needed to minimize barriers in intervention delivery.
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Early Coaching to Increase Water Intake in CKD.
Ivanova, MD, Gozhenko, AI, Crestanello, T, Ivanov, DD
Annals of nutrition & metabolism. 2020;:69-70
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INTRODUCTION In observational studies, increased water intake improves kidney function but not in adults with CKD stage 3 and more. CKD WIT trial has shown a nonsignificant gradual decline in kidney function after 1 year of coaching to increase water intake (CIWI) [1]. We propose that CIWI may benefit in CKD stage 1-2 (G1 and G2) and depends on functional renal functional reserve (RFR) [2, 3]. OBJECTIVE Parallel-group randomized trial was aimed to determinate the effectiveness of CIWI dependence of estimated glomerular filtration rate (eGFR) stage and RFR in adults with CKD 1-2 stages. METHODS CKD WIT trial was taken as the basis for prospective multicenter randomized trial named "Early Coaching to Increase Water Intake in CKD (ECIWIC)." The primary outcome was the change in kidney function by eGFR from baseline to 12 months. Secondary outcomes included 1-year change in urine albumin/Cr ratio, and patient-reported overall quality of health (QH) ranged from 0 (worst possible) to 10 (best possible). CIWI aimed to have the diuresis being 1.7-2 L. There were 4 groups with nondiet sodium restriction which consisted of 31 patients each: 2 groups with CKD G1 and CKD G2, undergoing CIWI and 2 others with CKD G1 and CKD G2 without CIWI (Fig. 1a). Overall checks were made at 0, 6, and 12 months. RFR evaluation was performed using 0.45% sodium chloride oral solution. RESULTS Of our randomized 124 patients (mean age 53.2 years; men 83 [67%], 0 died), mean change in 24-h urine volume was 0.6 L per day in G1 with CIWI group and 0.5 L in G2. No statistically significant data on eGFR depending CIWI were obtained (Fig. 1b). However, the trend suggests that CIWI improves eGFR in CKD G1 (from 95 to 96 mL/min/1.73 m2) and preserves eGFR decline in CKD G2 (78-78). The QH values were also preserved (from 7 to 7 in G1 and G2 groups). Although coaching to maintain the same water intake did not preserve physiological and pathological eGFR decreasing in CKD G1-2 (G1 from 96 to 93, G2 from 76 to 73; t = 0.6, p = 0.29, and p ≤ 0.05 in all groups) and the QH was declined (from 7 to 6 in both groups). An individual analysis of the RFR has shown that patients with RFR more than 50% (G1 19 patients, 61%, and G2 13 patients, 42%) had reliable preservation of eGFR with its increase of 1.5 mL/min on CIWI, while patients with low functional renal reserve had a drop of eGFR at 1.1 mL/min/m2 within 12 months. Patients with low normal serum sodium levels have shown worse results on CIWI. CONCLUSIONS With CKD G1, the CIWI leads to the preservation of the renal function with its increase of GFR per 1 mL/min/m2/per year in comparison with the same water intake. In CKD G2, the CIWI prevents physiological and pathological loss of renal function, and RFR above 50% aids restoration of eGFR both in CKD G1-2. ECIWIC trial demonstrates benefit of CIWI in patients with CKD 1-2 and preserved RFR.
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Adding web-based behavioural support to exercise referral schemes for inactive adults with chronic health conditions: the e-coachER RCT.
Taylor, AH, Taylor, RS, Ingram, WM, Anokye, N, Dean, S, Jolly, K, Mutrie, N, Lambert, J, Yardley, L, Greaves, C, et al
Health technology assessment (Winchester, England). 2020;(63):1-106
Abstract
BACKGROUND There is modest evidence that exercise referral schemes increase physical activity in inactive individuals with chronic health conditions. There is a need to identify additional ways to improve the effects of exercise referral schemes on long-term physical activity. OBJECTIVES To determine if adding the e-coachER intervention to exercise referral schemes is more clinically effective and cost-effective in increasing physical activity after 1 year than usual exercise referral schemes. DESIGN A pragmatic, multicentre, two-arm randomised controlled trial, with a mixed-methods process evaluation and health economic analysis. Participants were allocated in a 1 : 1 ratio to either exercise referral schemes plus e-coachER (intervention) or exercise referral schemes alone (control). SETTING Patients were referred to exercise referral schemes in Plymouth, Birmingham and Glasgow. PARTICIPANTS There were 450 participants aged 16-74 years, with a body mass index of 30-40 kg/m2, with hypertension, prediabetes, type 2 diabetes, lower limb osteoarthritis or a current/recent history of treatment for depression, who were also inactive, contactable via e-mail and internet users. INTERVENTION e-coachER was designed to augment exercise referral schemes. Participants received a pedometer and fridge magnet with physical activity recording sheets, and a user guide to access the web-based support in the form of seven 'steps to health'. e-coachER aimed to build the use of behavioural skills (e.g. self-monitoring) while strengthening favourable beliefs in the importance of physical activity, competence, autonomy in physical activity choices and relatedness. All participants were referred to a standard exercise referral scheme. PRIMARY OUTCOME MEASURE Minutes of moderate and vigorous physical activity in ≥ 10-minute bouts measured by an accelerometer over 1 week at 12 months, worn ≥ 16 hours per day for ≥ 4 days including ≥ 1 weekend day. SECONDARY OUTCOMES Other accelerometer-derived physical activity measures, self-reported physical activity, exercise referral scheme attendance and EuroQol-5 Dimensions, five-level version, and Hospital Anxiety and Depression Scale scores were collected at 4 and 12 months post randomisation. RESULTS Participants had a mean body mass index of 32.6 (standard deviation) 4.4 kg/m2, were referred primarily for weight loss and were mostly confident self-rated information technology users. Primary outcome analysis involving those with usable data showed a weak indicative effect in favour of the intervention group (n = 108) compared with the control group (n = 124); 11.8 weekly minutes of moderate and vigorous physical activity (95% confidence interval -2.1 to 26.0 minutes; p = 0.10). Sixty-four per cent of intervention participants logged on at least once; they gave generally positive feedback on the web-based support. The intervention had no effect on other physical activity outcomes, exercise referral scheme attendance (78% in the control group vs. 75% in the intervention group) or EuroQol-5 Dimensions, five-level version, or Hospital Anxiety and Depression Scale scores, but did enhance a number of process outcomes (i.e. confidence, importance and competence) compared with the control group at 4 months, but not at 12 months. At 12 months, the intervention group incurred an additional mean cost of £439 (95% confidence interval -£182 to £1060) compared with the control group, but generated more quality-adjusted life-years (mean 0.026, 95% confidence interval 0.013 to 0.040), with an incremental cost-effectiveness ratio of an additional £16,885 per quality-adjusted life-year. LIMITATIONS A significant proportion (46%) of participants were not included in the primary analysis because of study withdrawal and insufficient device wear-time, so the results must be interpreted with caution. The regression model fit for the primary outcome was poor because of the considerable proportion of participants [142/243 (58%)] who recorded no instances of ≥ 10-minute bouts of moderate and vigorous physical activity at 12 months post randomisation. FUTURE WORK The design and rigorous evaluation of cost-effective and scalable ways to increase exercise referral scheme uptake and maintenance of moderate and vigorous physical activity are needed among patients with chronic conditions. CONCLUSIONS Adding e-coachER to usual exercise referral schemes had only a weak indicative effect on long-term rigorously defined, objectively assessed moderate and vigorous physical activity. The provision of the e-coachER support package led to an additional cost and has a 63% probability of being cost-effective based on the UK threshold of £30,000 per quality-adjusted life-year. The intervention did improve some process outcomes as specified in our logic model. TRIAL REGISTRATION Current Controlled Trials ISRCTN15644451. FUNDING This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 63. See the NIHR Journals Library website for further project information.
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Impact of Physician Referral to Health Coaching on Patient Engagement and Health Risks: An Observational Study of UPMC's Prescription for Wellness.
Parkinson, MD, Hammonds, T, Keyser, DJ, Wheeler, JR, Peele, PB
American journal of health promotion : AJHP. 2020;(4):366-375
Abstract
PURPOSE Evaluate impact of physician referral to health coaching on patient engagement and health risk reduction. DESIGN Four-year retrospective, observational cohort study with propensity-matched pair comparisons. SETTING Integrated delivery and finance system in Pittsburgh, Pennsylvania. SAMPLE 10 457 adult insured members referred to health coaching by their physician; 37 864 other members identified for health coaching through insurer-initiated outreach. INTERVENTION Practice-based, technology-supported workflow and process for physician prescribing of health coaching during regular office visit, with follow-up on patient's progress and implementation supports. MEASURES Patient engagement based on completion of pre-enrollment assessment, formal enrollment in health coaching, completion of required sessions, health risk levels, and number of health risks pre- and post-health coaching referral. ANALYSIS Difference-in-difference analysis to assess change in health risk levels and number of health risks pre- and post-health coaching and probability weighting to control for potential confounding between groups. RESULTS Members referred by a physician were significantly more likely to enroll in a health coaching program (21.0% vs 6.0%, P < .001) and complete the program requirements (8.5% vs 2.7%, P < .001) than when referred by insurer-initiated outreach; significant within group improvement in health risk levels from baseline (P < .001) was observed for both the groups. CONCLUSIONS Patients are significantly more likely to engage in health coaching when a referral is made by a physician; engagement in health coaching significantly improves health risk levels.
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DIAL now protocol: A randomized trial examining the provision of phone coaching to those with sub-optimal early weight loss during an Internet weight management program.
Unick, JL, Pellegrini, CA, Dunsiger, SI, Demos, KE, Thomas, JG, Bond, DS, Webster, J, Wing, RR
Contemporary clinical trials. 2020;:105953
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BACKGROUND While low-intensity Internet-delivered weight loss (IDWL) programs are efficacious, many patients fail to achieve clinically significant weight loss (WL). Given the positive association between 4-week and post-treatment WL, providing a more intensive intervention for those with sub-optimal 4-week WL may improve outcomes for a greater proportion of individuals. This stepped-care approach would minimize cost by reserving more aggressive treatment for those with sub-optimal early WL. OBJECTIVE This randomized trial examines whether the provision of brief or extended phone coaching for those with sub-optimal early WL improves 4- and 12-month WL when compared to no coaching. Secondary aims include examination of cost/kg WL and intervention engagement. METHODS 450 individuals (age 18-70 years, BMI: 25-45 kg/m2) will be randomized to: 1) IDWL+3 weeks of coaching ('Brief'), 2) IDWL+12 weeks of coaching ('Extended'), or 3) IDWL only ('Control'). All individuals will receive a 4-month IDWL program followed by an 8-month IDWL maintenance program. At week 4, individuals will be classified as early sub-optimal responders (<4% WL) or initial responders (≥4% WL). Individuals with sub-optimal early WL randomized to 'Brief' or 'Extended' will receive 3 and 12 weeks of phone coaching respectively, starting at week 5. Those with sub-optimal early WL randomized to 'Control', and initial responders will not receive any coaching. Assessments will occur at 4 and 12 months. DISCUSSION Study findings can inform the development of more effective IDWL programs. This model which provides additional support to those with sub-optimal early WL can easily be translated into healthcare and community settings.
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E-Coaching: the DianaWeb study to prevent breast cancer recurrences.
Gianfredi, V, Nucci, D, Balzarini, M, Acito, M, Moretti, M, Villarini, A, Villarini, M
La Clinica terapeutica. 2020;(1):e59-e65
Abstract
INTRODUCTION Breast cancer is the most common cancer in women worldwide, for which the survival rate is increasing over time. Growing evidence are showing that the effect of lifestyle could have the same weight of the effect of the usual clinical-pathological risk factors on survival rate. The DianaWeb study responds to the pressing request of patients diagnosed with breast cancer to know the most advanced point of scientific research on the prevention of recurrences, to have a virtual space to meet, where to receive advice and practical information for the daily management the lifestyle change. DianaWeb is a community-based participatory research, dedicated to breast cancer patients, aimed to monitor lifestyle, provide them tips to encourage sustainable lifestyle changes, and to analyze clinical outcomes. In order to achieve these aims, DianaWeb uses a specific interactive website (http://www.dianaweb.org/). METHODS The web architecture has been designed essential and light, with a rigorous implantation that brings the figure of the woman to the center. In order to humanized the project the acronym used to identify the study was Diana (Diet and Androgens), a classical female name, who was illustrated as a female avatar, aimed to symbolize all women. The graphical interface was developed using seven pastel tones colors, which become a fundamental elements of the layout, such as frame, navigation menu, and separation interspaces. RESULTS The project started in 2015, and in 4 days the web site was visited by more than 1000 people. A total of 2823 persons enrolled in the study, but 2182 did not send the full documentations, 61 persons abandoned the study, 641 timely answered to the questionnaires. CONCLUSIONS The high number of participants' interaction within the web page, confirmed the high usability of the web page and the great interest of patients. Prevention of breast cancer recurrences with low cost technologies, easily available to everybody, is a priority for both public health and public finances.
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Weight Reduction by the Low-Insulin-Method-A Randomized Controlled Trial.
Röhling, M, Martin, K, Ellinger, S, Schreiber, M, Martin, S, Kempf, K
Nutrients. 2020;(10)
Abstract
Continuous high insulin levels are associated with weight gain and lead to cardiometabolic diseases. Therefore, we have developed the Low-Insulin-Method and integrated it into the multi-component, occupational healthcare program SHAPE-AND-MOTION-Medical-Accompanied-Slimming (SAMMAS) to reduce daily insulin levels for long-term weight reduction in overweight or obesity. Employees were randomized into a starting intervention group (SI, n = 15) or waiting list control group (WL, n = 15). SAMMAS consisted of group-based seminars, low-carbohydrate nutrition including formula diet, continuous glucose monitoring, telemetric monitoring, and telemedical coaching. Both groups received telemetric devices at baseline. Intention-to-treat analyses were performed after 12, 26, and 52 weeks. The estimated treatment difference in weight reduction after 12 weeks, which is the primary endpoint of the study, showed a pronounced effect in favour of SI (-6.3 kg with (95% confidence interval) (-7.4; -4.5) (p < 0.001)) after 12 weeks. Furthermore, SI improved fasting blood glucose, HbA1c, quality of life, fasting insulin, blood pressure, and eating behaviour (all p < 0.05) in the within-group analysis, while WL did not. After 26 and 52 weeks, weight reduction could be maintained in the whole group (both groups together) by -6.7 kg (-9.5; -3.8) (p < 0.001) and -6.1 kg (-9.2; -2.7) (p < 0.01). SAMMAS supports clinically relevant weight reduction and long-term weight loss maintenance in individuals with overweight or obesity.
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Health coaching to encourage obese adults to enroll in commercially-available weight management programs: The path to health study.
Heredia, NI, Lee, M, Hwang, KO, Reininger, BM, Fernandez, ME, McNeill, LH
Contemporary clinical trials. 2019;:1-9
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Physicians are recommended to screen and refer obese patients to weight management programs (WMPs). There are often limited referral options for physicians, though commercially-available WMPs could be a potential solution. The purpose of this study (Path to Health) was to evaluate the efficacy of health coaching to promote enrollment in commercially-available WMPs through a two-arm, RCT with obese patients (n = 168) randomly assigned to intervention (n = 84) or control groups (n = 84). Intervention participants received phone health coaching to help them select and enroll in WMPs. We collected data on program enrollment, weight, self-reported physical activity (PA), and fruit and vegetable (FV) intake at baseline, 3- and 6-months. We used logistic regression to assess the intervention effect on enrollment in WMPs and longitudinal regression models to evaluate the effect on weight change, PA and FV intake. The average age was 54.7 years, 59% were female and 43% were Black and 49% were White. At 6 months, 39% of the intervention group (vs. 29% of control) had enrolled in WMPs. We found no longitudinal intervention effect on weight, PA and FV intake. We found that there was more weight loss for those who completed ≥4 calls as compared to those who completed <4 calls. We also found significant dose response relationships for PA and FV intake at 3 months. In this study, we found that phone health coaching was successful in increasing obese adults' enrollment in commercially-available WMPs and that there was a dose response relationship for weight and behavioral outcomes.
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Telemedicine-Based Health Coaching Is Effective for Inducing Weight Loss and Improving Metabolic Markers.
Johnson, KE, Alencar, MK, Coakley, KE, Swift, DL, Cole, NH, Mermier, CM, Kravitz, L, Amorim, FT, Gibson, AL
Telemedicine journal and e-health : the official journal of the American Telemedicine Association. 2019;(2):85-92
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BACKGROUND To assess the efficacy of health coaching (HC) delivered through videoconferencing (VC) to favorably change physical activity (PA), weight, and metabolic markers in adults with high body mass index (BMI). MATERIALS AND METHODS Thirty adults (BMI ≥30 kg/m2) were randomly assigned to one of three groups: VC, in-person (IP), or control group (CG). Participants received wireless watches and weight scales to sync with their personal smartphones; recorded data were wirelessly uploaded to a secure database. Participants assigned to VC and IP received individualized HC by a multidisciplinary team (registered dietitian, exercise physiologist, and medical doctor) based on data uploaded over the 12-week intervention. Steps/day and weight loss were analyzed through analyses of covariance. RESULTS Within- and between-group changes in weight (kg), glucose, insulin, hemoglobin A1c (HbA1c), and Homeostasis Model Assessment estimate of insulin resistance (HOMA-IR) were analyzed through analyses of variance. Weight loss was greater (p < 0.05) for VC (8.23 ± 4.5 kg; 7.7%) than IP (3.2 ± 2.6 kg; 3.4%) and CG (2.9 ± 3.9 kg; 3.3%), respectively. Steps/day were significantly higher in VC than IP at week 4 and VC was significantly higher than the CG at weeks 6, 8, 9, and 11 (p ≤ 0.05). No within- or between-group differences were found for glucose, insulin, or HbA1C. HOMA-IR decreased for VC only (p ≤ 0.05). CONCLUSIONS Our innovative, multidisciplinary, telemedicine HC delivered through VC led to more favorable changes in weight loss, PA (steps/day), and HOMA-IR than IP or no HC. VC may be an economical approach to improve health and promote behavior change in obese adults. CLINICAL TRIAL REGISTRATION NUMBER ClinicalTrials.gov identifier NCT03278951.
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Protocol for a cluster-randomized controlled trial of a technology-assisted health coaching intervention for weight management in primary care: The GEM (goals for eating and moving) study.
Wittleder, S, Ajenikoko, A, Bouwman, D, Fang, Y, McKee, MD, Meissner, P, Orstad, SL, Rehm, CD, Sherman, SE, Smith, S, et al
Contemporary clinical trials. 2019;:37-45
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INTRODUCTION Over one-third of American adults have obesity with increased risk of chronic disease. Primary care providers often do not counsel patients about weight management due to barriers such as lack of time and training. To address this problem, we developed a technology-assisted health coaching intervention called Goals for Eating and Moving (GEM) to facilitate obesity counseling within the patient-centered medical home (PCMH) model of primary care. The objective of this paper is to describe the rationale and design of a cluster-randomized controlled trial to test the GEM intervention when compared to Enhanced Usual Care (EUC). METHOD We have randomized 19 PCMH teams from two NYC healthcare systems (VA New York Harbor Healthcare System and Montefiore Medical Group practices) to either the GEM intervention or EUC. Eligible participants are English and Spanish-speaking primary care patients (ages 18-69 years) with obesity or who are overweight with comorbidity (e.g., arthritis, sleep apnea, hypertension). The GEM intervention consists of a tablet-delivered goal setting tool, a health coaching visit and twelve telephone calls for patients, and provider counseling training. Patients in the EUC arm receive health education materials. The primary outcome is mean weight loss at 1 year. Secondary outcomes include changes in waist circumference, diet, and physical activity. We will also examine the impact of GEM on obesity-related provider counseling competency and attitudes. CONCLUSION If GEM is found to be efficacious, it could provide a structured approach for improving weight management for diverse primary care patient populations with elevated cardiovascular disease risk.