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OBJECTIVE: To determine differences in obesity, type 2 diabetes, and hypertension in Black patients compared with White patients with multiple sclerosis (MS). DESIGN: Cross-sectional database review. SETTING: Large academic medical center research records database. PARTICIPANTS: A total of 3191 patient cases (N=3191; 77% female, 34% Black) identified by MS diagnosis within the medical record. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Diagnosis codes for type 2 diabetes and hypertension. Body mass index (BMI), race, age, and sex were collected. Analysis of variance (continuous variables) and chi-square analyses (categorical variables) were conducted to determine differences in obesity, diabetes, and hypertension between race and sex. Logistic regression was conducted to determine odds ratios (ORs) of developing diabetes and hypertension based on race, sex, BMI, and age. RESULTS: Black patients were more than twice as likely to be diagnosed as having diabetes (OR, 2.15 [95% CI, 1.70-2.72]; P<.0001) or hypertension (OR, 2.44 [95% CI, 2.05-2.91], P<.0001) compared with White patients. Sex did not present a greater likelihood of being diagnosed as having diabetes; however, men were 1.22 times more likely be diagnosed as having hypertension compared with women (95% CI, 1.01-1.49; P=.0439). Increased age and BMI were also significantly associated with likelihood of diagnosis of diabetes and hypertension (age: diabetes OR, 1.05 [95% CI, 1.04-1.06], P<.0001; hypertension OR, 1.06 [95% CI, 1.05-1.06], P<.0001; BMI: diabetes obese vs normal: OR, 2.11 [95% CI, 1.43-3.11], P=.0002; hypertension: obese vs normal: OR, 1.72 [95% CI, 1.39-2.13], P<.0001). CONCLUSIONS: Black patients with MS are significantly more likely to have cardiometabolic conditions than White patients. These conditions have been associated with poorer health outcomes for people with MS and may have some effect on the differences in MS disease course reported in Black patients.
Subject(s)
Diabetes Mellitus, Type 2 , Hypertension , Multiple Sclerosis , Diabetes Mellitus, Type 2/epidemiology , Female , Humans , Hypertension/complications , Hypertension/epidemiology , Male , Multiple Sclerosis/complications , Multiple Sclerosis/epidemiology , Obesity/complications , Obesity/epidemiology , White PeopleABSTRACT
BACKGROUND: Pilot trials indicate that both a low glycemic load (GL) diet and calorie restriction (CR) can be implemented successfully in people with multiple sclerosis (pMS) and may improve MS symptoms and physical function, but large randomized clinical trials (RCTs) have not yet been conducted. The purpose of this study is to test these interventions alone and in combination to determine their efficacy for improving clinical and patient reported outcomes (PROs) in pMS. METHODS: This 32-week, two-arm, RCT at two centers will randomly assign 100 adults with relapsing-remitting or secondary progressive MS to a low GL diet (nâ¯=â¯50) or a standard GL diet (nâ¯=â¯50). Both diet groups will complete two study phases: a eucaloric phase (16â¯weeks) and a CR phase (16â¯weeks). Groceries for the study meal plans will be delivered to participants' homes weekly. The primary outcome is physical function, measured by timed 25-ft walk test. Secondary outcomes are pain, fatigue, mood, and anxiety. DISCUSSION: This will be the most rigorous intervention trial to date of a low GL diet and CR in adults with MS, and among the first to assess the impact of intentional weight loss on MS symptoms. Results will provide valuable insight for recommending dietary change, weight loss, or both to adults with MS. These non-drug interventions pose few risks and have potential to yield significant improvements in MS symptoms. TRIAL REGISTRATION ID: NCT05327322.
Subject(s)
Caloric Restriction , Glycemic Load , Humans , Caloric Restriction/methods , Adult , Female , Multiple Sclerosis, Chronic Progressive/diet therapy , Male , Multiple Sclerosis, Relapsing-Remitting/diet therapy , Fatigue , Middle Aged , Multiple Sclerosis/diet therapy , Affect , AnxietyABSTRACT
Introduction: Intermittent fasting (IF) has become a popular dietary pattern for adults with multiple sclerosis (MS), and initial studies in animal models and human trials indicate promising results for improving symptoms and slowing disease progression. Most studies published to date have focused on alternate day fasting or fasting mimicking diets including a 5:2 pattern, in which participants greatly restrict calorie intake on two non-consecutive days and eat regularly on other days; however, time restricted eating (TRE) may be equally effective for improving symptoms and may lead to better long term adherence due to its focus only on the time of day in which calories are consumed with no restriction on number of calories or types of food consumed. Methods: The purpose of this pilot study was to determine the feasibility and acceptability of a TRE intervention in adults with relapsing remitting MS (RRMS). Participants (n = 12) were instructed to eat all food within an 8-h window every day and fast the remaining 16 h for 8 weeks. Results: The eating pattern was determined to be feasible based on retention rates (n = 11; 92%) and acceptable based on participant feedback. Discussion: Exploratory results of changes in cognition, pain, and fatigue, indicate that further study of TRE in this population is warranted. Clinical trial registration: https://clinicaltrials.gov/ct2/show/NCT04389970; NCT04389970.
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CONTEXT: The workplace may be an ideal venue for engaging African American women in behavioral interventions for weight reduction. OBJECTIVE: To examine the effectiveness of a culturally enhanced EatRight dietary intervention among a group of predominately African American women in a workplace setting. DESIGN: Crossover design study. SETTING: Workplace. PARTICIPANTS: A total of 39 women volunteered for this study, of whom 27 completed it. INTERVENTION: The control period involved observation of participants for 22 weeks after receiving standard counseling on lifestyle methods to achieve a healthy weight; following the control period, participants crossed over to the 22-week intervention period. The intervention was culturally enhanced using feedback derived from formative assessment and delivered as 15 group sessions. MAIN OUTCOME MEASURES: The primary outcome measure was the difference in weight change between the control and intervention periods; changes in waist circumference and quality of life were secondary outcomes. RESULTS: Most participants were obese, with a mean baseline body mass index of 36 kg/m², weight of 97.9 kg, and waist circumference of 111 cm. Weight increased during the control period by 0.7 kg but decreased by 2.6 kg during the intervention (net difference = -3.4 kg, P <.001), with 30% of participants losing 5% or more of body weight. Compared to the control period, there was a significant decrease in waist circumference (-3.6 cm, P =.006) and improvement in weight-related quality of life (5.7, P =.03). CONCLUSIONS: This pilot study demonstrated the feasibility of a culturally enhanced behavioral weight loss intervention in a predominately African American workplace setting. The workplace may be conducive for targeting African American women who are disproportionately affected by obesity.
Subject(s)
Black or African American/psychology , Counseling , Feeding Behavior , Health Promotion/methods , Weight Loss/physiology , Workplace , Adult , Black or African American/statistics & numerical data , Body Mass Index , Cross-Over Studies , Cultural Characteristics , Feedback , Female , Humans , Life Style , Middle Aged , Obesity/diet therapy , Obesity/ethnology , Outcome Assessment, Health Care , Pilot Projects , Quality of Life/psychology , Weight Loss/ethnology , Young AdultABSTRACT
Objective: To describe and compare (1) classification of obesity using clinical proxies of body composition that are easily accessible in the outpatient clinic setting, (2) cardiometabolic risk using existing screening tools and staging systems, and (3) the presence of metabolic syndrome (MetS) using four commonly-used definitions in adults with spinal cord injury (SCI). Design: Retrospective chart review Setting: Outpatient Veterans Affairs (VA) SCI Annual Evaluation Clinic Participants: Patients who attended an annual evaluation appointment with demographic, anthropometric, and biochemical data documented in their medical records as part of routine medical care. Outcome measures: Obesity classification (body mass index, waist circumference, ideal body weight percentage), cardiometabolic risk scores (Framingham Risk Score, Cardiometabolic Disease Staging System, Edmonton Obesity Staging System), and MetS classification (using four commonly-used definitions) were described and compared. Results: Of the 155 veterans included in this analysis, 93% were considered "at risk" by at least one of the measurements studied. However, there was considerable variation between the different screening tools. The κ-agreement between various definitions of MetS ranged from fair to moderate. Conclusion: Screening tools that were developed for the non-SCI population produced variable assessments of risk when applied to veterans with SCI. Due to the fair to moderate inter-rater agreement between MetS definitions, it is unknown which definition is superior to identify MetS in the SCI population. An SCI-specific screening tool is needed to accurately classify obesity, cardiometabolic risk, and MetS in order to provide timely education and intervention.
Subject(s)
Cardiovascular Diseases , Metabolic Syndrome , Spinal Cord Injuries , Adult , Cardiovascular Diseases/diagnosis , Cardiovascular Diseases/epidemiology , Cardiovascular Diseases/etiology , Humans , Metabolic Syndrome/diagnosis , Metabolic Syndrome/epidemiology , Metabolic Syndrome/etiology , Obesity/complications , Obesity/epidemiology , Retrospective Studies , Risk Factors , Spinal Cord Injuries/complications , Spinal Cord Injuries/diagnosis , Spinal Cord Injuries/epidemiologyABSTRACT
BACKGROUND: Children with physical disabilities report higher rates of sedentary lifestyle and unhealthy dietary patterns than non-disabled peers. These behaviors can increase comorbidities, caregiver burden, and healthcare costs. Innovative interventions are needed to assist caregivers of children with physical disabilities improve health behaviors. OBJECTIVE: /Hypothesis: The purpose of this pilot study was to test the usability and preliminary efficacy of an e-health and telecoaching intervention compared to telecoaching alone. METHODS: Parent/child dyads (nâ¯=â¯65) were randomized into either the e-health and telephone group (e-HT) or the telephone only group (TO). All participants received regular calls from a telecoach, and the e-HT group received access to a website with personalized weekly goals for diet and physical activity, and access to resources to meet these goals. At the conclusion of the intervention, participants in the e-HT group were asked to complete a semi-structured interview to discuss the usability of the e-health platform. RESULTS: Fifty of the 65 randomized dyads (77%) completed all baseline measures and had at least one intervention call. Forty families (80% of those that started the intervention) completed the study (50% spina bifida, 24% mobility limitation, diagnosis not reported). Age of the children ranged from 6 to 17 years old. Both groups had high adherence to scheduled phone calls (e-HT (nâ¯=â¯17): 81%, TO (nâ¯=â¯23): 86%); however no significant differences in dietary intake or physical activity were seen within or between groups. Primary themes to emerge from qualitative interviewers were: the platform should target children rather than parents, parents valued the calls more than the website, and schools need to be involved in interventions. CONCLUSIONS: E-health interventions are a promising way to promote healthy behaviors in children with physical disability, but technology must be balanced with ease of use for parents while also engaging the child.
Subject(s)
Diet , Disabled Persons , Exercise , Internet , Parents , Telemedicine/methods , Telephone , Adolescent , Adult , Caregivers , Child , Female , Health Behavior , Health Promotion , Humans , Male , Mobility Limitation , Nutritional Status , Pilot Projects , Program Evaluation , Spinal DysraphismABSTRACT
BACKGROUND: Evidence from observational studies increasingly highlights the association between unhealthy diet and poor health outcomes in adults with multiple sclerosis (MS), but very few intervention trials for dietary change have been completed. Improving diet quality via a low glycemic load (GL) diet has demonstrated improvements in cardiometabolic risks, cognitive risks, and psychosocial variables in diseases other than MS. The purpose of this study was to test the feasibility of delivering a low GL dietary intervention implemented via telehealth in a sample of adults with relapsing remitting MS (RRMS). The secondary purpose was to explore the potential impact of the diet on MS outcomes and cardiometabolic risks. METHODS: Participants followed a low GL diet consisting of 100g of carbohydrate and GL of ≤45 points/1000 kcal daily for 12 weeks. Each participant received weekly calls from a telecoach, education and behavioral supports via weekly emails, and recorded all food intake on a mobile app. Feasibility was measured as time to recruit, retention and study completion, and intervention adherence. An a priori cut point of 80% completion was used to determine feasibility. Exploratory outcomes included the Multiple Sclerosis Functional Composite (MSFC) and patient-reported outcomes of anxiety, pain, mood, and fatigue. Cardiometabolic risks included body composition, fasting glucose, hemoglobin A1c, and blood pressure. RESULTS: Twenty adults with RRMS (85% female, 50% African American) enrolled in the study and n=18 (90%) completed the intervention and follow-up measures. Participants completed 90% of scheduled calls and recorded at least one meal on 82% of intervention days (mean (SD) = 68 (25.5) days). Participants exceeded recommended daily GL reductions (recommended daily GL: 96.66 (12.97) points, reported follow-up daily GL: 90.32 (39.36) points). Timed 25-foot walk test and symbol digit modalities test both changed in the desired direction. Sleep, mood, anxiety, emotional health, and pain all moved in the expected directions, and anxiety (r=.24), pain (r=-.43), and emotional health (r=-.36) were moderately correlated with reductions in GL. Participants lost a mean of 2.93 (6.31, p=.003) kg, and had reductions in both fat and lean mass (fat mass: 1.94 (2.5) kg; lean mass: .72 (1.29) kg). CONCLUSION: A low GL dietary intervention is feasible for adults with RRMS and may lead to improvements in MS outcomes and cardiometabolic risk. Additional research is needed with more tightly controlled feeding trials and larger sample sizes to further understand the impact of this dietary pattern on RRMS.
Subject(s)
Multiple Sclerosis , Telemedicine , Adult , Diet , Feasibility Studies , Female , Humans , Life Style , Male , Multiple Sclerosis/therapyABSTRACT
BACKGROUND: The rate of physical activity is substantially lower in persons with multiple sclerosis (MS) than in the general population. This problem can be reversed through rigorous and reproducible delivery of behavioral interventions that target lifestyle physical activity in MS. These interventions are, in part, based on a series of phase II randomized controlled trials (RCTs) supporting the efficacy of an internet-delivered behavioral intervention, which is based on social cognitive theory (SCT) for increasing physical activity in MS. OBJECTIVE: This paper outlines the strategies and monitoring plan developed based on the National Institutes of Health Behavior Change Consortium (NIH BCC) treatment fidelity workgroup that will be implemented in a phase III RCT. METHODS: The Behavioral Intervention for Physical Activity in Multiple Sclerosis (BIPAMS) study is a phase III RCT that examines the effectiveness of an internet-delivered behavioral intervention based on SCT and is supported by video calls with a behavioral coach for increasing physical activity in MS. BIPAMS includes a 6-month treatment condition and 6-month follow-up. The BIPAMS fidelity protocol includes the five areas outlined by the NIH BCC. The study design draws on the SCT behavior-change strategy, ensures a consistent dose within groups, and plans for implementation setbacks. Provider training in theory and content will be consistent between groups with monitoring plans in place such as expert auditing of calls to ensure potential drift is addressed. Delivery of treatment will be monitored through the study website and training will focus on avoiding cross-contamination between conditions. Receipt of treatment will be monitored via coaching call notes and website monitoring. Lastly, enactment of treatment for behavioral and cognitive skills will be monitored through coaching call notes among other strategies. The specific strategies and monitoring plans will be consistent between conditions within the constraints of utilizing existing evidence-based interventions. RESULTS: Enrollment began in February 2018 and will end in September 2019. The study results will be reported in late 2020. CONCLUSIONS: Fidelity-reporting guidelines provided by the NIH BCC were published in 2004, but protocols are scarce. This is the first fidelity-monitoring plan involving an electronic health behavioral intervention for increasing physical activity in MS. This paper provides a model for other researchers utilizing the NIH BCC recommendations to optimize the rigor and reproducibility of behavioral interventions in MS. TRIAL REGISTRATION: ClinicalTrials.gov NCT03490240; https://www.clinicaltrials.gov/ct2/show/NCT03490240. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/12319.
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The need among people with disabilities to improve their own health and prevent/manage secondary conditions requires a better balance between reactive and anticipatory care.
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There is an obvious disconnect between evidence of benefits and rates of participation in exercise and physical activity among people living with multiple sclerosis (MS). We propose that the problem with exercise behavior in MS (i.e. lack of broad or increasing participation by people with MS despite evidence of meaningful benefits) might be ameliorated through the inclusion of behavior change theory in the design of exercise programs and promotion efforts, as has been undertaken in other populations such as breast cancer survivors. This paper reviews Social Cognitive Theory as an example approach for informing interventions for increasing exercise and physical activity behavior outside of MS and provides an overview of current knowledge regarding the application of this theory for physical activity in MS. We then outline future research necessary for informing trials that design, implement, and test theory-based interventions for physical activity promotion in MS. If theories of behavior change are adopted for informing exercise and physical activity research in MS, we can take a major step forward in addressing the problem of exercise and physical activity participation that has plagued the field for more than 25 years.
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BACKGROUND: Persons with multiple sclerosis (MS) have many health conditions related to overweight and obesity, but little is known about how body composition among those with MS compares to those without MS at the same weight. OBJECTIVE: To compare differences in whole body and regional body composition between persons with and without MS matched for sex and body mass index (BMI). METHODS: Persons with MS (n = 51) and non-MS controls (n = 51) matched for sex and BMI. Total mass, lean mass, fat mass, and percent body fat (%BF) of total body and arm, leg, and trunk segments were assessed using dual-energy X-ray absorptiometry (DXA). RESULTS: Men with MS had significantly less whole body lean mass (mean difference: 9933.5 ± 3123.1 g, p < 0.01) and higher fat mass (mean difference: 6079.0 ± 2137.4 g, p = .01) and %BF (mean difference: 9.43 ± 2.04%, p < 0.01) than BMI-matched non-MS counterparts. Further, men with MS had significantly lower lean mass in the arm (p = 0.02) and leg (p < 0.01) and higher fat mass in the arm (p = 0.01), leg (p = 0.03) and trunk (p = 0.03) than men without MS. Men with MS had significantly higher %BF in all three regions (p < 0.01) than men without MS. There were no differences between women with and without MS. CONCLUSIONS: We observed significant differences in whole body and regional body composition between BMI-matched men with and without MS. Additional research is needed to further explore differences in body composition, adipose distribution, and the impact of these differences on the health and function of men with MS.
Subject(s)
Adipose Tissue/metabolism , Body Composition , Body Mass Index , Disabled Persons , Multiple Sclerosis/complications , Obesity/complications , Absorptiometry, Photon , Adult , Arm , Body Fluid Compartments/metabolism , Body Weight , Female , Humans , Leg , Male , Middle Aged , Multiple Sclerosis/metabolism , Obesity/metabolism , Overweight , Sex Factors , TorsoABSTRACT
BACKGROUND & AIMS: Segmental body composition may be an important indicator of health and nutritional status in conditions where variations in fat and lean mass are frequently isolated to a particular body segment (e.g. paralysis, sarcopenia). Until recently, segment-specific body composition could only be assessed using invasive and expensive methods such as dual-energy x-ray absorptiometry (DXA), magnetic resonance imaging (MRI), or computed tomography (CT). Bioelectrical impedance analysis (BIA) may be a rapid, inexpensive alternative for assessing segmental composition, but it has not been fully validated for this purpose. The purpose of this study was to compare segmental estimates of lean and fat mass using BIA versus a criterion standard of DXA. METHODS: A cross-sectional pilot study was conducted in n = 30 healthy adults. Outcome measures included total mass, fat mass and lean mass of arm, leg and trunk. Pearson correlation coefficients (r) and paired-samples t-tests (t) were used to assess relationships between each outcome as measured by BIA and DXA. RESULTS: Although the methods were strongly correlated for all measures, (r > .87 for all segments) BIA routinely overestimated lean mass for arm and trunk (mean difference arm: 0.97 kg, p = .008; trunk: 5.58 kg, p < .0001); and underestimated fat mass for arm and leg (mean difference arm: 0.42 kg, p < .0001; leg: 1.94 kg p < .0001). BIA overestimated total body lean mass in 93% of participants and underestimated total body fat mass in 90% of participants. CONCLUSIONS: Significant discrepancies were noted between DXA and BIA in all body segments. Further research is needed to refine BIA methods for segmental composition estimates in heterogeneous samples and disease-specific populations before this methods can be used reliably in a clinical setting.
Subject(s)
Absorptiometry, Photon , Body Composition , Electric Impedance , Adolescent , Adult , Aged , Cross-Sectional Studies , Female , Humans , Male , Middle Aged , Nutritional Status , Pilot Projects , Predictive Value of Tests , Young AdultABSTRACT
BACKGROUND: We propose a phase-III, randomized controlled trial (RCT) that examines the effectiveness of a behavioral intervention based on social cognitive theory (SCT) and delivered through the Internet using e-learning approaches for increasing physical activity and secondary outcomes (e.g., symptoms) in a large sample of people with multiple sclerosis (MS) residing throughout the United States. METHODS/DESIGN: The proposed phase-III trial will use a parallel group, RCT design that examines the effect of a 6-month behavioral intervention for increasing physical activity and secondarily improving mobility, cognition, symptoms, and quality of life (QOL) in persons with MS. The primary outcome is accelerometer-measured moderate-to-vigorous physical activity (MVPA). The secondary outcomes include self-report measures of physical activity, walking impairment, cognition, fatigue, depression, anxiety, pain, sleep quality, and QOL. The tertiary outcomes are mediator variables based on SCT. Participants (Nâ¯=â¯280) will be randomized into behavioral intervention (nâ¯=â¯140) or attention and social contact control (nâ¯=â¯140) conditions using computerized random numbers with concealed allocation. The conditions will be administered over 6-months by persons who are uninvolved in screening, recruitment, random assignment, and outcome assessment. There will be a 6-month follow-up without intervention access/content. We will collect primary, secondary, and tertiary outcome data every 6â¯months over the 12-month period. Data analysis will involve intent-to-treat principles and latent growth modeling (LGM). DISCUSSION: The proposed research will provide evidence for the effectiveness of a novel, widely scalable approach for increasing lifestyle physical activity and improving secondary outcomes and QOL in persons with MS.
Subject(s)
Behavior Therapy/methods , Exercise , Life Style , Multiple Sclerosis/therapy , Quality of Life , Telemedicine/methods , Accelerometry/methods , Adult , Cognition , Exercise/physiology , Exercise/psychology , Exercise Therapy/methods , Exercise Therapy/psychology , Female , Humans , Internet , Male , Multiple Sclerosis/diagnosis , Multiple Sclerosis/physiopathology , Multiple Sclerosis/psychology , Outcome Assessment, Health Care , Self ReportABSTRACT
BACKGROUND: Technology-based lifestyle behavioral interventions (i.e., telehealth, mHealth, eHealth, and/or digital health) are becoming an alternative standard of care and possess several advantages over traditional clinical settings such as convenience, cost, and the ability to tailor plans and feedback to a participant's individual needs. These technology-based interventions also present unique challenges to intervention fidelity due to extra elements involved in executing the intervention. Intervention fidelity monitoring is essential to ensure internal and external validity, yet the development and utilization of fidelity protocols is under-reported in the literature. The purpose of this paper is to describe the intervention fidelity protocol for the 24-START study, a behavior change intervention delivered through telephone and internet. This paper also discusses the results of a pilot audit conducted to determine the feasibility of monitoring adherence to the fidelity protocol. METHODS: The 24-START fidelity protocol was developed in accordance with the five fidelity areas outlined by the NIH Behavior Change Consortium (NIH BCC) including: design of study, provider training, delivery of treatment, receipt of treatment, and enactment of treatment. The fidelity strategies provided by the NIH BCC in each area were tailored to fit the specific design of the 24-START study. Twenty-six total fidelity strategies were developed in accordance with the five areas and a corresponding fidelity monitoring plan was created. Because these strategies are only beneficial if implemented, the fidelity monitoring plan was developed to ensure the fidelity strategies are consistently implemented over the course of the intervention. RESULTS: A pilot audit of nine participant files was conducted to test the feasibility of the fidelity protocol developed. Out of the nine participant files reviewed, 89% of scheduled phone calls between a telehealth coach and participant were successfully completed. Of the completed calls, telehealth coaches delivered the intervention as intended 85.3% of the time, and 74% of planned secondary contacts made through the internet were delivered successfully. Additionally, between treatment group dosing was found to be equal. Several weak areas in the fidelity protocol were identified for improvement. The results were satisfactory and the audit was deemed feasible for ongoing use. CONCLUSIONS: The NIH BCC provides a valuable framework for telehealth interventions to develop fidelity protocols ultimately contributing to improved internal and external validity, better translation of results, increased transparency, and increased opportunities for replication within the field. The 24-START pilot audit found the fidelity protocol efficacious and feasible while also identifying areas of weakness in need of revision. The refined protocol will continue to be utilized throughout the data collection phase. Future telehealth interventions should develop and disclose fidelity protocols to improve the overall quality and standard of telehealth interventions.
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BACKGROUND: We lack a comprehensive assessment of the risks and benefits of calorie restriction in older adults at high risk for cardiometabolic disease. Calorie restriction may reduce visceral adipose tissue (VAT) but also have negative effects on lean mass and quality of life. METHODS: We conducted a 52-week, randomized controlled trial involving 164 older adults with obesity taking at least one medication for hyperlipidemia, hypertension, or diabetes. Interventions included an exercise intervention alone (Exercise), or with diet modification and body weight maintenance (Maintenance), or with diet modification and energy restriction (Weight Loss). The primary outcome was change in VAT at 12 months. Secondary outcomes included cardiometabolic risk factors, functional status, and quality of life. RESULTS: A total of 148 participants had measured weight at 12 months. Despite loss of -1.6% ± 0.3% body fat and 4.1% ± 0.7% initial body weight, Weight Loss did not have statistically greater loss of VAT (-192.6 ± 185.2 cm3) or lean mass (-0.4 ± 0.3 kg) compared with Exercise (VAT = -21.9 ± 173.7 cm3; lean mass = 0.3 ± 0.3 kg). Quality of life improved in all groups with no differences between groups. No significant changes in physical function were observed. Weight Loss had significantly greater improvements in blood glucose (-8.3 ± 3.6 mg/dL, p < .05) and HDL-cholesterol (5.3 ± 1.9, p < .01) compared with Exercise. There were no group differences in the frequency of adverse events. CONCLUSIONS: While moderate calorie restriction did not significantly decrease VAT in older adults at high risk for cardiometabolic disease, it did reduce total body fat and cardiometabolic risk factors without significantly more adverse events and lean mass loss.
Subject(s)
Caloric Restriction/methods , Obesity/diet therapy , Quality of Life , Weight Loss/physiology , Aged , Body Mass Index , Female , Follow-Up Studies , Humans , Male , Retrospective Studies , Risk Factors , Time Factors , Treatment OutcomeABSTRACT
OBJECTIVE: The purposes of this study were to assess the accuracy of clinical measures for predicting adiposity when compared with a criterion standard of body fat percentage measured by dual-energy X-ray absorptiometry and to determine the most appropriate cut points for classifying obesity for each measure in adolescents with physical disability. DESIGN: Body mass index, triceps skinfolds, and waist, arm, and leg circumferences were collected on 29 adolescents aged 14-17 yrs with spinal cord injury, cerebral palsy, or spina bifida. Percentage of body fat was measured using dual-energy X-ray absorptiometry. Multiple linear regression models were used to assess the ability of measures to predict percentage of body fat. Receiver operating characteristic curves were used to identify optimal cut points for each measure. RESULTS: Although all clinical measures correlated with body fat as measured by dual-energy X-ray absorptiometry, current cut points are not adequate in this group. Using a body mass index of 20 kg/m (boys) and 19 kg/m (girls) was optimal but still misclassified a significant number of participants as nonobese in this group. Using the optimal cut points for waist circumference, which were 83 cm (boys) and 78 cm (girls), was the best predictor. CONCLUSIONS: Body mass index, triceps skinfolds, and waist, leg, and arm circumferences are valid measures for estimating obesity in adolescents with physical disability, but further research is needed to validate disability-specific cut points.
Subject(s)
Disabled Persons , Obesity/diagnosis , Risk Assessment/methods , Absorptiometry, Photon , Adolescent , Body Fat Distribution , Body Mass Index , Cerebral Palsy/complications , Female , Humans , Linear Models , Male , Sensitivity and Specificity , Sex Factors , Skinfold Thickness , Spinal Cord Injuries/complications , Spinal Dysraphism/complications , Waist CircumferenceABSTRACT
We conducted a study designed to evaluate whether the benefits of intentional weight loss exceed the potential risks in a group of community-dwelling obese older adults who were at increased risk for cardiometabolic disease. The CROSSROADS trial used a prospective randomized controlled design to compare the effects of changes in diet composition alone or combined with weight loss with an exercise only control intervention on body composition and adipose tissue deposition (Specific Aim #1: To compare the effects of changes in diet composition alone or combined with weight loss with an exercise only control intervention on body composition, namely visceral adipose tissue), cardiometabolic disease risk (Specific Aim #2: To compare the effects of a change in diet composition alone or combined with weight loss with an exercise only control intervention on cardiometabolic disease risk), and functional status and quality of life (Specific Aim #3: To compare the effects of a change in diet composition alone or combined with weight loss with an exercise only control intervention on functional status and quality of life). Participants were randomly assigned to one of three groups: Exercise Only (Control) Intervention, Exercise + Diet Quality + Weight Maintenance Intervention, or Exercise + Diet Quality + Weight Loss Intervention. CROSSROADS utilized a lifestyle intervention approach consisting of exercise, dietary, and behavioral components. The development and implementation of the CROSSROADS protocol, including a description of the methodology, detailing specific elements of the lifestyle intervention, assurances of treatment fidelity, and participant retention; outcome measures and adverse event monitoring; as well as unique data management features of the trial results, are presented in this article.