The association between cardiovascular health and cognition in adults with Down syndrome.

INTRODUCTION: Evidence in the general population suggests that predictors of cardiovascular health such as moderate to vigorous physical activity (MVPA), cardiorespiratory fitness, and systolic blood pressure are associated with cognitive function. Studies supporting these associations in adults with Down syndrome (DS) are limited. The purpose of this study was to examine the associations between systolic blood pressure, cardiorespiratory fitness, and MVPA on cognition in adults with DS. METHODS: This is a cross-sectional analysis using baseline data from a trial in adults with DS. Participants attended a laboratory visit where resting blood pressure, cardiorespiratory fitness (VO2 Peak), and cognitive function (CANTAB® DS Battery) were obtained. The cognitive battery included tests measuring multitasking, episodic memory, and reaction time. Physical activity (accelerometer) was collected over the week following the laboratory visit. Pearson correlations and linear regressions were used to measure the impact of systolic blood pressure, cardiorespiratory fitness, and MVPA on cognitive outcomes. RESULTS: Complete data was available for 72 adults with DS (26.8 ± 9.3 years of age, 57% female). At baseline, VO2 Peak (21.1 ± 4.2 ml/kg/min) and MVPA were low (14.4 ± 14.4 min/day), and systolic blood pressure was 118.3 ± 13.3 mmHg. VO2 Peak was correlated with simple movement time (rho = - 0.28, p = 0.03) but was not significant using a linear regression controlling for age and sex. Systolic blood pressure was significantly associated with episodic memory (first attempt memory score: ß = - 0.11, p = 0.002; total errors: ß = 0.58, p = 0.001) and reaction time (five-choice movement time: ß = 4.11, p = 0.03; simple movement time: ß = 6.14, p = 0.005) using age- and sex-adjusted linear regressions. No associations were observed between MVPA and multitasking, episodic memory, or reaction time. CONCLUSION: Predictors of cardiovascular health, including cardiorespiratory fitness and systolic blood pressure, were associated with some aspects of cognition in adults with DS. While future research should examine the role of improved cardiovascular health on delaying decreases in cognitive function and dementia in adults with DS, we recommend that health care providers convey the importance of exercise and cardiovascular health to their patients with DS. TRIAL REGISTRATION: NCT04048759, registered on August 7, 2019.

An open-source system for efficient clinical trial support: The COMET study experience.

Exercise clinical trials are complex, logistically burdensome, and require a well-coordinated multi-disciplinary approach. Challenges include managing, curating, and reporting on many disparate information sources, while remaining responsive to a variety of stakeholders. The Combined Exercise Trial (COMET, NCT04848038) is a one-year comparison of three exercise modalities delivered in the community. Target enrollment is 280 individuals over 4 years. To support rigorous execution of COMET, the study team has developed a suite of scripts and dashboards to assist study stakeholders in each of their various functions. The result is a highly automated study system that preserves rigor, increases communication, and reduces staff burden. This manuscript describes system considerations and the COMET approach to data management and use, with a goal of encouraging further development and adaptation by other study teams in various fields.

Recruitment methods and yield rates for a multisite clinical trial exploring risk reduction for Alzheimer's disease (rrAD).

INTRODUCTION: The risk reduction for Alzheimer's disease (rrAD) trial was a multisite clinical trial to assess exercise and intensive vascular pharmacological treatment on cognitive function in community-dwelling older adults at increased risk for Alzheimer's disease. METHODS: Eligibility, consent, and randomization rates across different referral sources were compared. Informal interviews conducted with each site's project team were conducted upon study completion. RESULTS: Initially, 3290 individuals were screened, of whom 28% were eligible to consent, 805 consented to participate (87.2% of those eligible), and 513 (36.3% of those consented) were randomized. Emails sent from study site listservs/databases yielded the highest amount (20.9%) of screened individuals. Professional referrals from physicians yielded the greatest percentage of consented individuals (57.1%). Referrals from non-professional contacts (ie, friends, family; 75%) and mail/phone contact from a site (73.8%) had the highest yield of randomization. DISCUSSION: Professional referrals or email from listservs/registries were most effective for enrolling participants. The greatest yield of eligible/randomized participants came from non-professional and mail/phone contacts. Future trials should consider special efforts targeting these recruitment approaches. Highlights: Clinical trial recruitment is commonly cited as a significant barrier to advancing our understanding of cognitive health interventions.The most cited referral source was email, followed by interviews/editorials on the radio, television, local newspapers, newsletters, or magazine articles.The referral method that brought in the largest number of contacts was email but did not result in the greatest yield of consents or eligible participants.The sources that yielded the greatest likelihood of consent were professional referrals (ie, physician), social media, and mail/phone contact from study site.The greatest yield of eligible/randomized participants came from non-professional contacts and mail/phone contact from a site.Findings suggest that sites may need to focus on more selective referral sources, such as using contact mailing and phone lists, rather than more widely viewed recruitment sources, such as social media or TV/radio advertisements.

Impact of Diet and Exercise Interventions on Cognition and Brain Health in Older Adults: A Narrative Review.

The ability to preserve cognitive function and protect brain structure from the effects of the aging process and neurodegenerative disease is the goal of non-pharmacologic, lifestyle interventions focused on brain health. This review examines, in turn, current diet and exercise intervention trends and the collective progress made toward understanding their impact on cognition and brain health. The diets covered in this review include the Mediterranean diet (MeDi), Dietary Approaches to Stop Hypertension (DASH), Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND), ketogenic diet, intermittent fasting, and weight loss management. The exercise approaches covered in this review include endurance, resistance, combined exercise programs, yoga, tai chi, and high-intensity interval training. Although valuable evidence is building concerning how diet and exercise influence cognitive performance and brain structure, many of the open questions in the field are concerned with why we see these effects. Therefore, more strategically designed intervention studies are needed to reveal the likely multiple mechanisms of action in humans.

Pre-post intervention exploring cognitive function and relationships with weight loss, intervention adherence and dropout.

Objective: To evaluate the association between baseline cognitive function, intervention dropout, adherence and 3-month weight loss (WL) when controlling for confounding demographic variables. Methods: 107 (Mage = 40.9 yrs.), BMI in the overweight and obese range (BMI = 35.6 kg/m2), men (N = 17) and women (N = 90) completed a 3-month WL intervention. Participants attended weekly behavioral sessions, comply with a reduced calorie diet, and complete 100 min of physical activity (PA)/wk. Cognitive function tasks at baseline included Flanker (attention), Stroop (executive control) and working memory, demographics, body weight and cardiovascular fitness were assessed at baseline. Session attendance, adherence to PA and diet were recorded weekly. Results: Baseline attention was positively correlated with age (p < .05), education (p < .05), attendance (p < .05), diet (p < .05) and PA (p < .05). Baseline executive control (p < .05) and working memory (p < .05) were each associated with % WL. Baseline executive control (p < .01) and working memory (p < .001) were also each associated with education. ANOVA indicated that baseline attention (p < .01) was associated with WL, specifically for comparing those who achieved 5-10% WL (p < .01) and those who achieved greater than 10% WL (p < .01) to those who dropped. Significance: Results suggest that stronger baseline attention is associated with completion of a 3-mo. WL intervention. Executive control and working memory are associated with amount of WL achieved. NCT registration: US NIH Clinical Trials, NCT01664715.

COMbined Exercise Trial (COMET) to improve cognition in older adults: Rationale and methods.

Substantial evidence suggests physical exercise may sustain cognitive function and perhaps prevent Alzheimer's Disease (1, 2). Current public health recommendations call for older adults to do at least 150 min a week of aerobic exercise (e.g. walking) and twice a week resistance exercise (e.g. weight lifting) for physical health. Yet, much remains unknown about how these exercise modalities support brain health independently or in combination. The COMbined Exercise Trial (COMET) is designed to test the combined and independent effects of aerobic and resistance training specifically focusing on exercise-related changes in 1) cognitive performance, 2) regional brain volume, 3) physical function, and 4) blood-based factors. To explore these questions, we will enroll 280 cognitively normal older adults, age 65-80 years, into a 52-week community-based exercise program. Participants will be randomized into one of four arms: 1) flexibility/toning- control 2) 150 min of aerobic exercise only, 3) progressive resistance training only, or 4) combined aerobic and progressive resistance training. Outcomes assessed include a comprehensive cognitive battery, blood biomarkers, brain magnetic resonance imaging, physiological biomarkers, cardiorespiratory fitness, physical function, and battery of psychosocial questionnaires is assessed at baseline, 6 and 12-months. COMET will provide rigorous randomized controlled trial data to understand the effects of the most common exercise modalities, and their combination (i.e., the standard public health recommendation), on brain health.

The impact of exercise and cumulative physical activity on energy intake and diet quality in adults enrolled in the Midwest Exercise Trial for the Prevention of Weight Regain.

The purpose of this study was to assess impact of different volumes of exercise as well as cumulative moderate to vigorous physical activity (MVPA) on energy intake (EI) and diet quality, as assessed by the Healthy Eating Index-2010(HEI-2010), across a 12-month weight maintenance intervention. Participants were asked to attend group behavioural sessions, eat a diet designed for weight maintenance and exercise either 150, 225 or 300 min/week. Dietary intake was assessed by 3-d food records, and MVPA was assessed by accelerometry. Two hundred and twenty-four participants (42·5 years of age, 82 % female) provided valid dietary data for at least one time point. There was no evidence of group differences in EI, total HEI-2010 score or any of the HEI-2010 component scores (all P > 0·05). After adjusting for age, sex, time, group and group-by-time interactions, there was an effect of cumulative MVPA on EI (1·08, P = 0·04), total HEI-2010 scores (-0·02, P = 0·003), Na (-0·006, P = 0·002) and empty energy scores (-0·007, P = 0·004. There was evidence of a small relationship between cumulative daily EI and weight (ß: 0·00187, 95 % CI 0·001, P = 0·003). However, there was no evidence for a relationship between HEI total score (ß: -0·006, 95 % CI 0·07, 0·06) or component scores (all P > 0·05) and change in weight across time. The results of this study suggest that increased cumulative MVPA is associated with clinically insignificant increases in EI and decreases in HEI.

A Randomized Trial Evaluating Exercise for the Prevention of Weight Regain.

OBJECTIVE: This study aimed to evaluate the effectiveness of three levels of exercise on weight regain subsequent to clinically meaningful weight loss (WL). METHODS: Adults with overweight or obesity (n = 298) initiated a 3-month behavioral WL intervention, which included reduced energy intake, increased exercise, and weekly behavioral counseling. Participants achieving ≥5% WL (n = 235) began a 12-month behavioral WL maintenance intervention and were randomized to 150 min/wk (n = 76), 225 min/wk (n = 80), or 300 min/wk (n = 79) of partially supervised moderate-to-vigorous-intensity exercise. RESULTS: Participants randomized to 150, 225, and 300 minutes of exercise completed 129 ± 30, 153 ± 49 and 179 ± 62 min/wk of exercise (supervised + unsupervised), respectively. Mean WL at 3 months (9.5 ± 3.1 kg) was similar across randomized groups (P = 0.68). Weight change across 12 months was 1.1 ± 6.5 kg, 3.2 ± 5.7 kg, and 2.8 ± 6.9 kg in the 150, 225, and 300 min/wk groups, respectively. Intent-to-treat analysis revealed no significant overall trend across the three treatment groups (P = 0.09), effects for group (P = 0.08), or sex (P = 0.21). CONCLUSIONS: This study found no evidence for an association between the volume of moderate-to-vigorous-intensity exercise and weight regain across 12 months following clinically relevant WL. Further, results suggest that exercise volumes lower than those currently recommended for WL maintenance, when completed in conjunction with a behavioral weight-maintenance intervention, may minimize weight regain over 12 months.

Cognitive Training: Associations and Implications for Weight Management and Translational Research.

Behavioral weight loss programs combining energy restriction and increased physical activity (PA) are generally successful in producing clinically significant weight loss (≥5%) over 3-6 mos. However, weight maintenance (≥ 2 yrs.) continues to be problematic, due in part to an inability of individuals to continue adherence to diet and PA recommendations. It is hypothesized that neurocognitive processes, specifically executive functions (EFs, i.e., inhibition, working memory, mental flexibility), underlie self-regulation, self-efficacy, and are essential for the adoption and maintenance of health behaviors. Behavioral weight loss programs generally attempt to improve self-regulation; however, these skills are difficult to implement long-term. Strengthening EFs through cognitive training may improve weight maintenance by improving self-efficacy and self-regulation, resulting in improved program attendance and improved adherence to dietary and PA recommendations. Although randomized trials have not been conducted to specifically evaluate this hypothesis, results from the available literature suggest the potential for cognitive training to improve weight maintenance.

The IGNITE trial: Participant recruitment lessons prior to SARS-CoV-2.

Full and diverse participant enrollment is critical to the success and generalizability of all large-scale Phase III trials. Recruitment of sufficient participants is among the most significant challenges for many studies. The novel SARS-CoV-2 coronavirus pandemic has further changed and challenged the landscape for clinical trial execution, including screening and randomization. The Investigating Gains in Neurocognition in an Intervention Trial of Exercise (IGNITE) study has been designed as the most comprehensive test of aerobic exercise effects on cognition and brain health. Here we assess recruitment into IGNITE prior to the increased infection rates in the United States, and examine new challenges and opportunities for recruitment with a goal of informing the remaining required recruitment as infection containment procedures are lifted. The results may assist the design and implementation of recruitment for future exercise studies, and outline opportunities for study design that are flexible in the face of emerging threats.

A dyadic approach for a remote physical activity intervention in adults with Alzheimer's disease and their caregivers: Rationale and design for an 18-month randomized trial.

Adults with Alzheimer's disease and related dementia (ADRD) and their caregivers represent a sizeable and underserved segment of the population with low levels of moderate physical activity (MPA). Options for increasing MPA in community dwelling adults with ADRD and their caregivers are limited. A home-based physical activity intervention delivered remotely via video conferencing to groups of adults with ADRD and their caregivers (RGV), represents a potentially effective approach for increasing MPA in this group. We will conduct an 18-month randomized trial (6 mos. Active intervention, 6 mos. Maintenance, 6 mos. no contact) to compare the effectiveness of the RGV approach with usual care, enhanced with caregiver support (EUC), for increasing MPA in 100 community dwelling adults with ADRD and their caregiver. The primary aim is to compare MPA (min/wk.), assessed by accelerometer, across the 6-mo. active intervention in adults with ADRD randomized to RGV or EUC. Secondarily, we will compare adults with ADRD and their caregivers randomized to RGV or ECU on the following outcomes across 18 mos.: MPA (min/wk.), sedentary time (min/wk.), percentage meeting 150 min/wk. MPA goal, functional fitness, activities of daily living, quality of life, residential transitions, cognitive function, and caregiver burden. Additionally, we will evaluate the influence of age, sex, BMI, attendance (exercise/support sessions), use of recorded sessions, self-monitoring, peer interactions during group sessions, caregiver support, type and quality of dyadic relationship, and number of caregivers on changes in MPA in adults with ADRD and their caregiver across 18 mos.

The promotion of physical activity for the prevention of Alzheimer's disease in adults with Down Syndrome: Rationale and design for a 12 Month randomized trial.

Nearly all individuals with Down Syndrome (DS) display pathology associated with Alzheimer's disease (AD) beginning as early as age 30. Previous research in typically developed adults suggests that increased moderate-to-vigorous physical activity (MVPA) may improve cognitive function and protect against age-related structural and functional changes in the brain; however, the potential impact of increased MVPA on the development of AD in adults with DS has not been evaluated. Despite the potential positive impact of MVPA on cognition and AD risk, participation in MVPA among young adults with DS is low. The limited research evaluating strategies for increasing MVPA in adults with DS has been unsuccessful in increasing MVPA. Results from our preliminary investigation where we remotely delivered real-time MVPA, led by a trained health educator, to groups of adults with DS in their homes via video conferencing on a tablet computer demonstrated high attendance, increased MVPA during group sessions, and improvements in cognitive function. However, the sustainability, impact on total daily MVPA, optimal session frequency, and potential impacts on cognitive function and brain health of remotely delivered group MVPA sessions in adults with DS are unknown. Therefore, we will conduct a trial in 80 non-demented adults with DS to determine the feasibility and potential efficacy of remotely delivered group MVPA sessions to increase daily MVPA, relative to a usual care control. Secondarily we will assess the impact of MVPA on cardiovascular fitness, quality of life, cognitive function and brain parameters related to AD. NCT REGISTRATION: NCT04048759.

Modeling interactions between brain function, diet adherence behaviors, and weight loss success.

INTRODUCTION: Obesity is linked to altered activation in reward and control brain circuitry; however, the associated brain activity related to successful or unsuccessful weight loss (WL) is unclear. METHODS: Adults with obesity (N = 75) completed a baseline functional magnetic resonance imaging (fMRI) scan before entering a WL intervention (ie,3-month diet and physical activity [PA] program). We conducted an exploratory analysis to identify the contributions of baseline brain activation, adherence behavior patterns, and the associated connections to WL at the conclusion of a 3-month WL intervention. Food cue-reactivity brain regions were functionally identified using fMRI to index brain activation to food vs nonfood cues. Food consumption, PA, and class attendance were collected weekly during the 3-month intervention. RESULTS: The left middle frontal gyrus (L-MFG, BA 46) and right middle frontal gyrus (R-MFG; BA 9) were positively activated when viewing food compared with nonfood images. Structural equation modeling with bootstrapping was used to investigate a hypothesized path model and revealed the following significant paths: (1) attendance to 3-month WL, (2) R-MFG to attendance, and (3) indirect effects of R-MFG through attendance on WL. CONCLUSION: Findings suggest that brain activation to appetitive food cues predicts future WL through mediating session attendance, diet, and PA. This study contributes to the growing evidence of the importance of food cue reactivity and self-regulation brain regions and their impact on WL outcomes.

Physical activity across the curriculum (PAAC3): Testing the application of technology delivered classroom physical activity breaks.

Only 43% of children in the U.S., ages 6-11 yrs., meet current physical activity (PA) guidelines. To satisfy the MVPA requirement, schools have begun incorporating MVPA in the form of activity breaks or MVPA academic lessons. We completed two, 3 academic-yr. cluster randomized trials (DK61489, DK85317) called "Physical Activity Across the Curriculum" (PAAC) which involved increasing MVPA in the classroom. Across 3-yrs. teachers in PAAC schools delivered ~60 min/wk. (12 min/day) of MVPA. Although short of our MVPA goal (20 min/d), the PAAC approach substantially increased in-school MVPA. Teacher reluctance to devote additional time to develop and integrate PA lessons into their curriculum was the overwhelming barrier to meeting the MVPA goal. Therefore, to reduce barriers to delivery of classroom PA we developed a 3-academic yr. cluster randomized trial (2 yrs. active intervention, 1 yr. follow-up) to compare the effectiveness and sustainability of technology delivered (PAAC-R) and classroom teacher delivered (PAAC-T) activity breaks for increasing classroom MVPA in elementary school students in grades 2 and 3 at baseline who will progress to grades 4-5. NCT registration: NCT03493139.

The Influence of Classroom Physical Activity Participation and Time on Task on Academic Achievement.

OBJECTIVES: Determine the impact of classroom-based physically active lessons on time-on-task. Secondarily, determine the relationship of time-on-task with academic achievement controlling for key demographic variables. METHODS: Seventeen elementary schools were cluster randomized to receive classroom physical activity (A+PAAC, N=9) or control (i.e., no physical activity, N=8) for a 3-year trial. Teachers were trained to deliver physically active lessons with moderate-to-vigorous intensity targeting 100 minutes per week. Outcome measures included academic achievement (Weschler Individual Achievement Test-III), administered at baseline and repeated each spring for 3 years, time spent in moderate-to-vigorous physical activity (MVPA), and time spent on task (TOT) pre- and post-physical activity. Multilevel modeling was utilized to estimate the impacts of percent time spent in MVPA and percent TOT post-lesson on academic achievement and the change in these impacts over 3 years, accounting for dependency among observations and covariates including age, gender, race, free or reduced lunch, BMI, and fitness. RESULTS: A greater percentage of time performing MVPA were each significantly associated with higher math scores (p=.034) and spelling scores (p<.001), but not reading scores. Academic achievement was not associated with TOT. CONCLUSION: Findings suggest that a greater percentage of time spent participating in MVPA results in higher math scores and spelling scores, but not reading scores, independent of TOT. Future studies should continue to evaluate the influence of physically active classroom lessons on time spent on task and its impact on academic achievement. Furthermore, strategies are needed to maximize impact and to determine the sustainability of physical activity's effect on classroom behavior and academic achievement.

Investigating Gains in Neurocognition in an Intervention Trial of Exercise (IGNITE): Protocol.

Despite the ubiquity of normal age-related cognitive decline there is an absence of effective approaches for improving neurocognitive health. Fortunately, moderate intensity exercise is a promising method for improving brain and cognitive health in late life, but its effectiveness remains a matter of skepticism and debate because of the absence of large, comprehensive, Phase III clinical trials. Here we describe the protocol for such a randomized clinical trial called IGNITE (Investigating Gains in Neurocognition in an Intervention Trial of Exercise), a study capable of more definitively addressing whether exercise influences cognitive and brain health in cognitively normal older adults. We are conducting a 12-month, multi-site, randomized dose-response exercise trial in 639 cognitively normal adults between 65 and 80 years of age. Participants are randomized to (1) a moderate intensity aerobic exercise condition of 150 min/week (N = 213), (2) a moderate intensity aerobic exercise condition at 225 min/week (N = 213), or (3) a light intensity stretching-and-toning control condition for 150 min/week (N = 213). Participants are engaging in 3 days/week of supervised exercise and two more days per week of unsupervised exercise for 12 months. A comprehensive cognitive battery, blood biomarkers and battery of psychosocial questionnaires is assessed at baseline, 6 and 12-months. In addition, brain magnetic resonance imaging, physiological biomarkers, cardiorespiratory fitness, physical function, and positron emission tomography of amyloid deposition are assessed at baseline and at the 12-month follow-up. The results from this trial could transform scientific-based policy and health care recommendations for approaches to improve cognitive function in cognitively normal older adults.

Energy Expenditure and Intensity of Group-Based High-Intensity Functional Training: A Brief Report.

Background: High-intensity functional training (HIFT) may offer an attractive, time-efficient alternative to traditional aerobic exercise. However, limited information is available in the literature regarding HIFT meeting exercise guidelines for energy expenditure (improve health outcomes: ≥1000 kcal/wk; weight management: ≥2000 kcal/wk) and level of intensity (moderate: 3-6 metabolic equivalents [METs], vigorous: ≥6 METs) elicited by this approach. Thus, the primary aim was to objectively measure energy expenditure and intensity of HIFT sessions. Methods: \Energy expenditure was assessed in 20 adults (18-50 y, 50% females). The HIFT session format included the following segments: warm-up (∼5 min), exercise (∼35 min), and cooldown (∼5 min). Participant oxygen consumption (COSMED, L/min and mL/kg/min), heart rate (Polar RS400), and physical activity (ActiGraph GT3X+) were collected in 15-second intervals. Average kcal per minute, METs, total kcal per session, and percent maximum heart rate (HRmax) were calculated. Results: METs ranged from 5.5 to 11.6 for the complete session (including warm-up and cooldown). Participant's HRmax was ∼80% (range: 69%-100%). Average energy expenditure was ∼485 kcal per session (∼1400 kcal/wk). The vigorous-intensity exercise portion (∼35 min) contributed to 80% of total energy expenditure. Conclusions: HIFT has the potential to meet the recommendations for exercise to improve health outcomes.

Rationale and methods for a multicenter clinical trial assessing exercise and intensive vascular risk reduction in preventing dementia (rrAD Study).

Alzheimer's Disease (AD) is an age-related disease with modifiable risk factors such as hypertension, hypercholesterolemia, obesity, and physical inactivity influencing the onset and progression. There is however, no direct evidence that reducing these risk factors prevents or slows AD. The Risk Reduction for Alzheimer's Disease (rrAD) trial is designed to study the independent and combined effects of intensive pharmacological control of blood pressure and cholesterol and exercise training on neurocognitive function. Six hundred and forty cognitively normal older adults age 60 to 85 years with hypertension and increased risk for dementia will be enrolled. Participants are randomized into one of four intervention group for two years: usual care, Intensive Reduction of Vascular Risk factors (IRVR) with blood pressure and cholesterol reduction, exercise training (EX), and IRVR+EX. Neurocognitive function is measured at baseline, 6, 12, 18, and 24 months; brain MRIs are obtained at baseline and 24 months. We hypothesize that both IRVR and EX will improve global cognitive function, while IRVR+EX will provide a greater benefit than either IRVR or EX alone. We also hypothesize that IRVR and EX will slow brain atrophy, improve brain structural and functional connectivity, and improve brain perfusion. Finally, we will explore the mechanisms by which study interventions impact neurocognition and brain. If rrAD interventions are shown to be safe, practical, and successful, our study will have a significant impact on reducing the risks of AD in older adults. NCT Registration: NCT02913664.

Remote delivery of weight management for adults with intellectual and developmental disabilities: Rationale and design for a 24 month randomized trial.

Adults with intellectual and developmental disabilities (IDD) represent an underserved segment of the US population with a high prevalence of obesity and limited options for weight management. Previous research has demonstrated clinically meaningful weight loss of 7% of total body weight in in adults with IDD using an enhanced Stop Light Diet (eSLD) in combination with monthly at-home face-to-face (FTF) behavioral sessions, and a recommendation for increased physical activity. However, the time and cost associated with FTF delivery (travel + sessions) limits the potential for scaling and implementation and suggests the need for the evaluation of less costly and burdensome strategies for intervention delivery. Therefore, we will conduct a 24-mo. randomized trial to compare a weight management intervention (6 mos. weight loss, 12 mos. maintenance, 6 mos. no-contact follow-up) delivered to 120 overweight/obese adults with IDD in their home, either remotely (RD) using video conferencing on a tablet computer, or during FTF visits. Our primary aim is whether RD is non-inferior to FTF for weight loss (0-6 mos.). Secondarily, we will compare the RD and FTF groups on mean weight loss, the proportion of participants who achieve clinically meaningful weight loss, and changes in quality of life across 24 months. We will also conduct cost analysis, cost-effectiveness, and contingent valuation analyses to compare the RD and FTF groups.

Distance learning strategies for weight management utilizing online social networks versus group phone conference call.

OBJECTIVE: The increase in technology and online social networks (OSNs) may present healthcare providers with an innovative modality for delivering weight management programmes that could have an impact on health care at the population level. The objective of this study was to evaluate the feasibility and efficacy of using an OSN to deliver a weight loss programme to inform future, large-scale trials. METHODS: Seventy individuals (age = 47 ± 12.4, minority = 24.3%) with obesity (BMI = 36.2 ± 4.0) completed a 6-month weight loss intervention and were randomized to either a conference call or OSN delivery group. Weight loss was achieved by reducing energy intake by 500-700 kcal·d-1 below estimated total daily energy expenditure and progressing physical activity to 300 min/week. Behavioural weight loss strategies were delivered weekly throughout the intervention. RESULTS: Conference call and OSN groups produced clinically meaningful weight loss of ≥5% from baseline to 6 months (phone = -6.3 ± 6.4%, OSN = -5.8 ± 6.7%). There was no significant difference in weight change between groups (p = 0.765). CONCLUSION: The phone and OSN groups met the American Heart Association/American College of Cardiology/The Obesity Society's Guidelines by reducing baseline weight by 5-10% within 6 months. OSNs appear to be a viable delivery platform for weight loss interventions; however, larger scale adequately powered trials are needed.