Study design and methods: U.S. study to protect brain health through lifestyle intervention to reduce risk (U.S. POINTER).

INTRODUCTION: The U.S. study to protect brain health through lifestyle intervention to reduce risk (U.S. POINTER) is conducted to confirm and expand the results of the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) in Americans. METHODS: U.S. POINTER was planned as a 2-year randomized controlled trial of two lifestyle interventions in 2000 older adults at risk for dementia due to well-established factors. The primary outcome is a global cognition composite that permits harmonization with FINGER. RESULTS: U.S. POINTER is centrally coordinated and conducted at five clinical sites (ClinicalTrials.gov: NCT03688126). Outcomes assessments are completed at baseline and every 6 months. Both interventions focus on exercise, diet, cognitive/social stimulation, and cardiovascular health, but differ in intensity and accountability. The study partners with a worldwide network of similar trials for harmonization of methods and data sharing. DISCUSSION: U.S. POINTER is testing a potentially sustainable intervention to support brain health and Alzheimer's prevention for Americans. Impact is strengthened by the targeted participant diversity and expanded scientific scope through ancillary studies.

Trial of the MIND Diet for Prevention of Cognitive Decline in Older Persons.

BACKGROUND: Findings from observational studies suggest that dietary patterns may offer protective benefits against cognitive decline, but data from clinical trials are limited. The Mediterranean-DASH Intervention for Neurodegenerative Delay, known as the MIND diet, is a hybrid of the Mediterranean diet and the DASH (Dietary Approaches to Stop Hypertension) diet, with modifications to include foods that have been putatively associated with a decreased risk of dementia. METHODS: We performed a two-site, randomized, controlled trial involving older adults without cognitive impairment but with a family history of dementia, a body-mass index (the weight in kilograms divided by the square of the height in meters) greater than 25, and a suboptimal diet, as determined by means of a 14-item questionnaire, to test the cognitive effects of the MIND diet with mild caloric restriction as compared with a control diet with mild caloric restriction. We assigned the participants in a 1:1 ratio to follow the intervention or the control diet for 3 years. All the participants received counseling regarding adherence to their assigned diet plus support to promote weight loss. The primary end point was the change from baseline in a global cognition score and four cognitive domain scores, all of which were derived from a 12-test battery. The raw scores from each test were converted to z scores, which were averaged across all tests to create the global cognition score and across component tests to create the four domain scores; higher scores indicate better cognitive performance. The secondary outcome was the change from baseline in magnetic resonance imaging (MRI)-derived measures of brain characteristics in a nonrandom sample of participants. RESULTS: A total of 1929 persons underwent screening, and 604 were enrolled; 301 were assigned to the MIND-diet group and 303 to the control-diet group. The trial was completed by 93.4% of the participants. From baseline to year 3, improvements in global cognition scores were observed in both groups, with increases of 0.205 standardized units in the MIND-diet group and 0.170 standardized units in the control-diet group (mean difference, 0.035 standardized units; 95% confidence interval, -0.022 to 0.092; P = 0.23). Changes in white-matter hyperintensities, hippocampal volumes, and total gray- and white-matter volumes on MRI were similar in the two groups. CONCLUSIONS: Among cognitively unimpaired participants with a family history of dementia, changes in cognition and brain MRI outcomes from baseline to year 3 did not differ significantly between those who followed the MIND diet and those who followed the control diet with mild caloric restriction. (Funded by the National Institute on Aging; ClinicalTrials.gov number, NCT02817074.).

Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) study: Rationale, design and baseline characteristics of a randomized control trial of the MIND diet on cognitive decline.

Alzheimer's dementia (AD) is the sixth leading cause of death in the U.S., with an estimated $305 billion cost of care in 2020. Currently there are no cures or therapies to ameliorate the disease progression and symptoms. Growing evidence links a diet characterized by high antioxidant components with benefits to cognitive function, which is indicative of the preventative potential of dietary inteventions. The Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) study is a 3-year, multicenter, randomized controlled trial to test the effects of the MIND diet on cognitive function in 604 individuals at risk for AD. Men and women ages 65 to 84 years were recruited. Eligible participants were randomized to either the MIND diet with mild caloric restriction or their usual diet with mild caloric restriction. Cognitive assessments, medical history, blood pressure, anthropometric measurements, and blood and urine sample collections will be taken at baseline and follow-up visits. MRI scans will be completed on approximately half of the enrolled participants at the start and end of the study. Unique features of the MIND study include: 1) a dietary pattern, rather than single nutrient or food, tested in an at-risk population; 2) foods featured as key components of the MIND diet (i.e. extra-virgin olive oil, blueberries, and nuts) provided for participants; and 3) MRI scans of brain structure and volume that may provide potential mechanistic evidence on the effects of the diet. Results from the study will be crucial to the development of dietary guidelines for the prevention of AD.

Randomized Trial of a Lifestyle Intervention for Urban Low-Income African Americans with Type 2 Diabetes.

BACKGROUND: African Americans suffer more than non-Hispanic whites from type 2 diabetes, but diabetes self-management education (DSME) has been less effective at improving glycemic control for African Americans. Our objective was to determine whether a novel, culturally tailored DSME intervention would result in sustained improvements in glycemic control in low-income African-American patients of public hospital clinics. RESEARCH DESIGN AND METHODS: This randomized controlled trial (n = 211) compared changes in hemoglobin A1c (A1c) at 6, 12, and 18 months between two arms: (1) Lifestyle Improvement through Food and Exercise (LIFE), a culturally tailored, 28-session community-based intervention, focused on diet and physical activity, and (2) a standard of care comparison group receiving two group DSME classes. Cluster-adjusted ANCOVA modeling was used to assess A1c changes from baseline to 6, 12, and 18 months, respectively, between arms. RESULTS: At 6 months, A1c decreased significantly more in the intervention group than the control group (- 0.76 vs - 0.21%, p = 0.03). However, by 12 and 18 months, the difference was no longer significant (12 months - 0.63 intervention vs - 0.45 control, p = 0.52). There was a decrease in A1c over 18 months in both the intervention (ß = - 0.026, p = 0.003) and the comparison arm (ß = - 0.018, p = 0.048) but no difference in trend (p = 0.472) between arms. The intervention group had greater improvements in nutrition knowledge (11.1 vs 6.0 point change, p = 0.002) and diet quality (4.0 vs - 0.5 point change, p = 0.018) while the comparison group had more participants with improved medication adherence (24% vs 10%, p < 0.05) at 12 months. CONCLUSIONS: The LIFE intervention resulted in improved nutrition knowledge and diet quality and the comparison intervention resulted in improved medication adherence. LIFE participants showed greater A1c reduction than standard of care at 6 months but the difference between groups was no longer significant at 12 and 18 months. NIH TRIAL REGISTRY NUMBER: NCT01901952.

Development of a lifestyle intervention for the metabolic syndrome: Discovery through proof-of-concept.

OBJECTIVE: The aim was to describe the early phases of the progressive development of a lifestyle treatment for sustained remission of the metabolic syndrome (MetS) using the Obesity-Related Behavioral Intervention Trials (ORBIT) model for behavioral treatment development as a guide. METHODS: Early discovery and design phases produced a 3-component (diet, physical activity, stress), group-based lifestyle treatment with an intensive 6-month phase followed by monthly, participant-led maintenance meetings. In the proof-of-concept phase, 26 participants with the MetS (age 53 ± 7 years, 77% female, and 65% ethnic minority) were recruited in a quasi-experimental design to determine if treatment could achieve the prespecified benchmark of MetS remission in ≥50% at 2.5 years. Exploratory outcomes focused on MetS components, weight, and patient-centered benefits on energy/vitality and psychosocial status. RESULTS: MetS remission was achieved in 53.8% after a median of 2.5 years. At 2.5 years, an increase of +15.4% reported eating ≥3 servings of vegetables/day, +7.7% engaged in ≥150 minutes of moderate-to-vigorous physical activity/week; and +11.5% reported experiencing no depression in the past 2 weeks. Weight loss ≥5% was achieved by 38.5%, and energy/vitality, negative affect, and social support improved. Median group attendance over 2.5 years was 73.8%. CONCLUSIONS: It is plausible that this lifestyle program can produce a remission in the MetS, sustained through 2.5 years. After refinements to enhance precision and strength, progression to feasibility pilot testing and a randomized clinical trial will determine its efficacy as a cost-effective lifestyle option for managing the MetS in the current health care system. (PsycINFO Database Record

Effect of an obesity best practice alert on physician documentation and referral practices.

The Centers for Medicare & Medicaid Services Electronic Health Record Meaningful Use Incentive Program requires physicians to document body mass index (BMI) and a follow-up treatment plan for adult patients with BMI ≥ 25. To examine the effect of a best practice alert on physician documentation of obesity-related care and referrals to weight management treatment, in a cluster-randomized design, 14 primary care clinics at an academic medical center were randomized to best practice alert intervention (n = 7) or comparator (n = 7). The alert was triggered when both height and weight were entered and BMI was ≥30. Both intervention and comparator clinics could document meaningful use by selecting a nutrition education handout within the alert. Intervention clinics could also select a referral option from the list of clinic and community-based weight management programs embedded in the alert. Main outcomes were proportion of eligible patients with (1) obesity-related documentation and (2) referral. There were 26,471 total primary care encounters with 12,981 unique adult patients with BMI ≥ 30 during the 6-month study period. Documentation doubled (17 to 33%) with implementation of the alert. However, intervention clinics were not significantly more likely to refer patients to weight management than comparator clinics (2.8 vs. 1.3%, p = 0.07). Although the alert was associated with increased physician meaningful use compliance, it was not an effective strategy for improving patient access to weight management services. Further research is needed to understand system-level characteristics that influence obesity management in primary care.

Integrative Therapy Approaches for Posttraumatic Stress Disorder: A Special Focus on Treating Veterans.

Over the past decade, the use of integrative health modalities, such as mind-body interventions, art therapy, nutrition, and exercise, to treat stress-related mental health conditions, including posttraumatic stress disorder (PTSD), in military and veteran populations has been increasing. The use of integrative therapies for PTSD provides options for veterans who are not interested in traditional modalities, have limited access to traditional treatments, or are seeking a more comprehensive approach to managing their PTSD or subthreshold symptoms. These therapies show promise for improving overall well-being and comorbid conditions with PTSD, such as pain or migraines, but yield mixed data for PTSD symptoms. The aim of this article is to review the evidence for the most promising integrative health modalities for treating PTSD, with a special focus on the treatment of veterans, as well as to offer recommendations and suggestions for clinicians.

Design of a lifestyle intervention to slow menopause-related progression of intra-abdominal adipose tissue in women: The Women in the Southside Health and Fitness (WISHFIT) study.

BACKGROUND: Changes in reproductive hormones during menopause are associated with accumulation of intra-abdominal adipose tissue (IAAT), a subclinical indicator of cardiometabolic disease risk. Independent of reproductive hormones, unhealthy lifestyle contributes to IAAT gain. The Women in the Southside Health and Fitness (WISHFIT) Study aims to develop a lifestyle approach to slowing IAAT accumulation as women begin the menopausal transition. METHODS: The primary aim is to develop and conduct a proof-of-concept test of a multi-component, multi-level behavioral intervention targeting jointly physical activity, diet, and psychological well-being. Participants attend group sessions over 2 years to experiment with healthy living through both experiential and didactic learning, cultivate a health network, and draw on community resources to sustain change. The primary endpoint is 2-year IAAT progression, assessed using computerized tomography. Behavioral targets of treatment and secondary endpoints will be evaluated at 6, 12, 18 and 24 months. Change in social networks and community support will be assessed at 2 years. RESULTS: WISHFIT recruited 71 pre- and peri-menopausal Caucasian and African American women (mean ± SD age = 47.6 ± 3.4 yrs; BMI = 33.6 ± 7.3 kg/m2; 52% African American). Baseline IAAT was 2104.1 ± 1201.3 cm3. IAAT, physical activity, BMI, and self-reported family income and resilience differed by ethnicity at baseline. CONCLUSIONS: WISHFIT is a multi-component, multi-level intervention aimed at producing a sustained improvement in physical activity, diet, and psychological well-being early in the menopausal transition to slow menopause-related accumulation of IAAT. It provides a model for the process of developing a behavioral treatment to manage a chronic disease.

Design of the Lifestyle Improvement through Food and Exercise (LIFE) study: a randomized controlled trial of self-management of type 2 diabetes among African American patients from safety net health centers.

The Lifestyle Improvement through Food and Exercise (LIFE) study is a community-based randomized-controlled trial to measure the effectiveness of a lifestyle intervention to improve glycemic control among African Americans with type 2 diabetes attending safety net clinics. The study enrolled African American adults with a diagnosis of type 2 diabetes and HbA1c ≥ 7.0 who had attended specific safety net community clinics in the prior year. 210 patients will be enrolled and randomized to either the LIFE intervention or a standard of care control group, which consists of two dietitian-led diabetes self-management classes. The LIFE intervention was delivered in 28 group sessions over 12 months and focused on improving diet through dietitian-led culturally-tailored nutrition education, increasing physical activity through self-monitoring using an accelerometer, increasing ability to manage blood sugar through modifications to lifestyle, and providing social support for behavior change. In addition to the group sessions, peer supporters made regular telephone calls to participants to monitor progress toward behavioral goals and provide social support. The 12-month intervention phase was followed by a six-month maintenance phase consisting of two group sessions. The primary outcome of the study is change in A1C from baseline to 12 months, and an additional follow-up will occur at 18 months. The hypothesis of the study is that the participants in the LIFE intervention will show a greater improvement in glycemic control over 12 months than participants in the control group.

A self-management intervention for African Americans with comorbid diabetes and hypertension: a pilot randomized controlled trial.

INTRODUCTION: The objective of this pilot 6-month randomized controlled trial was to determine the effectiveness of an intensive, community-based, group intervention that focused on diet, physical activity, and peer support for reducing weight among urban-dwelling African Americans with comorbid type 2 diabetes and hypertension. METHODS: Sixty-one participants were randomized into an intervention or control group. The 6-month intervention consisted of 18 group sessions led by a dietitian in a community setting and weekly telephone calls from a peer supporter. The intervention featured culturally tailored nutrition education, behavioral skills training, and social support focused on changes to diet and physical activity. The control group consisted of two 3-hour group sessions of diabetes self-management education taught by a community health worker. Outcome measures were assessed at baseline and 6 months. The primary outcome was achievement of a 5% weight reduction at 6 months. A secondary outcome was achievement of a 0.5 percentage-point reduction in hemoglobin A1c (HbA1c). RESULTS: Groups did not differ in achievement of the weight-loss goal. Intervention participants lost a mean of 2.8 kg (P = .01); control participants did not lose a significant amount of weight. A greater proportion of intervention (50.0%) than control (21.4%) participants reduced HbA1c by 0.5 percentage points or more at 6 months (P = .03). CONCLUSION: The intervention was more effective than usual care (short-term diabetes education) at improving glycemic control, but not weight, in low-income African Americans with comorbid diabetes and hypertension. A community-based 6-month group class with culturally tailored education, behavioral skills training, and peer support can lead to a clinically significant reduction in HbA1c.

Socioeconomic status, energy cost, and nutrient content of supermarket food purchases.

BACKGROUND: The relative affordability of energy-dense versus nutrient-rich foods may promote socioeconomic disparities in dietary quality and obesity. Although supermarkets are the largest food source in the American diet, the associations between SES and the cost and nutrient content of freely chosen food purchases have not been described. PURPOSE: To investigate relationships of SES with the energy cost ($/1000 kcal) and nutrient content of freely chosen supermarket purchases. METHODS: Supermarket shoppers (n=69) were recruited at a Phoenix AZ supermarket in 2009. The energy cost and nutrient content of participants' purchases were calculated from photographs of food packaging and nutrition labels using dietary analysis software. Data were analyzed in 2010-2011. RESULTS: Two SES indicators, education and household income as a percentage of the federal poverty guideline (FPG), were associated with the energy cost of purchased foods. Adjusting for covariates, the amount spent on 1000 kcal of food was $0.26 greater for every multiple of the FPG, and those with a baccalaureate or postbaccalaureate degree spent an additional $1.05 for every 1000 kcal of food compared to those with no college education. Lower energy cost was associated with higher total fat and less protein, dietary fiber, and vegetables per 1000 kcal purchased. CONCLUSIONS: Low-SES supermarket shoppers purchase calories in inexpensive forms that are higher in fat and less nutrient-rich.