ABSTRACT
BACKGROUND: The presence of risk factors for type 2 diabetes and cardiovascular disease, or the conditions themselves, contributes to lower health-related quality of life (HRQoL) among adults. Although community-based lifestyle intervention programs have been shown to be effective for improving risk factors for these diseases, the impact of these interventions on HRQoL has rarely been described. PURPOSE: To examine changes in HRQoL following participation in the Group Lifestyle Balance program, a community translation of the Diabetes Prevention Program lifestyle intervention for adults with prediabetes and/or the metabolic syndrome. METHODS: Participants enrolled in the 12-month, 22-session intervention program (N = 223) completed the EuroQol Health Questionnaire (EQ-5D-3L) at baseline, 6, and 12 months. Linear mixed-effects regression models determined change in EQ-5D-visual analog scale (VAS) and Index scores post-intervention. RESULTS: Mean EQ-5D-VAS was improved by +7.38 (SE = 1.03) at 6 months and by +6.73 (SE = 1.06) at 12 months post-intervention (both; p < 0.0001). Mean changes in EQ-5D index values were +0.00 (SE = 0.01; NS) and +0.01 (SE = 0.01; p < 0.05), respectively. Adjusted for age, baseline score, and achieving intervention goals, mean change in EQ-5D-VAS was +11.83 (SE = 1.61) at 6 months and +11.23 (SE = 1.54) at 12 months (both; p < 0.0001). Adjusted mean change in EQ-5D index value was +0.04 (SE = 0.01) at 6 months and +0.05 (SE = 0.01) at 12 months (both; p < 0.01). CONCLUSION: Participation in a community lifestyle intervention program resulted in improved HRQoL among adults with prediabetes and/or the metabolic syndrome. These benefits to HRQoL, together with improved clinical and behavioral outcomes, should increase the appeal of such programs for improving health.
Subject(s)
Diabetes Mellitus, Type 2/prevention & control , Life Style , Sickness Impact Profile , Adult , Female , Humans , Male , Middle Aged , Residence Characteristics , Surveys and QuestionnairesABSTRACT
About 75% of African-Americans (AAs) ages 20 or older are overweight and nearly 50% are obese, but community-based programs to reduce diabetes risk in AAs are rare. Our objective was to reduce weight and fasting plasma glucose (FPG) and increase physical activity (PA) from baseline to week-12 and to month-12 among overweight AA parishioners through a faith-based adaptation of the Diabetes Prevention Program called Fit Body and Soul (FBAS). We conducted a single-blinded, cluster randomized, community trial in 20 AA churches enrolling 604 AAs, aged 20-64 years with BMI ≥ 25 kg/m(2) and without diabetes. The church (and their parishioners) was randomized to FBAS or health education (HE). FBAS participants had a significant difference in adjusted weight loss compared with those in HE (2.62 vs. 0.50 kg, p = 0.001) at 12-weeks and (2.39 vs. -0.465 kg, p = 0.005) at 12-months and were more likely (13%) than HE participants (3%) to achieve a 7% weight loss (p < 0.001) at 12-weeks and a 7% weight loss (19 vs. 8%, p < 0.001) at 12-months. There were no significant differences in FPG and PA between arms. Of the 15.2% of participants with baseline pre-diabetes, those in FBAS had, however, a significant decline in FPG (10.93 mg/dl) at 12-weeks compared with the 4.22 mg/dl increase in HE (p = 0.017), and these differences became larger at 12-months (FBAS, 12.38 mg/dl decrease; HE, 4.44 mg/dl increase) (p = 0.021). Our faith-based adaptation of the DPP led to a significant reduction in weight overall and in FPG among pre-diabetes participants. CLINICALTRIALS. GOV IDENTIFIER: NCT01730196.
Subject(s)
Black or African American , Diabetes Mellitus, Type 2/prevention & control , Health Education/organization & administration , Overweight/therapy , Religion , Weight Reduction Programs/organization & administration , Adult , Blood Glucose , Body Mass Index , Diabetes Mellitus, Type 2/ethnology , Exercise , Female , Humans , Life Style , Male , Middle Aged , Obesity/ethnology , Obesity/therapy , Overweight/ethnology , Risk Factors , Single-Blind Method , Socioeconomic Factors , United States/epidemiology , Weight LossABSTRACT
INTRODUCTION: The Diabetes Prevention Program (DPP) lifestyle intervention has been translated to community settings using the DPP goals of 7% weight loss and 150min of moderate physical activity (PA) per week. Given that PA is a primary lifestyle goal and has been linked to improvements in metabolic health in the DPP, it is important to understand the role that PA plays in translation effort success. The purpose of this review is to thoroughly evaluate the reporting of PA methodology and results in DPP-based translations in order to guide future prevention efforts. METHODS: PubMed and Ovid databases were searched to identify peer-reviewed original research articles on DPP-based translations for adults at-risk for developing diabetes or cardiovascular disease, limited to English language publications from January 2002-March 2015. RESULTS: 72 original research articles describing 57 translation studies met eligibility criteria. All 57 study interventions included a PA goal, 47 studies (82%) collected participant PA information, and 34 (60%) provided PA results. CONCLUSIONS: Despite PA being a primary intervention goal, PA methodology and results are under-reported in published DPP translation studies. This absence and inconsistency in reporting PA needs addressed in order to fully understand translation efforts' impact on participant health.
Subject(s)
Community Health Services , Diabetes Mellitus/prevention & control , Exercise , Life Style , Adult , Female , Health Education , Humans , Male , Preventive Medicine , Public HealthABSTRACT
INTRODUCTION: Diabetes and obesity pose a significant burden for the U.S. military beneficiary population, creating a great need to provide evidence-based diabetes and obesity prevention services for military personnel, retirees, and their dependents. Despite increasing dissemination of the Diabetes Prevention Program (DPP) lifestyle intervention nationwide, formal evaluation of implementation of this highly successful program is limited in the military setting. The purpose of this study is to prospectively evaluate delivery of a direct adaptation of a 1-year DPP lifestyle intervention at a U.S. Air Force medical facility, Wright-Patterson Medical Center (WPMC), to determine the feasibility of delivery of the program in a group of at-risk active duty military, retirees, and family members, as well as assess effectiveness in improving weight and other risk factors for type 2 diabetes. MATERIALS AND METHODS: A pre/post study design was utilized to evaluate feasibility and effectiveness of the DPP Group Lifestyle Balance (GLB), an up-to-date, 22-session direct adaptation of the DPP curriculum, at WPMC. Participants chose to complete the 1-year program either in coach-led face-to-face groups or via DVD with weekly telephonic coach contact. The study was approved by the University of Pittsburgh and WPMC Institutional Review Boards. RESULTS: A total of 99 individuals enrolled in the study, with 83 (84%) and 77 (78%) completing 6- and 12-month follow-up assessments, respectively. The mean age of participants at baseline was 57 (range 20-85 years), with 63% being female. The group was comprised of individuals who were non-Hispanic White (73.7%), non-Hispanic Black (18.2%), and other race or Hispanic ethnicity (8.1%). Within this group, there were 10 active duty military, 37 retirees, and 52 family members. The DPP-GLB program was shown to be feasible to implement in this military healthcare setting as demonstrated by the high engagement over the course of the year-long program. Significant improvements were shown in the two main behavioral goals: mean weight (-12.8 lbs, -6.3%, P < .001) and mean physical activity (PA) (+18.9 Met-hrs/wk, P < .001). In addition, significant improvements in other diabetes and cardiovascular risk factors including low-density lipoprotein cholesterol, fasting insulin, diastolic blood pressure, and waist circumference were noted, as well as improvement in health-related quality of life. CONCLUSIONS: These results demonstrate that the DPP-GLB program delivered via face-to-face groups or DVD was feasible and effective in improving weight, PA levels, and diabetes and cardiovascular risk factors in this group of active and retired military personnel and their family members. The program was well received by the program participants as well as the WPMC team. These findings offer a model for provision of the DPP-GLB program throughout the Military Health System.
Subject(s)
Diabetes Mellitus, Type 2 , Military Personnel , Humans , Female , Young Adult , Adult , Middle Aged , Aged , Aged, 80 and over , Male , Diabetes Mellitus, Type 2/prevention & control , Quality of Life , Life Style , ObesityABSTRACT
Several efficacy trials and subsequent dissemination studies indicate that behavioral lifestyle interventions for diabetes risk reduction require, at a minimum, provision of 4 to 6 months of frequent intervention contact to induce clinically meaningful weight losses of at least 5% of initial body weight. Weekly contact during the first several months of intervention, followed by less frequent but regular therapeutic contact for a longer time period, appears necessary for participants to adopt and enact behavioral self-regulatory skills such as the self-monitoring of diet, weight, and physical activity and the problem solving of common physical, social, and cognitive barriers that impede sustained weight loss. In-person contact is associated with the largest effect sizes but may not be a necessary component for clinically meaningful weight loss. Regardless of intervention mode, setting, or provider, the interactive process of feedback and social support is crucial for skill development and sustained weight loss.
Subject(s)
Behavior Therapy/organization & administration , Diabetes Mellitus, Type 2/prevention & control , Health Behavior , Obesity/prevention & control , Risk Reduction Behavior , Conditioning, Operant , Diabetes Mellitus, Type 2/psychology , Diabetes Mellitus, Type 2/therapy , Female , Humans , Male , Obesity/psychology , Obesity/therapy , Social Support , Weight LossABSTRACT
PURPOSE: To examine the effectiveness of 3 lifestyle intervention programs in an active duty military population. DESIGN: Experimental design with stratified random assignment to 1 of 3 intervention groups. Measures were taken at baseline, 3 months and 6 months. SETTING: A Military Treatment Facility in the western U.S. SUBJECTS/INTERVENTION: 122 active duty service members were enrolled and randomly assigned to 1 of 3 lifestyle intervention programs: the Diabetes Prevention Program-Group Lifestyle Balance (DPP-GLB), the Better Body Better Life (BBBL) program or the Fitness Improvement Program (FIP). MEASURES: weight, abdominal circumference, lipid and HbA1c levels, physical activity, and well-being as measured by the RAND SF-36 questionnaire. ANALYSIS: Statistical analyses were performed to assess changes over time. RESULTS: 83 participants completed the study (BBBL N = 23, FIP N = 30, DPP-GLB N = 30). The DPP-GLB participants had statistically significant decreases in weight (-3.1 pounds, p = .01) and abdominal circumference (-0.9 inches; p = .01) over time. HbA1c was also significantly lower in this group at 6 months compared to baseline (p = .036). There were no statistically significant changes in weight, abdominal circumference, or HbA1c in the FIP or BBBL groups. No significant changes were observed in lipids in any of the groups. CONCLUSION: Results from this study indicate that the DPP-GLB program may be effective in reducing weight, abdominal circumference, and HbA1c in an active duty U.S. military population.
Subject(s)
Diabetes Mellitus, Type 2 , Diabetes Mellitus , Military Personnel , Behavior Therapy , Exercise , Humans , Life StyleABSTRACT
BACKGROUND: The importance of leisure sedentary behavior (LSB) change in diabetes prevention efforts is not well known. This study examines the relationships between changes in self-reported LSB and the primary intervention goals (weight and moderate-intensity to vigorous-intensity physical activity [MVPA]) during a community-based translation of the Diabetes Prevention Program (the Group Lifestyle Balance Program). METHODS: A total of 322 adults at risk for type 2 diabetes were recruited from 3 community centers, a worksite, and military site. Community and worksite participants were randomized to immediate or delayed-delivery (control) intervention. All military site participants (n = 99) received immediate intervention. Logistic and linear generalized estimating equations were used to determine associations between LSB changes and weight-related outcomes and MVPA. RESULTS: Results were obtained for 259 (80.4%) participants. The LSB decreased after 6 and 12 months (mean [95% confidence interval]: -25.7 [-38.6 to -12.8] and -16.1 [-28.2 to -3.9] min/d; both P < .05). Each 20-minute reduction in LSB was associated with a 5% increase in odds of meeting the weight-loss goal (6 mo: odds ratio = 1.05 [1.002 to 1.102]; P = .042; adjusted model including MVPA), but LSB was not related to changes in reported MVPA minutes or MVPA goal achievement. CONCLUSION: Within the context of existing lifestyle intervention programs, reducing sedentary behavior has the potential to contribute to weight loss separately from reported MVPA improvement.
Subject(s)
Behavior Therapy , Diabetes Mellitus, Type 2/prevention & control , Exercise/physiology , Leisure Activities , Life Style , Sedentary Behavior , Television/statistics & numerical data , Weight Loss , Adult , Aged , Female , Goals , Health Behavior , Humans , Male , Middle Aged , Motivation , Self Report , Treatment OutcomeABSTRACT
The Diabetes Prevention Program (DPP) and its translational adaptations have been shown to be effective. However, individual-level economic impacts, such as the out-of-pocket costs borne by participants due to involvement in these programs have not been consistently and thoroughly evaluated. As cost is an important consideration that will impact the willingness of individuals to participate in such programs, this study examined direct monetary costs to participants in the Group Lifestyle Balance (GLB) DPP. Older adults (n = 134, mean age 62.8 years) with body mass index (BMI) ≥24 kg/m2 and prediabetes and/or metabolic syndrome participated in this GLB intervention, with two-thirds randomized to begin the intervention immediately and one-third functioning as a control for 6 months before receiving the entire intervention. Food and activity time and costs borne by participants were measured by self-report at baseline and after 6 months. Significant improvements in clinical metabolic measures, weight, and physical activity levels were achieved after 6 months in the intervention group compared both with baseline and the controls. Food costs did not increase among intervention participants. Costs related to physical activity did not change consistently over the course of the intervention. This DPP-GLB lifestyle intervention was effective in reducing risk factors for Type 2 diabetes mellitus among a diverse group of older participants without significantly increasing their out-of-pocket costs for food or physical activity over the course of the intervention. These results should help reduce concerns of individuals who are hesitant to participate in similar programs due to costs. The clinical trial registration number of this study is NCT01050205.
Subject(s)
Diabetes Mellitus, Type 2 , Metabolic Syndrome , Prediabetic State , Aged , Body Mass Index , Diabetes Mellitus, Type 2/prevention & control , Humans , Life Style , Middle Aged , Prediabetic State/prevention & controlABSTRACT
INTRODUCTION: We assessed the cost-effectiveness of a community-based, modified Diabetes Prevention Program (DPP) designed to reduce risk factors for type 2 diabetes and cardiovascular disease. METHODS: We developed a Markov decision model to compare costs and effectiveness of a modified DPP intervention with usual care during a 3-year period. Input parameters included costs and outcomes from 2 projects that implemented a community-based modified DPP for participants with metabolic syndrome, and from other sources. The model discounted future costs and benefits by 3% annually. RESULTS: At 12 months, usual care reduced relative risk of metabolic syndrome by 12.1%. A modified DPP intervention reduced relative risk by 16.2% and yielded life expectancy gains of 0.01 quality-adjusted life-years (3.67 days) at an incremental cost of $34.50 ($3,420 per quality-adjusted life-year gained). In 1-way sensitivity analyses, results were sensitive to probabilities that risk factors would be reduced with or without a modified DPP and that patients would enroll in an intervention, undergo testing, and acquire diabetes with or without an intervention if they were risk-factor-positive. Results were also sensitive to utilities for risk-factor-positive patients. In probabilistic sensitivity analysis, the intervention cost less than $20,000 per quality-adjusted life-year gained in approximately 78% of model iterations. CONCLUSION: We consider the modified DPP delivered in community and primary care settings a sound investment.
Subject(s)
Cardiovascular Diseases/prevention & control , Diabetes Mellitus, Type 2/prevention & control , Cardiovascular Diseases/epidemiology , Community Health Services , Cost-Benefit Analysis , Decision Support Techniques , Diabetes Mellitus, Type 2/epidemiology , Diet , Humans , Life Style , Markov Chains , Pennsylvania/epidemiology , Sensitivity and Specificity , Time FactorsABSTRACT
INTRODUCTION: This study examines the feasibility and effectiveness of an intensive lifestyle intervention adapted for people with impaired mobility. STUDY DESIGN: This was a randomized, wait-list controlled trial. The experimental group immediately received the 12-month weight loss program; the wait-list control group received it after a 6-month delay. Between-group comparisons were conducted for the 6-month RCT study design. Repeated measures were conducted for both groups combined after receiving the 12-month intervention. Data were collected August 2015-February 2017 and analyzed in 2017. SETTING/PARTICIPANTS: A community-based sample received 23, group-based sessions via a mix of telephone and in-person sessions in a hospital-based setting. Participants with impaired mobility (n=66) were middle-aged (49.80 [SD=11.37] years), mostly White (66.7%), female (66.7%), and most commonly had spinal cord injury (47.0%). INTERVENTION: The 12-month intervention delivered 23 group-based sessions that promoted weight loss through reducing caloric intake and increasing physical activity. MAIN OUTCOME MEASURES: Primary outcomes were effectiveness measured as change in weight and time spent in moderate physical activity. Feasibility was assessed in 12-month combined group analyses, measured as retention, attendance, and dietary self-monitoring. RESULTS: The 6-month RCT results showed that the immediate and delayed groups differed significantly (p<0.05) in weight (-1.66 [SD=4.42] kg loss vs 0.05 [SD=4.15] kg gain) and moderate physical activity (52.93 [SD=90.74] minutes/week increase vs -14.22 [SD=96.02] minutes/week decrease), accounting for baseline weight, time with disability, and age of onset. The 12-month results with groups combined demonstrated 74.2% retention and 77.7% core session attendance. Self-monitoring was higher in the delayed group (77.3%), who used a smartphone app, than the immediate group (47.3%), who mostly used paper trackers. Participants achieved significant 12-month weight loss of 3.31 (SD=10.13) kg (d=0.33) in mixed modeling analyses with groups combined yet did not significantly increase moderate physical activity. CONCLUSIONS: Group Lifestyle Balance Adapted for Individuals with Impaired Mobility is a feasible, effective approach to teach healthy lifestyle skills to individuals with mobility impairment, yielding modest weight loss and enhanced self-efficacy. TRIAL REGISTRATION: This study is registered at www.clinicaltrials.gov NCT03307187.
Subject(s)
Weight Loss , Weight Reduction Programs , Body Weight , Female , Healthy Lifestyle , Humans , Life Style , Middle AgedABSTRACT
Faith-based initiatives for lifestyle change show promise in helping to promote healthy behaviors in African American communities. It has been suggested that faith communities and programs within faith communities can influence health care practices and health care planning especially in high risk, minority populations. African American individuals are more likely to attend and participate in faith-based services than Whites from similar backgrounds. Our proposed intervention, Fit Body and Soul, has been adopted and modified from the proven diabetes prevention program (DPP) lifestyle intervention program, and uses the church-community experiences of the "Body and Soul" study as a faith-based effort. The intervention has been developed keeping in mind the church mission and goal of being spiritually healthy and has adopted bible scripture to develop a 12-session intervention. In this article, we present the development of the church-based Fit Body and Soul behavioral lifestyle intervention using community-based participatory research in partnership with African American churches.
Subject(s)
Black or African American/psychology , Diabetes Mellitus, Type 2/ethnology , Diabetes Mellitus, Type 2/prevention & control , Health Behavior/ethnology , Program Development , Religion and Medicine , Adult , Black or African American/statistics & numerical data , Aged , Diabetes Mellitus, Type 2/psychology , Female , Health Education/organization & administration , Humans , Life Style/ethnology , Male , Middle Aged , Risk Reduction Behavior , United States/epidemiologyABSTRACT
BACKGROUND: People with impaired mobility (IM) disabilities have a higher prevalence of obesity and obesity-related chronic conditions; however, lifestyle interventions that address the unique needs of people with IM are lacking. OBJECTIVE: This paper describes an adapted evidence-based lifestyle intervention developed through community-based participatory research (CBPR). METHODS: Individuals with IM, health professionals, disability group representatives, and researchers formed an advisory board to guide the process of thoroughly adapting the Diabetes Prevention Program Group Lifestyle Balance (DPP GLB) intervention after a successful pilot in people with IM. The process involved two phases: 1) planned adaptations to DPP GLB content and delivery, and 2) responsive adaptations to address issues that emerged during intervention delivery. RESULTS: Planned adaptations included combining in-person sessions with conference calls, providing arm-based activity trackers, and adding content on adaptive cooking, adaptive physical activity, injury prevention, unique health considerations, self-advocacy, and caregiver support. During the intervention, participants encountered numerous barriers, including health and mental health issues, transportation, caregivers, employment, adjusting to disability, and functional limitations. We addressed barriers with responsive adaptations, such as supporting electronic self-monitoring, offering make up sessions, and adding content and activities on goal setting, problem solving, planning, peer support, reflection, and motivation. CONCLUSIONS: Given the lack of evidence on lifestyle change in people with disabilities, it is critical to involve the community in intervention planning and respond to real-time barriers as participants engage in change. A randomized controlled trial (RCT) is underway to examine the usability, feasibility, and preliminary effectiveness of the adapted intervention.
Subject(s)
Community Participation , Disabled Persons , Health Promotion , Life Style , Mobility Limitation , Obesity/prevention & control , Advisory Committees , Caregivers , Community-Based Participatory Research , Cooking , Diabetes Mellitus/prevention & control , Exercise , Humans , SafetyABSTRACT
Purpose The purpose of this study is to evaluate the feasibility and effectiveness of an adapted Diabetes Prevention Program (DPP) lifestyle program, DPP Group Lifestyle Balance (GLB), delivered in 3 economically diverse senior/community centers. Methods The DPP-GLB was implemented in 3 senior/community centers in Allegheny County, PA. A 6-month delayed control intervention design was used. Participants were randomized to begin the DPP-GLB immediately (immediate) or after a 6-month delay (delayed). Adults (n = 134; mean age = 62.8 years) with BMI ≥24 kg/m2 and prediabetes and/or the metabolic syndrome took part. Weight, physical activity (PA), and diabetes and cardiovascular disease (CVD) risk factors were assessed at 6, 12, and 18 months from baseline. Results At 6 months, the immediate group demonstrated greater mean weight loss than the delayed control group as well as significantly greater improvements in PA, A1C, fasting insulin, and waist circumference. In pre-post analyses, both randomized groups showed similar success that was maintained at 18 months. Conclusions The DPP-GLB delivered in economically diverse community centers was effective in this group of older adults. These findings support provision of coverage for prevention programs in older adults at risk for diabetes/CVD, which is important considering the large number of individuals who will be Medicare eligible in the near future.
Subject(s)
Diabetes Mellitus/prevention & control , Health Promotion/methods , Prediabetic State/therapy , Program Evaluation , Risk Reduction Behavior , Aged , Diabetes Mellitus/etiology , Feasibility Studies , Female , Humans , Male , Metabolic Syndrome/complications , Metabolic Syndrome/therapy , Middle Aged , Pennsylvania , Risk Factors , Social Class , Time FactorsABSTRACT
OBJECTIVE: To evaluate barriers to and strategies for medication adherence and predictors of adherence and the primary outcome in the Diabetes Prevention Program (DPP). RESEARCH DESIGN AND METHODS: Within a randomized, controlled primary prevention study for type 2 diabetes, we collected data on study medication adherence, its predictors, and health outcomes in 27 clinical centers across mainland U.S. and Hawaii. Medication arm participants included 2,155 adults with impaired glucose tolerance randomly assigned to either metformin or matched placebo treatment arms. Structured interviews were used to promote medication adherence and to collect data regarding adherence. Adherence was measured by pill count. The primary DPP outcome of type 2 diabetes was assessed by fasting plasma glucose and oral glucose tolerance test. RESULTS: Older age-groups were more adherent than the youngest group (P = 0.01) in the metformin group. The most frequently reported barrier to adherence was "forgetting" (22%). Women reported more adverse effects of metformin (15 vs. 10%, P = 0.002) in the metformin group. Odds of nonadherence increased as participants reported more than one barrier (odds ratio 19.1, P < 0.001). Odds of adherence increased as participants reported multiple strategies to take medication (2.69, P < 0.0001). There was a 38.2% risk reduction for developing diabetes for those adherent to metformin compared with those adherent to placebo (P < 0.0003). CONCLUSIONS: DPP medication adherence results are unique in primary prevention for a chronic disease in a large multiethnic sample. Our finding that adherence was associated with risk reduction for diabetes supports the development of brief interventions in clinical settings where medication adherence is a challenge.
Subject(s)
Diabetes Mellitus, Type 2/prevention & control , Hypoglycemic Agents/therapeutic use , Metformin/therapeutic use , Patient Compliance/statistics & numerical data , Adult , Aged , Aged, 80 and over , Blood Glucose/analysis , Diabetes Mellitus, Type 2/blood , Diabetes Mellitus, Type 2/drug therapy , Female , Glucose Tolerance Test/methods , Humans , Hypoglycemic Agents/adverse effects , Logistic Models , Male , Metformin/adverse effects , Middle Aged , Odds Ratio , Prognosis , Treatment OutcomeABSTRACT
The U.S. Diabetes Prevention Program (DPP) showed that lifestyle participants who achieved ≥7% weight loss and ≥150 min/week physical activity experienced the greatest reduction in type 2 diabetes incidence. Demographic, clinical, and program factors that are related to achieving both these lifestyle goals have seldom been explored in community-delivered DPP programs. The purpose of this investigation is to examine factors associated with concurrent achievement of weight loss and physical activity goals in a 12-month community DPP lifestyle intervention. Adults [n = 223; age = 58.4 (SD = 11.5); BMI = 33.8 (SD = 6.0)] with glucose or HbA1c values in the pre-diabetes range and/or metabolic syndrome risk factors enrolled from one worksite and three community centers in the Pittsburgh, PA metropolitan area between January 2011 and January 2014. Logistic regression analyses determined the demographic, clinical and program adherence factors related to goal achievement at 6, 12, and 18 months. Participants achieving both intervention goals at 6 months (n = 57) were more likely to attend sessions [Adjusted Odds Ratio (AOR) =1.48], self-weigh (AOR = 1.19), and self-monitor behaviors (AOR = 1.18) than those meeting neither goal (n = 35; all p < 0.05). Baseline BMI (AOR = 0.87, p < 0.01), elevated glycemic status (AOR = 0.49, p < 0.05), and female sex (AOR = 0.52, p < 0.05) were inversely related to goal achievement at 6 months. Meeting either lifestyle goal at 6 months had the strongest association with meeting both goals at 12 and 18 months. Our study supports the importance of early engagement, regular attendance, self-monitoring, and self-weighing for goal achievement. Dissemination efforts should consider alternative approaches for those not meeting goals by 6 months to enhance long-term success.
Subject(s)
Diabetes Mellitus, Type 2/prevention & control , Goals , Healthy Lifestyle , Blood Glucose , Body Mass Index , Diabetes Mellitus, Type 2/blood , Exercise , Female , Glycated Hemoglobin/metabolism , Humans , Information Dissemination , Logistic Models , Male , Metabolic Syndrome/blood , Metabolic Syndrome/prevention & control , Metabolic Syndrome/therapy , Middle Aged , Odds Ratio , Patient Compliance , Prediabetic State/blood , Prediabetic State/therapy , Treatment Outcome , Weight LossABSTRACT
BACKGROUND: A behavioral lifestyle intervention program with goals of increasing physical activity (PA) and losing weight was shown to be efficacious for preventing type 2 diabetes and decreasing risk for cardiovascular disease in the U.S. Diabetes Prevention Program (DPP). Modified versions of the DPP lifestyle intervention are being translated into diverse community settings and have been successful in decreasing weight and improving metabolic markers. However, comprehensive evaluations of PA levels within these community translation intervention efforts are rare. PURPOSE: To evaluate the effectiveness of a DPP-based community lifestyle intervention for improving PA levels. METHODS: 223 overweight adults at-risk for type 2 diabetes and/or cardiovascular disease were randomized (immediate or 6-month delayed-start) to a 12-month DPP-based lifestyle intervention. Past-month PA level was assessed at baseline and post-intervention with the Modifiable Activity Questionnaire. Simple and mixed-effects regression models were used to determine changes in PA level between and within groups over time. RESULTS: The between-group mean difference for change in PA levels from baseline to 6 months indicated significantly greater improvement in the intervention compared to the delayed-start group [+6.72 (SE=3.01) MET-hrs/week; p=0.03]. Examining combined within-group change from baseline to post-intervention, mean PA levels significantly increased by +14.69 (SE=1.43) and +9.50 (SE= 1.40) MET-hrs/week at 6 and 12 months post-intervention, respectively. This PA change offset to approximately +10 MET-hrs/week at both 6 and 12 months after adjusting for baseline PA level and season (all; p<0.01). Other than season, sex impacted on change in PA level. CONCLUSIONS: This community-based lifestyle intervention significantly increased PA levels among overweight adults at risk for type 2 diabetes and cardiovascular disease, even after adjusting for key variables. CLINICALTRIALSGOV IDENTIFIER: NCT01050205.
ABSTRACT
UNLABELLED: Latinos bear a disproportionate burden of the dual pandemic of obesity and diabetes. However, successful interventions addressing this disparity through primary care are lacking. To address this gap, the 5-year Vida Sana (Healthy Life) study tests a culturally adapted and technology-enhanced group-based Diabetes Prevention Program intervention in a randomized controlled trial with overweight/obese Latino adults who have metabolic syndrome and/or pre-diabetes. Eligible, consenting patients (n=186) from a large community-based multispecialty group practice in Northern California will be randomly assigned to receive the culturally-adapted intervention or usual care. The RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework guided the planned evaluations. The primary aim is to determine the effectiveness of the intervention (the "E" in RE-AIM). We hypothesize that the intervention will lead to a greater mean reduction in weight at 24months (primary endpoint) vs. usual care. Secondary outcomes will include measures of cardiometabolic risk factors (e.g., blood pressure), psychosocial well-being (e.g., health-related quality of life), and behavior change (e.g., physical activity). The secondary aim is to evaluate the other RE-AIM dimensions using mixed methods: reach (e.g., participation rate of the target population), adoption (e.g., participating clinic and provider characteristics), implementation (e.g., intervention fidelity), and maintenance (e.g., sustainability in the practice setting). These findings have real word applicability with value to clinicians, patients, and other decision makers considering effective diabetes prevention programs for primary care that would support the millions of Latino adults who experience a disproportionate burden of diabetes. TRIAL REGISTRATION: NCT02459691.
Subject(s)
Culturally Competent Care , Diabetes Mellitus, Type 2/prevention & control , Hispanic or Latino , Life Style , Metabolic Syndrome/therapy , Prediabetic State/therapy , Primary Health Care/methods , Weight Reduction Programs/methods , California , Caloric Restriction/methods , Exercise , HumansABSTRACT
OBJECTIVE: To determine whether an evidence-based, behavioral lifestyle intervention program delivered at a worksite setting is effective in improving type 2 diabetes and cardiovascular disease risk factors. METHODS: A randomized 6-month delayed control design was utilized, with two thirds of the participants assigned to begin intervention immediately, and one third beginning 6 months later. The year-long program (weekly for 3 months transitioning to monthly) focused on weight loss and increasing physical activity. RESULTS: The immediate intervention group had greater mean weight loss (-10.4 lb, 5.1%, vs -2.3 lb, 1%; P = 0.0001) than the delayed control group at 6 months and relatively greater improvements in activity, HbA1c, and other risk factors. The delayed group experienced similar improvements after completing the intervention program. CONCLUSIONS: A worksite behavioral lifestyle intervention is feasible and effective in significantly improving risk factors for type 2 diabetes and cardiovascular disease.
Subject(s)
Cardiovascular Diseases/prevention & control , Diabetes Mellitus, Type 2/prevention & control , Health Behavior , Life Style , Occupational Health Services , Occupational Health , Adult , Aged , Exercise , Feasibility Studies , Female , Humans , Male , Middle Aged , Outcome Assessment, Health Care , Risk Factors , Weight Loss , WorkplaceABSTRACT
Effective interventions targeting comorbid obesity and depression are critical given the increasing prevalence and worsened outcomes for patients with both conditions. RAINBOW is a type 1 hybrid design randomized controlled trial. The objective is to evaluate the clinical and cost effectiveness and implementation potential of an integrated, technology-enhanced, collaborative care model for treating comorbid obesity and depression in primary care. Obese and depressed adults (n = 404) will be randomized to usual care enhanced with the provision of a pedometer and information about the health system's services for mood or weight management (control) or with the Integrated Coaching for Better Mood and Weight (I-CARE) program (intervention). The 12-month I-CARE program synergistically integrates two proven behavioral interventions: problem-solving therapy with as-needed intensification of pharmacotherapy for depression (PEARLS) and standardized behavioral treatment for obesity (Group Lifestyle Balance(™)). It utilizes traditional (e.g., office visits and phone consults) and emerging care delivery modalities (e.g., patient web portal and mobile applications). Follow-up assessments will occur at 6, 12, 18, and 24 months. We hypothesize that compared with controls, I-CARE participants will have greater improvements in weight and depression severity measured by the 20-item Depression Symptom Checklist at 12 months, which will be sustained at 24 months. We will also assess I-CARE's cost-effectiveness and use mixed methods to examine its potential for reach, adoption, implementation, and maintenance. This study offers the potential to change how obese and depressed adults are treated-through a new model of accessible and integrative lifestyle medicine and mental health expertise-in primary care.
Subject(s)
Antidepressive Agents/therapeutic use , Behavior Therapy/methods , Depressive Disorder/therapy , Obesity/therapy , Research Design , Affect , Age Factors , Antidepressive Agents/administration & dosage , Behavior Therapy/economics , Body Mass Index , Body Weight , Combined Modality Therapy , Cost-Benefit Analysis , Depressive Disorder/epidemiology , Female , Humans , Male , Obesity/epidemiology , Primary Health Care/organization & administration , Racial Groups , Sex Factors , Socioeconomic FactorsABSTRACT
Strategies for management of pre-diabetes within the community setting are needed. An adaptation of the successful Diabetes Prevention Program lifestyle intervention delivered by trained diabetes educators was evaluated. Results indicate that trained diabetes educators offer an important community resource for health care providers for their patients with pre-diabetes.