Community-based diabetes prevention randomized controlled trial in refugees with depression: effects on metabolic outcomes and depression.
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SUBMITTER: Wagner JA
PROVIDER: S-EPMC10229534 | biostudies-literature | 2023 May
REPOSITORIES: biostudies-literature
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Community-based diabetes prevention randomized controlled trial in refugees with depression: effects on metabolic outcomes and depression.
Wagner Julie A JA Bermúdez-Millán Angela A Buckley Thomas E TE Buxton Orfeu M OM Feinn Richard S RS Kong Sengly S Kuoch Theanvy T Scully Mary F MF
Scientific reports 20230530 1
Depression and antidepressant medications increase risk for type 2 diabetes. Cambodian-Americans have exceedingly high rates of both depression and diabetes. This paper reports outcomes of a diabetes prevention trial for Cambodian-Americans with depression. Primary outcomes were HbA1c, insulin resistance and depressive symptoms. Participants were aged 35-75, Khmer speaking, at risk for diabetes, and met study criteria for likely depression by either (a) antidepressant medication and/or (b) prolo ...[more]
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Project description:Our most recent RCT provides evidence that indicated depression prevention is effective in reducing depressive symptoms in adolescents when implemented in the school community. In the present study we further test the potential effects of this prevention approach on symptoms related to depression: anxiety, suicidality, somatic symptoms, and perfectionism. We conducted exploratory analyses in 130 adolescents with elevated depressive symptoms aged between 12 and 16 years old (M = 13.59; SD = 0.68; 63.8% girls) who were randomly assigned to the experimental (OVK 2.0) or active control condition (psycho-education). Self-reported anxiety, suicidality, somatic symptoms, and perfectionism were assessed at pretest, post intervention, as well as 6- and 12-months follow-up. Latent growth curve analyses revealed that there was a significant decrease in anxiety in both conditions and that this decrease was significantly larger in the intervention condition than in the control condition. Somatic symptoms and socially prescribed perfectionism decreased significantly in the intervention condition and suicidality decreased significantly in the control condition. Yet there was no difference in decrease in suicidality, somatic symptoms, and perfectionism between the two conditions. This study suggest that screening on depressive symptoms and providing a CBT depression prevention program for adolescents with elevated depressive symptoms, can decrease comorbid symptoms of anxiety and therefore ensure better outcomes. We discuss the clinical implications as well suggestions for future research. Clinical Trial Registration: The study is registered in the Dutch Trial Register for RCTs (NTR5725). Date registered: 11th of March 2016.
| S-EPMC7940696 | biostudies-literature
Project description:BackgroundRefugees have high levels of psychological distress that hamper lifestyle change efforts. We previously reported that community health educator (CHE) diabetes prevention interventions decreased HbA1c and depressive symptoms among Cambodian-American refugees with depression; this paper reports health behavior outcomes of those interventions.MethodsParticipants were aged 35-75, Khmer speaking, at risk for diabetes, and met study criteria for likely depression by either a) antidepressant medication and/or b) prolonged elevated depressive symptoms. Participants were randomized to one of three CHE interventions: 1) lifestyle intervention called Eat, Walk, Sleep (EWS), 2) EWS plus medication therapy management with a pharmacist/CHE team (EWS + MTM), or, 3) social services (SS; control). Physical activity and sleep were measured with 7 days of actigraphy. Nutrition was measured as carbohydrates as reported in a culturally tailored food frequency questionnaire. Assessments were at baseline, end point (12 months), and follow-up (15 months).ResultsThe n = 188 participants were 78% female, average age of 55 years, half had a household income < $20,000, and modal education was 7.0 years. Individuals in the two treatment groups that received the EWS intervention significantly increased their brown rice consumption (p < .001, Cohen's d = 0.76) and their moderate-to-vigorous activity (p = .039, d = 0.32). No intervention changed sleep duration, timing, efficiency or wake after sleep onset. Across groups, individuals who increased brown rice consumption, increased vigorous activity and decreased total sleep time variability showed decreased HbA1c, with small effect sizes.ConclusionsCHEs may improve nutrition and physical activity in refugees with depression but more intensive interventions may be required to impact sleep. Improvements in all three behaviors appear to be associated with HbA1c lowering TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT02502929.
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Project description:Aims/hypothesis: Dietary restriction (DR) reduces adiposity and improves metabolism in patients with one or more symptoms of the metabolic syndrome. Nonetheless, it remains elusive whether the benefits of DR in humans are mediated by calorie or nutrient restriction. This study was conducted to identify whether isocaloric dietary protein restriction is sufficient to confer the beneficial effects of dietary restriction in patients with metabolic syndrome. Methods: We performed a prospective, randomized controlled dietary intervention under constant nutritional and medical supervision. A total of 21 individuals diagnosed with the metabolic syndrome was randomly assigned for caloric restriction (CR; n = 11, mean age 49 ± 8.5 years, female 63%; diet of 5,941 ± 686 KJ per day) or isocaloric dietary protein restriction (PR; n = 10, mean age 51.6 ± 8.9 years, female 50%; diet of 8,409 ± 2,360 KJ per day) and followed for 27 days. Results: Like CR, PR promoted weight loss (-6.6%, P= 0.0041) due to reduction in adiposity (-9.9%, P= 0.0007), associated with reductions in blood glucose (-52.7%, P= 0.0002), lipid levels (cholesterol, -35.4%, P= 0.0010; triglycerides, -39.5% P= 0.0022) and blood pressure (systolic, -37.7 P< 0.0001; diastolic, -73.2% P< 0.0001). PR resulted in enrichment of metabolic pathways related to the immune system such as B cell proliferation, lymphocyte proliferation and leukocyte proliferation in subcutaneous adipose tissue. Hence, a reduction in calorie intake or changes in the gut microbiome are not necessary to confer the metabolic benefits of DR. Instead, a reduction in protein intake with a mild increase in carbohydrate intake to maintain the isocaloric balance of the diet is sufficient to improve metabolic control. Conclusions/interpretation: Protein restriction is sufficient to confer almost the same clinical outcomes as calorie restriction without the need for a reduction in calorie intake. The isocaloric characteristic of the PR intervention makes this approach a more attractive and less drastic dietary strategy in clinical settings and has greater potential to be used as adjuvant therapy for people with the metabolic syndrome.
2022-06-20 | GSE192587 | GEO
Project description:ContextAdolescent offspring of depressed parents are at markedly increased risk of developing depressive disorders. Although some smaller targeted prevention trials have found that depression risk can be reduced, these results have yet to be replicated and extended to large-scale, at-risk populations in different settings.ObjectiveTo determine the effects of a group cognitive behavioral (CB) prevention program compared with usual care in preventing the onset of depression.Design, setting, and participantsA multicenter randomized controlled trial conducted in 4 US cities in which 316 adolescent (aged 13-17 years) offspring of parents with current or prior depressive disorders were recruited from August 2003 through February 2006. Adolescents had a past history of depression, current elevated but subdiagnostic depressive symptoms, or both. Assessments were conducted at baseline, after the 8-week intervention, and after the 6-month continuation phase.InterventionAdolescents were randomly assigned to the CB prevention program consisting of 8 weekly, 90-minute group sessions followed by 6 monthly continuation sessions or assigned to receive usual care alone.Main outcome measureRate and hazard ratio (HR) of a probable or definite depressive episode (ie, depressive symptom rating score of > or = 4) for at least 2 weeks as diagnosed by clinical interviewers.ResultsThrough the postcontinuation session follow-up, the rate and HR of incident depressive episodes were lower for those in the CB prevention program than for those in usual care (21.4% vs 32.7%; HR, 0.63; 95% confidence interval [CI], 0.40-0.98). Adolescents in the CB prevention program also showed significantly greater improvement in self-reported depressive symptoms than those in usual care (coefficient, -1.1; z = -2.2; P = .03). Current parental depression at baseline moderated intervention effects (HR, 5.98; 95% CI, 2.29-15.58; P = .001). Among adolescents whose parents were not depressed at baseline, the CB prevention program was more effective in preventing onset of depression than usual care (11.7% vs 40.5%; HR, 0.24; 95% CI, 0.11-0.50), whereas for adolescents with a currently depressed parent, the CB prevention program was not more effective than usual care in preventing incident depression (31.2% vs 24.3%; HR, 1.43; 95% CI, 0.76-2.67).ConclusionThe CB prevention program had a significant prevention effect through the 9-month follow-up period based on both clinical diagnoses and self-reported depressive symptoms, but this effect was not evident for adolescents with a currently depressed parent.Trial registrationclinicaltrials.gov Identifier: NCT00073671.
| S-EPMC2737625 | biostudies-literature
Project description:ObjectiveThis study examined the short- and long-term effects of a community-based lifestyle intervention among Latino youth with obesity.MethodsLatino adolescents (14-16 years old) were randomized to a 3-month lifestyle intervention (n = 67) or comparison control (n = 69) and followed for 12 months. The intervention included weekly nutrition and health classes delivered to groups of families and exercise sessions (3 days/week) delivered to groups of adolescents. Comparison youth received laboratory results and general health information. Primary outcomes included insulin sensitivity and weight-specific quality of life (QoL) with secondary outcomes of BMI percentile (BMI%), waist circumference, and percent body fat.ResultsAt 3 months, youth in the intervention group exhibited significant increases in insulin sensitivity (P < 0.05) and weight-specific QoL (P < 0.001), as well as reductions in BMI%, waist circumference, and percent body fat compared with controls. Increases in weight-specific QoL and reductions in BMI% and percent body fat remained significant at 12 months (P < 0.001), while changes in insulin sensitivity did not. In a subsample of youth with prediabetes at baseline, insulin sensitivity (P = 0.01), weight-specific QoL (P < 0.001), and BMI% (P < 0.001) significantly improved at 3 months.ConclusionsLifestyle intervention can improve cardiometabolic and psychosocial health in a vulnerable population of Latino adolescents at high risk for developing type 2 diabetes.
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Project description:IntroductionHispanics are at increased risk of developing type 2 diabetes. Lifestyle interventions are effective in preventing diabetes and restoring glucose regulation.MethodsWe recruited Hispanic men and women (N = 320) who were residents of the Lower Yakima Valley, Washington, aged 18 years or older with hemoglobin A1c (HbA1c) levels higher than 6% to a parallel 2-arm randomized-controlled trial conducted from 2008 through 2012. The trial compared participants in the intervention arm, who received an immediate educational curriculum (n = 166), to participants in the control arm, who received a delayed educational curriculum (n = 154). The home-based curriculum consisted of 5 sessions led by community health workers and was designed to inform participants about diabetes, diabetes treatment, and healthy dietary and physical activity behaviors. Participants were randomly assigned to the intervention and control arms, and analysts were blinded as to participant arm. We evaluated intervention effects on HbA1c levels; frequency (times per week) of fruit and vegetable consumption; and frequency (times per week) of mild, moderate, and strenuous leisure-time physical activity. At baseline, 3 months, and 6 months after randomization, participants completed a questionnaire and provided a blood sample. Analysts were blinded to intervention arm.ResultsThe immediate intervention group (-0.64% [standard error (SE) 0.10]) showed a significant improvement in HbA1c scores (-37.5%, P = .04) compared with the delayed intervention group (-0.44%, P = .14). No significant changes were seen for dietary end points or changes in physical activity. We did observe a trend of greater increases in frequency of moderate and vigorous physical activity and a smaller increase in mild physical activity in the immediate intervention group than in the delayed intervention group.ConclusionThis home-based intervention delivered by CHWs was associated with a clinically and statistically significant reduction in HbA1c levels in Hispanic adults with HbA1c levels higher than 6%.
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Project description:This study tested the plausibility of a theoretical model of change for the Penn Resiliency Program (PRP), a cognitive-behavioral (CB) depression prevention program for adolescents. Middle school students (N = 697) were randomized to PRP, an assessment-only control condition (CON), or a placebo-control condition (PLA). Explanatory style and depressive symptoms were evaluated over 24 months of follow-up. Relative to both CON and PLA, there were significant indirect effects of PRP on 12-month levels of depressive symptoms through improvements in explanatory style in two of three participating schools. Within a third school, where PRP was not effective in targeting depressive symptoms (Gillham et al., 2007), there was no evidence of group differences in growth in explanatory style or indirect effects. When effective, PRP's CB training provides incremental value over non-specific components and there are indirect effects on depressive symptoms through improvements in explanatory style.
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Project description:BackgroundThe prevalence of obesity and its associated comorbidities continue to rise in the United States. Populations who are uninsured and from racial and ethnic minority groups continue to be disproportionately affected. These populations also experience fewer clinically meaningful outcomes in most weight loss trials. Weight gain prevention presents a useful strategy for individuals who experience barriers to weight loss. Given the often-limited weight management resources available to patients in primary care settings serving vulnerable patients, evaluating interventions with pragmatic designs may help inform the design of comprehensive obesity care delivered in primary care.ObjectiveThis study aims to evaluate the effectiveness of Balance, a 2-arm, 12-month pragmatic randomized controlled trial of a digital weight gain prevention intervention, delivered to patients receiving primary care within federally qualified community health centers.MethodsBalance was a 2-arm, 12-month pragmatic randomized controlled trial of a digital weight gain prevention intervention delivered to individuals who had a BMI of 25-40 kg/m2, spoke English or Spanish, and were receiving primary care within a network of federally qualified community health centers in North Carolina. The Balance intervention was designed to encourage behavioral changes that result in a slight energy deficit. Intervention participants received tailored goal setting and tracking, skills training, self-monitoring, and responsive health coaching from registered dietitians. Weight was measured at regular primary care visits and documented in the electronic health record. We compared the percentage of ≤3% weight gain in each arm at 24 months after randomization-our primary outcome-using individual empirical best linear unbiased predictors from the linear mixed-effects model. We used individual empirical best linear unbiased predictors from participants with at least 1 electronic health record weight documented within a 6-month window centered on the 24-month time point.ResultsWe randomized 443 participants, of which 223 (50.3%) participants were allocated to the intervention arm. At baseline, participants had a mean BMI of 32.6 kg/m2. Most participants were Latino or Hispanic (n=200, 45.1%) or non-Latino or Hispanic White (n=115, 26%). In total, 53% (n=235) of participants had at least 1 visit with weight measured in the primary time window. The intervention group had a higher proportion with ≤3% weight gain at 6 months (risk ratio=1.12, 95% CI 0.94-1.28; risk difference=9.5, 95% CI -4.5 to 16.4 percentage points). This difference attenuated to the null by 24 months (risk ratio=1.00, 95% CI 0.82-1.20; risk difference=0.2, 95% CI -12.1 to 11.0 percentage points).ConclusionsIn adults with overweight or obesity receiving primary care at a community health center, we did not find long-term evidence to support the dissemination of a digital health intervention for weight gain prevention.Trial registrationClinicalTrials.gov NCT03003403; https://clinicaltrials.gov/study/NCT03003403.International registered report identifier (irrid)RR2-10.1186/s12889-019-6926-7.
| S-EPMC11009856 | biostudies-literature
Project description:BackgroundExisting studies of mental health interventions in low-resource settings have employed highly structured interventions delivered by non-professionals that typically do not vary by client. Given high comorbidity among mental health problems and implementation challenges with scaling up multiple structured evidence-based treatments (EBTs), a transdiagnostic treatment could provide an additional option for approaching community-based treatment of mental health problems. Our objective was to test such an approach specifically designed for flexible treatments of varying and comorbid disorders among trauma survivors in a low-resource setting.Methods and findingsWe conducted a single-blinded, wait-list randomized controlled trial of a newly developed transdiagnostic psychotherapy, Common Elements Treatment Approach (CETA), for low-resource settings, compared with wait-list control (WLC). CETA was delivered by lay workers to Burmese survivors of imprisonment, torture, and related traumas, with flexibility based on client presentation. Eligible participants reported trauma exposure and met severity criteria for depression and/or posttraumatic stress (PTS). Participants were randomly assigned to CETA (n = 182) or WLC (n = 165). Outcomes were assessed by interviewers blinded to participant allocation using locally adapted standard measures of depression and PTS (primary outcomes) and functional impairment, anxiety symptoms, aggression, and alcohol use (secondary outcomes). Primary analysis was intent-to-treat (n = 347), including 73 participants lost to follow-up. CETA participants experienced significantly greater reductions of baseline symptoms across all outcomes with the exception of alcohol use (alcohol use analysis was confined to problem drinkers). The difference in mean change from pre-intervention to post-intervention between intervention and control groups was -0.49 (95% CI: -0.59, -0.40) for depression, -0.43 (95% CI: -0.51, -0.35) for PTS, -0.42 (95% CI: -0.58, -0.27) for functional impairment, -0.48 (95% CI: -0.61, -0.34) for anxiety, -0.24 (95% CI: -0.34, -0.15) for aggression, and -0.03 (95% CI: -0.44, 0.50) for alcohol use. This corresponds to a 77% reduction in mean baseline depression score among CETA participants compared to a 40% reduction among controls, with respective values for the other outcomes of 76% and 41% for anxiety, 75% and 37% for PTS, 67% and 22% for functional impairment, and 71% and 32% for aggression. Effect sizes (Cohen's d) were large for depression (d = 1.16) and PTS (d = 1.19); moderate for impaired function (d = 0.63), anxiety (d = 0.79), and aggression (d = 0.58); and none for alcohol use. There were no adverse events. Limitations of the study include the lack of long-term follow-up, non-blinding of service providers and participants, and no placebo or active comparison intervention.ConclusionsCETA provided by lay counselors was highly effective across disorders among trauma survivors compared to WLCs. These results support the further development and testing of transdiagnostic approaches as possible treatment options alongside existing EBTs.Trial registrationClinicalTrials.gov NCT01459068 Please see later in the article for the Editors' Summary.
| S-EPMC4227644 | biostudies-literature
Project description:Study objectivesInsomnia is a common precursor to depression; yet, the potential for insomnia treatment to prevent depression has not been demonstrated. Cognitive behavioral therapy for insomnia (CBT-I) effectively reduces concurrent symptoms of insomnia and depression and can be delivered digitally (dCBT-I); however, it remains unclear whether treating insomnia leads to sustained reduction and prevention of depression. This randomized controlled trial examined the efficacy of dCBT-I in reducing and preventing depression over a 1-year follow-up period.MethodsPatients with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) insomnia disorder were randomly assigned to receive dCBT-I or an attentional control. The follow-up sample included 358 patients in the dCBT-I condition and 300 patients in the online sleep education condition. The primary outcome measure was relative rate ratios for depression at 1-year follow-up. Insomnia responses to treatment were also tested as predictors of incident depression at the 1-year follow-up.ResultsAt 1-year follow-up, depression severity continued to be significantly lower in the dCBT-I condition relative to control. In addition, the number of individuals who reported no depression at 1-year follow-up was 51% higher in the dCBT-I condition relative to control. In those with minimal to no depression at baseline, the incident rate of moderate-to-severe depression at 1-year follow-up was reduced by half in the dCBT-I condition relative to the control condition.ConclusiondCBT-I showed robust effects as an intervention that prevents depression. Future research should examine dose-response requirements and further characterize mechanisms of action of dCBT-I for depression prevention.Clinical trialSleep to Prevent Evolving Affective Disorders; NCT02988375.
| S-EPMC6783888 | biostudies-literature