Mindfulness-based intervention for depression and insulin resistance in adolescents: Protocol for BREATHE, a multisite, pilot and feasibility randomized controlled trial.

BACKGROUND: Elevated depression symptoms have been associated with higher insulin resistance in adolescents, and consequently, greater risk for type 2 diabetes (T2D). Mindfulness-based intervention (MBI) may be suited for adolescents at risk for T2D given its potential to decrease depression and improve stress-related behavior/physiology underpinning insulin resistance. To prepare for a future multisite efficacy randomized controlled trial, a rigorous, multisite, pilot and feasibility study is needed to test this approach. The current paper describes the design and protocol for a multisite, pilot and feasibility randomized controlled trial of six-week MBI, cognitive-behavioral therapy (CBT), and health education (HealthEd) group interventions, to assess multisite fidelity, feasibility, and acceptability. METHODS: Participants are N = 120 adolescents ages 12-17, with body mass index (BMI) ≥85th percentile, elevated depression symptoms (20-item Center for Epidemiologic Studies-Depression Scale total score > 20), and family history of diabetes. Enrollment occurs across four United States (US) sites, two in Colorado, one in Washington, D·C., and one in Maryland. Group interventions are delivered virtually by trained psychologists and co-facilitators. Assessments occur at baseline, six-week follow-up, and one-year follow-up. RESULTS: Primary outcomes are intervention implementation fidelity, based upon expert ratings of audio-recorded sessions (≥80% adherence/competence), and recruitment feasibility, based upon percentage enrollment of eligible youth (≥80%). Secondary outcomes are intervention training fidelity/feasibility/acceptability, recruitment timeframe, and retention/assessment feasibility. CONCLUSION: Findings will inform optimization of training, recruitment, intervention delivery, retention, and assessment protocols for a multisite, efficacy randomized controlled trial evaluating MBI for decreasing depression and improving insulin resistance in adolescents at risk for developing T2D.

Cognitive-behavioral therapy and exercise training in adolescent females with elevated depression symptoms and at-risk for type 2 diabetes: Protocol for a randomized controlled trial.

BACKGROUND: Adolescent-onset type 2 diabetes (T2D) is a major public health concern of growing proportions. Prevention, therefore, is critical. Unfortunately, standard-of-care treatment for T2D prevention (e.g., exercise training) show insufficient effectiveness and do not address key modifiable barriers (e.g., depression symptoms) to exercise engagement. Depression symptoms are associated with both poorer physical fitness and greater insulin resistance, the key risk factor in adolescent-onset T2D. Thus, a targeted prevention approach that addresses depression symptoms in combination with exercise training may offer a novel approach to mitigating T2D risk. METHODS: This manuscript describes the design and study protocol for a multi-site, four-arm randomized controlled trial comparing the efficacy of group cognitive-behavioral therapy, group exercise training, and their combinations for the targeted prevention of worsening insulin resistance in N = 300 adolescent females at-risk for T2D with BMI ≥85th percentile and elevated depression symptoms. All four intervention arms will run in parallel and meet weekly for 1 h per week for 6-week to 6-week segments (12 weeks total). Outcomes are assessed at baseline, 6-week mid-treatment, 12-week follow-up, and 1-year follow-up. RESULTS: The primary outcome is insulin resistance. Key secondary outcomes include insulin sensitivity, cardiorespiratory fitness, physical activity, depression symptoms, and body measurements. CONCLUSION: Study findings will guide the ideal sequencing of two brief T2D prevention interventions for ameliorating the course of insulin resistance and lessening T2D risk in vulnerable adolescents. These interventions will likely be cost-effective and scalable for dissemination, having the potential for significant public health impact on communities at risk for T2D.

Identification of Facilitators and Barriers of Healthy Living and Type 2 Diabetes Prevention Among Latinx Families.

Youth-onset type 2 diabetes (T2D) is on the rise and may be associated with more adverse health outcomes than adult onset. Latinx adolescents are disproportionately at risk for T2D yet are underrepresented in prevention efforts. Extant interventions to prevent T2D in Latinx adolescents show limited effectiveness. Comprehensive understanding of Latinx adolescent/family needs is lacking, but necessary for cultural tailoring of T2D prevention. Researchers conducted focus groups with 32 Latinx adolescents (age 10-18 years) from Northern Colorado and 31 Spanish-speaking parents/caregivers, with 2.5-hr semistructured youth-specific and parent-specific discussions, respectively. No participants included in this study had T2D. Qualitative data were analyzed for emergent themes about barriers/facilitators of healthy living and T2D prevention preferences. Thematic content analysis yielded eight themes within three categories: barriers to healthy living, facilitators of healthy living, and program preferences. Barriers to healthy living included individual motivational factors/food preferences; financial cost and time demands of healthy eating/exercise; negative emotions; and external/relational factors such as parent feeding pressure and peer pressure/bullying. Facilitators of healthy living included individual motivational factors/enjoyment of healthy living and supportive family structure. Program preferences were for family-based programming with adolescent breakout sessions and for facilitation by culturally competent facilitators. T2D is recognized as a serious health concern among Latinx families. There is a need for culturally tailored prevention programming that, in order to be acceptable, should address cultural and socioeconomic considerations, provide coping skills for adolescent-specific psychosocial stressors, and utilize a family-based programming framework with adolescent breakout sessions and culturally competent facilitators.

La diabetes tipo 2 (DT2) que comienza en la juventud está en aumento y esta asociada con peores resultados en comparación con los de la edad adulta. Los adolescentes Latinx tienen un riesgo desproporcionado de DT2 sin embargo, no están representados en los esfuerzos de prevención. Las intervenciones existentes muestran una eficacia limitada. La comprensión sobre las necesidades de los adolescentes y las familias Latinx son escasas, pero son necesarias para prevenir DT2. Se realizaron grupos de enfoque con 32 adolescentes Latinx (de 10 a 18 añ3os) del Norte de Colorado y 31 padres de habla hispana, con sesiones de 2.5 horas para jóvenes y para padres. Ningún participante en este estudio tenía DT2. Se analizaron datos cualitativos que identificaron barreras/facilitadores para una vida sana y preferencias de programas para prevenir DT2. Las barreras incluyeron factores individuales; el costo y el tiempo para tener alimentación/ejercicio sano; emociones negativas; y factores externos como la presión de los padres/compañeros. Los facilitadores incluyeron factores individuales/disfrute de la salud y el apoyo familiar. Las preferencias fueron basada en la familia, con grupos de adolescentes y con facilitadores culturalmente competentes. La DT2 es un grave problema entre las familias Latinx. Se necesitan programas de prevención que consideren la cultura y factores socioeconómicos. También se deben proporcionar habilidades de afrontamiento de los estresores psicosociales para adolescentes, a través de facilitadores culturalmente competentes y utilizar programación basada en la familia, con actividades culturales para adolescentes.

Addressing Anxiety and Stress for Healthier Eating in Teens (ASSET): A Pilot Randomized Controlled Trial Protocol for Reducing Anxiety, Disinhibited Eating, Excess Weight Gain, and Cardiometabolic Risk in Adolescent Girls.

(1) Background: Standard-of-care lifestyle interventions show insufficient effectiveness for the prevention and treatment of excess weight and its associated cardiometabolic health concerns in adolescents, necessitating more targeted preventative approaches. Anxiety symptoms are common among adolescents, especially girls at risk for excess weight gain, and have been implicated in the onset and maintenance of disinhibited eating. Thus, decreasing elevated anxiety in this subset of adolescent girls may offer a targeted approach to mitigating disinhibited eating and excess weight gain to prevent future cardiometabolic health problems. (2) Methods: The current paper describes the protocol for a multisite pilot and feasibility randomized controlled trial of group cognitive behavioral therapy (CBT) and group interpersonal psychotherapy (IPT) in N = 40 adolescent girls (age 12-17 years) with elevated anxiety symptoms and body mass index (BMI; kg/m2) ≥ 75th percentile for age/sex. (3) Results: Primary outcomes are multisite feasibility of recruitment, protocol procedures, and data collection, intervention fidelity, retention at follow-ups, and acceptability of interventions and study participation. (4) Conclusions: Findings will inform the protocol for a future fully-powered multisite randomized controlled trial to compare CBT and IPT efficacy for reducing excess weight gain and preventing adverse cardiometabolic trajectories, as well as to evaluate theoretically-informed treatment moderators and mediators.