Pilot testing the feasibility of a game intervention aimed at improving help seeking and coping among sexual and gender minority youth: protocol for a randomized controlled trial

Background: Sexual and gender minority youth (SGMY; e.g., lesbian, gay, bisexual, and transgender youth) experience myriad substance use and mental health disparities compared with their cisgender (non-transgender) heterosexual peers. Despite much research showing these disparities are driven by experiences of bullying and cyberbullying victimization, few interventions have aimed to improve the health of bullied SGMY. One possible way to improve the health of bullied SGMY is via an online-accessible game intervention. Nevertheless, little research has examined the feasibility of using an online-accessible game intervention with SGMY. Objectives: To describe the protocol for a randomized controlled trial (RCT) pilot testing the feasibility and limited-efficacy of a game-based intervention for increasing help-seeking-related knowledge, intentions, self-efficacy, and behaviors, productive coping skills use, and coping flexibility, and reducing health risk factors and behaviors among SGMY. Methods: We enrolled 240 SGMY aged 14-18 years residing in the United States into a two-arm prospective RCT. The intervention is a theory-based, community-informed, computer-based, role playing game with three primary components: (1) encouraging help-seeking behaviors; (2) encouraging use of productive coping; and (3) raising awareness of online resources. SGMY randomized to both the intervention and control conditions will receive a list of SGMY-inclusive resources covering a variety of health-related topics. Control condition participants received only the list of resources. Notably, all study procedures are conducted online. We conveniently sampled SGMY using online website advertisements. Study assessments occur at enrollment, 1 month after enrollment, and 2 months after enrollment. The primary outcomes of this feasibility study include implementation procedures, game demand, and game acceptability. Secondary outcomes include help-seeking intentions, self-efficacy, and behaviors; productive coping strategies and coping flexibility; and knowledge and use of online resources. Tertiary outcomes include bullying and cyberbullying victimization; loneliness; mental health issues; substance use; and internalized sexual and gender minority stigma. Results: From April through July 2018, 240 participants were enrolled and randomized. Half of the enrolled participants (n=120) were randomized into the intervention condition, and half (n=120) into the control condition. At baseline, 52% of participants identified as gay or lesbian, 27% as bisexual, 24% as queer, and 12% as another non-heterosexual identity. Nearly half (47%) of participants were a gender minority, 37% were cisgender boys, and 16% were cisgender girls. There were no differences in demographic characteristics between intervention and control condition participants. Data collection is anticipated to end in November 2018. Conclusions: Online-accessible game interventions overcome common impediments of face-to-face interventions and present a unique opportunity to reach SGMY and improve their health. This trial will provide data on feasibility and limited-efficacy that can inform future online studies and a larger RCT aimed at improving health equity for SGMY. Trial Registration: ClinicalTrials.gov NCT03501264; https://clinicaltrials.gov/ct2/show/NCT03501264 (Archived by WebCite at http://www.webcitation.org/72HpafarW

Feasibility and acceptability of a beverage intervention for Hispanic adults: results from a pilot randomized controlled trial

Objective To assess the feasibility and acceptability of a beverage intervention in Hispanic adults. Design Eligible individuals identified as Hispanic, were 18-64 years old and had BMI 30.0-50.0 kg/m(2). Participants were randomized 2:2:1 to one of three beverages: Mediterranean lemonade (ML), green tea (GT) or flavoured water control (FW). After a 2-week washout period, participants were asked to consume 32 oz (946 ml) of study beverage daily for 6 weeks and avoid other sources of tea, citrus, juice and sweetened beverages; water was permissible. Fasting blood samples were collected at baseline and 8 weeks to assess primary and secondary efficacy outcomes. Setting Tucson, AZ, USA. Participants Fifty-two participants were recruited over 6 months; fifty were randomized (twenty-one ML, nineteen GT, ten FW). Study population mean (sd) age 44.6 (sd 10.2) years, BMI 35.9 (4.6) kg/m(2); 78 % female. Results Forty-four (88 %) completed the 8-week assessment. Self-reported adherence was high. No significant change (95 % CI) in total cholesterol (mg/dl) from baseline was shown -1.7 (-14.2, 10.9), -3.9 (-17.2, 9.4) and -13.2 (-30.2, 3.8) for ML, GT and FW, respectively. Mean change in HDL-cholesterol (mg/dl) -2.3 (-5.3, 0.7; ML), -1.0 (-4.2, 2.2; GT), -3.9 (-8.0, 0.2; FW) and LDL-cholesterol (mg/dl) 0.2 (-11.3, 11.8; ML), 0.5 (-11.4, 12.4; GT), -9.8 (-25.0, 5.4; FW) were also non-significant. Fasting glucose (mg/dl) increased significantly by 5.2 (2.6, 7.9; ML) and 3.3 (0.58, 6.4; GT). No significant change in HbA1c was demonstrated. Due to the small sample size, potential confounders and effect modifiers were not investigated. Conclusions Recruitment and retention figures indicate that a larger-scale trial is feasible; however, favourable changes in cardiometabolic biomarkers were not demonstrated.University of Arizona Mel and Enid Zuckerman College of Public Health through the Diabetes Development Fund12 month embargo; published online: 19 November 2018This item from the UA Faculty Publications collection is made available by the University of Arizona with support from the University of Arizona Libraries. If you have questions, please contact us at [email protected]

Feasibility and acceptability of a beverage intervention for Hispanic adults: a protocol for a pilot randomized controlled trial

Background: In the U.S., Hispanics have among the highest rates of overweight and obesity when compared to other racial/ethnic groups placing them at a greater risk for obesity-related disease. Identifying intervention strategies to reduce caloric intake and/or improve cardiometabolic health in Hispanics is critical to reducing morbidity and mortality among this large and growing population. Evidence exists to support diet-specific behavioral interventions, including beverage modifications, in reducing obesity-related health risks. However, the acceptability and feasibility of a beverage intervention in obese Hispanic adults has not been robustly evaluated. Methods: The objective of this pilot study is to assess the feasibility and acceptability of a randomized, controlled beverage intervention in 50 obese Hispanic adults ages 18-64 over 8-weeks. Eligible participants were obese (30-50.0 kg/m(2)), between the ages 18-64, self-identified as Hispanic, and were able to speak, read, and write in either English and/or Spanish. Study recruitment was completed August 2017. Upon the completion of baseline assessments, participants will be randomized to either Mediterranean lemonade, Green Tea, or flavored water control. After completing a 2-week washout period, participants will be asked to consume 32 oz. per day of study beverage for 6-weeks while avoiding all other sources of tea, lemonade, citrus, juice, and other sweetened beverages; water is permissible. Primary outcomes will be recruitment, retention, and acceptability of the intervention strategies. Our study will also evaluate participant-reported tolerance and as an exploratory aim, assess safety/toxicity-related to renal and/or liver function. Fasting blood samples will be collected at baseline and 8-weeks to assess the primary efficacy outcomes: total cholesterol, high-density lipoprotein (HDL), and low-density lipoprotein (LDL). Secondary outcomes include fasting glucose, hemoglobin A1c (HbA1c), and high-sensitivity C-reactive protein (hs-CRP). Discussion: This pilot study will provide important feasibility, safety, and early efficacy data necessary to design a larger, adequately-powered randomized controlled trial.University of Arizona Mel and Enid Zuckerman College of Public Health through the Diabetes Development FundUA Open Access Publishing Fund.This item from the UA Faculty Publications collection is made available by the University of Arizona with support from the University of Arizona Libraries. If you have questions, please contact us at [email protected]

Feasibility of a web-accessible game-based intervention aimed at improving help seeking and coping among sexual and gender minority youth: results from a randomized controlled trial

PURPOSE: To address the gap in interventions for improving sexual and gender minority youth (SGMY; e.g., lesbian, gay, bisexual, and transgender youth) health, we tested the feasibility of a game-based intervention for increasing help-seeking, productive coping skills, resource knowledge/use, and well-being. METHODS: We conducted a 2-arm randomized controlled trial testing a theory-based, community-informed, Web-accessible computer role playing game intervention. Control condition received a list of resources. Primary hypotheses were high levels of implementation success, game demand, and game acceptability. RESULTS: We randomized 240 SGMY aged 14–18 into the intervention (n=120) or control (n=120) conditions. Participants completed baseline (100%), 1-month follow-up (T2; 73.3%), and 2-month follow-up (T3; 64.4%) surveys. Among intervention participants, 55.8% downloaded and played the game. Of those who played, 46.2% reported a desire to play it again and 50.8% would recommend it. Game acceptability exceeded hypothesized benchmarks, wherein participants reported high positive affect (M=2.36; 95% CI:2.13,2.58), low negative affect (M=2.75; 95% CI:2.55,2.95), low tension/annoyance (M=3.18; 95% CI:2.98,3.39), and high competence (M=2.23; 95% CI:2.04,2.43) while playing the game. In multivariable intent-to-treat analyses of 38 secondary/tertiary outcomes, intervention participants reported significantly larger reductions than control participants in cyberbullying victimization (T2 b=−0.28; 95% CI:−0.56,−0.01), binge drinking frequency (T2 b=−0.39; 95% CI:−0.71,−0.06), and marijuana use frequency (T3 b=−2.78; 95% CI:−4.49,−1.08). CONCLUSIONS: We successfully implemented a Web-accessible game trial with SGMY. The game-based intervention was feasible and acceptable to SGMY, and preliminary results show it improved several health-related behaviors. A larger scale trial is needed to test whether the game-based intervention can reduce health inequities for SGMY