Mechanisms by Which the Fun for Wellness Intervention May Promote Subjective Well-Being in Adults with Obesity: a Reanalysis Using Baseline Target Moderation.

Fun For Wellness (FFW) is a self-efficacy theory-based online behavioral intervention that aims to promote growth in physical activity and well-being. The FFW conceptual model for the promotion of subjective well-being posits that FFW exerts both a positive direct effect, and a positive indirect effect through well-being self-efficacy, on subjective well-being. Subjective well-being is defined in FFW as an individual's satisfaction with their status in seven key domains of their life. Well-being self-efficacy is defined in FFW as the degree to which an individual perceives that they have the capability to attain a positive status in seven key domains of their life. The objective of this study was to use baseline target moderation to assess variation in the impact of FFW on subjective well-being dimensions in adults with obesity. Data (N = 667) from the Well-Being and Physical Activity Study (ClinicalTrials.gov, identifier: NCT03194854) were reanalyzed. There was evidence that well-being self-efficacy at baseline moderated the direct effect of FFW on well-being self-efficacy at 30 days post-baseline for the occupational and psychological dimensions. Both of these findings suggest a "compensatory" effect. Similarly, there was evidence that well-being self-efficacy at baseline moderated the indirect effect of FFW on subjective well-being at 60 days post-baseline through well-being self-efficacy at 30 days post-baseline for the occupational and psychological dimensions. Both of these findings suggest a "compensatory" effect. Finally, there was evidence that well-being self-efficacy at baseline moderated the direct effect of FFW on subjective well-being at 60 days post-baseline for the community, occupational, and physical dimensions. Each of these three findings suggests some version of a "rich-get-richer" effect. In summary, results provide both supportive and unsupportive (i.e., interpersonal, economic, and overall dimensions) evidence regarding variation in the impact of the FFW intervention and should impact the design of future FFW trials.

Measurement of Physical Activity Self-Efficacy in Adults With Obesity: A Latent Variable Approach to Explore Dimensionality, Temporal Invariance, and External Validity.

The objective of this study was to improve the measurement of physical activity self-efficacy (PASE) in adults with obesity. To accomplish this objective, a latent variable approach was used to explore dimensionality, temporal invariance, and external validity of responses to a newly developed battery of PASE scales. Data (Nbaseline = 461 and N30 days postbaseline = 427) from the Well-Being and Physical Activity Study (ClinicalTrials.gov, identifier: NCT03194854), which deployed the Fun For Wellness intervention, were analyzed. A two-dimensional factor structure explained responses to each PASE scale at baseline. There was strong evidence for at least partial temporal measurement invariance for this two-dimensional structure in each PASE scale. There was mixed evidence that the effectiveness of the Fun For Wellness intervention exerted a direct effect on latent PASE in adults with obesity at 30 days postbaseline (i.e., external validity) of this two-dimensional structure.

Effectiveness of the Fun for Wellness Online Behavioral Intervention to Promote Well-Being Actions in Adults With Obesity or Overweight: A Randomized Controlled Trial.

The purpose of this study was to evaluate the effectiveness of the Fun For Wellness (FFW) online intervention to increase well-being actions in adults with obesity in the United States in relatively uncontrolled settings. The FFW intervention is guided by self-efficacy theory. The study design was a large-scale, prospective, double-blind, and parallel-group randomized controlled trial. Data collection occurred at baseline, 30 days after baseline, and 60 days after baseline. Participants (N = 667) who were assigned to the FFW group (nFFW = 331) were provided with 30 days of 24-hr access to FFW. Supportive evidence was provided for the effectiveness of FFW in real-world settings to promote, either directly or indirectly, three dimensions of well-being actions: community, occupational, and psychological. This study shows that theory-based intervention may be effective in promoting well-being actions in adults with obesity in the United States.

Physician Mistrust, Medical System Mistrust, and Perceived Discrimination: Associations with HIV Care Engagement and Viral Load.

Medical mistrust is an important risk factor for many health outcomes. For individuals with HIV and substance use co-morbidities, mistrust may influence engagement with health care, and affect overall health and transmission risk. Medical mistrust can be measured by an individual's mistrust of his/her physician, or mistrust of the medical system. This study examined both types of mistrust among 801 substance-using individuals with uncontrolled HIV infection. The aims were to determine how physician mistrust, medical system mistrust, and discrimination experiences were associated with engagement in HIV primary care. Findings indicated higher levels of physician mistrust, but not medical system mistrust, were associated with a longer time since the last visit to an HIV provider. Longer time since seeing an HIV care provider was associated with higher viral load. This study refines our understanding of the relationship between mistrust and HIV care engagement for a large, diverse sample of substance-using individuals.

Effectiveness of the fun for wellness online behavioral intervention to promote well-being and physical activity: protocol for a randomized controlled trial.

BACKGROUND: Fun For Wellness (FFW) is an online behavioral intervention developed to encourage growth in well-being by providing capability-enhancing learning opportunities to participants. Self-efficacy theory guides the conceptual model underlying the FFW intervention. Some initial evidence has been provided for the efficacy of FFW to promote: well-being self-efficacy; interpersonal, community, psychological and economic subjective well-being; and, interpersonal and physical well-being actions. The purpose of this paper is to describe the protocol for a new randomized controlled trial (RCT) designed to provide the first investigation of the effectiveness of FFW to increase well-being and physical activity in adults with obesity in the United States of America. METHODS: The study design is a large-scale, prospective, parallel group RCT. Approximately 9 hundred participants will be randomly assigned to the FFW or Usual Care (UC) group to achieve a 1:1 group (i.e. , FFW: UC) assignment. Participants will be recruited through an online panel recruitment company. Data collection, including determination of eligibility, will be conducted online and enrollment is scheduled to begin on 8 August 2018. Data collection will occur at baseline, 30 days and 60 days after baseline. Instruments to measure demographic information, anthropometric characteristics, self-efficacy, physical activity and well-being will be included in the battery. Data will be modeled under an intent to treat approach and/or a complier average causal effect approach depending on the level of observed engagement with the intervention. DISCUSSION: The effectiveness trial described in this paper builds upon the 2015 FFW efficacy trial and has the potential to be important for at least three reasons. The first reason is based upon a general scientific approach that the potential utility of interventions should be evaluated under both ideal (e.g., more controlled) and real-world (e.g., less controlled) conditions. The second reason is based upon the global need for readily scalable online behavioral interventions that effectively promote physical activity in adults. The third reason is based upon the troubling global trend toward obesity along with evidence for obesity as a risk factor for several major non-communicable diseases. TRIAL REGISTRATION: ClinicalTrials.gov, identifier: NCT03194854 , registered 21 June 2017.

Patterns of Substance Use and Arrest Histories Among Hospitalized HIV Drug Users: A Latent Class Analysis.

Using baseline data from the NIDA Clinical Trials Network 0049 study (Project HOPE), we performed latent class analyses (LCA) to identify discrete classes, or clusters, of people living with HIV (PLWH) based on their past year substance use behaviors and lifetime arrest history. We also performed multinomial logistic regressions to identify key characteristics associated with class membership. We identified 5 classes of substance users (minimal drug users, cocaine users, substantial cocaine/hazardous alcohol users, problem polysubstance users, substantial cocaine/heroin users) and 3 classes of arrest history (minimal arrests, non-drug arrests, drug-related arrests). While several demographic variables such as age and being Black or Hispanic were associated with class membership for some of the latent classes, participation in substance use treatment was the only covariate that was significantly associated with membership in all classes in both substance use and arrest history LCA models. Our analyses reveal complex patterns of behaviors among substance using PLWH and suggest that HIV intervention strategies may need to take into consideration such nuanced differences to better inform future studies and program implementation.

Psychosocial Factors Associated with Problem Drinking Among Substance Users with Poorly Controlled HIV Infection.

AIMS: We aimed to identify psychosocial factors related to problem drinking among patients with poorly controlled human immunodeficiency virus (HIV) infection. SHORT SUMMARY: We aimed to identify psychosocial factors related to problem drinking among those with poorly controlled HIV infection. Increased levels of interpersonal conflict were associated with greater severity of alcohol problems. Poorer mental health, medical mistrust and less satisfaction with one's physician related to excessive drinking. METHODS: This secondary analysis used baseline data from a large multisite randomized controlled trial of substance users whose HIV infection was currently poorly controlled, from 11 urban hospitals across the USA. Participants were HIV-infected adult inpatients (n = 801; 67% male, 75% African American) with substance use histories. Participants self-reported on their drinking, perceived health, mental health, social relationships and patient-provider relationship. Structural equation models examined psychosocial factors associated with problem drinking, controlling for demographic covariates. RESULTS: Increased levels of interpersonal conflict were associated with greater severity of alcohol problems. Poorer mental health, medical mistrust and less satisfaction with one's physician were associated with excessive drinking. CONCLUSIONS: Several psychosocial factors, including interpersonal conflict, poor mental health (i.e. anxiety, depression and somatization), medical mistrust and less satisfaction with one's provider, were associated with problem drinking among HIV-infected substance users with poorly controlled HIV infection. The co-occurrence of these concerns highlights the need for comprehensive services (including attention to problem drinking, social services, mental health and quality medical care) in this at-risk group.

Centering Predictor Variables in Three-Level Contextual Models.

Hierarchical data are becoming increasingly complex, often involving more than two levels. Centering decisions in multilevel models are closely tied to substantive hypotheses and require researchers to be clear and cautious about their choices. This study investigated the implications of group mean centering (i.e., centering within context; CWC) and grand mean centering (CGM) of predictor variables in three-level contextual models. The goals were to (a) determine equivalencies in the means and variances across the centering options and (b) use the algebraic relationships between the centering choices to clarify the interpretation of the estimated parameters. We provide recommendations to assist the researcher in making centering decisions for analysis of three-level contextual models.

A cross-sectional assessment of the long term effects of brief strategic family therapy for adolescent substance use.

BACKGROUND: Young adult drug use and law-breaking behaviors often have roots in adolescence. These behaviors are predicted by early drug use, parental substance use disorders, and disrupted and conflict-ridden family environments. AIM: To examine long-term outcomes of Brief Strategic Family Therapy (BSFT) compared to treatment as usual (TAU) in the rates of drug use, number of arrests and externalizing behaviors in young adults who were randomized into treatment conditions as adolescents. DESIGN: 261 of 480 adolescents who had been randomized to BSFT or TAU in the BSFT effectiveness study were assessed at a single time, 3-7 years post randomization. METHODS: Assessments of drug use, externalizing behaviors, arrests and incarcerations were conducted using Timeline Follow Back, Adult Self Report, and self-report, respectively. Drug use, arrests and incarcerations were examined using negative binomial models and externalizing behaviors were examined using linear regression. RESULTS: When compared with TAU, BSFT youth reported lower incidence of lifetime (IRR = 0.68, 95%CI [0.57, 0.81]) and past year (IRR = 0.54, 95%CI [0.40, 0.71]) arrests; lower rates of lifetime (IRR = 0.63, 95%CI [0.49, 0.81]) and past year (IRR = 0.70, 95%CI [0.53, 0.92]) incarcerations; and lower scores on externalizing behaviors at follow-up (B = -0.42, SE = .15, p = .005). There were no differences in drug use. CONCLUSIONS AND SCIENTIFIC SIGNIFICANCE: BSFT may have long term effects in reducing the number of arrests, incarcerations and externalizing problems. These effects could be explained by the improvements in family functioning that occurred during the effectiveness study. This study contributes to the literature by reporting on the long term outcomes of family therapy for adolescent drug abuse.

An application of the Complier Average Causal Effect analysis to examine the effects of a family intervention in reducing illicit drug use among high-risk Hispanic adolescents.

The Complier Average Causal Effect (CACE) method has been increasingly used in prevention research to provide more accurate causal intervention effect estimates in the presence of noncompliance. The purpose of this study was to provide an applied demonstration of the CACE analytic approach to evaluate the relative effects of a family-based prevention intervention, Familias Unidas, in preventing/reducing illicit drug use for those participants who received the intended dosage. This study is a secondary data analysis of a randomized controlled trial designed to evaluate the relative efficacy of Familias Unidas with high-risk Hispanic youth. A total of 242 high-risk Hispanic youth aged 12-17 years and their primary caregivers were randomized to either Familias Unidas or Community Practice and assessed at baseline, 6 months and 12 months postbaseline. CACE models were estimated with a finite growth mixture model. Predictors of engagement were included in the CACE model. Findings indicate that, relative to the intent-to-treat (ITT) analytic approach, the CACE analytic approach yielded stronger intervention effects among both initially engaged and overall engaged participants. The CACE analytic approach may be particularly helpful for studies involving parent/family-centered interventions given that participants may not receive the intended dosage. Future studies should consider implementing the CACE analysis in addition to ITT analysis when examining the effects of family-based prevention programs to determine whether, and the extent to which, the CACE analysis has more power to uncover intervention effects.

Examining the Performance of the Sexual Minority Adolescent Stress Inventory with Transgender and Gender-Diverse Youth and Sexual Minority Emerging Adults: A Methodological Study.

Purpose: We examined the psychometric properties and criterion validity of the Sexual Minority Adolescent Stress Inventory (SMASI) among 730 sexual minority (SM) and transgender and gender-diverse (TGD) youth aged 14 to 24 years who participated in a human immunodeficiency virus study. Methods: We tested the factor structure of the global scale and subscales and measurement invariance across age, gender identity, sex assigned at birth, sexual identity, ethnoracial identity, and city. For criterion validity, we regressed mental health and substance use measures on the global scale. Results: The global scale had excellent fit (comparative fit index = 0.95) and high reliability (omega = 0.89). Subscale model fit was adequate. We confirmed invariance by gender identity and age and established criterion validity. Conclusion: The SMASI exhibits strong psychometric properties among SM emerging adults and TGD youth. Modifications could enhance the SMASI to better capture both sexual and gender minority stress among ethnoracial minority youth.

Using causal mediation to examine self-efficacy as a mechanism through which continuing care interventions reduce alcohol use.

OBJECTIVE: Understanding the causal mechanisms through which telephone and mobile health continuing care approaches reduce alcohol use can help develop more efficient interventions that effectively target these mechanisms. Self-efficacy for successfully coping with high-risk alcohol relapse situations is a theoretically and empirically supported mediator of alcohol treatment. This secondary analysis aims to examine self-efficacy as a mechanism through which remote-delivered continuing care interventions reduce alcohol use. METHOD: The study included 262 adults (Mage = 46.9, SD = 7.4) who had completed 3 weeks of an intensive outpatient alcohol treatment program. The sample was predominantly male (71%), African American (82%), and completed a high school education (71%). The four-arm randomized clinical trial compared three active continuing care interventions (telephone monitoring and counseling [TMC], addiction comprehensive health enhancement support system [ACHESS], and combined delivery of TMC and ACHESS) to usual care and assessed longitudinal measures of alcohol use and self-efficacy. Analyses employed the potential outcomes framework and sensitivity analyses to address threats to causal inference resulting from an observed mediator variable. RESULTS: Relative to usual care, the two intervention conditions that included TMC reduced alcohol use through improvements to self-efficacy. There was no evidence that self-efficacy mediated the effect of ACHESS on alcohol use. CONCLUSIONS: Based on our findings, self-efficacy is an important mechanism through which telephone continuing care interventions affect alcohol use. Future research to identify which components of TMC influence self-efficacy and factors that mediate ACHESS effects could enhance the effectiveness of remote delivery of continuing care. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Multilevel modeling in psychosomatic medicine research.

The primary purpose of this study is to provide an overview of multilevel modeling for Psychosomatic Medicine readers and contributors. The article begins with a general introduction to multilevel modeling. Multilevel regression modeling at two levels is emphasized because of its prevalence in psychosomatic medicine research. Simulated data sets based on some core ideas from the Familias Unidas effectiveness study are used to illustrate key concepts including communication of model specification, parameter interpretation, sample size and power, and missing data. Input and key output files from Mplus and SAS are provided. A cluster randomized trial with repeated measures (i.e., three-level regression model) is then briefly presented with simulated data based on some core ideas from a cognitive-behavioral stress management intervention in prostate cancer.

Optimizing the US-AUDIT for Alcohol Screening in U.S. College Students.

This study examined cutoff scores on the new (2014) US-AUDIT (Alcohol Use Disorders Identification Test), adapted for U.S. standard drinks. No studies have examined optimal cutoff scores on the US-AUDIT for college students. 250 undergraduates (65% men) completed the US-AUDIT. At-risk drinkers reported at least four binge drinking episodes per week. Likely alcohol use disorder was assessed with a self-report diagnostic measure. Using the Youden method, the ideal cutoff to identify at-risk drinkers for the US-AUDIT was 5 for men (sensitivity = .93, specificity = .96) and 6 for women (sensitivity = .77, specificity = .86); and to identify likely alcohol use disorder was 13 for men (sensitivity = .69, specificity = .81) and 8 for women (sensitivity = .83, specificity = .80). Cutoffs were lower than the original AUDIT. Different US-AUDIT cutoffs for men and women should be used for likely alcohol use disorder, which may reflect differences in drinking quantity and frequency. Empirical guidelines for alcohol screening with the new US-AUDIT may be used to enhance research or identification of at-risk drinkers in college settings, or for college students in primary care or other health care settings.

Secondary Analysis to Inform the Development of Adaptive Preventive Interventions.

For the past 30 years, scholars across the fields of epidemiology, education, psychology, and numerous other fields have worked to develop interventions designed to reduce risk and enhance protection to prevent mental, emotional, and behavioral problems across the lifespan. This article presents a series of next steps that leverage this foundational science to inform the development of adaptive preventive interventions. Adaptive preventive interventions (APIs) tailor the intervention to fit the diverse, sometimes changing, needs of participants with the goal of better prevention outcomes for more individuals. Secondary analyses of data from preventive intervention trials to identify moderators, mediators, and antecedents of attrition and intervention failure can be useful for designing effective APIs. Moderators that identify intervention effect heterogeneity can be used within an API to tailor the intervention to meet the unique needs of important participant subgroups. Mediators and predictors of disengagement and attrition can be helpful tailoring variables in an API to trigger change to the intervention. Preventive intervention trials that incorporate frequent assessment of potential mediators, moderators, and antecedents of attrition during the intervention period are needed. Secondary analyses of data from preventive intervention trials provide an important foundation for next-generation APIs.

Reducing Screen-Based Sedentary Behavior Among Overweight and Obese Hispanic Adolescents Through a Family-Based Intervention.

BACKGROUND: Sedentary behaviors, including screen-based activities, are associated with obesity, cardiovascular, and mental health risks. In the US, minority and socioeconomically disadvantaged youth engage in substantial sedentariness, requiring targeted interventions. Familias Unidas for Health and Wellness (FUHW) is a family intervention to reduce risks among Hispanic youth with overweight and obesity. Analyses examined (1) FUHW's impact on parent and adolescent screen-based sedentary behavior and (2) differential intervention effects by adolescent gender, internalizing symptoms, and body mass index. METHODS: A total of 280 overweight/obese Hispanic middle schoolers and parents were randomized to FUHW or control and assessed at baseline, 6, 12, and 24 months between 2015 and 2019. RESULTS: Linear growth models showed that exposure to FUHW was not associated with parent sedentary behavior over time (b = -0.11, P = .32) but was associated with decreases in adolescent sedentary behavior (b = -0.27, P = .03). Neither gender nor internalizing symptoms moderated intervention effects, but there were differential effects by body mass index. Compared to controls, FUHW showed significant decreases in sedentary behavior among overweight (b = -0.85, P < .01) and obese (b = -0.79, P < .01) youth but not severely obese youth. CONCLUSIONS: FUHW reduced youth screen-based sedentary behavior. Youth with severe obesity require additional intervention.

Modeling site effects in the design and analysis of multi-site trials.

BACKGROUND: Careful consideration of site effects is important in the analysis of multi-site clinical trials for drug abuse treatment. The statistical choices for modeling these effects have implications for both trial planning and interpretation of findings. OBJECTIVES: Three broad approaches for modeling site effects are presented: omitting site from the analysis; modeling site as a fixed effect; and modeling site as a random effect. Both the direct effect of site and the interaction of site and treatment are considered. METHODS: The statistical model, and consequences, for each approach are presented along with examples from existing clinical trials. Power analysis calculations provide sample size requirements for adequate statistical power for studies utilizing 6, 8, 10, 12, 14, and 16 treatment sites. RESULTS: Results of the power analyses showed that the total sample required falls rapidly as the number of sites increases in the random effect approach. In the fixed effect approach in which the interaction of site and treatment is considered, the required number of participants per site decreases as the number of sites increases. CONCLUSIONS: Ignoring site effects is not a viable option in multi-site clinical trials. There are advantages and disadvantages to the fixed effect and random effect approaches to modeling site effects. SCIENTIFIC SIGNIFICANCE: The distinction between efficacy trials and effectiveness trials is rarely sharp. The choice between random effect and fixed effect statistical modeling can provide different benefits depending on the goals of the study.

The influence of health locus of control on the patient-provider relationship.

The physician-patient relationship is important to the successful delivery of health care. Health locus of control (HLOC) of the patient, the extent to which individuals attribute their health to their own actions or to external agents, may affect the patient-provider relationship. This study examined the influences of HIV and HLOC on trust in physician among a population of predominantly minority women and their family members. Powerful others HLOC demonstrated a positive relationship with trust in physician and chance HLOC had a negative relationship with trust in physician. HIV moderated both of these relationships.

A multilevel mediation model of stress and coping for women with HIV and their families.

Families are influential systems and may be an important context in which to consider the stress and coping process. To date, many studies have focused on modeling the stress and coping process for the individual, isolated from the family. The purpose of this secondary analysis was to investigate a cross-sectional stress and coping model for HIV-positive African-American mothers recruited from HIV service facilities in South Florida (n=214) and their family members (n=294). Avoidance coping was hypothesized to mediate the relationship between stress and psychological distress. In addition, the family average of individual stress was hypothesized to moderate the relationship between avoidance coping and psychological distress. For all constructs, individuals reported on themselves and multilevel modeling techniques were used to account for similarities between members of the same family. The estimated mediation effect was significant. Aggregated family stress significantly moderated the relationship between avoidance coping and psychological distress. This study suggests that individuals exhibit different relationships between avoidance coping and psychological outcomes and that average stress reported by members of a family moderates the relationship between avoidance coping and psychological distress.

Effectiveness of the Fun for Wellness Web-Based Behavioral Intervention to Promote Physical Activity in Adults With Obesity (or Overweight): Randomized Controlled Trial.

BACKGROUND: Insufficient physical activity in the adult population is a global pandemic. Fun for Wellness (FFW) is a self-efficacy theory- and Web-based behavioral intervention developed to promote growth in well-being and physical activity by providing capability-enhancing opportunities to participants. OBJECTIVE: This study aimed to evaluate the effectiveness of FFW to increase physical activity in adults with obesity in the United States in a relatively uncontrolled setting. METHODS: This was a large-scale, prospective, double-blind, parallel-group randomized controlled trial. Participants were recruited through an online panel recruitment company. Adults with overweight were also eligible to participate, consistent with many physical activity-promoting interventions for adults with obesity. Also consistent with much of the relevant literature the intended population as simply adults with obesity. Eligible participants were randomly assigned to the intervention (ie, FFW) or the usual care (ie, UC) group via software code that was written to accomplish equal allocations to the FFW and UC groups. Data collection was Web based, fully automated, and occurred at three time points: baseline, 30 days after baseline (T2), and 60 days after baseline (T3). Participants (N=461) who were assigned to the FFW group (nFFW=219) were provided with 30 days of 24-hour access to the Web-based intervention. A path model was fit to the data consistent with the FFW conceptual model for the promotion of physical activity. RESULTS: There was evidence for a positive direct effect of FFW on transport-related physical activity self-efficacy (beta=.22, P=.02; d=0.23), domestic-related physical activity self-efficacy (beta=.22, P=.03; d=0.22), and self-efficacy to regulate physical activity (beta=.16, P=.01; d=0.25) at T2. Furthermore, there was evidence for a positive indirect effect of FFW on physical activity at T3 through self-efficacy to regulate physical activity at T2 (beta=.42, 95% CI 0.06 to 1.14). Finally, there was evidence for a null direct effect of FFW on physical activity (beta=1.04, P=.47; d=0.07) at T3. CONCLUSIONS: This study provides some initial evidence for both the effectiveness (eg, a positive indirect effect of FFW on physical activity through self-efficacy to regulate physical activity) and the ineffectiveness (eg, a null direct effect of FFW on physical activity) of the FFW Web-based behavioral intervention to increase physical activity in adults with obesity in the United States. More broadly, FFW is a scalable Web-based behavioral intervention that may effectively, although indirectly, promote physical activity in adults with obesity and therefore may be useful in responding to the global pandemic of insufficient physical activity in this at-risk population. Self-efficacy to regulate physical activity appears to be a mechanism by which FFW may indirectly promote physical activity in adults with obesity. TRIAL REGISTRATION: ClinicalTrials.gov, identifier: NCT03194854; https://clinicaltrials.gov/ct2/show/NCT03194854.