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Randomized Controlled Trial of the SystemCHANGE Intervention on Behaviors Related to Cardiovascular Risk in HIV+ Adults.

ABSTRACT: OBJECTIVE:To examine the effect of a lifestyle behavior intervention (SystemCHANGE) on physical activity and diet quality among sedentary people living with HIV (PLHIV). All participants expressed a desire to improve lifestyle health behaviors. METHODS:One hundred and seven HIV+ adults were randomized to either the intervention (6, in-person, standardized group sessions focusing on improving lifestyle behaviors) or a control condition (general advice on AHA diet and exercise guidelines). All participants wore an ActiGraph accelerometer and completed 24-hour dietary recalls at baseline, 3, and 6 months. Generalized estimating equations were used to examine intervention effects. The primary activity outcome was time spent in moderate-to-vigorous physical activity, and the primary dietary outcome was Healthy Eating Index. RESULTS:Mean age was 53 years, 65% were male, and 86% African American. Approximately 90% attended at least half of the sessions and 60% attended 5 or more sessions. The intervention did not significantly improve our primary lifestyle behavior endpoints (P ? 0.05); however, intervention participants consumed fewer carbohydrates-primarily sugar-sweetened beverages-per day and lost 0.732 kg body weight compared with a 0.153 weight gain in the control group (P = 0.03). CONCLUSIONS:Among sedentary PLHIV at high risk of cardiovascular disease, the SystemCHANGE intervention reduced daily carbohydrate intake and body weight, but did not increase physical activity or improve overall diet quality. Future work should identify fundamental personal, interpersonal, and contextual factors that will increase physical activity and improve overall diet quality among this population, and integrate these factors into tailored, lifestyle interventions for aging PLHIV.

SUBMITTER: Webel AR

PROVIDER: S-EPMC5889354 | biostudies-literature | 2018 May

REPOSITORIES: biostudies-literature

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Randomized Controlled Trial of the SystemCHANGE Intervention on Behaviors Related to Cardiovascular Risk in HIV+ Adults.

Webel Allison R AR Moore Shirley M SM Longenecker Chris T CT Currie Jackson J Horvat Davey Christine C Perazzo Joseph J Sattar Abdus A Josephson Richard A RA

Journal of acquired immune deficiency syndromes (1999) 20180501 1

<h4>Objective</h4>To examine the effect of a lifestyle behavior intervention (SystemCHANGE) on physical activity and diet quality among sedentary people living with HIV (PLHIV). All participants expressed a desire to improve lifestyle health behaviors.<h4>Methods</h4>One hundred and seven HIV+ adults were randomized to either the intervention (6, in-person, standardized group sessions focusing on improving lifestyle behaviors) or a control condition (general advice on AHA diet and exercise guide ...[more]

PMID: 29373392

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Project description:BackgroundPeople experiencing homelessness have higher rates of HIV than those who are stably housed. Mental health needs, substance use problems, and issues unique to homelessness such as lack of shelter and transiency need to be considered with regard to HIV prevention. To date, HIV prevention interventions for young adults experiencing homelessness have not specifically addressed modifiable real-time factors such as stress, sexual or drug use urge, or substance use, or been delivered at the time of heightened risk. Real-time, personalized HIV prevention messages may reduce HIV risk behaviors.ObjectiveThis pilot study tested the initial efficacy of an innovative, smartphone-based, just-in-time adaptive intervention that assessed predictors of HIV risk behaviors in real time and automatically provided behavioral feedback and goal attainment information.MethodsA randomized attention control design was used among young adults experiencing homelessness, aged 18-25 years, recruited from shelters and drop-in centers in May 2019. Participants were randomized to either a control or an intervention group. The intervention (called MY-RID [Motivating Youth to Reduce Infection and Disconnection]) consisted of brief messages delivered via smartphone over 6 weeks in response to preidentified predictors that were assessed using ecological momentary assessments. Bayesian hierarchical regression models were used to assess intervention effects on sexual activity, drug use, alcohol use, and their corresponding urges.ResultsParticipants (N=97) were predominantly youth (mean age 21.2, SD 2.1 years) who identified as heterosexual (n=51, 52%), male (n=56, 57%), and African American (n=56, 57%). Reports of sexual activity, drug use, alcohol use, stress, and all urges (ie, sexual, drug, alcohol) reduced over time in both groups. Daily drug use reduced by a factor of 13.8 times over 6 weeks in the intervention group relative to the control group (Multimedia Appendix 4). Lower urges for sex were found in the intervention group relative to the control group over the duration of the study. Finally, there was a statistically significant reduction in reports of feeling stressed the day before between the intervention and control conditions (P=.03).ConclusionsFindings indicate promising intervention effects on drug use, stress, and urges for sex in a hard-to-reach, high-risk population. The MY-RID intervention should be further tested in a larger randomized controlled trial to further investigate its efficacy and impact on sexual risk behaviors.Trial registrationClinicalTrials.gov NCT03911024; https://clinicaltrials.gov/ct2/show/NCT03911024.

Project description:BackgroundIn much of eastern and southern Africa, the incidence of HIV and other sexually transmitted infections (STIs) remains high despite the scale-up of promising biomedical and behavioral interventions. Studies have documented the crucial role of transactional sex-the exchange of money, material support, or goods, in sexual relationships-and heavy alcohol use in contributing to men's and women's health outcomes. Existing policy responses to this challenge have largely focused on women, through the provision of pre-exposure prophylaxis (PrEP) or structural interventions such as education subsidies and cash transfers. However, the effectiveness of these interventions has been hindered by the relative lack of interventions and programs targeting men's behavior. We describe the protocol for a study that will test an economic intervention designed to reduce men's engagement in HIV/STI-related risk behaviors in Kenya.MethodsWe will conduct a randomized controlled trial among income-earning men in Kenya who are aged 18-39 years and self-report alcohol use and engagement in transactional sex. The study will enroll 1500 participants and randomize them to a control group or savings group. The savings group will receive access to a savings account that includes lottery-based incentives to save money regularly, opportunities to develop savings goals/strategies, and text message reminders about their savings goals. The control group will receive basic health education. Over a period of 24 months, we will collect qualitative and quantitative data from participants and a subset of their female partners. Participants will also be tested for HIV and other STIs at baseline, 12, and 24 months.DiscussionThe findings from this study have the potential to address a missing element of HIV/STI prevention efforts in sub-Saharan Africa by promoting upstream and forward-looking behavior and reducing the risk of acquiring HIV/STIs in a high HIV/STI burden setting. If this study is effective, it is an innovative approach that could be scaled up and could have great potential for scientific and public health impact in Kenya.Trial registrationClinicalTrials.gov NCT05385484 . Registered on May 23, 2022.

Project description:BackgroundStudies have shown associations among food and activity behaviors and body weight of Latino fathers and adolescents. However, few Latino father-focused interventions have been designed to improve energy balance-related behaviors (EBRBs) and weight status among early adolescents. Thus, this efficacy study aims to evaluate the Padres Preparados, Jóvenes Saludables (Padres) youth obesity prevention program for positive changes in EBRBs (fruit, vegetable, sugar-sweetened beverage (SSB), sweet/salty snack, and fast-food consumption, physical activity, and screen time) and weight status among low-income Latino fathers and adolescents (10-14 years).MethodsA two-arm (treatment versus delayed-treatment control group) randomized controlled trial was conducted to evaluate the efficacy of 8 weekly experiential learning sessions (2.5 hours each) based on social cognitive theory. The sessions included food preparation, parenting skills, nutrition, and physical activity. The program was delivered to father-adolescent dyads (mothers were encouraged to attend) in trusted community-based settings in a Midwest metropolitan area between 2017 and 2019. In March 2020, in-person implementation was discontinued due to COVID-19 pandemic restrictions, which limited the sample size. Father/adolescent dyads were randomized to treatment or control group within each site. Surveys and measurements were completed by fathers and adolescents to assess changes in food and activity behaviors from baseline to post-intervention. Adolescents also completed 24-hour dietary recall interviews at baseline and post-intervention. Intervention effects were assessed using linear regression mixed models adjusted for covariates and accounting for clustering of participants within sites.ResultsData from 147 father/adolescent dyads who completed at least the baseline data collection were used. No significant differences were observed for baseline to post-intervention changes in adolescents' and fathers' EBRBs or weight status between treatment and control groups. Fathers' SSB and fast food intakes were not statistically significant (p = 0.067 and p = 0.090, respectively).ConclusionsThe Padres program resulted in no significant improvements in adolescent and father EBRBs and weight status. Additional Latino father-focused interventions are needed to examine intervention effects on EBRBs among Latino adolescents.Trial registrationThe Padres Preparados, Jóvenes Saludables study is registered with the U.S. National Library of Medicine, ClinicalTrials.gov Identifier: NCT03469752 (19/03/2018).

Project description:Introduction: To determine the effects of a novel lifestyle intervention combining lifestyle behavioral education with the complementary-integrative health modality of guided imagery (GI) on dietary and physical activity behaviors in adolescents. The primary aim of this study was to determine the incremental effects of the lifestyle education, stress reduction GI (SRGI), and lifestyle behavior GI (LBGI) components of the intervention on the primary outcome of physical activity lifestyle behaviors (sedentary behavior, light, moderate, and vigorous physical activity), as well as dietary intake behaviors, at the completion of the 12-week intervention. The authors hypothesized that the intervention would improve obesity-related lifestyle behaviors. Materials and Methods: Two hundred and thirty-two adolescent participants (aged 14-17 years, sophomore or junior year of high school) were cluster randomized by school into one of four intervention arms: nonintervention Control (C), Lifestyle education (LS), SRGI, and LBGI. After-school intervention sessions were held two (LS) or three (SRGI, LBGI) times weekly for 12 weeks. Physical activity (accelerometry) and dietary intake (multiple diet recalls) outcomes were assessed pre- and postintervention. Primary analysis: intention-to-treat (ITT) mixed-effects modeling with diagonal covariance matrices; secondary analysis: ad hoc subgroup sensitivity analysis using only those participants adherent to protocol. Results: ITT analysis showed that the Healthy Eating Index (HEI) increased in the LS group compared with C (p = 0.02), but there was no additional effect of GI. Among adherent participants, sedentary behavior was decreased stepwise relative to C in SRGI (d = -0.73, p = 0.004) > LBGI (d = -0.59, p = 0.04) > LS (d = -0.41, p = 0.07), and moderate + vigorous physical activity was increased in SRGI (d = 0.58, p = 0.001). Among adherent participants, the HEI was increased in LS and SRGI, and glycemic index reduced in LBGI. Conclusions: While ITT analysis was negative, among adherent participants, the Imagine HEALTH lifestyle intervention improved eating habits, reduced sedentary activity, and increased physical activity, suggesting that GI may amplify the role of lifestyle education alone for some key outcomes. Clinical Trials.gov ID: NCT02088294.

Project description:The high morbidity and mortality in African Americans associated with behavior-linked chronic diseases are well documented.We tested the efficacy of an intervention to increase multiple health-related behaviors in African Americans. In a multisite cluster-randomized controlled trial, groups of African American human immunodeficiency virus (HIV)-serodiscordant heterosexual couples in Atlanta (Georgia), Los Angeles (California), New York (New York), and Philadelphia (Pennsylvania) were allocated to an individual-focused health promotion that addressed multiple health-related behaviors or to a couple-focused HIV/sexually transmitted disease (STD) risk reduction intervention. Primary outcomes were adherence to fruit and vegetable consumption and physical activity guidelines assessed preintervention, immediately postintervention, and 6 and 12 months postintervention. Secondary outcomes included fatty food consumption, prostate and breast cancer screening, and alcohol use. Generalized estimating equations tested the efficacy of the health promotion intervention over the postintervention assessments.Health promotion intervention participants were more likely to report consuming 5 or more servings of fruits and vegetables daily (rate ratio [RR], 1.38; 95% confidence interval [CI], 1.18 to 1.62) and adhering to physical activity guidelines (1.39; 1.22 to 1.59) compared with HIV/STD intervention participants. In the health promotion intervention compared with the HIV/STD intervention, participants consumed fatty foods less frequently (mean difference, -0.18; 95% CI, -0.30 to -0.07), more men received prostate cancer screening (RR, 1.51; 95% CI, 1.21 to 1.88), and more women received a mammogram (RR, 1.26; 95% CI, 1.06 to 1.50). Alcohol use did not differ between the intervention groups.This trial demonstrates the efficacy of interventions targeting multiple health-related behaviors in African American HIV-seropositive and HIV-seronegative men and women. Trial Registration clinicaltrials.gov Identifier: NCT00644163.

Dataset Information

Randomized Controlled Trial of the SystemCHANGE Intervention on Behaviors Related to Cardiovascular Risk in HIV+ Adults.

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Randomized Controlled Trial of the SystemCHANGE Intervention on Behaviors Related to Cardiovascular Risk in HIV+ Adults.

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