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A gender- and culturally-sensitive weight loss intervention for Hispanic males: The ANIMO randomized controlled trial pilot study protocol and recruitment methods.

ABSTRACT: Hispanic men have the highest rates of overweight and obesity when compared to men of other racial/ethnic groups, placing them at increased risk for obesity-related disease. Yet, Hispanic men are grossly underrepresented in weight loss research. Tailored intervention strategies to improve obesity treatment programs for this vulnerable racial/ethnic subgroup are needed. This manuscript describes recruitment strategies, methodology, and participant characteristics of the ANIMO study, a 24-week randomized controlled pilot trial testing the effects of a gender- and culturally-sensitive weight loss intervention (GCSWLI) on body weight in Hispanic men compared to a wait-list control condition. The ANIMO study included two phases. The first phase was a 12-week GCSWLI. Participants attended weekly in-person individual sessions guided by a trained bilingual Hispanic male lifestyle coach, were prescribed a daily reduced calorie goal, and 225?min of moderate-intensity physical activity per week. In the second phase, GCSWLI participants received bi-weekly phone calls across a 12-week follow-up. Wait-list control (WLC) participants from phase 1 received the GCSWLI plus mobile health technology support. Recruitment strategies included face-to-face efforts at a swap meet (outdoor marketplace), family/friend referrals, printed advertisements and social media. Recruitment, screening, and participant enrollment occurred over three months. Overall, 143 men expressed interest in participation. Of these, 115 were screened and 78% (n?=?90) were eligible to participate; 45% of enrolled participants (n?=?52) completed baseline assessments and 43% (n?=?50) were randomized (mean age of 43.3?±?11.4 years; BMI: 34.1?±?5.3?kg/m2; 58% Spanish monolingual). Parameter estimates from ANIMO will support future adequately powered trials for this health disparate population. Trial registration:ClinicalTrials.gov: NCT02783521.

SUBMITTER: Garcia DO

PROVIDER: S-EPMC5898526 | biostudies-literature | 2018 Mar

REPOSITORIES: biostudies-literature

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A gender- and culturally-sensitive weight loss intervention for Hispanic males: The ANIMO randomized controlled trial pilot study protocol and recruitment methods.

Garcia David O DO Valdez Luis A LA Bell Melanie L ML Humphrey Kyle K Hingle Melanie M McEwen Marylyn M Hooker Steven P SP

Contemporary clinical trials communications 20180209

Hispanic men have the highest rates of overweight and obesity when compared to men of other racial/ethnic groups, placing them at increased risk for obesity-related disease. Yet, Hispanic men are grossly underrepresented in weight loss research. Tailored intervention strategies to improve obesity treatment programs for this vulnerable racial/ethnic subgroup are needed. This manuscript describes recruitment strategies, methodology, and participant characteristics of the ANIMO study, a 24-week ran ...[more]

PMID: 29696238

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Project description:BackgroundDespite the benefits of genetic counseling and testing, uptake of cancer genetic services is generally low and Black/African American (Black) women are substantially less likely to receive genetic services than non-Hispanic White women. Our team developed a culturally sensitive, narrative decision aid video to promote uptake of genetic counseling among Black women at risk for a hereditary breast cancer syndrome that can be incorporated in conjunction with population-based cancer risk assessment in a clinical setting. We report here a pilot study to demonstrate changes in intention to access genetic counseling and intervention satisfaction.MethodsBlack women who were personally unaffected by breast cancer and were recommended for genetic counseling based on family history screening in a mammography center were recruited at the time of the mammogram. A prospective, pre-post survey study design, guided by theoretical constructs, was used to evaluate baseline and immediate post-intervention psychosocial factors, including intention to participate in genetic counseling and intervention satisfaction.ResultsPilot recruitment goals were met (n = 30). Pre-intervention, 50% of participants indicated that they were extremely likely to make a genetic counseling appointment, compared with 70% post-intervention (p = 0.05). After watching the intervention, 50% of participants indicated that the video changed their mind regarding genetic counseling.ConclusionsThis study demonstrated cultural satisfaction with a decision aid intervention designed to motivate Black women with hereditary breast cancer risk to attend a genetic counseling appointment. Our study showed that intention may be a specific and key construct to target in interventions designed to support decision-making about genetic services. Study results informed the design of a subsequent large scale, randomized implementation study.Trial registrationTrial registration: Clinicaltrials.gov NCT04082117 . Registered September 9, 2019. Retrospectively registered.

Project description:There is a need for culturally relevant nutrition programs targeted to underserved cancer survivors.Our aim was to examine the effect of a culturally based approach to dietary change on increasing fruit/vegetable (F/V) intake and decreasing fat intake among Hispanic breast cancer survivors.Participants were randomized to Intervention and Control groups. Diet recalls, detailed interviews, fasting blood, and anthropometric measures were collected at baseline, 3, 6, and 12 months.Hispanic women (n=70) with stage 0 to III breast cancer who completed adjuvant treatment and lived in New York City were randomized between April 2011 and March 2012.The Intervention group (n=34) participated in ¡Cocinar Para Su Salud!, a culturally based nine-session (24 hours over 12 weeks) intervention including nutrition education, cooking classes, and food-shopping field trips. The Control group (n=36) received written dietary recommendations for breast cancer survivors.Change at 6 months in daily F/V servings and percent calories from total fat were the main outcome measures.Linear regression models adjusted for stratification factors and estimated marginal means were used to compare changes in diet from baseline to 3 and 6 months.Baseline characteristics were the following: mean age 56.6 years (standard deviation 9.7 years), mean time since diagnosis 3.4 years (standard deviation 2.7 years), mean body mass index (calculated as kg/m²) 30.9 (standard deviation 6.0), 62.9% with annual household income ?$15,000, mean daily servings of all F/V was 5.3 (targeted F/V 3.7 servings excluding legumes/juices/starchy vegetables/fried foods), and 27.7% of daily calories from fat. More than 60% in the Intervention group attended seven or more of nine classes, with overall study retention of 87% retention at 6 months. At month 6, the Intervention group compared with Control group reported an increase in mean servings of F/V from baseline (all F/V: +2.0 vs -0.1; P=0.005; targeted F/V: +2.7 vs +0.5; P=0.002) and a nonsignificant decrease in percent calories from fat (-7.5% vs -4.4%; P=0.23) and weight (-2.5 kg vs +3.8 kg; P=0.22).¡Cocinar Para Su Salud! was effective at increasing short-term F/V intake in a diverse population of Hispanic breast cancer survivors.

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Project description:BACKGROUND:The shortage of organs for kidney transplantation for patients with end-stage renal disease (ESRD) is magnified in Hispanics/Latin Americans in the United States. Living donor kidney transplantation (LDKT) is the treatment of choice for ESRD. However, compared to their representation on the transplant waitlist, fewer Hispanics receive a LDKT than non-Hispanic whites. Barriers to LDKT for Hispanics include: lack of knowledge, cultural concerns, and language barriers. Few interventions have been designed to reduce LDKT disparities. This study aims to reduce Hispanic disparities in LDKT through a culturally targeted intervention. METHODS/DESIGN:Using a prospective effectiveness-implementation hybrid design involving pre-post intervention evaluation with matched controls, we will implement a complex culturally targeted intervention at two transplant centers in Dallas, TX and Phoenix, AZ. The goal of the study is to evaluate the effect of Northwestern Medicine's® Hispanic Kidney Transplant Program's (HKTP) key culturally targeted components (outreach, communication, education) on Hispanic LDKT rates over five years. The main hypothesis is that exposure to the HKTP will reduce disparities by increasing the ratio of Hispanic to non-Hispanic white LDKTs and the number of Hispanic LDKTs. We will also examine other process and outcome measures including: dialysis patient outreach, education session attendance, marketing efforts, Hispanic patients added to the waitlist, Hispanic potential donors per potential recipient, and satisfaction with culturally competent care. We will use mixed methods based on the Promoting Action on Research Implementation in Health Services (revised PARIHS) and the Consolidated Framework for Implementation Research (CFIR) frameworks to formatively evaluate the fidelity and innovative adaptations to HKTP's components at both study sites, to identify moderating factors that most affect implementation fidelity, and to identify adaptations that positively and negatively affect outcomes for patients. DISCUSSION:Our study will provide new knowledge about implementing culturally targeted interventions and their impact on reducing health disparities. Moreover, the study of a complex organizational-level intervention's implementation over five years is rare in implementation science; as such, this study is poised to contribute new knowledge to the factors influencing how organizational-level interventions are sustained over time. TRIAL REGISTRATION:(ClinicalTrials.gov registration # NCT03276390 , date of registration: 9-7-17, retrospectively registered).

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A gender- and culturally-sensitive weight loss intervention for Hispanic males: The ANIMO randomized controlled trial pilot study protocol and recruitment methods.

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A gender- and culturally-sensitive weight loss intervention for Hispanic males: The ANIMO randomized controlled trial pilot study protocol and recruitment methods.

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