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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:BackgroundHispanic men have disproportionate rates of overweight and obesity compared with other racial and ethnic subpopulations. However, few weight loss interventions have been developed specifically for this high-risk group. Furthermore, the use of mobile health (mHealth) technologies to support lifestyle behavior changes in weight loss interventions for Hispanic men is largely untested.ObjectiveThis single-arm pilot study examined the feasibility and acceptability of integrating mHealth technology into a 12-week gender- and culturally sensitive weight loss intervention (GCSWLI) for Hispanic men with overweight and obesity.MethodsA total of 18 Hispanic men (mean age 38, SD 10.9 years; mean BMI 34.3, SD 5.5 kg/m²; 10/18, 56% Spanish monolingual) received a GCSWLI, including weekly in-person individual sessions, a daily calorie goal, and prescription of ≥225 minutes of moderate-intensity physical activity per week. mHealth technology support included tailored SMS text messaging, behavior self-monitoring support using Fitbit Charge 2, and weight tracking using a Fitbit Aria Wi-Fi Smart Scale. Changes in weight from baseline to 12 weeks were estimated using a paired 2-tailed t test. Descriptive analyses characterized the use of Fitbit and smart scales. Semistructured interviews were conducted immediately after intervention to assess the participants' weight loss experiences and perspectives on mHealth technologies.ResultsOf 18 participants, 16 (89%) completed the 12-week assessments; the overall attrition rate was 11.1%. The mean weight loss at week 12 was -4.7 kg (95% CI 7.1 to -2.4 kg; P<.001). Participants wore the Fitbit 71.58% (962/1344) of the intervention days and logged their body weight using the smart scale (410/1344, 30.51% of the intervention days). Participants identified barriers to the use of the technology, such as lack of technological literacy and unreliable internet access for the smart scale.ConclusionsAlthough clinically significant weight loss was achieved by integrating mHealth technology into the GCSWLI, adherence to the prescribed use of technology was modest. Addressing barriers to the use of such technologies identified in our work may help to refine an mHealth intervention approach for Hispanic men.Trial registrationClinicalTrials.gov NCT02783521; https://clinicaltrials.gov/ct2/show/NCT02783521.

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:BackgroundGiven the increase in the prevalence of overweight and obesity worldwide, the number of digital weight loss interventions has also risen. However, these interventions often lack theoretical background and data on long-term effectiveness. The consideration of individual and gender differences in weight-related psychological parameters might enhance the efficacy and sustainability of mobile-based weight loss interventions.ObjectiveThis paper presented an introduction to and the process evaluation of a 12-week gender-sensitive mobile health (mHealth) weight loss intervention (I-GENDO) combining computer-based and self-tailoring features.MethodsBetween August 2020 and August 2021, individuals with overweight (BMI 25.0-29.9 kg/m²), those with obesity class I (BMI 30.0-34.9 kg/m²), and those with obesity class II (BMI 35.0-39.9 kg/m²) were recruited to the I-GENDO project, a multicenter study in Germany. The mHealth intervention aimed at targeting individual psychological factors associated with the development and persistence of overweight and obesity (eg, emotional eating) using computer-based tailoring. Moreover, the intervention took a gender-sensitive approach by implementing self-tailoring of gender-targeted module versions. The computer-based assignment of the main modules, self-selection of gender-targeted module versions, and use patterns were evaluated while considering gender. Moreover, gender differences in the usability assessment were analyzed.ResultsData from the intervention arm of the study were processed. A total of 116 individuals with overweight and obesity (77/116, 66.4% women; age mean 47.28, SD 11.66 years; BMI mean 33.58, SD 3.79 kg/m2) were included in the analyses. Overall, the compliance (90/109, 82.6%) and satisfaction with the app (mean 86% approval) were high and comparable with those of other mobile weight loss interventions. The usability of the intervention was rated with 71% (5.0/7.0 points) satisfaction. More women obtained the main module that focused on emotion regulation skills. Most men and women selected women-targeted versions of the main modules. Women used the app more frequently and longer than men. However, women and men did not differ in the progress of use patterns throughout the intervention.ConclusionsWe developed a tailored gender-sensitive mHealth weight loss intervention. The usability of and engagement with the intervention were satisfactory, and the overall satisfaction with the intervention was also high. Gender differences must be considered in the evaluation of the effectiveness and sustainability of the intervention.

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.

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/m(2)) 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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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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