Engineering an Online STI Prevention Program: CSE2
3 de julio de 2019 actualizado por: Linda Collins, Penn State University
The Intersection of Alcohol and Sex: Engineering an Online STI Prevention Program
The overall objective of the proposed research is to reduce the incidence of sexually transmitted infections (STIs) among college students.
The investigators propose to accomplish this by using the innovative, engineering-inspired multiphase optimization strategy (MOST) to develop a highly effective, appealing, economical, and readily scalable internet-delivered behavioral intervention targeting the intersection of alcohol use and sexual risk behavior.
The rate of STIs on college campuses is alarming: one in four college students is diagnosed with an STI at least once during their college experience.
Sexual activity when drinking alcohol is highly prevalent among college students.
Alcohol use is known to contribute to the sexual risk behaviors that are most responsible for the transmission of STIs, namely unprotected sex, contact with numerous partners, and "hook-ups" (casual sexual encounters).
Few interventions have been developed that explicitly target the intersection of alcohol use and sexual risk behaviors, and none have been optimized.
In order to reduce the incidence of STI transmission among this and other high-risk groups, a new approach is needed.
MOST is a comprehensive methodological framework that brings the power of engineering principles to bear on optimization of behavioral interventions.
MOST enables researchers to experimentally test the individual components in an intervention to determine their effectiveness, indicating which components need to be revised and re-tested.
Given the high rates of alcohol use and sex among college students, the college setting provides an ideal opportunity for intervening on alcohol use and sexual risk behaviors.
The proposed study will include a diverse population of college students on 4 campuses which will increase the generalizability of the findings.
The specific aims are to (1) develop and pilot test an initial set of online intervention components targeting the link between alcohol use and sexual risk behaviors, (2) use the MOST approach to build an optimized preventive intervention, and (3) evaluate the effectiveness of the newly optimized preventive intervention using a fully powered randomized controlled trial (RCT).
This work will result in a new, more potent behavioral intervention that will reduce the incidence of STIs among college students in the US, and will lay the groundwork for a new generation of highly effective STI prevention interventions aimed at other subpopulations at risk.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
- Conductual: Solo beneficios percibidos
- Conductual: Normas cautelares y autoeficacia
- Conductual: Normas descriptivas solas
- Conductual: Normas descriptivas y autoeficacia
- Conductual: Normas descriptivas y beneficios percibidos
- Conductual: Expectativas solo
- Conductual: Expectativas y autoeficacia
- Conductual: Expectativas y normas cautelares
- Conductual: Expectativas, normas cautelares, beneficios, eficacia
- Conductual: Expectativas y normas descriptivas
- Conductual: Expectativas, normas descriptivas y prescriptivas
- Conductual: Knowledge Alone
- Conductual: Self-efficacy alone
- Conductual: Benefits and self-efficacy
- Conductual: Injunctive norms alone
- Conductual: Injunctive norms and benefits
- Conductual: Injunctive norms, benefits, self-efficacy
- Conductual: Descriptive norms, benefits, self-efficacy
- Conductual: Descriptive norms and injunctive norms
- Conductual: Descriptive and injunctive norms, self-efficacy
- Conductual: Descriptive and injunctive norms, and benefits
- Conductual: Descriptive & injunctive norms, benefits, efficacy
- Conductual: Expectancies and perceived benefits
- Conductual: Expectancies, benefits, self-efficacy
- Conductual: Expectancies, injunctive norms, self-efficacy
- Conductual: Expectancies, injunctive norms, and benefits
- Conductual: Expectancies, descriptive norms, & self-efficacy
- Conductual: Expectancies, descriptive norms, benefits
- Conductual: Expectancies, descriptive norms, benefits, efficacy
- Conductual: Expectancies, descriptive & injunctive norms, efficacy
- Conductual: Expectancies, descriptive & injunctive norms, benefits
- Conductual: Expectancies, descriptive & injunctive, benefits, efficacy
Descripción detallada
As part of the MOST approach, the investigators will conduct a series of screening experiments to build an optimized intervention.
The current study is the second (of two) screening experiments.
The first screening experiment corresponds to clinicaltrials.gov
ID # NCT02897804.
Tipo de estudio
Intervencionista
Inscripción (Actual)
2946
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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California
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Fresno, California, Estados Unidos, 93740
- Fresno State University
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North Dakota
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Fargo, North Dakota, Estados Unidos, 58108
- North Dakota State University
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Tennessee
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Murfreesboro, Tennessee, Estados Unidos, 37132
- Middle Tennessee State University
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Texas
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College Station, Texas, Estados Unidos, 77843
- Texas A&M University
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 30 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Currently enrolled at an American college or university
- A first-year student or first-year transfer student
- 18 years of age or older
- Have not gone through previous versions of itMatters before
Exclusion Criteria:
- Not a first-year student or transfer student
- Younger than 18 years of age
- Have gone through previous versions of itMatters
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación factorial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Conocimiento solo
Los participantes tendrán acceso al módulo de conocimiento por un período de hasta 3 semanas.
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Increase knowledge relate d STIs, STI risk, alcohol impairment, condom use skills, alcohol use behavior tracking skills, testing & treatment services.
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Experimental: Autoeficacia sola
Los participantes tendrán acceso al módulo de conocimiento más el módulo de autoeficacia por un período de hasta 3 semanas.
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Increase self-efficacy to us e protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
|
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Experimental: Normas cautelares solas
Los participantes tendrán acceso al módulo de conocimiento más el módulo de normas cautelares por un período de hasta 3 semanas.
|
Correct misperceptions regarding approval of alcohol misuse & sexual risk taking.
|
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Experimental: Normas descriptivas y autoeficacia
Los participantes tendrán acceso al módulo de conocimiento más las normas descriptivas y los módulos de autoeficacia por un período de hasta 3 semanas.
|
Corrija las percepciones erróneas sobre la prevalencia de conductas sexuales de riesgo inducidas por el alcohol, el uso/uso indebido de alcohol y las conductas sexuales de riesgo y aumente la autoeficacia para usar estrategias conductuales de protección (p. ej., habilidades de negociación de condones) para reducir las relaciones sexuales sin protección.
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Experimental: Normas descriptivas y beneficios percibidos
Los participantes tendrán acceso al módulo de conocimiento más los módulos de normas descriptivas y beneficios percibidos por un período de hasta 3 semanas.
|
Corregir las percepciones erróneas de la prevalencia de conductas sexuales de riesgo inducidas por el alcohol, el uso/uso indebido de alcohol y las conductas sexuales de riesgo y aumentar los beneficios percibidos para utilizar estrategias conductuales de protección para reducir las consecuencias negativas de participar en conductas sexuales bajo la influencia del alcohol.
|
|
Experimental: Normas descriptivas y normas prescriptivas
Los participantes tendrán acceso al módulo de conocimiento más los módulos de normas descriptivas y normas cautelares por un período de hasta 3 semanas.
|
Correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors and correct misperceptions regarding approval of alcohol misuse & sexual risk taking.
|
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Experimental: Expectativas solo
Los participantes tendrán acceso al módulo de conocimientos más el módulo de expectativas por un período de hasta 3 semanas.
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Disminuir la expectativa de que se necesita alcohol para tener un buen encuentro sexual.
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Experimental: Expectativas y autoeficacia
Los participantes tendrán acceso al módulo de conocimientos más los módulos de expectativas y autoeficacia por un período de hasta 3 semanas.
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Reducir la expectativa de que se necesita alcohol para tener un buen encuentro sexual y aumentar la autoeficacia para usar estrategias conductuales de protección (por ejemplo, habilidades de negociación de condones) para reducir el sexo sin protección.
|
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Experimental: Expectativas y beneficios percibidos
Los participantes tendrán acceso al módulo de conocimiento más los módulos de expectativas y beneficios percibidos por un período de hasta 3 semanas.
|
Decrease the expectation that alcohol is needed to have good sexual encounter and increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol.
|
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Experimental: Expectativas y normas cautelares
Los participantes tendrán acceso al módulo de conocimiento más los módulos de expectativas y normas cautelares por un período de hasta 3 semanas.
|
Disminuya la expectativa de que se necesita alcohol para tener un buen encuentro sexual y corrija las percepciones erróneas con respecto a la aprobación del uso indebido de alcohol y la asunción de riesgos sexuales.
|
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Experimental: Expectativas, normas cautelares y beneficios
Los participantes tendrán acceso al módulo de conocimiento más los módulos de expectativas, normas cautelares y beneficios percibidos por un período de hasta 3 semanas.
|
Decrease the expectation that alcohol is needed to have good sexual encounter; correct misperceptions regarding approval of alcohol misuse & sexual risk taking; and increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol.
|
|
Experimental: Expectativas, normas cautelares, beneficios, eficacia
Los participantes tendrán acceso al módulo de conocimiento más los módulos de expectativas, normas cautelares, beneficios percibidos y autoeficacia por un período de hasta 3 semanas.
|
Disminuir la expectativa de que se necesita alcohol para tener un buen encuentro sexual; corregir las percepciones erróneas con respecto a la aprobación del uso indebido de alcohol y la asunción de riesgos sexuales; aumentar los beneficios percibidos para usar estrategias conductuales protectoras para reducir las consecuencias negativas de participar en conductas sexuales bajo la influencia del alcohol; y aumentar la autoeficacia para usar estrategias conductuales de protección (p. ej., habilidades de negociación de condones) para reducir las relaciones sexuales sin protección.
|
|
Experimental: Expectativas y normas descriptivas
Los participantes tendrán acceso al módulo de conocimiento más los módulos de expectativas y normas descriptivas por un período de hasta 3 semanas.
|
Disminuir la expectativa de que se necesita alcohol para tener un buen encuentro sexual y corregir las percepciones erróneas de la prevalencia de conductas sexuales de riesgo inducidas por el alcohol, uso/abuso de alcohol y conductas sexuales de riesgo.
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Experimental: Perceived benefits alone
Participants will have access to the knowledge module plus the perceived benefits module for a period up to 3 weeks.
*Also referred to as 'benefits' in other arm descriptions**
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Aumentar los beneficios percibidos para usar estrategias conductuales protectoras para reducir las consecuencias negativas de participar en conductas sexuales bajo la influencia del alcohol.
|
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Experimental: Benefits and self-efficacy
Participants will have access to the knowledge module plus perceived benefits and self-efficacy modules for a period up to 3 weeks.
|
Increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
|
|
Experimental: Injunctive norms and self-efficacy
Participants will have access to the knowledge module plus injunctive norms and self-efficacy modules for a period up to 3 weeks.
|
Corrija las percepciones erróneas con respecto a la aprobación del uso indebido de alcohol y la asunción de riesgos sexuales y aumente la autoeficacia para usar estrategias conductuales de protección (por ejemplo, habilidades de negociación de condones) para reducir el sexo sin protección.
|
|
Experimental: Injunctive norms and benefits
Participants will have access to the knowledge module plus injunctive norms and perceived benefits modules for a period up to 3 weeks.
|
Correct misperceptions regarding approval of alcohol misuse & sexual risk taking and increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
|
|
Experimental: Injunctive norms, benefits, self-efficacy
Participants will have access to the knowledge module plus the injunctive norms, perceived benefits, and self-efficacy modules for a period up to 3 weeks.
|
Correct misperceptions regarding approval of alcohol misuse & sexual risk taking; increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
|
|
Experimental: Descriptive norms alone
Participants will have access to the knowledge module plus the descriptive norms modules for a period up to 3 weeks.
|
Corregir las percepciones erróneas sobre la prevalencia de las conductas sexuales de riesgo inducidas por el alcohol, el consumo/abuso de alcohol y las conductas sexuales de riesgo.
|
|
Experimental: Descriptive norms, benefits, self-efficacy
Participants will have access to the knowledge module plus the descriptive norms, perceived benefits, and self-efficacy modules for a period up to 3 weeks.
|
Correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
|
|
Experimental: Descriptive and injunctive norms, self-efficacy
Participants will have access to the knowledge module plus the injunctive norms and self-efficacy modules for a period up to 3 weeks.
|
orrect misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; correct misperceptions regarding approval of alcohol misuse & sexual risk taking; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
|
|
Experimental: Descriptive and injunctive norms, and benefits
Participants will have access to the knowledge module plus the descriptive norms, injunctive norms, and perceived benefits modules for a period up to 3 weeks.
|
Correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; correct misperceptions regarding approval of alcohol misuse & sexual risk taking; and increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol.
|
|
Experimental: Descriptive & injunctive norms, benefits, efficacy
Participants will have access to the knowledge module plus the descriptive norms, injunctive norms, perceived benefits, and self-efficacy modules for a period up to 3 weeks.
|
Correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; correct misperceptions regarding approval of alcohol misuse & sexual risk taking; increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol; and Increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
|
|
Experimental: Expectancies, benefits, self-efficacy
Participants will have access to the knowledge module plus the expectancies, perceived benefits, and self-efficacy modules for a period up to 3 weeks.
|
Decrease the expectation that alcohol is needed to have good sexual encounter; increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
|
|
Experimental: Expectancies, injunctive norms, self-efficacy
Participants will have access to the knowledge module plus the expectancies, injunctive norms, and self-efficacy modules for a period up to 3 weeks.
|
Decrease the expectation that alcohol is needed to have good sexual encounter; correct misperceptions regarding approval of alcohol misuse & sexual risk taking; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
|
|
Experimental: Expectancies, descriptive norms, self-efficacy
Participants will have access to the knowledge module plus the expectancies, descriptive norms, and self-efficacy modules for a period up to 3 weeks.
|
Decrease the expectation that alcohol is needed to have good sexual encounter; correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
|
|
Experimental: Expectancies, descriptive norms, benefits
Participants will have access to the knowledge module plus the expectancies, descriptive norms, and perceived benefits modules for a period up to 3 weeks.
|
Decrease the expectation that alcohol is needed to have good sexual encounter; correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; and increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol.
|
|
Experimental: Expectancies, descriptive norms, benefits, efficacy
Participants will have access to the knowledge module plus the expectancies, descriptive norms, perceived benefits, and self-efficacy modules for a period up to 3 weeks.
|
Decrease the expectation that alcohol is needed to have good sexual encounter; correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
|
|
Experimental: Expectancies, descriptive and injunctive norms
Participants will have access to the knowledge module plus the expectancies , descriptive norms, and injunctive norms modules for a period up to 3 weeks.
|
Disminuir la expectativa de que se necesita alcohol para tener un buen encuentro sexual; corregir las percepciones erróneas sobre la prevalencia de las conductas sexuales de riesgo inducidas por el alcohol, el consumo/abuso de alcohol y las conductas sexuales de riesgo; y corregir las percepciones erróneas con respecto a la aprobación del uso indebido de alcohol y la asunción de riesgos sexuales.
|
|
Experimental: Expectancies, descriptive & injunctive norms, efficacy
Participants will have access to the knowledge module plus the expectancies , descriptive norms, injunctive norms, and self-efficacy modules for a period up to 3 weeks.
|
Decrease the expectation that alcohol is needed to have good sexual encounter; correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; correct misperceptions regarding approval of alcohol misuse & sexual risk taking; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
|
|
Experimental: Expectancies, descriptive & injunctive norms, benefits
Participants will have access to the knowledge module plus the expectancies, descriptive norms, injunctive norms, and perceived benefits modules for a period up to 3 weeks.
|
Decrease the expectation that alcohol is needed to have good sexual encounter; correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; correct misperceptions regarding approval of alcohol misuse & sexual risk taking; and increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol.
|
|
Experimental: Expectancies, descriptive & injunctive, benefits, efficacy
Participants will have access to the knowledge module plus the expectancies, descriptive norms, injunctive norms, perceived benefits, and self-efficacy modules for a period up to 3 weeks.
|
Decrease the expectation that alcohol is needed to have good sexual encounter; correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; correct misperceptions regarding approval of alcohol misuse & sexual risk taking; increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Descriptive norms about the intersection of alcohol and sex collected via an online questionnaire.
Periodo de tiempo: This measure will be assessed immediately following the 3-week intervention.
|
This scale consists of 6 items and will be created as a weighted scale score.
Analyses will report the mean and standard deviation and expected mean values from a regression analysis.
The scale will reflect the average perceived prevalence of the alcohol and sex behaviors.
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This measure will be assessed immediately following the 3-week intervention.
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Injunctive norms about the intersection of alcohol and sex collected via an online questionnaire.
Periodo de tiempo: his measure will be assessed immediately following the 3-week intervention.
|
This scale consists of 6 items and will be created as a weighted scale score.
Analyses will report the mean and standard deviation and expected mean values from a regression analysis.
The scale will reflect the average perceived approval of the alcohol and sex behaviors, ranging from strongly disapprove to strongly approve.
|
his measure will be assessed immediately following the 3-week intervention.
|
|
Expectancies about the intersection of alcohol use and sex collected via an online questionnaire.
Periodo de tiempo: This measure will be assessed immediately following the 3-week intervention.
|
This scale consists of 10 items and will be created as a weighted scale score.
Analyses will report the mean and standard deviation and expected mean values from a regression analysis.
The scale will reflect the average number of drinks expected to experience the 10 different outcomes.
|
This measure will be assessed immediately following the 3-week intervention.
|
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Perceived benefits about using protective behavioral strategies collected via an online questionnaire.
Periodo de tiempo: This measure will be assessed immediately following the 3-week intervention.
|
This scale consists of 11 items and will be created as a weighted scale score.
Analyses will report the mean and standard deviation and expected mean values from a regression analysis.
The scale will reflect the average likelihood of contracting an STI using the listed behaviors.
|
This measure will be assessed immediately following the 3-week intervention.
|
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Self-efficacy to use protective behavioral strategies collected via an online questionnaire.
Periodo de tiempo: This measure will be assessed immediately following the 3-week intervention.
|
This scale consists of 9 items and will be created as a weighted scale score.
Analyses will report the mean and standard deviation and expected mean values from a regression analysis.
The scale will reflect the average level of confidence is using protective behavioral strategies to reduce the risk of contracting and STI, ranging from not at all confident to extremely confident.
|
This measure will be assessed immediately following the 3-week intervention.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Binge drinking behavior collected via an online questionnaire.
Periodo de tiempo: This measure will be assessed 1 month following the completion of the intervention.
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This item asks how many times in the past two weeks a male has 5 or more drinks in a 2-hour period (or females 4 or more drinks in a 2-hour period).
This variable will be collapsed into 1 or more times versus other and reported as a prevalence of this behavior and used as a dichotomous outcome in regression analyses.
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This measure will be assessed 1 month following the completion of the intervention.
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Unprotected sex behavior at most recent sex collected via an online questionnaire.
Periodo de tiempo: This measure will be assessed 1 month following the completion of the intervention.
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This item asks whether or not a condom was used for oral, anal or vaginal sex.
This variable will be collapsed into a dichotomous variable with unprotected anal or vaginal sex versus other and reported as a prevalence of this behavior and used as a dichotomous outcome in regression analyses.
|
This measure will be assessed 1 month following the completion of the intervention.
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Penetrative sex at most recent hookup collected via an online questionnaire.
Periodo de tiempo: This measure will be assessed 1 month following the completion of the intervention.
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This item asks whether or not the most recent hookup included vaginal or anal sex.
This variable will be collapsed into a dichotomous variable with penetrative sex versus other and reported as a prevalence of this behavior and used as a dichotomous outcome in regression analyses.
|
This measure will be assessed 1 month following the completion of the intervention.
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
18 de septiembre de 2017
Finalización primaria (Actual)
31 de diciembre de 2017
Finalización del estudio (Actual)
31 de diciembre de 2017
Fechas de registro del estudio
Enviado por primera vez
17 de enero de 2018
Primero enviado que cumplió con los criterios de control de calidad
17 de enero de 2018
Publicado por primera vez (Actual)
24 de enero de 2018
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
5 de julio de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
3 de julio de 2019
Última verificación
1 de julio de 2019
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- R01AA022931-2
- R01AA022931 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Solo beneficios percibidos
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Physician Recommended NutriceuticalsRothman Institute OrthopedicsDesconocido