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PilAm Go4Health Weight Loss Program to Prevent Heart Disease

3 de abril de 2019 actualizado por: Melinda Bender, University of California, San Francisco

Pilipino Americans Go4Health Weight Loss Program to Prevent Heart Disease

This is a pilot randomized controlled trial intervention to improve lifestyle behaviors (physical activity and health diet) for Filipino Americans with type 2 diabetes on metformin. If the PilAm Go4Health intervention demonstrates potential efficacy, it may identify effective intervention strategies to significantly reduce risks for heart disease risks (i.e., metabolic syndrome) in Filipino Americans.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Filipino Americans are the second largest Asian population and fastest growing racial group in the United States. They have one of the highest rates of insulin resistance (type 2 diabetes = T2DM) and central obesity (fat distributions primarily in the abdominal region). T2DM and central obesity are two of five major risk factors for metabolic syndrome that lead to cardiovascular disease and stroke. Key factors contributing to obesity and T2DM in Filipinos are their physical inactivity, and a diet high in fat and soda intake. However, there are very few research studies on improving health behaviors to reduce risks for metabolic syndrome in Filipino Americans. To help reduce the risk of developing metabolic syndrome in overweight/obese Filipino Americans with T2DM, the proposed project will test a culturally appropriate health behavior intervention program to reduce weight and waist circumference, through increasing physical activity, and lowering fat and sugar sweetened beverage intake. This intervention uses a mobile phone health app and social networking to encourage adherence to target health behaviors. The goals are to:

  1. To assess feasibility and acceptability of the culturally appropriate PilAm Go4Health Weight Loss Program
  2. To obtain preliminary estimates of the effect of the intervention on weight
  3. To conduct post-program process evaluations too improve the intervention relevancy for the target population.

Tipo de estudio

Intervencionista

Inscripción (Actual)

45

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

  • Estados Unidos
    • California
      • San Francisco, California, Estados Unidos, 94115
        • San Francisco / Daly City Communities

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 80 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  1. Self-identified as Filipino
  2. Age > 18 years
  3. BMI for Asians > 23 kg/m2
  4. Physician diagnosed T2DM diabetes confirmed by clinical data (e.g. documentation of fasting blood glucose >126 mg/dL or a positive oral glucose tolerance test (OGTT) > 200 mg/dl, HbA1c > 6.5%)
  5. On metformin for T2DM

4) waist circumference: men > 40 inches, women > 35 inches 6) Physically inactive - most leisure time spent without much physical activity 7) No cognitive impairment per the Mini-Cog test 8) has a mobile smart phone (iPhone 4s or above, or android phone) 9) English speaking. Only one member per household allowed to enroll in the study.

Exclusion Criteria:

  1. Uncontrolled T2DM
  2. Glucose metabolism associated disease (Cushing's syndrome, Acromegaly, and Pheochromocytoma currently under treatment, chronic pancreatitis), 2) Thyroid disease - sub-optimally treated
  3. Known medical conditions or other physical problems needing a special exercise program (e.g., prior myocardial infarction, history of angioplasty or angina, admission for hospital evaluation of chest pain, use of nitroglycerin for angina, chronic obstructive pulmonary disease, or uncontrolled hypertension)
  4. Recent acute coronary syndrome, congestive heart failure
  5. Currently participating in a lifestyle modification program
  6. Planning a trip outside of the US during the 6-month study period
  7. Known eating disorder
  8. Planning a surgery in the next 7-months
  9. Taking long-term antibiotics (including HIV-related agents), anti-tuberculosis agents (except isoniazid alone as prophylaxis), or prescription weight-loss drugs

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 paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Intervention - PilAm Go4Health Program
In the first 3 months this groups will start with the PilAm Go4Health Weight-loss Program lifestyle intervention. After 3 months this group will transition to a 3-month maintenance phase where they will continue to maintain the physical activity and healthy eating behaviors learned in the PilAm Go4Health Weight-loss Program lifestyle intervention and will complete the study for a total of 6 months.
Conductual: PilAm Go4Health Weight-loss Program
This is a 3-month lifestyle intervention program promoting weight loss through physical activity and health diet using a mobile health application (app), pedometer to track daily step-counts, and social networking (in-person and virtual social networking through Facebook) to reduce risks for metabolic syndrome in Filipino Americans with type 2 diabetes on metformin. Subjects will be asked: 1) to use a mobile app diary every day to input their weight, and calories (food and drink intake) and 2) wear a pedometer everyday to monitor their physical activity (step-counts).
Otros nombres:
  • PilAm Go4Health Program
Comparador activo: Active control - pedometer only
In the first 3 months this groups will start with a pedometer only. After 3 months, this group will transition to receive the PilAm Go4Health Weight-loss Program lifestyle intervention for the next 3 month and will complete the study for a total of 6 months
Conductual: Active Control
This is a 3-month active control using a pedometer only without any education related to wt loss, physical activity, health eating, or tracking healthy behaviors
Otros nombres:
  • pedometer only

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Feasibility for Participant Enrollment and Retention
Periodo de tiempo: Baseline to 6-months
Able to enroll at least 20 eligible participants per arm (measured by count), and retain at least 80% of enrolled participants in each arm
Baseline to 6-months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Weight Change in Kilograms
Periodo de tiempo: Baseline to 3 months
weight change in kilograms over a 3 month period. Intervention group will have a significantly greater reduction in weight change compared to the active control from baseline to 3-months
Baseline to 3 months
Percent Change in Weight (kg) From Baseline and 3 Months
Periodo de tiempo: Baseline to 3 months
100 x change in weight (kg) at 3 months divided by weight (kg) at baseline. Intervention group will have a significantly greater reduction in % weight change compared to the active control from baseline to 3-months.
Baseline to 3 months
Change in Waist Circumference
Periodo de tiempo: baseline to 3 months
Change in waist circumference over time within groups
baseline to 3 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University of California, San Francisco

Investigadores

  • Investigador principal: Melinda S Bender, PhD, University of California, San Francisco

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

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)

1 de noviembre de 2014

Finalización primaria (Actual)

1 de junio de 2016

Finalización del estudio (Actual)

1 de agosto de 2017

Fechas de registro del estudio

Enviado por primera vez

8 de noviembre de 2014

Primero enviado que cumplió con los criterios de control de calidad

12 de noviembre de 2014

Publicado por primera vez (Estimar)

13 de noviembre de 2014

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

8 de abril de 2019

Última actualización enviada que cumplió con los criterios de control de calidad

3 de abril de 2019

Última verificación

1 de abril de 2019

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 14-14158
  • 14CRP19560008 (Otro número de subvención/financiamiento: American Heart Association)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

Data generated under this project will be administered in accordance with both University and NIH policies, including the NIH Data Sharing Policy and Implementation Guidance of March 5, 2003. That data set will be made available to qualified investigators within one year after completion of our investigators' data analyses and publication of papers presenting the results of those analyses.

Requests will be reviewed and acted on by the PI or in consultation with a UCSF representative. After approval, the PI will prepare the requested dataset. This dataset will be carefully screened to make certain that all identifying information has been removed, including information that could be combined so as to identify an individual. Data will be provided in comma separated variables (CSV) text format rather than a proprietary format either on a CD or through a password-protected download from our website.

Marco de tiempo para compartir IPD

That data set will be made available to qualified investigators within one year after completion of our investigators' data analyses and publication of papers presenting the results of those analyses.

Criterios de acceso compartido de IPD

Data generated under this project will be administered in accordance with both University and NIH policies, including the NIH Data Sharing Policy and Implementation Guidance of March 5, 2003.Requests will be reviewed and acted on by the PI or in consultation with a University of California San Francisco (UCSF) representative. After approval, the PI will prepare the requested dataset. This dataset will be carefully screened to make certain that all identifying information has been removed, including information that could be combined so as to identify an individual. Data will be provided in comma separated variables (CSV) text format rather than a proprietary format either on a computer disk (CD) or through a password-protected download from our website.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • CIF
  • RSC

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. .

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