Programa de Salud Conductual de Red Social de Microclínicas para el Manejo de la Obesidad y la Diabetes en Jordania
Este estudio tiene como objetivo prevenir la obesidad y la diabetes evaluando cambios en la presión arterial, el peso corporal, la glucosa en sangre en ayunas y la hemoglobina glucosilada (HbA1c) en los participantes en Jordania, al tiempo que se investiga cómo la pérdida de peso en un individuo puede influir en los cambios de peso en otros.
Microclinic Behavioral Health Full Program (education curriculum in classroom setting, plus full social interaction program)
+ Microclinic Behavioral Health Basic Program (education-only in classroom setting; no structured social interactions)
Enfermedades Cardiovasculares+15
+ Enfermedades del Sistema Endocrino
+ Enfermedades metabólicas
Estudio de Prevención
Resumen
Fecha de inicio: 1 de enero de 2012
Fecha en la que se inscribió al primer participante.I. Objectives Because social network-based programs have shown promise as a viable public health intervention strategy, we designed the MCP program to leverage existing social relationships to propagate positive health behaviors in efforts to prevent and manage obesity and diabetes. We conduct a trial to examine the effectiveness of the Microclinic Behavioral Health Program via 3 arm trial in Jordan of a 6 month intervention with 2 years followup. Furthermore, we aim to uncover the social mechanism of the intervention -- notably to define the pathways through which the social network behavioral health program worked by partitioning the different social network processes of direct causal induction (i.e. change catalyzed by a social network) from homophilly (i.e. where social networks are formed based on similar health behaviors), and confounding (i.e. correlation with exogenous shared variable). Notably, we seek to determine the presence of the amplification of metabolic changes over time due to the cross-propagation of health behaviors between persons in a social network. II. Study Design Randomized Control Study: This study is a randomized control study of adults (>= 18 years old) with Type 2 diabetes mellitus, pre-diabetes, or at risk for diabetes, who will be randomly assigned to an intervention group consisting of the Microclinic Behavioral Health Enhanced Program (Group A), a group who will receive the Microclinic Behavioral Health Basic Program without the social network components (Group B) , and controls receiving standard care and risk factor monitoring (Group C). III. Study Procedures a. Participant Recruitment (1-3 months) The aim of recruitment is to inform individuals with diabetic, pre-diabetic, or at risk for diabetes in the community about the microclinic study, and encourage patients to participate. The recruitment process will consist of interconnected strategies including: 1) the distribution of posters and invitations in four catchment areas, and a broader media campaign, and 2) recruitment by nurses through clinics in two pilot locations around Amman. Recruitment: Outreach strategies to recruit patients at risk for diabetes and with Type 2 diabetes include: a) The Royal Health Awareness Society will lead an outreach effort to spread the word about the Microclinic Social Network Behavioral Health Trial. The effort will involve distribution of posters and flyers in the public sphere, and, if possible, airing of radio or television spots. b) At the three assigned Ministry of Health local health centers, a Project Officer for each center will work with Project nurses trained in research, Institutional Review Board approved protocol, and data collection to recruit patients at risk for diabetes, pre-diabetes, and with type 2 diabetes to the Microclinic Social Network Behavioral Health Trial. Potential participants, consisting of both local residents and refugees in Jordan will be contacted by phone or referred to the trial in person during their visit to local Jordan Ministry of Health centers and asked if they would be willing to participate. Group A shall receive the 6 month Microclinic Behavioral Health Full Program, via trained Project Nurses, and a classroom curriculum that will increase the knowledge and skills in diabetes self-management and peer support and monitoring. The educational curriculum includes sessions on the causes of diabetes, prevention of complications, symptoms, self-management strategies, diet, exercise, but with emphasis on peer monitoring, social support, and structured social interactions. Each session is 2-3 hours. Group B receiving a modified Microclinic Behavioral Health Basic Program that has the same educational curriculum and classroom setting, but a modified version that does not emphasize the importance of social support, without structured social interaction enhancing components. Group C receiving no intervention and therefore, standard care as the control group, with parallel measurement of risk factors (to alleviate monitoring bias). A critical component of this project is the evaluation aimed at assessing the long term efficacy and sustainability of the Microclinic interventions in improving body weight and glucose in a resource limited setting over a 2 year time span. The program evaluation will collect demographic, medical history, clinical data, behavioral data from all participants during the 6 month main program as well as at 2 years after baseline.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 914 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Prevención
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 18 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria: diagnosed with type 2 diabetes, pre-diabetes, or 'at-risk for diabetes' (defined below) live in the catchment area of the study provide informed consent to participate. Exclusion Criteria: participants who are not diagnosed with type 2 diabetes, pre-diabetes, or 'at-risk for diabetes' are not able to provide informed consent due to mental illness women who are pregnant. Pregnant women may participate in consultation with their physician. However, data related to their participation in the trial will not be included in data analysis. 'At-risk of diabetes' is defined as either: a) having a history of diabetes in close family AND being overweight/obese, or b) having a family history of diabetes AND having either high BP or high serum cholesterol.
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.3 grupos de intervención están designados en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalGrupo II
ExperimentalGrupo III
Sin IntervenciónObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene 3 ubicaciones
Abu Nseir Ministry of Health Center
Amman, JordanAbrir Abu Nseir Ministry of Health Center en Google MapsKreibet Al Souq Ministry of Health Center
Amman, JordanNaour Ministry of Health Center
Amman, Jordan