Lifestyle Changes Through Exercise and Nutrition (LEAN)
4 de junio de 2018 actualizado por: Robert L. Newton, Jr., Pennington Biomedical Research Center
The Lifestyle Changes Through Exercise and Nutrition (LEAN) Project
The goal of The LEAN project intervention is to promote weight loss, healthy dietary habits, increased physical activity, improved blood glucose and cholesterol, and weight related quality of life in obese African American adults through a sustainable, technology enhanced, church-based program.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Descripción detallada
The LEAN Project is a community-based weight loss program that is delivered through churches serving lower-income, obese, African American adults.
The intervention will involve training community health coaches to deliver the intervention.
These community health coaches will be individuals who are members of the church and who are willing to be trained on how to deliver behaviorally-based, empirically proven, lifestyle change interventions.
These community health coaches will be trained by the staff at Pennington Biomedical, who have experience training and delivering these types of interventions.
The community health coaches will deliver the intervention through their respective church after being trained.
Weekly text messages will be sent to participants in order to supplement the intervention sessions and provide support.
The primary aim is to determine if the trained community health coach church-based intervention will result in significant weight loss.
Secondary aims will assess blood glucose, cholesterol, physical activity, food intake, and weight related quality of life.
Tipo de estudio
Intervencionista
Inscripción (Actual)
97
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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Louisiana
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Baton Rouge, Louisiana, Estados Unidos, 70808
- Pennington Biomedical Research Center
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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 75 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- self-identify as African American
- a member of a participating church
- age 18-75 years old
- BMI > 30
- own a mobile phone with text message capabilities
- at risk for diabetes (diagnosed nuclear family member or gestational diabetes) or diagnosed with type 2 diabetes
- willing to provide written informed consent
- willing to change diet, physical activity and weight
- able to participate in face-face counselling sessions as scheduled
- low to moderate cardiovascular disease risk
Exclusion Criteria:
- currently participating in a weight loss program
- currently using weight loss medication or have lost weight (>10 lbs in last year)
- planning to move from the area within the next year
- given birth within the past year, are currently pregnant or plan to become pregnant within the next year
- planning to have bariatric surgery within 2 years
- history of major depression, suicidal behavior or eating disorder
- hospitalization for a mental disorder or substance abuse in the last year
- have cancer or had cancer within the past 5 years.
- serious heart problems such as arrhythmias, cardiomyopathy, congestive heart failure
- stroke or heart attack in the last six months
- high blood pressure [systolic ≥160, or diastolic ≥100]
- chronic inflammatory conditions, including but not limited to severe arthritis, lupus, or inflammatory bowel disease
- diseases that are life threatening or that can interfere with or be aggravated by exercise or weight loss
- unwilling or unable to provide informed consent
- physician's or principal investigator's decision to exclude
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: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Weight loss intervention
Churches randomized to the intervention condition will receive the community health coach delivered church based intervention for 6 months followed by 6 months of weight maintenance.
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The intervention will involve utilizing trained community health coaches to deliver the weight loss intervention.
There will be 10 group based sessions conducted at each church over 6 months.
Session frequency will be 4 weekly sessions (4) for the first month, bimonthly sessions for 2 months (4) and monthly sessions for 2 months (2).
The study is based upon weight loss strategies that have been utilized in the Diabetes Prevention Program.
The group sessions will be augmented by utilizing text messages.
The text messages will be delivered weekly and three types of messages will be delivered: 1) lesson content, 2) motivational, 3) behavioral prompts.
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Experimental: Delayed Treatment Control Group
Churches in the delayed treatment control condition will receive information on various health topics relevant to African Americans, such as strokes, lupus, sickle cell, etc. via text message during the first six months.
Participants in this group will not receive any behavioral strategies designed to alter weight, physical activity, or diet during this time.
They will receive the community health coach delivered church based weight loss intervention after 6 months.
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The intervention will involve utilizing trained community health coaches to deliver the weight loss intervention.
There will be 10 group based sessions conducted at each church over 6 months.
Session frequency will be 4 weekly sessions (4) for the first month, bimonthly sessions for 2 months (4) and monthly sessions for 2 months (2).
The study is based upon weight loss strategies that have been utilized in the Diabetes Prevention Program.
The group sessions will be augmented by utilizing text messages.
The text messages will be delivered weekly and three types of messages will be delivered: 1) lesson content, 2) motivational, 3) behavioral prompts.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Percent weight loss
Periodo de tiempo: Month 6 and Year 1
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Percent weight loss will be calculated at 6 and 12 months.
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Month 6 and Year 1
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Body Fat Percentage
Periodo de tiempo: Screening, Month 6 and Year 1
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The participant's body fat percentage is measured using the portable Tanita Body Composition Analyzer (SC-240).
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Screening, Month 6 and Year 1
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Change in Blood Glucose
Periodo de tiempo: Screening, Month 6 and Year 1
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The Alere Cholestech LDX® Analyzer is engineered to provide accurate, actionable, and readily accessible glucose testing results.
The Cholestech uses fingerstick sampling and small sample size (40μL) that makes results less time consuming and easy to obtain.
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Screening, Month 6 and Year 1
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Change in Blood Pressure
Periodo de tiempo: Screening, Month 6 and Year 1
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Blood pressure will be measured using an automatic blood pressure cuff (Omeron, Model BP710 or similar).
Participants will rest for approximately 5 minutes prior to blood pressure measurement to ensure accurate at rest reading.
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Screening, Month 6 and Year 1
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Change in Food Intake
Periodo de tiempo: Screening, Month 6 and Year 1
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The National Cancer Institute (NCI) fat screener estimates the percentage of energy from fat by asking patients to report the frequency of consuming specific foods over the past 12 months.
A standard 7-item fruit and vegetable screener developed by the NCI and National 5 a Day Program grantees asks how often fruit and vegetables were consumed in the past month.
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Screening, Month 6 and Year 1
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Change in Physical activity
Periodo de tiempo: Screening, Month 6 and Year 1
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The International Physical Activity Questionnaire (IPAQ) questionnaire is a self-report measure of physical activity.
The metabolic equivalent task (MET) minutes in each domain of leisure time activity, that is, sedentary, light, moderate, and vigorous intensity, will be calculated.
The IPAQ has been shown to be a reliable and valid measure of physical activity and has been sensitive to changes in physical activity resulting from intervention programs.
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Screening, Month 6 and Year 1
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Change in Quality of Life
Periodo de tiempo: Screening, Month 6 and Year 1
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. Each participant's quality of life will be assessed using the Impact of Weight on Quality of Life Survey.
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Screening, Month 6 and Year 1
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Satisfaction Questionnaire
Periodo de tiempo: Month 6 and Year 1
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Each participant's satisfaction with the different elements of the study, including the community health coaches, the intervention, and the text messages, will be measured using a questionnaire developed by the investigators.
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Month 6 and Year 1
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Change in Blood Cholesterol
Periodo de tiempo: Screening, Month 6 and Year 1
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The Alere Cholestech LDX® Analyzer is engineered to provide accurate, actionable, and readily accessible cholesterol testing results.
The Cholestech uses fingerstick sampling and small sample size (40μL) that makes results less time consuming and easy to obtain.
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Screening, Month 6 and Year 1
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Change in Pulse
Periodo de tiempo: Screening, Month 6 and Year 1
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Pulse will be measured using an automatic blood pressure cuff (Omeron, Model BP710 or similar).
Participants will rest for approximately 5 minutes prior to pulse measurement to ensure accurate at rest reading.
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Screening, Month 6 and Year 1
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Robert L Newton, Jr., PhD, Pennington Biomedical Research Center
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
- Nguyen T, Irwin ML, Dewan AT, Cartmel B, Harrigan M, Ferrucci LM, Sanft T, Li F, Lu L, Salinas YD. Examining the effect of obesity-associated gene variants on breast cancer survivors in a randomized weight loss intervention. Breast Cancer Res Treat. 2021 Jun;187(2):487-497. doi: 10.1007/s10549-021-06151-5. Epub 2021 Mar 6.
- Newton RL Jr, Carter LA, Johnson W, Zhang D, Larrivee S, Kennedy BM, Harris M, Hsia DS. A Church-Based Weight Loss Intervention in African American Adults using Text Messages (LEAN Study): Cluster Randomized Controlled Trial. J Med Internet Res. 2018 Aug 24;20(8):e256. doi: 10.2196/jmir.9816.
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 junio de 2016
Finalización primaria (Actual)
23 de septiembre de 2017
Finalización del estudio (Actual)
23 de septiembre de 2017
Fechas de registro del estudio
Enviado por primera vez
7 de julio de 2016
Primero enviado que cumplió con los criterios de control de calidad
8 de agosto de 2016
Publicado por primera vez (Estimar)
11 de agosto de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
6 de junio de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
4 de junio de 2018
Última verificación
1 de junio de 2018
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- PBRC 2016-018
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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 Weight loss intervention
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University of RochesterTerminadoObesidad | Exceso de pesoEstados Unidos
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University of North Carolina, Chapel HillWeight Watchers InternationalTerminadoSobrepeso y ObesidadEstados Unidos
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The Miriam HospitalNational Institute on Minority Health and Health Disparities (NIMHD)Aún no reclutando
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University Hospital, GhentTerminado
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University of PennsylvaniaWeight Watchers InternationalTerminado
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University of RochesterActivo, no reclutandoObesidad | Exceso de peso | Estilo de vida saludable | Riesgos cardiovasculares | Investigación de implementaciónEstados Unidos
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University of OxfordOxford University Hospitals NHS TrustDesconocidoSíntomas de comportamientoReino Unido
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Munich Municipal HospitalTechnical University of Munich; University of RegensburgDesconocido
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Shiraz University of Medical SciencesTerminado
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Heidelberg UniversityDesconocidoRetraso de idioma | Trastornos del desarrollo del lenguajeAlemania