Lifestyle Changes Through Exercise and Nutrition (LEAN)
4 de junho de 2018 atualizado 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.
Visão geral do estudo
Status
Concluído
Intervenção / Tratamento
Descrição detalhada
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 estudo
Intervencional
Inscrição (Real)
97
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Louisiana
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Baton Rouge, Louisiana, Estados Unidos, 70808
- Pennington Biomedical Research Center
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 75 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Percent weight loss
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Body Fat Percentage
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Robert L Newton, Jr., PhD, Pennington Biomedical Research Center
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de junho de 2016
Conclusão Primária (Real)
23 de setembro de 2017
Conclusão do estudo (Real)
23 de setembro de 2017
Datas de inscrição no estudo
Enviado pela primeira vez
7 de julho de 2016
Enviado pela primeira vez que atendeu aos critérios de CQ
8 de agosto de 2016
Primeira postagem (Estimativa)
11 de agosto de 2016
Atualizações de registro de estudo
Última Atualização Postada (Real)
6 de junho de 2018
Última atualização enviada que atendeu aos critérios de controle de qualidade
4 de junho de 2018
Última verificação
1 de junho de 2018
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- PBRC 2016-018
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .