- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02938312
Journey to Better Health (JTBH)
Deep South Network for Cancer Control - Healthier Weight Among African American Women
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Using a cluster-randomized study design, 400 overweight or obese African American women living in 8 rural counties in Alabama and Mississippi associated with the Deep South Network for Cancer Control will be assigned to either a weight loss only or weight loss plus community strategies condition for 2 years.
Weight Loss Only condition: In year 1, participants will attend weekly in-person group sessions (1.5 hours each) aimed at behavioral changes for weight loss (diet and physical activity) for 6 months followed by twice a month meetings for 3 months, then monthly meetings for 3 months. In year 2, monthly phone calls will be used to encourage continued behavior change or weight maintenance. In-person group meetings will be facilitated by a trained lay staff and community health advisors. Monthly phone calls will be conducted by the community health advisor.
Weight Loss Plus Community Strategies condition: Participants will receive the same weight loss program as the Weight Loss Only condition. In addition, a community-based organization or other non-profit group in the targeted community will receive funds and technical assistance to implement community-wide efforts to increase access to healthy affordable food and safe and convenient opportunities for physical activity (e.g., increase farmer's markets, develop walking trails).
Over the course of the study, participants will complete four full assessments to include measurement of height and weight (to calculate BMI), waist circumference, blood pressure, finger-stick blood draw for lipid and glucose testing, dietary recall, and questionnaires concerning participation in physical activity, self-efficacy for eating and exercise behaviors, depressive symptoms, perceived stress, social support, and demographic information (e.g., age, marital status, education, employment, household income).
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Alabama
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Birmingham, Alabama, Estados Unidos, 35294
- University of Alabama at Birmingham
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- African American female
- Live or work in target county
- BMI >= 25 kg/m2
Exclusion Criteria:
- Pregnant or planning to become pregnant in the next year
- Known major medical or psychological condition known to influence body weight
- Uncontrolled hypertension (BP > 160 mmHg systolic or >100 mmHg diastolic)
- Cardiovascular event in the preceding 12 months
- History of gastric bypass surgery
- History of psychiatric hospitalization in past 2 years
- History of substance abuse or eating disorder
- Any other condition by which a medical professional has suggested diet modification
- Physical activity and/or weight reduction would be contraindicated
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Comparador Ativo: Weight Loss Only
24- month weight loss program (year 1: weekly in-person meetings for 6 months, followed by 2 meetings per month for 3 months, then monthly for 3 months; year 2: monthly phone calls)
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Participants will attend in-person weekly sessions (about 1.5 hours each) for 6 months and then twice a month for 3 months and monthly for 3 months.
Sessions focus on behavioral techniques supporting healthy diet (including calorie restriction for weight loss) and achieving recommended amounts of physical activity per week.
During 1-year weight loss maintenance, participants receive monthly motivational phone calls.
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Experimental: Weight Loss Plus
Same intervention as "Weight Loss Only" but includes community-wide interventions to increase access to healthy affordable food and opportunities for safe and convenient physical activity
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Participants attend in-person meetings as described above.
This condition also includes community-wide strategies to increase access to healthy affordable food and safe opportunities for physical activity.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Weight
Prazo: baseline to 6-months
|
Measured weight (nearest kg)
|
baseline to 6-months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Waist Circumference
Prazo: baseline to 6-months
|
Measured circumference (nearest cm)
|
baseline to 6-months
|
Blood Pressure
Prazo: baseline to 6-months
|
Measured blood pressure (mmHG) - systolic and diastolic
|
baseline to 6-months
|
Lipids
Prazo: baseline to 6-months
|
Measured lipids - total cholesterol (mg/dL), Triglycerides (mg/dL), HDL, LDL, ratio
|
baseline to 6-months
|
Weight
Prazo: baseline to 12-months
|
Measured weight (nearest kg)
|
baseline to 12-months
|
Weight
Prazo: baseline to 24-months
|
Measured weight (nearest kg)
|
baseline to 24-months
|
Social Support for Healthy Eating and Exercise
Prazo: baseline to 6-months
|
Self-report questionnaire about perceived level of family and friend support for healthy eating and exercise.
Composite and subscale scores are calculated.
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baseline to 6-months
|
Social Support for Healthy Eating and Exercise
Prazo: baseline to 12-months
|
Self-report questionnaire about perceived level of family and friend support for healthy eating and exercise.
Composite and subscale scores are calculated.
|
baseline to 12-months
|
Social Support Healthy Eating and Exercise
Prazo: baseline to 24-months
|
Self-report questionnaire about perceived level of family and friend support for healthy eating and exercise.
Composite and subscale scores are calculated.
|
baseline to 24-months
|
Self Efficacy for Healthy Eating and Exercise
Prazo: baseline to 6-months
|
Self-report questionnaire about confidence in ability to eat healthy and exercise.
Composite and subscale scores are calculated.
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baseline to 6-months
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Self Efficacy for Healthy Eating and Exercise
Prazo: baseline to 12-months
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Self-report
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baseline to 12-months
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Self Efficacy for Healthy Eating and Exercise
Prazo: baseline to 24-months
|
Self-report questionnaire about confidence in ability to eat healthy and exercise.
Composite and subscale scores are calculated.
|
baseline to 24-months
|
Dietary Intake
Prazo: baseline to 6-months
|
24 hour recall
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baseline to 6-months
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Dietary Intake
Prazo: baseline to 12-months
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24 hour recall
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baseline to 12-months
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Dietary Intake
Prazo: baseline to 24-months
|
24 hour recall
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baseline to 24-months
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Perceived Stress Scale
Prazo: baseline to 6-months
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Self-report questionnaire about frequency of select stressful events.
Composite score is calculated based on responses.
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baseline to 6-months
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Perceived Stress Scale
Prazo: baseline to 12-months
|
Self-report questionnaire about frequency of select stressful events.
Composite score is calculated based on responses.
|
baseline to 12-months
|
Perceived Stress Scale
Prazo: baseline to 24-months
|
Self-report questionnaire about frequency of select stressful events.
Composite score is calculated based on responses.
|
baseline to 24-months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- F100708003
- 1U54CA153719 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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 .
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