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Journey to Better Health (JTBH)

21 de outubro de 2016 atualizado por: Monica L Baskin, University of Alabama at Birmingham

Deep South Network for Cancer Control - Healthier Weight Among African American Women

This study is being conducted in 8 rural counties in Alabama and Mississippi (4 per state). Approximately 400 overweight or obese African American women living in the selected counties will participate in a 2-year weight loss study.

Visão geral do estudo

Status

Concluído

Condições

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

Intervencional

Inscrição (Real)

409

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

    • Alabama
      • Birmingham, Alabama, Estados Unidos, 35294
        • University of Alabama at Birmingham

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

30 anos a 70 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Fêmea

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

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: 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)
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.
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
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.

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

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.
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.
baseline to 6-months
Self Efficacy for Healthy Eating and Exercise
Prazo: baseline to 12-months
Self-report
baseline to 12-months
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
baseline to 6-months
Dietary Intake
Prazo: baseline to 12-months
24 hour recall
baseline to 12-months
Dietary Intake
Prazo: baseline to 24-months
24 hour recall
baseline to 24-months
Perceived Stress Scale
Prazo: baseline to 6-months
Self-report questionnaire about frequency of select stressful events. Composite score is calculated based on responses.
baseline to 6-months
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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

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

1 de agosto de 2010

Conclusão Primária (Real)

1 de abril de 2015

Conclusão do estudo (Real)

1 de agosto de 2015

Datas de inscrição no estudo

Enviado pela primeira vez

17 de outubro de 2016

Enviado pela primeira vez que atendeu aos critérios de CQ

18 de outubro de 2016

Primeira postagem (Estimativa)

19 de outubro de 2016

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

24 de outubro de 2016

Última atualização enviada que atendeu aos critérios de controle de qualidade

21 de outubro de 2016

Última verificação

1 de outubro de 2016

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)?

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 .

Ensaios clínicos em Perda de peso

Ensaios clínicos em Weight Loss Only

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