Sisters in Health: A Weight Loss Study for African American Women
Visão geral do estudo
Status
Condições
Descrição detalhada
A disparity exists in the prevalence of overweight and obesity between non-Hispanic white (NHW) and African American (AA) women. More AA women (78.2%) are overweight or obese compared to NHW (61.2%). Obesity increases the risk of developing numerous chronic diseases, including type 2 diabetes (T2DM), hypertension, cardiovascular disease, and some cancers. Among AA women, there is a higher prevalence, and almost double the risk, of developing T2DM compared to NHW. African Americans also have higher rates of complications and mortality from T2DM, and are more at risk for hypertension compared to NHW. Obesity is a costly epidemic. Fortunately, weight is a modifiable risk factor for reducing or preventing obesity and related diseases.
Interventions to reduce overweight and obesity through lifestyle change have been less effective for AA women compared to NHW women. African American women tend to lose less weight in standard behavioral weight loss interventions. A potential reason for smaller weight loss is that compared to NHW women, AA women have been shown to engage in less physical activity (PA) during these interventions.
The Sisters in Health study will test the efficacy of a 6-month randomized controlled trial in overweight and obese African American women. Women will be recruited to participate in this study comparing a standard behavioral weight loss intervention (BWI) to a physical activity enhanced BWI (BWI-PA) for 6 months. The primary objective of this study is to determine if AA women randomized to the BWI-PA will experience greater weight loss and PA compared to women receiving the BWI. Women in both groups will receive 18 face-to-face sessions on a tapered basis (weekly to biweekly). Face-to-face sessions will provide women with the knowledge, behavioral skills and strategies for weight loss.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- 21-65 years old
Ability to read, write, and speak English
- Female gender
- African American/Black/African/Afro-Caribbean race (self-identified)
- BMI 25-45 (> 45 may have greater risks while participating)
- Meets criteria for low active (defined as <3 days/week of at most 20 min. of PA/day) assessed by X
- Willingness to be randomized
- Willingness to participate for 6 months, including attending face-to-face sessions & outside of session tasks
- Access to a computer reliable internet access
- Willingness to use an app for diet and physical activity monitoring
- Regularly used email address
- Not planning to relocate
- Able to attend group sessions on scheduled day
Exclusion Criteria:
- Recently lost weight, 5-10% in last 6 months
- Currently participating in another weight loss or PA study, or taking weight loss medication, and unwilling to discontinue those activities
- Pregnant or planning to become pregnant
- Any physical limitations to engaging in or increasing physical activity/exercise- assessed by PAR-Q (including but not limited to heart attack/myocardial infarction, congestive heart failure)
- Type 2 diabetes being treated with insulin
- Major psychological disorder
- History of diagnosed eating disorder
- Medications that affect weight (determined by study staff)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Physical Activity Enhanced Weight Loss Intervention
Participants will engage in 18 weight loss intervention group sessions over 6 months.
Sessions will occur weekly for the first 3 months, and biweekly for the latter 3 months.
Participants will receive a behavioral weight loss curriculum, calorie and physical activity recommendations.
This arm, uniquely, will receive a culturally based physical activity component.
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18 session, group-based, 6-month, physical activity enhanced behavioral weight loss intervention
|
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Comparador Ativo: Standard Weight Loss Intervention
Participants will engage in 18 weight loss intervention group sessions over 6 months.
Sessions will occur weekly for the first 3 months, and biweekly for the latter 3 months.
Participants will receive a behavioral weight loss curriculum, calorie and physical activity recommendations.
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18 session, group-based, 6-month, standard behavioral weight loss intervention
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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Change in Weight
Prazo: Baseline to 6 months
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Baseline to 6 months
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Cadeira de estudo: Deborah F. Tate, PhD, University of North Carolina, Chapel Hill
- Investigador principal: Loneke T. Blackman Carr, MA, RD, University of North Carolina, Chapel Hill
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
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 (Real)
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
- 15-0484
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