Physical Activity Intervention for Gestational Diabetes (GDM)
19 de julho de 2022 atualizado por: Sarah Keim
Gestational diabetes mellitus (GDM) portends an immediate, increased risk for Type 2 diabetes mellitus (T2DM).
The increased risk associated with having GDM is compounded by excess weight retention.
Therefore, the weeks and months immediately after a GDM-complicated pregnancy present an optimal window to initiate lifestyle changes to prevent or delay T2DM.
The long-term goal is to prevent T2DM among women with GDM.
This study's objective is to evaluate the efficacy of a novel, yet simple, activity-boosting intervention on weight loss among women with GDM.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
Gestational diabetes mellitus (GDM) portends an immediate, increased risk for Type 2 diabetes mellitus (T2DM).
The increased risk associated with having GDM is compounded by excess weight retention, a common issue after any pregnancy.
Considering excess weight is the best predictor of developing T2DM, the weeks and months immediately after a GDM-complicated pregnancy present an optimal window to initiate lifestyle changes to prevent or delay T2DM.
The long-term goal is to prevent T2DM among women with GDM.
This study's objective is to evaluate the efficacy of a novel, yet simple, activity-boosting intervention on weight loss among women with GDM in a parallel two-arm randomized controlled trial (n=80 women/arm, N=160).
The intervention uses ankle weights (2.5 pounds [1.1 kg]) worn on each ankle during routine daily activities (e.g., cleaning, cooking, child care) to increase energy expenditure.
The central hypothesis, based on existing literature and preliminary data, is that postpartum women with GDM will adopt an intervention that requires minimal additional time outside of their daily activities.
We anticipate that this will result in additional weight loss that is clinically significant when compared with controls who only receive standard information on recommended physical activity.
The rationale for the proposed research is that once an intervention that both improves T2DM factors and is easily adopted by women with GDM is known, early intervention specific to this restricted timeframe can be implemented.
Tipo de estudo
Intervencional
Inscrição (Real)
75
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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Ohio
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Columbus, Ohio, Estados Unidos, 43205
- Nationwide Children's Hospital
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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 e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Fêmea
Descrição
Inclusion Criteria:
- Age 18+ years
- Diagnosed with GDM in current pregnancy
- English language ability adequate for participation
- Plan to remain in the area for study duration
- Ability to provide informed consent
Exclusion Criteria:
- Prior Type 1 or Type 2 diabetes
- Pregnant with multiples (e.g., twin, triplets, etc.)
- Premature infant [<35 completed weeks gestation (assessed after delivery, before randomization)]
- Heart disease, serious illness, or conditions that may impede or prohibit participation in either study arm
- Pre-pregnancy BMI <18.5 (underweight)
- Live outside 35 mile radius of Ohio State University
- Woman is an appointed surrogate
- Infant will be adopted after delivery
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: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Intervention
Women will receive the standard recommendation for engaging in 150 minutes of physical activity per week, ankle weights (2.5 pounds [1.1 kg]/ankle), instructions on ankle weight usage (wear during normal activity for 2 hours/day, 7 days/week).
The weight type and weight amount were chosen based on previously published literature and used in our preliminary work.
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Women will receive the standard recommendation for engaging in 150 minutes of physical activity per week, ankle weights (2.5 pounds [1.1 kg]/ankle), documentation for ankle weight usage, an accelerometer, and instructions for accelerometer usage.
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Comparador de Placebo: Control
All women in the control group will receive the standard recommendation for engaging in 150 minutes of physical activity per week.
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Women will receive the standard recommendation for engaging in 150 minutes of physical activity per week.
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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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Weight loss
Prazo: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Postpartum weight loss will be defined as weight change from initial weigh-in at NCH Visit 1 to final weigh-in at NCH Visit 2. Weight will be measured in person using the Tanita.
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NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Body Fat %
Prazo: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Percent body fat will be defined as the change in initial measurement at NCH Visit 1 to final measurement at NCH Visit 2. Percent body fat will be measured in person using the Tanita.
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NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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BMI
Prazo: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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BMI will be defined as the change from initial measurement at NCH Visit 1 to final measurement at NCH Visit 2. BMI will be measured using the Tanita for weight and obstetric medical record for height.
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NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Waist-hip Ratio
Prazo: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Waist circumference (cm) will be assessed at the middle point between the ribs and the iliac crest, with the participant standing.
Hip circumference (cm) will be measured at the widest circumference of the buttocks.
Change in circumference will be defined as the change from initial measurement at NCH Visit 1 to final measurement at NCH Visit 2. Waist-hip ratio will be measured in person using metric cloth tape.
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NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Glycemia and Associated Biomarkers of Insulin Resistance and Metabolic Health: Oral Glucose Tolerance Test (OGTT)
Prazo: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Blood will be collected during both visits at NCH and sent to the NCH lab for analysis.
A fasting 2-hour, 75g OGTT will be conducted during both NCH visits.
Glucose tolerance will be measured in mg/dL.
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NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Glycemia and Associated Biomarkers of Insulin Resistance and Metabolic Health: HOMA
Prazo: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Blood will be collected during both visits at NCH and sent to the NCH lab for analysis.
Insulin sensitivity (β-cell function) will be measured using the Matsuda index and HOMA-IR.
Matsuda index score and HOMA-IR will be determined based on insulin values (μU/mL) and glucose values (mg/dL) obtained from the OGTT.
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NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Glycemia and Associated Biomarkers of Insulin Resistance and Metabolic Health: Hemoglobin A1c (HbA1c)
Prazo: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Blood will be collected during both visits at NCH and sent to the NCH lab for analysis.
HbA1c will be analyzed as a percentage.
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NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Glycemia and Associated Biomarkers of Insulin Resistance and Metabolic Health: Leptin
Prazo: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Blood will be collected during both visits at NCH and sent to the NCH lab for analysis.
Fasting serum leptin will be measured in ng/mL.
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NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Glycemia and Associated Biomarkers of Insulin Resistance and Metabolic Health: High sensitivity c-reactive protein (hs-CRP)
Prazo: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Blood will be collected during both visits at NCH and sent to the NCH lab for analysis.
hsCRP will be measured in mg/L.
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NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Glycemia and Associated Biomarkers of Insulin Resistance and Metabolic Health: Adiponectin
Prazo: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Blood will be collected during both visits at NCH and sent to the NCH lab for analysis.
Adiponectin will be measured in µg/mL.
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NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Glycemia and Associated Biomarkers of Insulin Resistance and Metabolic Health: Lipid Panel
Prazo: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Blood will be collected during both visits at NCH and sent to the NCH lab for analysis.
Lipids will be analyzed including total cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and triglycerides.
Lipids will be measured in mg/dL.
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NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Sarah Keim, PhD, MA, MS, Nationwide Children's Hospital
Publicações e links úteis
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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)
10 de setembro de 2018
Conclusão Primária (Real)
22 de fevereiro de 2022
Conclusão do estudo (Real)
1 de julho de 2022
Datas de inscrição no estudo
Enviado pela primeira vez
5 de setembro de 2018
Enviado pela primeira vez que atendeu aos critérios de CQ
7 de setembro de 2018
Primeira postagem (Real)
10 de setembro de 2018
Atualizações de registro de estudo
Última Atualização Postada (Real)
20 de julho de 2022
Última atualização enviada que atendeu aos critérios de controle de qualidade
19 de julho de 2022
Última verificação
1 de julho de 2022
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 18-00178
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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