- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01827826
Call-2-Health: Preventing Type II Diabetes (C2H)
Translating the Diabetes Prevention Project (DPP) in a Health Maintenance Organization (HMO) Setting
It is estimated that 30 million U.S. adults will have type 2 diabetes by 2050. Contributing to this national trend is the obesity epidemic. Three randomized trials have demonstrated that intensive behavioral interventions can prevent or delay the onset of diabetes. The purpose of this pilot study is to inform a future randomized, controlled Phase III trial of a population-based, telephonic, exercise and weight loss intervention to translate the findings of the Diabetes Prevention Program into practice. The telephonic intervention will be compared to usual care (30 participants in each group). The investigators will deliver the intervention in 12 weekly, 20-minute calls, with four subsequent maintenance calls, for a total of 16 calls over 24 weeks. Study outcomes will be measured at baseline and at 12 and 24 weeks.
For this planning grant the investigators do not have an overall hypothesis. The investigators' goal is to develop and test whether it is possible to do exercise and weight loss
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Washington
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Seattle, Washington, Estados Unidos, 98101
- Group Health Research Institute
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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:
- Male or female
- Age 40-74
- Receives primary care at Group Health Central, Rainier, or Poulsbo clinics in the greater Seattle area
- Can walk for more than 10 minutes
- Fasting plasma glucose (FPG) 105-125 mg/dl or glycolated hemoglobin (HbA1C) 5.7-6.4
- Body Mass Index (BMI) 25 kg/m2 or greater
Exclusion Criteria:
- Type 1 or 2 diabetes
- FPG > 125 mg/dl or < 105mg/dl at screening blood draw
- HbA1C > 6.4 or < 5.7 at screening blood draw
- Systolic blood pressure > 210 mmHg at the baseline clinic visit
- Exercise ≥ 30 minutes/day, at least five days a week
- Current participation in another structured weight loss treatment program or another intervention study
- Severe concurrent disease
- Unavailable for the 24-week study period
- Unable to read or speak English
- Pregnant or planning to become pregnant.
- Mentally or legally incapacitated such that informed consent cannot be obtained.
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 |
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Comparador Ativo: Intervention
Participants assigned to the intervention group worked with the study interventionist over the phone to reduce their risk for developing Diabetes Mellitus, Type 2. The intervention lasted for 24 weeks, with weekly phone calls for the first 12 weeks and 4 maintenance calls over the second 12 weeks.
Study measurements were taken at baseline, 12 weeks, 24 weeks, and 52 weeks.
After 24 weeks, the investigators randomly divided the intervention group in half.
The first group did not receive any more phone calls from the interventionist.
The second group continued to receive monthly 20-minute phone calls from the interventionist.
At 52 weeks post-baseline participants from both groups had their labs drawn, wore a pedometer for 3 days, and called in with a self-reported weight.
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Participants assigned to the intervention group received a total of 16 phone calls from the study interventionist over 24 weeks.
The first 12 weeks was the intervention phase and calls were made weekly.
The second 12 weeks was the maintenance phase and calls were made every 3 weeks.
After 24 weeks, the investigators continued to follow this group for 52 weeks post-randomization, allowing half of the group to continue to receive monthly maintenance calls while the other half received no further calls.
The study interventionist used behavior modification techniques to encourage intervention group participants to adopt healthy eating and exercise habits so that improvement might be seen in fasting glucose, glycated hemoglobin (HbA1c), weight, and waist/hip measurements.
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Sem intervenção: Control
Participants randomized into this group did not receive any intervention, although they were encouraged to follow-up with their doctor and follow through with usual clinical care.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Program feasibility: Uptake
Prazo: Baseline
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Measured by the number of people who consent to be in the study compared to the number who were eligible
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Baseline
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Program feasibility: Attendance
Prazo: 12 weeks
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Measured by the number of participants who return for their 12 week clinic visit
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12 weeks
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Program feasibility: Attendance
Prazo: 24 weeks
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Measured by the number of participants who return for their 24 week clinic visit
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24 weeks
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Program feasibility: Attendance
Prazo: 52 weeks
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Measured by the number of participants who complete their 52 week assignments (3 day pedometer, self-reported weight, fasting blood draw)
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52 weeks
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Fasting glucose
Prazo: Baseline, 12 weeks, 24 weeks, 52 weeks
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Measured via a fasting blood draw
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Baseline, 12 weeks, 24 weeks, 52 weeks
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Waist circumference
Prazo: Baseline, 12 weeks, 24 weeks
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in centimeters
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Baseline, 12 weeks, 24 weeks
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Blood pressure
Prazo: Baseline, 12 weeks, 24 weeks
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Measured using an automated clinical blood pressure monitor (Brand name: Omron, Model number HEM-907XL)
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Baseline, 12 weeks, 24 weeks
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Healthy eating habits
Prazo: Baseline, 12 weeks, 24 weeks
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Assessed using the Food Frequency Questionnaire
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Baseline, 12 weeks, 24 weeks
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Weight loss
Prazo: Baseline, 12 weeks, 24 weeks, 52 weeks
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Weight measured in kilograms
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Baseline, 12 weeks, 24 weeks, 52 weeks
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Changes in activity
Prazo: Baseline, 12 weeks, 24 weeks, 52 weeks
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Measured using the Modifiable Activity Questionnaire (MAQ)
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Baseline, 12 weeks, 24 weeks, 52 weeks
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Glycated hemoglobin (A1C)
Prazo: Baseline, 12 weeks, 24 weeks, 52 weeks
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Measured via a fasting blood draw
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Baseline, 12 weeks, 24 weeks, 52 weeks
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Total cholesterol (TC)
Prazo: Baseline, 12 weeks, 24 weeks, 52 weeks
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Measured via a fasting blood draw
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Baseline, 12 weeks, 24 weeks, 52 weeks
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High density lipoprotein (HDL)
Prazo: Baseline, 12 weeks, 24 weeks, 52 weeks
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Measured via a fasting blood draw
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Baseline, 12 weeks, 24 weeks, 52 weeks
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Low density lipoprotein (LDL)
Prazo: Baseline, 12 weeks, 24 weeks, 52 weeks
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Measured via fasting blood draw.
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Baseline, 12 weeks, 24 weeks, 52 weeks
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Body Mass Index (BMI)
Prazo: Baseline, 12 weeks, 24 weeks, 52 weeks
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Baseline, 12 weeks, 24 weeks, 52 weeks
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Physical activity level
Prazo: Baseline, 12 weeks, 24 weeks, 52 weeks
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Participants wore a blinded pedometer for 3 days
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Baseline, 12 weeks, 24 weeks, 52 weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Katherine Newton, PhD, Group Health Research Institute
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 (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 184802-16
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