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Efficacy of a Brief Intervention on Reduction of Systolic Blood Pressure

8 de março de 2019 atualizado por: University Medicine Greifswald

The Efficacy of a Computerized Brief Intervention Targeting Physical Activity, Sedentary Behavior, and Smoking Cessation on the Reduction of Systolic Blood Pressure in Individuals Aged 40 to 65 Years

This study examines the efficacy of individualized counseling letters to reduce systolic blood pressure level of ≥ 130 mmHg in individuals aged between 40 and 65 years. The computer-generated counseling letter intervention aimed to increase moderate-to-vigorous physical activity, to reduce sedentary time, and to achieve smoking abstinence.

Visão geral do estudo

Status

Concluído

Intervenção / Tratamento

Descrição detalhada

This study examines the efficacy of individualized counseling letters to reduce systolic blood pressure level of ≥ 130 mmHg in individuals aged between 40 and 65 years. The computer-generated counseling letter intervention aimed to increase moderate-to-vigorous physical activity, to reduce sedentary time, and to achieve smoking abstinence. Participants are recruited by nurses in routine care of primary medical practices.

Informed consent consists of: (i) participation in standardized measurement of blood pressure as well as waist and hip circumference at baseline and 12-month follow up, (ii) completion of standardized questionnaires at 4 time points (baseline, 4-month, 7-month, and 12-month follow-up). Participation in accelerometry was defined as an option. Individuals who agree to wear the accelerometer do this for 10 days at baseline and 12-month follow-up, each.

After baseline assessment, individuals are randomly allocated to a control and to an intervention group (ratio 1:1).

Intervention: The computerized intervention system includes three interactions with participants aiming to increase moderate-to-vigorous physical activity and to reduce sedentary time. For individuals who were daily smokers at baseline, the computerized intervention system includes three more interactions with participants aiming to foster the motivation to quit smoking. Recurrent assessments are initiated by the system and provide data for scheduling the proceeding intervention steps and selection of relevant content. Physical activity, sedentary time, smoking, and motivational measures to change or maintain behaviors according to the recommendations will be monitored over time and used to provide feedback in the form of letters.

Intervention group: Individuals in this group complete a tablet PC-supported assessment at baseline and 12-month follow-up, both at the general practice. At months 4 and 7, follow-up data are collected by study team members via phone call. According to the assessments (baseline, month 4, and month 7), participants receive three counseling letters aiming to increase moderate-to-vigorous physical activity and to reduce sedentary time. Additionally, individuals who were daily smokers at baseline, receive three counseling letters aiming to foster the motivation to quit smoking. The first letter is accompanied by a self-help manual covering specific information relevant for the particular stage of motivation to change smoking behavior according to the principles of the Transtheoretical Model of behavior change.

Control group: Individuals in this group complete a tablet PC-supported assessment at baseline and 12-month follow-up, both in the general practice. At months 4 and 7, follow-up data are collected by study team members via phone call.

Tipo de estudo

Intervencional

Inscrição (Real)

106

Estágio

  • Não aplicável

Contactos e Locais

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Locais de estudo

      • Greifswald, Alemanha, 17475
        • Institute of Social Medicine and Prevention, University Medicine Greifswald

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

40 anos a 65 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • men and women aged between 40 and 65 years
  • mean systolic blood pressure ≥ 130 mmHg at baseline

Exclusion Criteria:

  • cardiovascular event (myocardial infarction, stroke)
  • vascular intervention
  • cognitive impairment
  • inadequate language skills
  • severe disease with reduced life expectancy (< 2 years)

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
Experimental: Counseling letter (intervention group)
Intervention group: Individuals in this group complete a tablet PC-supported assessment at baseline and 12-month follow-up, both at the general practice. At months 4 and 7, follow-up data are collected by study team members via phone call. According to the assessments (baseline, month 4, and month 7), participants receive three counseling letters aiming to increase moderate-to-vigorous physical activity and to reduce sedentary time. Additionally, individuals who were daily smokers at baseline, receive three counseling letters aiming to foster the motivation to quit smoking. The first letter is accompanied by a self-help manual covering specific information relevant for the particular stage of motivation to change smoking behavior.

The brief counseling letter intervention aiming to reduce physical inactivity, sedentary time in leisure time as well as smoking is based on behavior change theories (Transtheoretical model of health behavior change and Health Action Process Approach).

The computerized intervention system includes up to six interactions with participants. Recurrent assessments are initiated by the system and provide data for scheduling the proceeding intervention steps and selection of relevant content. Physical activity, sedentary time, smoking, and motivational measures to change or maintain behaviors according to the recommendations will be monitored over time and used to provide feedback in the form of letters.

Sem intervenção: No counseling letter (control group)
Control group: Individuals in this group complete a tablet PC-supported assessment at baseline and 12-month follow-up, both in the general practice. At months 4 and 7, follow-up data are collected by study team members via phone call.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Systolic blood pressure
Prazo: Change from baseline mean systolic blood pressure at 12 months
Reduction of 4 mmHg mean systolic blood pressure in intervention group; Measures: standardized measurements of mean systolic blood pressure (in mmHg)
Change from baseline mean systolic blood pressure at 12 months

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Waist and hip circumference
Prazo: Change from baseline waist and hip circumference at 12 months
Reduction of waist and hip circumference in intervention group; Measures: standardized measurements of waist and hip circumference (in cm)
Change from baseline waist and hip circumference at 12 months
Physical activity by self-report
Prazo: Change from baseline physical activity at 12 months
Measures: assessement via tablet PC or phone calls (International Physical Activity Questionnaire, IPAQ)
Change from baseline physical activity at 12 months
Physical activity by accelerometry (if data are available)
Prazo: Change from baseline physical activity at 12 months
Measures: objective measurement of physical activity by accelerometry
Change from baseline physical activity at 12 months
Sedentary time by self-report
Prazo: Change from baseline sedentary time at 12 months
Measures: assessement via tablet PC or phone calls (last 7-d sedentary behavior questionnaire, SIT-Q-7d)
Change from baseline sedentary time at 12 months
Sedentary behavior by accelerometry (if data are available)
Prazo: Change from baseline physical inactivity at 12 months
Measures: objective measurement of sedentary behavior by accelerometry
Change from baseline physical inactivity at 12 months
Smoking by self-report
Prazo: Change from baseline smoking at 12 months
Measures: questions regarding smoking (assessment via tablet PC or phone calls)
Change from baseline smoking at 12 months

Colaboradores e Investigadores

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

Investigadores

  • Cadeira de estudo: Sabina Ulbricht, Dr., Institute of Social Medicine and Prevention, University Medicine Greifswald, Greifswald, Germany

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)

16 de janeiro de 2017

Conclusão Primária (Real)

1 de março de 2019

Conclusão do estudo (Real)

1 de março de 2019

Datas de inscrição no estudo

Enviado pela primeira vez

7 de março de 2017

Enviado pela primeira vez que atendeu aos critérios de CQ

7 de março de 2017

Primeira postagem (Real)

10 de março de 2017

Atualizações de registro de estudo

Última Atualização Postada (Real)

11 de março de 2019

Última atualização enviada que atendeu aos critérios de controle de qualidade

8 de março de 2019

Última verificação

1 de março de 2019

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • BB005/17

Plano para dados de participantes individuais (IPD)

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INDECISO

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