跳至主要内容
临床试验/NCT04114071
NCT04114071已完成不适用

TOSS Feasibility + Fitbit Community = Reduced Obesity in Older Black Women

University of Alabama at Birmingham1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年7月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Change in Physical Activity Behaviors From Baseline to 12 Weeks

研究概览

简要总结

The primary goal of this proposed physical activity (PA) intervention is to develop a realistic and an economical intervention to promote regular PA among older, overweight or obese Black women. Physical inactivity is prevalent among older Black women and this lifestyle behavior is both a destructive and expensive public health issue. Because many in this population do not engage in sufficient amounts of regular PA, this group miss the cardio-protective effects that may reduce many chronic conditions that disproportionately affect Blacks such as hypertension, diabetes, and obesity. The proposed obesity-reduction intervention is aligned with Stage 1 of the National Institute on Aging Stage Model for Behaviors Interventions Development. For the proposed hypothesis, the investigators propose a 2-group randomized controlled pilot, feasibility study in which 30 women will be randomized to receive either the TOSS PA Text messages Plus Fitbit community or the Control group and followed for 12 weeks to detect intervention effect.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

盲法说明

All participants will receive text messages during the 12-week intervention but the frequency, the content of the messages will be different for the control and intervention groups, and these differences will not be discussed.

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Black women
  • •60 years and older
  • •Have a BMI ≥ 25 kg/m2
  • •Do not meet the weekly 150 minutes of physical activity (PA)
  • •No health conditions that would prevent or limit PA or walking
  • •Able to read text messages
  • •Access to a mobile phone with text receiving capability
  • •Mobile phone with ability to download a Fitbit app.

排除标准

  • •Currently participating in another PA promotion program
  • •Non-English speaking
  • •A contraindication to exercise as indicated by the PA Readiness Questionnaire (PAR-Q) unless written permission was provided from the participant's primary care provider.

研究组 & 干预措施

Physical Activity intervention group

Experimental

Older overweight or obese Black women who participate in the physical activity intervention group will receive a daily text message from the TOSS study for 12 weeks, a Fitbit device plus have access to the Fitbit community option on their Fitbit app as an opportunity for virtual peer support. They will also receive an instruction pamphlet that describes the health benefits of regular physical activity (PA), safety instructions for PA, the national PA guidelines for older adults, suggested strategies to increase number of steps and an accelerometer pre and post-intervention.

干预措施: TOSS Feasibility + Fitbit Community = Reduced Obesity in Older Black Women (Behavioral)

Control group

Active Comparator

The control will only receive a weekly neutral text message during the 12-week intervention. For this project, a neutral text message is defined as a message that only provides facts about a topic.They will also receive a Fitbit device, an instruction pamphlet that describes the health benefits of regular physical activity (PA), safety instructions for PA, the national PA guidelines for older adults, suggested strategies to increase number of steps and an accelerometer pre and post-intervention

干预措施: TOSS Feasibility + Fitbit Community = Reduced Obesity in Older Black Women (Behavioral)

结局指标

主要结局

Change in Physical Activity Behaviors From Baseline to 12 Weeks

时间窗: Baseline and 12 weeks

number of steps

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pamela G Bowen PhD, CRNP, FNP-BC, BBA

Associate Professor

University of Alabama at Birmingham

研究点 (1)

Loading locations...

相似试验