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德州大学安德森癌症中心Utilization of a Peer-Based Approach for the Promotion of Physical Activity in Inactive Women
I. Determine whether the dyadic behavioral intervention produces greater engagement of moderate-intensity objective physical activity (PA) compared with the individual behavioral intervention.
SECONDARY OBJECTIVES:
I. Determine the effects of the dyadic behavioral intervention on hypothesized intervention mechanisms (e.g., autonomous motivation, social support, autonomy support, self-efficacy), and the associations of those mechanisms with PA outcomes.
II. Determine the effects of the dyadic behavioral intervention on secondary outcomes (i.e., self-reported moderate-intensity PA, lower body strength, blood pressure, anthropometric measures, mean daily steps, sedentary time) compared with the individual behavioral intervention.
III. Determine whether the dyadic behavioral intervention produces greater engagement of moderate-intensity PA compared with the individual control.
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP 1 (DYADIC INTERVENTION): Participants receive phone calls over 30-45 minutes each from a health coach weekly during month 1, twice monthly during months 2-4, and monthly during months 5-6 for a total of 12 phone calls that focus on identifying needs, practicing autonomy supportive behaviors, and the development of a mutual support plan. Participants also engage in at least one physical activity per week with their partner and monitor their own and each other's activity using a FitBit. Participants also wear an accelerometer for a minimum of 10 hours a day for 7 days. Participants also receive an electronic newsletter twice monthly during months 1-3 and monthly during months 4-6 that provides educational physical activity-related information and tips for overcoming barriers to physical activity.
GROUP 2 (INDIVIDUAL CONDITION): Participants are assigned to one of 2 groups.
GROUP 2A (INDIVIDUAL INTERVENTION): Participants receive phone calls from a health coach as in Intervention I that focus on providing support for behavioral skills, including monitoring physical activity, goal-setting, and problem-solving to overcome barriers to physical activity. Participants utilize a FitBit to monitor their physical activity and receive electronic newsletters twice monthly during months 1-3 and monthly during months 4-6 that provides educational physical activity-related information and tips for overcoming barriers to physical activity. Participants also wear an accelerometer for a minimum of 10 hours a day for 7 days.
GROUP 2B (HEALTH EDUCATION CONTROL): Participants utilize a FitBit to monitor their physical activity and receive electronic newsletters twice monthly during months 1-3 and monthly during months 4-6 to share basic health education related to physical activity and provide support for engagement. Participants also wear an accelerometer for a minimum of 10 hours a day for 7 days.
At completion of study, patients are followed up at 6 and 12 months.
A Peer-Based Approach to Enhance Physical Activity in Dyads of Inactive Women
- 2020-0809
- NCI-2020-13914 (注册标识符) (CTRP (Clinical Trial Reporting Program))
- 2020-0809 (其他标识符) (M D Anderson Cancer Center)
- R01HL155310 (美国 NIH 拨款/合同)
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性Group 1 (phone call, FitBit, newsletter, accelerometer) Participants receive phone calls over 30-45 minutes each from a health coach weekly during month 1, twice monthly during months 2-4, and monthly during months 5-6 for a total of 12 phone calls that focus on identifying needs, practicing autonomy supportive behaviors, and the development of a mutual support plan. Participants also engage in at least one physical activity per week with their partner and monitor their own and each other's activity using a FitBit. Participants also wear an accelerometer for a minimum of 10 hours a day for 7 days. Participants also receive an electronic newsletter twice monthly during months 1-3 and monthly during months 4-6 that provides educational physical activity-related information and tips for overcoming barriers to physical activity. | Activity Monitor Monitor physical activity with FitBit Activity Monitor Wear accelerometer 教育干预 Receive educational newsletter 调查管理 Ancillary studies 基于电话的干预 Receive phone call from health coach |
阳性对照Group 2A (phone call, FitBit, newsletter, accelerometer) Participants receive phone calls from a health coach as in Intervention I that focus on providing support for behavioral skills, including monitoring physical activity, goal-setting, and problem-solving to overcome barriers to physical activity. Participants utilize a FitBit to monitor their physical activity and receive electronic newsletters twice monthly during months 1-3 and monthly during months 4-6 that provides educational physical activity-related information and tips for overcoming barriers to physical activity. Participants also wear an accelerometer for a minimum of 10 hours a day for 7 days. | Activity Monitor Monitor physical activity with FitBit Activity Monitor Wear accelerometer 教育干预 Receive educational newsletter 调查管理 Ancillary studies 基于电话的干预 Receive phone call from health coach |
阳性对照Group 2B (FitBit, newsletter, accelerometer) Participants utilize a FitBit to monitor their physical activity and receive electronic newsletters twice monthly during months 1-3 and monthly during months 4-6 to share basic health education related to physical activity and provide support for engagement. Participants also wear an accelerometer for a minimum of 10 hours a day for 7 days. | Activity Monitor Monitor physical activity with FitBit Activity Monitor Wear accelerometer 教育干预 Receive educational newsletter 调查管理 Ancillary studies |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Change in objective minutes per week of moderate-intensity physical activity | Will use a linear mixed model (LMM) analysis, which includes the intervention as a fixed effect predictor and a dyad-specific random intercept to account for the dependent nature of the nested design (in the dyadic intervention group) to assess if the dyadic intervention led to increased moderate-intensity physical activity, relative to the individual intervention. will also assess changes in physical activity across time (i.e., at 6 and 12 months after baseline) using longitudinal data, where both within-dyad and within-subject (repeated measures across time points) correlations will be accounted for. Relevant covariates (e.g., age, race/ethnicity, dyad relationship, education, household income and composition, employment status, neighborhood environmental characteristics) will be adjusted for in the analysis. Potential effect modifiers, e.g., depressive symptoms, perceived stress, neighborhood environmental characteristics, will be explored. | Through study completion, an average of 1 year |
- Self-identify as female
- Age 18-65 years
- Speak English or Spanish
- Physically able to engage in low-to-moderate PA as assessed by the PA Readiness Questionnaire (PAR-Q), or with medical clearance
- Insufficient self-reported moderate-to-vigorous PA (< 150 minutes/week)
- Able to enroll with one eligible adult female partner
- Valid home address in the greater Houston area
- Have a functioning smartphone and able and willing to send and receive text messages
- Willing to use the Fitbit app and device
- Blood pressure reading < 160/100 mm Hg, or with medical clearance
- Pregnancy or considering pregnancy during the study period, self-reported
- Currently participating in a program or research study to promote physical activity or weight loss
- Plans to move outside the greater Houston area during the study period
德州大学安德森癌症中心1129 个活跃的临床试验可供探索国家心脏、肺和血液研究所759 个活跃的临床试验可供探索Texas