A Peer-Based Approach to Enhance Physical Activity in Dyads of Inactive Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Change in objective minutes per week of moderate-intensity physical activity
研究概览
简要总结
This clinical trial tests the effect of a physical activity intervention that emphasizes support between partners in women who are not physically active. Decisions about and participation in physical activity often involve others in one's social circle, including family and friends. Social support for physical activity and having someone with whom to engage in physical activity may promote behavioral change and help increase moderate-intensity physical activity in inactive women.
详细描述
PRIMARY OBJECTIVE:
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Survey Administration (Other)
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.
干预措施: Telephone-Based Intervention (Behavioral)
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.
干预措施: Activity Monitor (Device)
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.
干预措施: Activity Monitor (Device)
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.
干预措施: Educational Intervention (Other)
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.
干预措施: Educational Intervention (Other)
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.
干预措施: Survey Administration (Other)
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.
干预措施: Survey Administration (Other)
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.
干预措施: Telephone-Based Intervention (Behavioral)
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.
干预措施: Activity Monitor (Device)
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.
干预措施: Educational Intervention (Other)
结局指标
主要结局
Change in objective minutes per week of moderate-intensity physical activity
时间窗: Through study completion, an average of 1 year
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.
次要结局
未报告次要终点