A Randomized-Crossover Sleep and Physical Activity (PA) Intervention for Overweight/Obese and Sedentary African Americans
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Sleep experiences
研究概览
简要总结
This trial studies how well sleep and physical activity interventions work in increasing the physical activity of overweight or obese and sedentary African Americans. Sleep and physical activity interventions may help to increase physical activity among overweight and obese African American adults who do not get enough exercise.
详细描述
PRIMARY OBJECTIVES:
I. Determine the feasibility and satisfaction of a brief sleep intervention prior to or following a physical activity (PA) intervention and a contact control among overweight/obese sedentary African Americans.
II. Examine experiences of sleep among overweight/obese sedentary African Americans using qualitative focus groups/individual interviews.
SECONDARY OBJECTIVES:
I. Pilot test and evaluate the efficacy and sequential effects of a brief sleep intervention prior to or following a PA intervention in improving sleep, increasing physical activity, and reducing sedentary behavior, compared to a contact control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sedentary (not meeting Physical Activity Guidelines)
- •Overweight and/or obese adults (body mass index range: 25.0 or greater)
- •Average habitual sleep duration of =< 6 hours
- •Access to internet
- •Self-identify as black or African American
- •Able to engage in moderate intensity physical activity as determined by the Physical Activity Readiness Questionnaire (PAR-Q) or by physicians clearance (letter from physician or nurse practitioner) if endorsing any items on the PAR-Q
排除标准
- •Pre-existing sleep disorder (i.e., insomnia, sleep apnea, restless leg syndrome, narcolepsy, and sleep walking disorder via self-report)
- •High risk for obstructive sleep apnea (i.e., STOP-BANG score > 5)
- •Psychiatric disorder (current risk of severe depression as measured by Center for Epidemiologic Studies Depression Scale [CESD] > 15 with/without past history of diagnosed Diagnostic and Statistical Manual of Mental Disorders [DSM-V] disorder)
- •Self-reported physician diagnosed thyroid condition that is not currently being treated
- •Shift work or employment that requires weekly flights to a different time zone or overnight travel
- •Enrolled in weight management program
- •Excessive caffeine intake (> 400 mg caffeine intake/day or the equivalent of > 4 cups of coffee)
- •Plans to change residence out of Houston within the next 3 months
- •Self-reported pregnancy or less than 4 months postpartum
- •Participated in formative focus groups/individual interviews for this study
- •Blood pressure readings >= 140/90 mm or by physicians clearance (letter from physician or nurse practitioner) if blood pressure reading >= 140/90 mm Hg
- •Another household member is enrolled in the study
研究组 & 干预措施
Focus group and interview (focus group, interview)
Participants attend either a focus group or interview about the sleep intervention and sleep-related problems over 90 minutes.
干预措施: Focus Group (Other)
Focus group and interview (focus group, interview)
Participants attend either a focus group or interview about the sleep intervention and sleep-related problems over 90 minutes.
干预措施: Interview (Other)
Focus group and interview (focus group, interview)
Participants attend either a focus group or interview about the sleep intervention and sleep-related problems over 90 minutes.
干预措施: Questionnaire Administration (Other)
Group I (sleep intervention, health coaching session)
Participants receive a web-based sleep intervention weekly during weeks 1-4. Participants then receive 2 web-based health coaching sessions over 30-45 minutes consisting of topics such as healthy shopping, increasing physical activity, identifying barriers, and eating out during weeks 5-9. Participants may optionally complete an interview over 1 hour at week 9.
干预措施: Internet-Based Intervention (Other)
Group I (sleep intervention, health coaching session)
Participants receive a web-based sleep intervention weekly during weeks 1-4. Participants then receive 2 web-based health coaching sessions over 30-45 minutes consisting of topics such as healthy shopping, increasing physical activity, identifying barriers, and eating out during weeks 5-9. Participants may optionally complete an interview over 1 hour at week 9.
干预措施: Interview (Other)
Group I (sleep intervention, health coaching session)
Participants receive a web-based sleep intervention weekly during weeks 1-4. Participants then receive 2 web-based health coaching sessions over 30-45 minutes consisting of topics such as healthy shopping, increasing physical activity, identifying barriers, and eating out during weeks 5-9. Participants may optionally complete an interview over 1 hour at week 9.
干预措施: Questionnaire Administration (Other)
Group II (health coaching session, sleep intervention)
Participants receive 2 web-based health coaching sessions over 30-45 minutes consisting of topics such as healthy shopping, increasing physical activity, identifying barriers, and eating out during weeks 1-4. Participants then receive a web-based sleep intervention weekly during weeks 5-9. Participants may optionally complete an interview over 1 hour at week 9.
干预措施: Internet-Based Intervention (Other)
Group II (health coaching session, sleep intervention)
Participants receive 2 web-based health coaching sessions over 30-45 minutes consisting of topics such as healthy shopping, increasing physical activity, identifying barriers, and eating out during weeks 1-4. Participants then receive a web-based sleep intervention weekly during weeks 5-9. Participants may optionally complete an interview over 1 hour at week 9.
干预措施: Interview (Other)
Group II (health coaching session, sleep intervention)
Participants receive 2 web-based health coaching sessions over 30-45 minutes consisting of topics such as healthy shopping, increasing physical activity, identifying barriers, and eating out during weeks 1-4. Participants then receive a web-based sleep intervention weekly during weeks 5-9. Participants may optionally complete an interview over 1 hour at week 9.
干预措施: Questionnaire Administration (Other)
Group III (health education material, counseling session)
Participants receive educational material on healthy homes. Participants also receive 2 web-based counseling sessions over 30-45 minutes consisting of topics such as indoor air quality, CPR and first aid, and emergency preparedness at weeks 1 and 3. Participants may optionally complete an interview over 1 hour at week 9.
干预措施: Health Education (Behavioral)
Group III (health education material, counseling session)
Participants receive educational material on healthy homes. Participants also receive 2 web-based counseling sessions over 30-45 minutes consisting of topics such as indoor air quality, CPR and first aid, and emergency preparedness at weeks 1 and 3. Participants may optionally complete an interview over 1 hour at week 9.
干预措施: Internet-Based Intervention (Other)
Group III (health education material, counseling session)
Participants receive educational material on healthy homes. Participants also receive 2 web-based counseling sessions over 30-45 minutes consisting of topics such as indoor air quality, CPR and first aid, and emergency preparedness at weeks 1 and 3. Participants may optionally complete an interview over 1 hour at week 9.
干预措施: Interview (Other)
Group III (health education material, counseling session)
Participants receive educational material on healthy homes. Participants also receive 2 web-based counseling sessions over 30-45 minutes consisting of topics such as indoor air quality, CPR and first aid, and emergency preparedness at weeks 1 and 3. Participants may optionally complete an interview over 1 hour at week 9.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Sleep experiences
时间窗: Up to 9 weeks
Will examine experiences of sleep among overweight/obese sedentary African Americans using qualitative focus groups.
Determine the f easibility of a brief sleep intervention prior to or following a physical activity (PA) intervention
时间窗: Up to 9 weeks
Satisfaction of a brief sleep intervention prior to or following a PA intervention
时间窗: Up to 9 weeks
次要结局
- Sedentary behavior reduction(At 9 weeks)
- Sleep improvement(At 9 weeks)
- Physical activity increase(At 9 weeks)