跳至主要内容
临床试验/NCT04236882
NCT04236882
进行中(未招募)
不适用

A Randomized-Crossover Sleep and Physical Activity (PA) Intervention for Overweight/Obese and Sedentary African Americans

M.D. Anderson Cancer Center2 个研究点 分布在 1 个国家目标入组 28 人2019年10月4日

概览

阶段
不适用
干预措施
Internet-Based Intervention
疾病 / 适应症
Behavioral Disorder
发起方
M.D. Anderson Cancer Center
入组人数
28
试验地点
2
主要终点
Sleep experiences
状态
进行中(未招募)
最后更新
2个月前

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. II. Explore the correlations among psychosocial (e.g., perceived stress, affect, neighborhood characteristics), biomarker (e.g., non-fasting glucose levels, blood pressure), and health behavior (e.g., diet and sedentary behavior) with sleep and PA. OUTLINE: FOCUS GROUPS AND INTERVIEWS: Participants attend either a focus group or interview about the sleep intervention and sleep-related problems over 90 minutes. Participants are randomized to 1 of 3 groups. GROUP I: 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. GROUP II: 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. GROUP III: 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, cardiopulmonary resuscitation (CPR) and first aid, and emergency preparedness at weeks 1 and 3. Participants may optionally complete an interview over 1 hour at week 9.

注册库
clinicaltrials.gov
开始日期
2019年10月4日
结束日期
2030年4月30日
最后更新
2个月前
研究类型
Interventional
研究设计
Crossover
性别
All

研究者

责任方
Sponsor

入排标准

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

研究组 & 干预措施

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

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

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

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

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

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

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

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

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

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

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

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

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

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

  • Sleep improvement(At 9 weeks)
  • Physical activity increase(At 9 weeks)
  • Sedentary behavior reduction(At 9 weeks)

研究点 (2)

Loading locations...

相似试验