A Randomized-Crossover Sleep and Physical Activity (PA) Intervention for Overweight/Obese and Sedentary African Americans
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 28
- Locations
- 2
- Primary Endpoint
- Sleep experiences
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
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.
Intervention: 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.
Intervention: 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.
Intervention: 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.
Intervention: 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.
Intervention: 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.
Intervention: 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.
Intervention: 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.
Intervention: 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.
Intervention: 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.
Intervention: 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.
Intervention: 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.
Intervention: 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.
Intervention: Questionnaire Administration (Other)
Outcomes
Primary Outcomes
Sleep experiences
Time Frame: 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
Time Frame: Up to 9 weeks
Satisfaction of a brief sleep intervention prior to or following a PA intervention
Time Frame: Up to 9 weeks
Secondary Outcomes
- Sedentary behavior reduction(At 9 weeks)
- Sleep improvement(At 9 weeks)
- Physical activity increase(At 9 weeks)