Clinical trial NCT04236882: Sleep and Physical Activity Intervention for Increasing Physical Activity in Overweight or Obese and Sedentary African Americans
Official title: A Randomized-Crossover Sleep and Physical Activity (PA) Intervention for Overweight/Obese and Sedentary African Americans
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Behavioral Disorder
Endocrine System Disorder
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-01-22
Enrollment: 28
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Determine the f easibility of a brief sleep intervention prior to or following a physical activity (PA) intervention
timeFrame: Up to 9 weeks
measure: Satisfaction of a brief sleep intervention prior to or following a PA intervention
timeFrame: Up to 9 weeks
measure: Sleep experiences
timeFrame: Up to 9 weeks
Secondary outcomes:
measure: Sleep improvement
timeFrame: At 9 weeks
measure: Physical activity increase
timeFrame: At 9 weeks
measure: Sedentary behavior reduction
timeFrame: At 9 weeks
Other outcomes:
measure: Psychosocial behavior
timeFrame: Up to 9 weeks
measure: Biomarker analysis
timeFrame: Up to 9 weeks
measure: Health behavior
timeFrame: Up to 9 weeks
Locations:
city: Houston
country: United States
facility: The Univeristy of Texas M. D. Anderson Cancer Center
state: Texas
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Lorna McNeill
role: PRINCIPAL_INVESTIGATOR
References: