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Sleep and Physical Activity Intervention for Increasing Physical Activity in Overweight or Obese and Sedentary African Americans

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04236882
Enrollment
28
Registered
2020-01-22
Start date
2019-10-04
Completion date
2030-04-30
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Behavioral Disorder, Endocrine System Disorder

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.

Interventions

OTHERFocus Group

Attend focus group

BEHAVIORALHealth Education

Receive educational material on healthy homes

OTHERInternet-Based Intervention

Receive web-based sleep intervention

OTHERInterview

Complete interview

OTHERQuestionnaire Administration

Ancillary studies

Sponsors

M.D. Anderson Cancer Center
Lead SponsorOTHER
National Cancer Institute (NCI)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 65 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Determine the f easibility of a brief sleep intervention prior to or following a physical activity (PA) interventionUp to 9 weeks
Satisfaction of a brief sleep intervention prior to or following a PA interventionUp to 9 weeks
Sleep experiencesUp to 9 weeksWill examine experiences of sleep among overweight/obese sedentary African Americans using qualitative focus groups.

Secondary

MeasureTime frameDescription
Sleep improvementAt 9 weeksWill pilot test and evaluate the efficacy of a brief sleep intervention prior to or following a PA intervention in improving sleep.
Physical activity increaseAt 9 weeksWill pilot test and evaluate the efficacy of a brief sleep intervention prior to or following a PA intervention in increasing physical activity.
Sedentary behavior reductionAt 9 weeksWill pilot test and evaluate the efficacy of a brief sleep intervention prior to or following a PA intervention in reducing sedentary behavior.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORLorna McNeill

M.D. Anderson Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 11, 2026