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

Behavioral Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04236882
• Other study ID #: 2018-0568
• Secondary ID: NCI-2019-0703620
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 4, 2019
• Est. completion date: April 30, 2025

Study information

• Verified date: April 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 28
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Behavioral Disorder
• Endocrine System Diseases
• Overweight

Intervention

Other:
• Focus Group
Attend focus group

Behavioral:
• Health Education
Receive educational material on healthy homes

Other:
• Internet-Based Intervention
Receive web-based sleep intervention
• Internet-Based Intervention
Receive web-based health coaching sessions
• Internet-Based Intervention
Receive web-based counseling sessions
• Interview
Complete interview
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Psychosocial behavior	Will explore the correlations among psychosocial behavior (e.g., perceived stress, affect, neighborhood characteristics) with sleep and PA.	Up to 9 weeks
Other	Biomarker analysis	Will explore the correlations among biomarker levels (e.g., non-fasting glucose levels, blood pressure) with sleep and PA.	Up to 9 weeks
Other	Health behavior	Will explore the correlations among health behavior (e.g., diet and sedentary behavior) with sleep and PA.	Up to 9 weeks
Primary	Determine the f easibility of a brief sleep intervention prior to or following a physical activity (PA) intervention		Up to 9 weeks
Primary	Satisfaction of a brief sleep intervention prior to or following a PA intervention		Up to 9 weeks
Primary	Sleep experiences	Will examine experiences of sleep among overweight/obese sedentary African Americans using qualitative focus groups.	Up to 9 weeks
Secondary	Sleep improvement	Will pilot test and evaluate the efficacy of a brief sleep intervention prior to or following a PA intervention in improving sleep.	At 9 weeks
Secondary	Physical activity increase	Will pilot test and evaluate the efficacy of a brief sleep intervention prior to or following a PA intervention in increasing physical activity.	At 9 weeks
Secondary	Sedentary behavior reduction	Will pilot test and evaluate the efficacy of a brief sleep intervention prior to or following a PA intervention in reducing sedentary behavior.	At 9 weeks

External Links

•   MD Anderson Cancer Center