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

Not Applicable

Recruiting

• Conditions: Behavioral Disorder; Endocrine System Disorder
• Interventions: Other: Internet-Based Intervention; Other: Focus Group; Behavioral: Health Education; Other: Interview; Other: Questionnaire Administration

• Registration Number: NCT04236882
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Study Timeline

• Study Start: 2019-10-04
• Study First Submitted: 2019-11-04
• Study First Submitted QC: 2020-01-21
• Study First Posted: 2020-01-22
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-04
• Last Update Posted: 2024-10-08
• Primary Completion: 2025-04-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 28

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Focus group and interview (focus group, interview)	Interview	Participants attend either a focus group or interview about the sleep intervention and sleep-related problems over 90 minutes.
Group I (sleep intervention, health coaching session)	Interview	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 (health coaching session, sleep intervention)	Internet-Based 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.
Group III (health education material, counseling session)	Interview	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.
Group I (sleep intervention, health coaching session)	Internet-Based Intervention	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.
Focus group and interview (focus group, interview)	Focus Group	Participants attend either a focus group or interview about the sleep intervention and sleep-related problems over 90 minutes.
Focus group and interview (focus group, interview)	Questionnaire Administration	Participants attend either a focus group or interview about the sleep intervention and sleep-related problems over 90 minutes.
Group I (sleep intervention, health coaching session)	Questionnaire Administration	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 (health coaching session, sleep intervention)	Interview	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 (health education material, counseling session)	Internet-Based Intervention	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.
Group III (health education material, counseling session)	Health Education	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.
Group II (health coaching session, sleep intervention)	Questionnaire Administration	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 (health education material, counseling session)	Questionnaire Administration	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.

Primary Outcome Measures

Name	Time	Method
Sleep experiences	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	Up to 9 weeks
Satisfaction of a brief sleep intervention prior to or following a PA intervention	Up to 9 weeks

Secondary Outcome Measures

Name	Time	Method
Sleep improvement	At 9 weeks	Will pilot test and evaluate the efficacy of a brief sleep intervention prior to or following a PA intervention in improving sleep.
Physical activity increase	At 9 weeks	Will pilot test and evaluate the efficacy of a brief sleep intervention prior to or following a PA intervention in increasing physical activity.
Sedentary behavior reduction	At 9 weeks	Will pilot test and evaluate the efficacy of a brief sleep intervention prior to or following a PA intervention in reducing sedentary behavior.

Trial Locations

Locations (2)

The Univeristy of Texas M. D. Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States