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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Behavioral Disorder; Endocrine System Disorder
• Intervention / Treatment: Other: Questionnaire Administration; Other: Interview; Other: Focus Group; Other: Internet-Based Intervention; Other: Internet-Based Intervention; Other: Internet-Based Intervention; Behavioral: Health Education

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 Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Questionnaire Administration; Ancillary studies; Other: Interview; Complete interview; Other: Focus Group; Attend focus group
Experimental: 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.	Other: Questionnaire Administration; Ancillary studies; Other: Interview; Complete interview; Other: Internet-Based Intervention; Receive web-based sleep intervention; Other: Internet-Based Intervention; Receive web-based health coaching sessions; Other: Internet-Based Intervention; Receive web-based counseling sessions
Experimental: 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.	Other: Questionnaire Administration; Ancillary studies; Other: Interview; Complete interview; Other: Internet-Based Intervention; Receive web-based sleep intervention; Other: Internet-Based Intervention; Receive web-based health coaching sessions; Other: Internet-Based Intervention; Receive web-based counseling sessions
Active Comparator: 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.	Other: Questionnaire Administration; Ancillary studies; Other: Interview; Complete interview; Other: Internet-Based Intervention; Receive web-based sleep intervention; Other: Internet-Based Intervention; Receive web-based health coaching sessions; Other: Internet-Based Intervention; Receive web-based counseling sessions; Behavioral: Health Education; Receive educational material on healthy homes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Sleep experiences	Will examine experiences of sleep among overweight/obese sedentary African Americans using qualitative focus groups.	Up to 9 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychosocial behavior	Will explore the correlations among psychosocial behavior (e.g., perceived stress, affect, neighborhood characteristics) with sleep and PA.	Up to 9 weeks
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
Health behavior	Will explore the correlations among health behavior (e.g., diet and sedentary behavior) with sleep and PA.	Up to 9 weeks

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Lorna McNeill, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2019
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: November 4, 2019
• First Submitted That Met QC Criteria: January 21, 2020
• First Posted (Actual): January 22, 2020

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Overweight; Endocrine System Diseases
• Other Study ID Numbers: 2018-0568 (Other Identifier: M D Anderson Cancer Center); NCI-2019-07036 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No