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Active, Not Recruiting

NCT Number: NCT04236882

Sleep and Physical Activity Intervention for Increasing Physical Activity in Overweight or 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Focus Group

Other

Attend focus group

Health Education

Behavioral

Receive educational material on healthy homes

Internet-Based Intervention

Other

Receive web-based sleep intervention

interview

Other

Complete interview

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Determine the f easibility of a brief sleep intervention prior to or following a physical activity (PA) intervention

    Time frame: Up to 9 weeks

  2. Satisfaction of a brief sleep intervention prior to or following a PA intervention

    Time frame: Up to 9 weeks

  3. Sleep experiences

    Time frame: Up to 9 weeks

    Will examine experiences of sleep among overweight/obese sedentary African Americans using qualitative focus groups.

Secondary outcomes

  1. Sleep improvement

    Time frame: 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.

  2. Physical activity increase

    Time frame: 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.

  3. Sedentary behavior reduction

    Time frame: 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.

Other outcomes

  1. Psychosocial behavior

    Time frame: Up to 9 weeks

    Will explore the correlations among psychosocial behavior (e.g., perceived stress, affect, neighborhood characteristics) with sleep and PA.

  2. Biomarker analysis

    Time frame: Up to 9 weeks

    Will explore the correlations among biomarker levels (e.g., non-fasting glucose levels, blood pressure) with sleep and PA.

  3. Health behavior

    Time frame: Up to 9 weeks

    Will explore the correlations among health behavior (e.g., diet and sedentary behavior) with sleep and PA.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2030
Study completion
2030
First posted
Jan 22, 2020
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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