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

NCT04236882 | Active Not Recruiting

• 2 other identifiers: 2018-0568NCI-2019-07036
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

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.

Conditions

Endocrine System Disorder; Behavioral Disorder

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Sleep improvement

  At 9 weeks

• Physical activity increase

  At 9 weeks

• Sedentary behavior reduction

  At 9 weeks

Other Outcomes (3)

• Psychosocial behavior

  Up to 9 weeks

• Biomarker analysis

  Up to 9 weeks

• Health behavior

  Up to 9 weeks

Study Arms (4)

Focus group and interview (focus group, interview)

EXPERIMENTAL

Participants attend either a focus group or interview about the sleep intervention and sleep-related problems over 90 minutes.

Other: Focus Group; Other: Interview; Other: Questionnaire Administration

Group I (sleep intervention, health coaching session)

EXPERIMENTAL

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: Internet-Based Intervention; Other: Interview; Other: Questionnaire Administration

Group II (health coaching session, sleep intervention)

EXPERIMENTAL

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: Internet-Based Intervention; Other: Interview; Other: Questionnaire Administration

Group III (health education material, counseling session)

ACTIVE COMPARATOR

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.

Behavioral: Health Education; Other: Internet-Based Intervention; Other: Interview; Other: Questionnaire Administration

Interventions

Internet-Based Intervention OTHER

Receive web-based sleep intervention

Group I (sleep intervention, health coaching session); Group II (health coaching session, sleep intervention)

Interview OTHER

Complete interview

Focus group and interview (focus group, interview); Group I (sleep intervention, health coaching session); Group II (health coaching session, sleep intervention); Group III (health education material, counseling session)

Questionnaire Administration OTHER

Ancillary studies

Focus group and interview (focus group, interview); Group I (sleep intervention, health coaching session); Group II (health coaching session, sleep intervention); Group III (health education material, counseling session)

Focus Group OTHER

Attend focus group

Focus group and interview (focus group, interview)

Health Education BEHAVIORAL

Receive educational material on healthy homes

Group III (health education material, counseling session)

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

The Univeristy of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Mental Disorders; Endocrine System Diseases

Interventions

Focus Groups; Interviews as Topic

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Lorna McNeill

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2019
• First Posted: January 22, 2020
• Study Start: October 4, 2019
• Primary Completion (Estimated): April 30, 2030
• Study Completion (Estimated): April 30, 2030
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

US (2)