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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04236882
Recruitment Status : Recruiting
First Posted : January 22, 2020
Last Update Posted : January 22, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Obese Overweight Sedentary Lifestyle Behavioral: Health Education Other: Internet-Based Intervention Other: Interview Other: Survey Administration Not Applicable

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.

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: Participants are randomized to 1 of 3 groups.

GROUP I: Participants receive a web-based sleep intervention 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 at weeks 5 and 7. 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 at weeks 1 and 3. Participants then receive a web-based sleep intervention during weeks 5-8. 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 health coaching sessions over 30-45 minutes consisting of topics such as healthy shopping, increasing physical activity, identifying barriers, and eating out at weeks 1 and 3. Participants may optionally complete an interview over 1 hour at week 9.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Randomized-Crossover Sleep and Physical Activity (PA) Intervention for Overweight/Obese and Sedentary African Americans
Actual Study Start Date : October 4, 2019
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 1, 2020


Arm Intervention/treatment
Experimental: Group I (sleep intervention, health coaching session)
Participants receive a web-based sleep intervention 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 at weeks 5 and 7. Participants may optionally complete an interview over 1 hour at week 9.
Other: Internet-Based Intervention
Receive web-based sleep intervention

Other: Internet-Based Intervention
Receive web-based health coaching sessions

Other: Interview
Complete interview

Other: Survey Administration
Ancillary studies

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 at weeks 1 and 3. Participants then receive a web-based sleep intervention during weeks 5-8. Participants may optionally complete an interview over 1 hour at week 9.
Other: Internet-Based Intervention
Receive web-based sleep intervention

Other: Internet-Based Intervention
Receive web-based health coaching sessions

Other: Interview
Complete interview

Other: Survey Administration
Ancillary studies

Active Comparator: Group III (health education material, health coaching session)
Participants receive educational material on healthy homes. Participants also 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 at weeks 1 and 3. Participants may optionally complete an interview over 1 hour at week 9.
Behavioral: Health Education
Receive educational material on healthy homes

Other: Internet-Based Intervention
Receive web-based health coaching sessions

Other: Interview
Complete interview

Other: Survey Administration
Ancillary studies




Primary Outcome Measures :
  1. Assessing the efficacy of a sleep intervention prior to or following a physical activity (PA) intervention to increase: qualitative focus groups survey [ Time Frame: Up to 9 weeks ]
    Will assess the experiences of sleep among overweight/obese sedentary African Americans using qualitative focus groups.

  2. Assessing the brief sleep intervention prior to or following a physical activity (PA) intervention to determine the satisfaction survey [ Time Frame: Up to 9 weeks ]
    Will assess the satisfaction of a brief sleep intervention prior to or following a PA intervention and a contact control among overweight/obese sedentary African Americans.

  3. Sleep experiences among overweight/obese sedentary African Americans using qualitative focus groups survey. [ Time Frame: Up to 9 weeks ]
    Pre-intervention focus groups will be conducted to gain insight into how chronically sleep deprived (<6 hrs/night) community-members experience sleep



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Sedentary (not meeting Physical Activity Guidelines)
  • Overweight and/or obese adults (body mass index range: 25.0 to 40 kg/m^2)
  • Average habitual sleep duration of =< 6 hours
  • Access to internet
  • Self-identify as black or African American
  • Do not know of or have not been told by a physician about a contraindication to exercise

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] > 10 with/without past history of diagnosed Diagnostic and Statistical Manual of Mental Disorders [DSM-V] disorder)
  • Self-reported organ-related disorder (chronic obstructive pulmonary disease [COPD], cardiac arrhythmia, gastro-esophageal disorder)
  • Extreme chronotype (i.e., sleepiness after 12:45 am for item #10 in Morningness-Eveningness Questionnaire)
  • Shift work or employment that requires regular overnight travel
  • Habitual use of sleep aids (i.e., more than once a week)
  • Current weight loss (i.e., loss of 5 lbs in the past two weeks)
  • 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 (i.e., plans to change residency in next 6 months)
  • Self-reported pregnancy or less than 4 months postpartum
  • Positive history of bariatric surgery
  • Moderate alcohol use (women > 7 drinks/week; men > 14 drinks/week)
  • Alcohol use as a sleep aid (i.e., more than once a week)
  • Participated in formative focus groups 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04236882


Contacts
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Contact: Lorna McNeill 713-563-1103 lmcneill@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Lorna McNeill    713-563-1103      
Principal Investigator: Lorna McNeill         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Lorna McNeill M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT04236882    
Other Study ID Numbers: 2018-0568
NCI-2019-07036 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2018-0568 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: January 22, 2020    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Overweight
Body Weight
Signs and Symptoms