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

Primary Purpose

Behavioral Disorder, Endocrine System Disorder

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Focus Group
Health Education
Internet-Based Intervention
Internet-Based Intervention
Internet-Based Intervention
Interview
Questionnaire Administration
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Behavioral Disorder

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

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)

Arm Description

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

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.

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.

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.

Outcomes

Primary Outcome Measures

Determine the f easibility of a brief sleep intervention prior to or following a physical activity (PA) intervention
Satisfaction of a brief sleep intervention prior to or following a PA intervention
Sleep experiences
Will examine experiences of sleep among overweight/obese sedentary African Americans using qualitative focus groups.

Secondary Outcome Measures

Sleep improvement
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
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
Will pilot test and evaluate the efficacy of a brief sleep intervention prior to or following a PA intervention in reducing sedentary behavior.

Full Information

First Posted
November 4, 2019
Last Updated
September 19, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04236882
Brief Title
Sleep and Physical Activity Intervention for Increasing Physical Activity in Overweight or Obese and Sedentary African Americans
Official Title
A Randomized-Crossover Sleep and Physical Activity (PA) Intervention for Overweight/Obese and Sedentary African Americans
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 4, 2019 (Actual)
Primary Completion Date
April 30, 2025 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Behavioral Disorder, Endocrine System Disorder

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Focus group and interview (focus group, interview)
Arm Type
Experimental
Arm Description
Participants attend either a focus group or interview about the sleep intervention and sleep-related problems over 90 minutes.
Arm Title
Group I (sleep intervention, health coaching session)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group II (health coaching session, sleep intervention)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group III (health education material, counseling session)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Focus Group
Intervention Description
Attend focus group
Intervention Type
Behavioral
Intervention Name(s)
Health Education
Intervention Description
Receive educational material on healthy homes
Intervention Type
Other
Intervention Name(s)
Internet-Based Intervention
Intervention Description
Receive web-based sleep intervention
Intervention Type
Other
Intervention Name(s)
Internet-Based Intervention
Intervention Description
Receive web-based health coaching sessions
Intervention Type
Other
Intervention Name(s)
Internet-Based Intervention
Intervention Description
Receive web-based counseling sessions
Intervention Type
Other
Intervention Name(s)
Interview
Intervention Description
Complete interview
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Determine the f easibility of a brief sleep intervention prior to or following a physical activity (PA) intervention
Time Frame
Up to 9 weeks
Title
Satisfaction of a brief sleep intervention prior to or following a PA intervention
Time Frame
Up to 9 weeks
Title
Sleep experiences
Description
Will examine experiences of sleep among overweight/obese sedentary African Americans using qualitative focus groups.
Time Frame
Up to 9 weeks
Secondary Outcome Measure Information:
Title
Sleep improvement
Description
Will pilot test and evaluate the efficacy of a brief sleep intervention prior to or following a PA intervention in improving sleep.
Time Frame
At 9 weeks
Title
Physical activity increase
Description
Will pilot test and evaluate the efficacy of a brief sleep intervention prior to or following a PA intervention in increasing physical activity.
Time Frame
At 9 weeks
Title
Sedentary behavior reduction
Description
Will pilot test and evaluate the efficacy of a brief sleep intervention prior to or following a PA intervention in reducing sedentary behavior.
Time Frame
At 9 weeks
Other Pre-specified Outcome Measures:
Title
Psychosocial behavior
Description
Will explore the correlations among psychosocial behavior (e.g., perceived stress, affect, neighborhood characteristics) with sleep and PA.
Time Frame
Up to 9 weeks
Title
Biomarker analysis
Description
Will explore the correlations among biomarker levels (e.g., non-fasting glucose levels, blood pressure) with sleep and PA.
Time Frame
Up to 9 weeks
Title
Health behavior
Description
Will explore the correlations among health behavior (e.g., diet and sedentary behavior) with sleep and PA.
Time Frame
Up to 9 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lorna McNeill
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center

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

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