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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-07036 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2018-0568 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Focus Group | Other | Attend focus group |
| |
| 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 |
| 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. |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lorna McNeill | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Univeristy of Texas M. D. Anderson Cancer Center | Houston | Texas | 77030-4009 | United States | ||
| M D Anderson Cancer Center |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center | View source |
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|
| Health Education |
| Behavioral |
Receive educational material on healthy homes |
|
| Internet-Based Intervention | Other | Receive web-based sleep intervention |
|
| Internet-Based Intervention | Other | Receive web-based health coaching sessions |
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| Internet-Based Intervention | Other | Receive web-based counseling sessions |
|
| Interview | Other | Complete interview |
|
| Questionnaire Administration | Other | Ancillary studies |
|
| 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 |
| 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 |
| Houston |
| Texas |
| 77030 |
| United States |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D017144 | Focus Groups |
| D007407 | Interviews as Topic |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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