Behavioral DisorderNCT04236882
Sleep and Physical Activity Intervention for Increasing Physical Activity in Overweight or Obese and Sedentary African Americans
A study testing Focus Group, Health Education and Internet-Based Intervention in people with Behavioral Disorder and Endocrine System Disorder, run by M.D. Anderson Cancer Center at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Behavioral Disorder, Endocrine System Disorder
- What is being tested?
- Focus Group, Health Education and Internet-Based Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Oct 2019to 30 Apr 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Univeristy of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030-4009
M D Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Randomized-Crossover Sleep and Physical Activity (PA) Intervention for Overweight/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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Behavioral Disorder, Endocrine System Disorder
- Being tested
- Focus Group, Health Education, Internet-Based Intervention, Interview, Questionnaire Administration
- Medical subject headings
- Mental Disorders, Endocrine System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus GroupOther
Attend focus group
Health EducationBehavioural
Receive educational material on healthy homes
Internet-Based InterventionOther
Receive web-based sleep intervention
Internet-Based InterventionOther
Receive web-based health coaching sessions
Internet-Based InterventionOther
Receive web-based counseling sessions
InterviewOther
Complete interview
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Health Education; Other: Internet-Based Intervention; Other: Interview; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the f easibility of a brief sleep intervention prior to or following a physical activity (PA) intervention
Measured: Up to 9 weeks
Satisfaction of a brief sleep intervention prior to or following a PA intervention
Measured: Up to 9 weeks
Sleep experiences
Will examine experiences of sleep among overweight/obese sedentary African Americans using qualitative focus groups.
Measured: Up to 9 weeks
Secondary outcomes (3)
Sleep improvement
Will pilot test and evaluate the efficacy of a brief sleep intervention prior to or following a PA intervention in improving sleep.
Measured: 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.
Measured: 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.
Measured: At 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study start4 Oct 2019
- Primary completion30 Apr 2030 (estimated)
- Study completion30 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavioral DisorderStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Lorna McNeill, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04236882
- Sponsor's protocol ID
- 2018-0568
- Other IDs
- NCI-2019-07036, 2018-0568
- Status last verified
- Aug 2026
- First submitted
- 4 Nov 2019
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized-Crossover Sleep and Physical Activity (PA) Intervention for Overweight/Obese and Sedentary African Americans
- ClinicalTrials.gov ID
- NCT04236882
- Acronym / sponsor ID
- 2018-0568
- Conditions
- Behavioral Disorder, Endocrine System Disorder
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 4 Oct 2019 (actual)
- Primary completion
- 30 Apr 2030 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 22 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Focus group and interview (focus group, interview) | Experimental | Other: Focus Group, Other: Interview, Other: Questionnaire AdministrationParticipants 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 | Other: Internet-Based Intervention, Other: Interview, Other: Questionnaire AdministrationParticipants 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 | Other: Internet-Based Intervention, Other: Interview, Other: Questionnaire AdministrationParticipants 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 | Behavioral: Health Education, Other: Internet-Based Intervention, Other: Interview, Other: Questionnaire AdministrationParticipants 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. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focus GroupAttend focus group | Other | Focus group and interview (focus group, interview) |
| Health EducationReceive educational material on healthy homes | Behavioural | Group III (health education material, counseling session) |
| Internet-Based InterventionReceive web-based sleep intervention | Other | Group I (sleep intervention, health coaching session), Group II (health coaching session, sleep intervention) |
| Internet-Based InterventionReceive web-based health coaching sessions | Other | Group I (sleep intervention, health coaching session), Group II (health coaching session, sleep intervention) |
| Internet-Based InterventionReceive web-based counseling sessions | Other | Group III (health education material, counseling session) |
| InterviewComplete interview | Other | 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 AdministrationAncillary studies | Other | 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) |
Primary outcome
Determine the f easibility of a brief sleep intervention prior to or following a physical activity (PA) intervention
Time frame: Up to 9 weeks
Satisfaction of a brief sleep intervention prior to or following a PA intervention
Time frame: Up to 9 weeks
Sleep experiences
Time frame: Up to 9 weeks
Will examine experiences of sleep among overweight/obese sedentary African Americans using qualitative focus groups.
3 secondary outcomes
Sleep improvement
Time frame: At 9 weeks
Physical activity increase
Time frame: At 9 weeks
Sedentary behavior reduction
Time frame: At 9 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorna McNeill principal investigator
M.D. Anderson Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focus Group, Health Education and Internet-Based Intervention in people with Behavioral Disorder and Endocrine System Disorder, run by M.D. Anderson Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the f easibility of a brief sleep intervention prior to or following a physical activity (PA) intervention (time frame: Up to 9 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.