Insufficient SleepEarly Phase 1NCT05698693
Social Determinants of Sleep and Obesity
A Early Phase 1 study testing Sleep intervention in people with Insufficient Sleep and Physical Inactivity, run by University of Minnesota at 1 site in United States.
Trial summary
African American adults sleep less and obtain worse quality sleep compared to the national average, and emerging evidence links inadequate sleep with greater morbidity and mortality from chronic diseases such as diabetes, obesity, and cancer. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Insufficient Sleep, Physical Inactivity, Sedentary Behavior
- What is being tested?
- Sleep intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2023to 5 Jul 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Not meeting Physical Activity Guidelines
- age range: 21 to 65 years
- body mass index range: 25.0 to 40 kg/m2
- average self-reported habitual sleep duration of ≤6 hours
- self-identify as Black or African American.
Who cannot join
- Self-reported organ-related disorder (COPD, cardiac arrhythmia, gastro-esophageal disorder)
- pregnant or less than 4 months postpartum
- infant living in household less than 1 year old
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Social Determinants of Sleep and Obesity: Culturally Informing a Sleep Extension Intervention for African American Adults
African American adults sleep less and obtain worse quality sleep compared to the national average, and emerging evidence links inadequate sleep with greater morbidity and mortality from chronic diseases such as diabetes, obesity, and cancer. To address this public health concern, the proposed research seeks to use a multi-method approach to adapt a sleep intervention for African American adults with overweight/obesity not meeting national sleep duration or physical activity recommendations. The overall goal of the project is to reduce cancer and obesity-related health disparities among African Americans.
- Conditions
- Insufficient Sleep, Physical Inactivity, Sedentary Behavior, Obesity
- Being tested
- Sleep intervention, Contact Control
- Medical subject headings
- Sleep Deprivation, Sedentary Behavior, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep interventionBehavioural
The sleep extension intervention is a 4-week intervention consisting of weekly one-on-one contact with the goal of increasing total sleep time by 60 minutes by the end of four weeks conducted by Dr. Wu or a trained counselor.
Contact ControlBehavioural
This is healthy homes intervention.The program provides education on healthy homes, provide advice on specific healthy homes problems, and recommend actions to be taken by families, landlords, and community members.
| Study group | Role | What they receive |
|---|---|---|
| Sleep intervention | Experimental | The sleep extension intervention is a 4-week intervention consisting of weekly one-on-one contact with the goal of increasing total sleep time by 60 minutes by the end of four weeks conducted by Dr. Wu or a trained counselor. The first session will last 60 minutes and the content will include psychoeducation about the importance of sleep, sleep guidelines and target setting, and basic sleep hygiene. Participants in this condition will receive hardcopy weekly daily diary worksheets, and receive an online version of the sleep daily diary every morning to complete via text messaging. Sessions 2-4 will be between 15-30 minutes where Dr. Wu or a trained counselor will review the sleep diary, problem solve barriers to weekly goals, and sleep promoting behaviors will be reinforced. Material that would be covered during a missed session will be included in the next session the participant attends. Receives: Behavioral: Sleep intervention |
| Contact control | Active comparator | The content of the contacts for this intervention condition will be based on the National Center for Healthy Housing's Healthy Homes program, a program designed by the UT School of Public Health. Participants in this condition will meet with Dr. Wu or a trained research staff member. They will meet through Zoom once a week for four sessions to go through each educational module. Sessions will conclude with the development of an action plan for participants. Staff will check in with participants regarding whether they were able to complete the tasks on their action plan, and if not, the reasons for this and potential strategies that may facilitate completion. Receives: Behavioral: Contact Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
Feasibility is achieved if intervention adherence is 75% across participants in the intervention group.
Measured: 4 weeks
Satisfaction
Satisfaction is achieved if the average score ≥20 on the Client Satisfaction Questionnaire
Measured: 4 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start1 Nov 2023
- Primary completion5 Jul 2026
- Study completion5 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insufficient SleepStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- The study uses qualitative interviews (Aim 1; n=10) to inform the adaptation of a sleep intervention for African American adults with overweight/obesity, short sleep, and physical inactivity. The feasibility, satisfaction, and preliminary efficacy will be tested (Aim 2) using a 2-armed randomized control trial (n=80).
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ivan Wu, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05698693
- Sponsor's protocol ID
- 2022LS170
- Status last verified
- Jul 2026
- First submitted
- 4 Jan 2023
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Determinants of Sleep and Obesity: Culturally Informing a Sleep Extension Intervention for African American Adults
- ClinicalTrials.gov ID
- NCT05698693
- Acronym / sponsor ID
- 2022LS170
- Conditions
- Insufficient Sleep, Physical Inactivity, Sedentary Behavior, Obesity
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 5 Jul 2026 (actual)
- Study completion
- 5 Jul 2026 (actual)
- First posted
- 26 Jan 2023 (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.
African American adults sleep less and obtain worse quality sleep compared to the national average, and emerging evidence links inadequate sleep with greater morbidity and mortality from chronic diseases such as diabetes, obesity, and cancer. To address this public health concern, the proposed research seeks to use a multi-method approach to adapt a sleep intervention for African American adults with overweight/obesity not meeting national sleep duration or physical activity recommendations. The overall goal of the project is to reduce cancer and obesity-related health disparities among African Americans.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study uses qualitative interviews (Aim 1; n=10) to inform the adaptation of a sleep intervention for African American adults with overweight/obesity, short sleep, and physical inactivity. The feasibility, satisfaction, and preliminary efficacy will be tested (Aim 2) using a 2-armed randomized control trial (n=80).
| Arm | Type | Receives |
|---|---|---|
| Sleep intervention | Experimental | Behavioral: Sleep interventionThe sleep extension intervention is a 4-week intervention consisting of weekly one-on-one contact with the goal of increasing total sleep time by 60 minutes by the end of four weeks conducted by Dr. Wu or a trained counselor. The first session will last 60 minutes and the content will include psychoeducation about the importance of sleep, sleep guidelines and target setting, and basic sleep hygiene. Participants in this condition will receive hardcopy weekly daily diary worksheets, and receive an online version of the sleep daily diary every morning to complete via text messaging. Sessions 2-4 will be between 15-30 minutes where Dr. Wu or a trained counselor will review the sleep diary, problem solve barriers to weekly goals, and sleep promoting behaviors will be reinforced. Material that would be covered during a missed session will be included in the next session the participant attends. |
| Contact control | Active comparator | Behavioral: Contact ControlThe content of the contacts for this intervention condition will be based on the National Center for Healthy Housing's Healthy Homes program, a program designed by the UT School of Public Health. Participants in this condition will meet with Dr. Wu or a trained research staff member. They will meet through Zoom once a week for four sessions to go through each educational module. Sessions will conclude with the development of an action plan for participants. Staff will check in with participants regarding whether they were able to complete the tasks on their action plan, and if not, the reasons for this and potential strategies that may facilitate completion. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Not meeting Physical Activity Guidelines
- age range: 21 to 65 years
- body mass index range: 25.0 to 40 kg/m2
- average self-reported habitual sleep duration of ≤6 hours
- self-identify as Black or African American.
Key exclusion criteria (3 listed)
- Self-reported organ-related disorder (COPD, cardiac arrhythmia, gastro-esophageal disorder)
- pregnant or less than 4 months postpartum
- infant living in household less than 1 year old
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 |
|---|---|---|
| Sleep interventionThe sleep extension intervention is a 4-week intervention consisting of weekly one-on-one contact with the goal of increasing total sleep time by 60 minutes by the end of four weeks conducted by Dr. Wu or a trained counselor. | Behavioural | Sleep intervention |
| Contact ControlThis is healthy homes intervention.The program provides education on healthy homes, provide advice on specific healthy homes problems, and recommend actions to be taken by families, landlords, and community members. | Behavioural | Contact control |
Primary outcome
Feasibility
Time frame: 4 weeks
Feasibility is achieved if intervention adherence is 75% across participants in the intervention group.
Satisfaction
Time frame: 4 weeks post-intervention
Satisfaction is achieved if the average score ≥20 on the Client Satisfaction Questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Insufficient Sleep
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Sleep Promotion and Pediatric Hypertension
Insufficient Sleep, Hypertension
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Effect of Sleep Extension on Ceramides in People With Overweight and Obesity
Lifestyle Factors, Overweight and Obesity
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Partners in Children's Health (CSN): A Randomized Trial of an Attachment Based Intervention
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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.
Ivan Wu principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Sleep intervention in people with Insufficient Sleep and Physical Inactivity, run by University of Minnesota at 1 site 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Feasibility (time frame: 4 weeks). The study lists 2 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 14 Jul 2026.