No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
21 – 75
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Supportive Care
Participants needed
90 (estimated)
Sponsor
University of Minnesota · Other
Who this trial is looking for
This trial is looking for African American adults aged 21 to 75 who have trouble sleeping and are not active. Participants will take part in interviews to share their experiences and may join an intervention aimed at improving sleep and activity levels.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 21 and 75 years old.
I self-identify as Black or African American.
I have a body mass index (BMI) of 25 or higher.
I usually sleep 6 hours or less per night.
I do not meet physical activity guidelines.
You may not be able to join if
I have a self-reported organ-related disorder like COPD or heart issues.
I am pregnant or less than 4 months postpartum.
I have an infant living in my household who is less than 1 year old.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The proposed research aims to reduce obesity-related health disparities by promoting healthy lifestyle behaviors among African Americans (AAs), given the high disease burdens associated with low physical activity, insufficient sleep, and obesity. There will be two phases to the proposed research. Phase 1 (Aim 1) will encompass formative research and community engagement activities, and Phase 2 (Ai…
The proposed research aims to reduce obesity-related health disparities by promoting healthy lifestyle behaviors among African Americans (AAs), given the high disease burdens associated with low physical activity, insufficient sleep, and obesity. There will be two phases to the proposed research. Phase 1 (Aim 1) will encompass formative research and community engagement activities, and Phase 2 (Aim 2a and 2b) will be a randomized clinical trial.
The primary goal of Aim 1 is to conduct in-depth qualitative interviews in order to: (1) better understand sleep-related social contextual factors, knowledge, behaviors, and beliefs, and (2) discuss and receive feedback on an existing sleep intervention design and materials. The primary goal of Aim 2 is to explore the feasibility, satisfaction, and preliminary efficacy of a sleep intervention to increase sleep and physical activity (PA) among sedentary and short sleeping (≤6 hrs/night) African American adults with overweight/obesity, compared to a contact control group. (Aim 2a) An additional exploratory (Aim 2b) examines changes in cancer-relevant biomarkers between those who received the intervention vs the control condition (n = 20). Data will be collected from a sample of 20 participants (10 per condition) who volunteer to have their blood drawn pre- and post-intervention.
There are two phases of the study, and information gained during Phase 1 (Aim 1) will be used to inform Phase 2 (Aim 2). Thus, additional modifications to the protocol will be submitted prior to engagement in Phase 2.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
Phase 1:
* Not meeting Physical Activity Guidelines
* age range: 21 to 75 years
* body mass index: ≥25.0 kg/m2
* average self-reported habitual sleep duration of ≤6 hours
* self-identify as Black or African American
Phase 2:
* Not meeting Physical Activity Guidelines
* age ra…
Inclusion Criteria:
Phase 1:
* Not meeting Physical Activity Guidelines
* age range: 21 to 75 years
* body mass index: ≥25.0 kg/m2
* average self-reported habitual sleep duration of ≤6 hours
* self-identify as Black or African American
Phase 2:
* Not meeting Physical Activity Guidelines
* age range: 21 to 75 years
* body mass index: ≥25.0 kg/m2
* average self-reported habitual sleep duration of ≤6 hours
* self-identify as Black or African American
Exclusion Criteria:
Phase 1:
* 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
Phase 2:
* 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
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