Recruiting
Phase 1
Phase 2

Sleep Extension

Sponsor:

University of Minnesota

Code:

NCT06226077

Conditions

Obesity

Insufficient Sleep

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

sleep extension intervention

contact control intervention

Study Details

Brief summary:

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.

Conditions

Obesity

Insufficient Sleep

Study ID

NCT06226077

Start date

Oct 1, 2023

Status verified date

Dec, 2025

Completion date

Nov 1, 2026

Anticipated

Primary completion date

Nov 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: sleep extension intervention arm

sedentary and short sleep (=<6 hrs/night) African American adults with overweight/obesity randomized to the sleep extension intervention.

active comparator: education contact control arm

sedentary and short sleep (=<6 hrs/night) African American adults with overweight/obesity randomized to contact control intervention.

Interventions

sleep extension intervention

The sleep intervention aims to increase sleep duration by one-hour (15 minutes/week) over the course of 4-weeks using components from Cognitive Behavioral Therapy for Insomnia. More specifically, the intervention consists of psychoeducation, sleep extension, sleep hygiene, and stimulus control. Participants will meet with Dr. Wu or a trained staff member once a week over the course of 4-weeks via Zoom. The intervention will be adapted based on feedback from the community, knowledge gained during previous interviews.

contact control intervention

The control condition is a contact-control intervention whereby participants will meet with Dr. Wu or a trained staff member once-week over the course of 4-weeks to receive education materials from the Healthy Homes intervention developed by the UT School of Public Health.

Primary outcome measure

  • Feasibility of the sleep intervention [ Time Frame: 10 weeks ]
  • Satisfaction with the sleep intervention [ Time Frame: 10 weeks ]

Central Contacts and Locations

Central contacts

Rachel Price, MPH

612-624-2254price919@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55414

Contacts

Rachel Price, MPH

price919@umn.edu

More Information

Sponsor

University of Minnesota

Last update posted

Dec 17, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2025-12-17.