Behavioral Disorder / Internet-Based Intervention / Health Education · Interventional Study

Sleep and Physical Activity Intervention for Increasing Physical Activity in Overweight or Obese and Sedentary African Americans

ClinicalTrials.gov · August 10, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a planned feasibility and acceptability study of combined sleep and physical activity interventions in sedentary overweight or obese African American adults. No results are reported in this registry record; enrollment is active and outcome data have not yet been published.

What was studied

Interventional, Randomized, Crossover, Open label, Supportive Care purpose. Behavioral Disorder, Endocrine System Disorder; age from 21 Years; to 65 Years. Intervention: Focus group and interview (focus group, interview); Group I (sleep intervention, health coaching session); Group II (health coaching session, sleep intervention). Compared with: Group III (health education material, counseling session) — Active Comparator. n = 28. 2 sites: United States.

Key findings

Safety

No effect sizes, p-values, confidence intervals, or safety data are presented.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a registry record of an active interventional feasibility study with no reported results; it describes planned enrollment and outcome measures only.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Determine the f easibility of a brief sleep intervention prior to or following a physical activity (PA) intervention (assessed at Up to 9 weeks); Satisfaction of a brief sleep intervention prior to or following a PA intervention (assessed at Up to 9 weeks); Sleep experiences (assessed at Up to 9 weeks)

DesignInterventional, Randomized, Crossover, Open label, Supportive Care purpose

PopulationBehavioral Disorder, Endocrine System Disorder; age from 21 Years; to 65 Years

Sample size28

InterventionFocus group and interview (focus group, interview); Group I (sleep intervention, health coaching session); Group II (health coaching session, sleep intervention)

ComparatorGroup III (health education material, counseling session) — Active Comparator

Setting2 sites: United States

Reported figures

Quoted from the source exactly as published.

Planned enrollment28

Primary outcome: Feasibility of brief sleep intervention prior to or following PA interventionUp to 9 weeks

Primary outcome: Satisfaction of brief sleep intervention prior to or following PA interventionUp to 9 weeks

Primary outcome: Sleep experiencesUp to 9 weeks

Caveats

This is a registry record with no results reported; outcome data are not yet available.
No study protocol, detailed methods, inclusion/exclusion criteria, or comparator arm are described.
Primary endpoints are feasibility and satisfaction measures, not clinical or behavioral outcomes.
No effect sizes, p-values, confidence intervals, or safety data are presented.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

limited

Interventional feasibility study; no phase designation; design details sparse.

Directness

moderate

Targets overweight/obese sedentary African Americans; feasibility endpoints not clinical outcomes.

Consistency

insufficient

Registry record only; no results or comparison to other studies provided.

Risk of bias

insufficient

No methods, blinding, or allocation details reported in registry record.

Sample adequacy

limited

Estimated enrollment 28 participants; small sample appropriate for feasibility only.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT04236882). This is a study registration, not published results. Lead sponsor: M.D. Anderson Cancer Center. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 28 participants (ESTIMATED). Conditions: Behavioral Disorder, Endocrine System Disorder. Interventions: OTHER: Focus Group; BEHAVIORAL: Health Education; OTHER: Internet-Based Intervention; OTHER: Internet-Based Intervention; OTHER: Internet-Based Intervention; OTHER: Interview; OTHER: Questionnaire Administration. Primary outcome measures: 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 , Up to 9 weeks. Brief 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 enough exercise.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Behavioral DisorderNCT04236882Internet-Based InterventionHealth EducationM.D. Anderson Cancer CenterFocus GroupEndocrine System DisorderInterview