What is the mechanism of action of this treatment?

Common treatments for endocrine disorders often include lifestyle modifications such as improving sleep quality and increasing physical activity. Improving sleep quality and duration can enhance energy levels and motivation, which are crucial for managing endocrine disorders as they often involve metabolic and hormonal imbalances. Structured exercise programs help increase daily physical activity, which can improve insulin sensitivity, reduce abdominal obesity, and enhance cardiovascular health. These interventions are vital as they address the root causes of many endocrine disorders, such as type 2 diabetes and metabolic syndrome, by promoting better hormonal regulation and metabolic function.

What side effects are associated with this type of intervention?

Common treatments for endocrine disorders that focus on lifestyle modifications, such as improving sleep quality and structured exercise programs, generally have minimal side effects. Improving sleep quality can lead to better energy levels and overall well-being, but may initially cause changes in sleep patterns or mild insomnia as the body adjusts. Structured exercise programs can enhance physical performance and quality of life, though they may cause muscle soreness, fatigue, or minor injuries if not properly managed. Overall, these interventions are well-tolerated and associated with high satisfaction rates.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of endocrine disorders that align with the goals of improving sleep quality, duration, and energy levels, as well as supporting increased physical activity. For instance, metformin is commonly used for managing type 2 diabetes mellitus, an endocrine disorder, and has been shown to improve energy levels and support weight management. Additionally, medications like GLP-1 receptor agonists (e.g., exenatide) have been approved to enhance glycemic control and promote weight loss, indirectly supporting increased physical activity. While these drugs are not directly aimed at improving sleep, their overall benefits on metabolic health can contribute to better sleep and increased energy levels.

What other types of research exist?

Promising, novel alternatives to sleep and physical activity interventions for endocrine disorder patients in 2024 include: 1) mHealth interventions using mobile apps and wearable technology to monitor and encourage healthy behaviors, 2) Multicomponent interventions combining dietary changes with physical activity and behavioral therapy, 3) Pharmacotherapy targeting specific endocrine pathways, and 4) Personalized medicine approaches using genetic and metabolic profiling to tailor interventions.

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Sleep & Exercise Intervention for Obesity

N/A

Recruiting

Led By Lorna McNeill

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Overweight and/or obese adults (body mass index range: 25.0 or greater)

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

Must not have

Shift work or employment that requires weekly flights to a different time zone or overnight travel

Pre-existing sleep disorder (i.e., insomnia, sleep apnea, restless leg syndrome, narcolepsy, and sleep walking disorder via self-report)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 9 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial studies how online sessions to improve sleep and increase physical activity can help overweight or obese and sedentary African American adults. Better sleep may boost energy and motivation for exercise, while coaching offers practical tips for healthier living.

Who is the study for?

This trial is for overweight or obese African American adults who are sedentary, sleep less than 6 hours a night, and have internet access. They must be able to do moderate exercise (cleared by a questionnaire or doctor) but not currently in a weight management program, without untreated thyroid issues, severe depression risk, high caffeine intake, or plans to move from Houston soon.

What is being tested?

The study tests if interventions focused on improving sleep and increasing physical activity can help sedentary African Americans become more active. Participants will engage in focus groups, health education sessions, online activities, interviews and fill out questionnaires.

What are the potential side effects?

Since the interventions involve lifestyle changes rather than medication there may be minimal side effects such as muscle soreness from increased activity or changes in sleeping patterns during the adjustment period.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My BMI is 25 or higher, indicating I am overweight or obese.

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I am cleared by my doctor to do moderate exercise.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I work night shifts or travel across time zones for work weekly.

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I have a sleep disorder like insomnia or sleep apnea.

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I have a thyroid condition diagnosed by a doctor but am not receiving treatment for it.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 9 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 9 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 9 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Sleep experiences

Secondary study objectives

Physical activity increase

Sedentary behavior reduction

Sleep improvement

Other study objectives

Biomarker analysis

Health behavior

Psychosocial behavior

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Group II (health coaching session, sleep intervention)Experimental Treatment3 Interventions

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 II: Group I (sleep intervention, health coaching session)Experimental Treatment3 Interventions

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 III: Focus group and interview (focus group, interview)Experimental Treatment3 Interventions

Participants attend either a focus group or interview about the sleep intervention and sleep-related problems over 90 minutes.

Group IV: Group III (health education material, counseling session)Active Control4 Interventions

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.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for endocrine disorders often include lifestyle modifications such as improving sleep quality and increasing physical activity. Improving sleep quality and duration can enhance energy levels and motivation, which are crucial for managing endocrine disorders as they often involve metabolic and hormonal imbalances. Structured exercise programs help increase daily physical activity, which can improve insulin sensitivity, reduce abdominal obesity, and enhance cardiovascular health. These interventions are vital as they address the root causes of many endocrine disorders, such as type 2 diabetes and metabolic syndrome, by promoting better hormonal regulation and metabolic function.

Exercise Adherence in Men with Prostate Cancer Undergoing Androgen Deprivation Therapy: A Systematic Review and Meta-Analysis.The influence of prolonged strength training upon muscle and fat in healthy and chronically diseased older adults.Can exercise ameliorate treatment toxicity during the initial phase of testosterone deprivation in prostate cancer patients? Is this more effective than delayed rehabilitation?