Lifestyle and Sleep Intervention for Obesity

(STAR Trial)

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Drexel University

Must not be taking: Insomnia meds, Weight loss meds, Insulin

Disqualifiers: Diabetes, Eating disorder, Sleep apnea, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 16

Duration: 16 weeks

50 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is being performed to understand the effects of a lifestyle modification and sleep intervention on weight loss outcomes in adolescence. The main question the study aims to answer is: - What are the initial effects of a lifestyle modification and sleep intervention, including effects on weight, eating behaviors and dietary intake, and sleep? Participants will: * Participate in remote, group-based, weekly weight loss and sleep coaching for 16 weeks. * Complete study assessments at baseline (pre-intervention), mid-intervention, and post-intervention. * Complete daily sleep diaries for three 7-day periods at each assessment point.

Will I have to stop taking my current medications?

The trial requires that you are not currently using insomnia medication, weight loss medications, or insulin. If you have recently started or changed the dosage of any medication affecting appetite or body composition, you may not be eligible. The protocol does not specify other medication restrictions.

What data supports the effectiveness of the treatment Lifestyle Modification and Sleep Intervention for obesity?

Research suggests that improving sleep can help with weight loss, as sleep and obesity are closely linked. Studies have shown that better sleep can enhance the effects of diet and exercise, making it a promising addition to obesity treatment. ^{1 2 3 4 5}

Is the Lifestyle and Sleep Intervention for Obesity safe for humans?

Research on lifestyle and sleep interventions for obesity, including studies on sleep management and lifestyle modification, generally indicates that these approaches are safe for humans. These interventions focus on improving sleep and encouraging healthy habits, which are typically considered low-risk. ^{1 3 6 7 8}

How does the Lifestyle Modification and Sleep Intervention treatment for obesity differ from other treatments?

This treatment is unique because it combines lifestyle changes with sleep interventions, addressing both sleep duration and quality to help manage obesity. Unlike traditional treatments that focus solely on diet and exercise, this approach recognizes the role of sleep in weight management and aims to break the cycle of poor sleep and obesity. ^{1 2 3 9 10}

Research Team

Stephanie Manasse, Ph.D.

Principal Investigator

Drexel University

Eligibility Criteria

This trial is for adolescents struggling with obesity who are interested in improving their weight, eating habits, and sleep. They must be willing to participate in weekly remote coaching sessions for 16 weeks and keep daily sleep diaries at several points during the study.

Inclusion Criteria

Has a parent or guardian who is willing and able to participate

My BMI is in the top 15% for my age and sex.

Fluent in English

Exclusion Criteria

I have not started or changed the dose of medication affecting my appetite or body weight in the last 3 months.

I am currently on medication to lose weight.

Anticipation of a possible pregnancy in the next year

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive group-based lifestyle modification and sleep treatment, including nutritional education, physical activity education, and sleep tracking, over 16 weeks

16 weeks

16 sessions (remote)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of sleep, decision-making, and eating behaviors

4 weeks

Treatment Details

Interventions

• Lifestyle Modification and Sleep Intervention

Trial Overview The study tests a combined lifestyle modification and sleep intervention program on adolescents with obesity. It looks at how these changes affect weight loss, eating behaviors, dietary intake, and quality of sleep over the course of the intervention.

Participant Groups

Group I: Group Intervention Experimental Treatment 1 Intervention

All participants will receive group-based lifestyle modification and sleep treatment (16, 90-minute sessions over 16 weeks). All sessions will be delivered on Zoom (remotely) to small groups (n=5-10 each) of participants. The intervention involves lifestyle modification content (e.g., nutritional education, physical activity education, stimulus control, goal setting) and sleep content (e.g., psychoeducation regarding sleep and eating behavior, sleep tracking, establishing regular sleep-wake times).

Who Is Running the Clinical Trial?

Drexel University

Lead Sponsor

Trials

160

Recruited

48,600+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Findings from Research

Sleep extension has the potential to improve health outcomes related to obesity, such as glycemic control and blood pressure, based on preliminary findings from studies on habitually short sleepers.

While there are challenges in implementing sleep extension interventions, they may help mitigate the health risks associated with short sleep and obesity, indicating a need for further research to optimize these strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep Extension: A Potential Target for Obesity Treatment. Hoddy, KK., Potts, KS., Bazzano, LA., et al.[2021]

Insufficient sleep and irregular sleep patterns are linked to obesity and unhealthy eating behaviors, but the exact mechanisms are still unclear due to inconsistencies in existing research.

There is a need for more studies to explore how addressing sleep disturbances could enhance weight loss treatments, considering factors like sleep duration and sleep disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep, obesity, and weight loss in adults: is there a rationale for providing sleep interventions in the treatment of obesity? Coughlin, JW., Smith, MT.[2015]

In a 12-week trial involving 49 overweight or obese adults, those who received a combined weight management and sleep intervention (better weight-better sleep) lost weight faster compared to those who only received weight management support.

Participants in the combined intervention group also showed improved coping self-efficacy, suggesting that integrating sleep management with dietary and exercise interventions may enhance overall effectiveness in obesity treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The better weight-better sleep study: a pilot intervention in primary care. Logue, EE., Bourguet, CC., Palmieri, PA., et al.[2018]

In a study of 114 overweight or obese adults undergoing a 12-month behavioral weight loss intervention, those who lost at least 5% of their body weight experienced a significant reduction in obstructive sleep apnea (OSA) severity, as measured by the apnea-hypopnea index (AHI).

Conversely, individuals with OSA lost less weight and showed lower adherence to calorie goals and physical activity compared to those without OSA, indicating that OSA may hinder effective weight loss efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bidirectional Relationships Between Weight Change and Sleep Apnea in a Behavioral Weight Loss Intervention. Kline, CE., Burke, LE., Sereika, SM., et al.[2023]

An obesity management ontology was successfully developed, focusing on enhancing client participation in weight control through tailored interventions, with a high evaluation score of 4.5 out of 5.

The ontology includes 127 concepts related to obesity management, such as behavioral interventions and dietary advice, and was implemented in a prototype Android application to facilitate effective client engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an obesity management ontology based on the nursing process for the mobile-device domain. Kim, HY., Park, HA., Min, YH., et al.[2021]

A new mathematical model was developed to predict weight changes based on dietary energy intake, using data from 8 longitudinal studies with 157 participants, which showed strong accuracy in its predictions (R² values of 0.83 and 0.91).

This model can help obese patients and their doctors set realistic long-term weight maintenance goals by calculating the necessary dietary changes, making it a practical tool for weight management professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modeling weight-loss maintenance to help prevent body weight regain. Hall, KD., Jordan, PN.[2023]

Poor sleep disrupts hormones related to the food reward system, making it harder for individuals to lose weight and maintain weight-loss programs.

Conversely, obesity can lead to sleep disturbances, creating a cycle that complicates both weight management and sleep quality; exploring effective treatments is crucial for breaking this cycle.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inadequate sleep & obesity: Breaking the vicious cycle. Jaqua, EE., Mapar, A., Tran, MN., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Sleep Extension: A Potential Target for Obesity Treatment. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Sleep, obesity, and weight loss in adults: is there a rationale for providing sleep interventions in the treatment of obesity? [2015]

3. England pubmed.ncbi.nlm.nih.gov

The better weight-better sleep study: a pilot intervention in primary care. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Bidirectional Relationships Between Weight Change and Sleep Apnea in a Behavioral Weight Loss Intervention. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Effect of sleep on weight loss and adherence to diet and physical activity recommendations during an 18-month behavioral weight loss intervention. [2023]

6. Canada pubmed.ncbi.nlm.nih.gov

Development of an obesity management ontology based on the nursing process for the mobile-device domain. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Modeling weight-loss maintenance to help prevent body weight regain. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Study to Examine the Effect of a Lifestyle Modification Program in OSA. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Inadequate sleep & obesity: Breaking the vicious cycle. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Sleep Apnea and Sleep Habits: Relationships with Metabolic Syndrome. [2020]