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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how changes in lifestyle and sleep habits can help teenagers lose weight and improve their eating and sleep behaviors. Participants will join online group sessions to learn about nutrition, physical activity, and maintaining a healthy sleep routine. The trial seeks teens aged 14-18 who speak English, have a BMI in the 85th percentile or higher for their age and sex, and experience sleep issues such as trouble falling asleep or irregular sleep patterns. As an unphased trial, this study offers teens a unique opportunity to actively participate in research that could lead to healthier lifestyle changes.

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 prior data suggests that this lifestyle modification and sleep intervention is safe for adolescents?

Research has shown that changes in lifestyle and sleep habits are generally safe and manageable for most people. Previous studies have found that these changes can aid in weight loss and health improvement. For instance, one review found that intense lifestyle changes led to an average weight loss of up to 8 kg (about 17.6 pounds) over six months. Another study demonstrated significant improvements in body weight and obesity-related conditions.

These changes typically involve adjusting diet, exercise, and sleep patterns, which are common methods for managing weight. They focus on education, goal-setting, and habit tracking, all of which are non-invasive and carry minimal risk. Overall, participants in similar studies have not reported major side effects, making these changes a low-risk option for those seeking to manage weight and improve health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this treatment for obesity because it combines lifestyle modification with a unique emphasis on sleep intervention, delivered entirely through remote group sessions via Zoom. Unlike traditional options that often focus solely on diet and exercise, this treatment integrates sleep education and tracking, which can play a crucial role in managing weight and eating behaviors. This holistic approach aims to establish regular sleep patterns alongside nutritional and physical activity education, potentially leading to more sustainable, long-term weight management solutions.

What evidence suggests that this lifestyle and sleep intervention is effective for obesity?

Research has shown that lifestyle changes and improved sleep can aid weight loss in individuals with obesity. This trial will test a combined lifestyle modification and sleep intervention. One review found that those who improved their sleep as part of lifestyle changes often managed their weight better. Another study found that better sleep helped people adhere to lifestyle changes, resulting in weight loss over a year. In one lifestyle program, participants lost an average of 4.19 kilograms, with 40.3% losing at least 5% of their body weight. These findings suggest that focusing on both lifestyle and sleep can lead to significant weight loss. ^{3 4 6 7 8}

Who Is on the Research Team?

Stephanie Manasse, Ph.D.

Principal Investigator

Drexel University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10825984/

a systematic review and meta-analysis - PMC - PubMed Central This systematic review examines the efficacy of sleep interventions alone or as a part of lifestyle interventions for the management of overweight or obesity ...

2. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-024-17708-6

a systematic review and meta-analysis | BMC Public Health This systematic review examines the efficacy of sleep interventions alone or as a part of lifestyle interventions for the management of overweight or obesity ...

3. ahajournals.org ahajournals.org/doi/10.1161/circ.147.suppl_1.51

Abstract 51: Better Sleep Health is Associated With Greater ... Conclusions: Better sleep health was associated with greater adherence to lifestyle modification during a 12-month behavioral weight loss ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0090825825007279

Integration of a lifestyle modification intervention for women ... Moreover, the LMI was found to be effective in helping patients lose a mean of 4.19 kgs during the intervention, with 40.3 % of patients losing at least 5 % of ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2791455

Effect of an Interdisciplinary Weight Loss and Lifestyle ... An 8-week interdisciplinary weight loss and lifestyle intervention significantly improved OSA severity and other outcomes compared with usual care alone.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7027681/

Lifestyle Modification Approaches for the Treatment of ... The Obesity Guideline's systematic review of high-intensity lifestyle interventions revealed mean weight losses of up to 8 kg (about 8% of weight) at 6 months, ...

7. nyaspubs.onlinelibrary.wiley.com nyaspubs.onlinelibrary.wiley.com/doi/full/10.1111/nyas.15278

Behavior‐change lifestyle interventions for the treatment of ... Most behavior-change lifestyle interventions had moderate effects in reducing obesity outcomes (e.g., body weight, BMI, and BMI z-score).

8. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2025.1649655/full

Health outcomes of lifestyle treatment for patients with ... This study demonstrates that structured lifestyle treatment supports improvements in BMI, HRQoL, and PA levels, even with reduced in-person contact.