Behavioral Weight Loss + Sleep Health for Obesity

(DREAM Trial)

Overseen By Kristen Bing

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Must not be taking: Sleep medications, Anti-obesity, Antipsychotics, Stimulants

Disqualifiers: Diabetes, Hypertension, Thyroid disorder, others

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

Compensation: Varies

Number of Visits: 3

Duration: 6 months

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a program combining weight loss strategies with sleep health improvements, called BWL+Sleep, can help people lose weight and sleep better. The researchers aim to determine the program's feasibility and effectiveness for participants. Suitable candidates include individuals with a BMI between 25-40, who experience poor sleep and are not very active. Participants should not have major health issues like heart disease or diabetes and should live or work near the study location. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance weight loss and sleep health strategies.

What prior data suggests that this behavioral weight loss and sleep health intervention is safe?

Studies have shown that combining a weight loss program with a sleep health plan can lead to improvements in both weight and sleep quality. Research indicates that losing at least 5% of starting weight through these programs can enhance sleep duration and quality. This suggests that most people find the treatment manageable.

In another study, a similar program reduced fast food consumption. However, some participants found it harder to stay awake during the day, highlighting a possible side effect of focusing on better sleep.

Overall, the treatment appears safe for most people, aiding in both weight loss and sleep improvement. Some individuals might experience increased daytime sleepiness, which could affect daily activities. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Behavioral Weight Loss + Sleep Health intervention for obesity because it combines two critical aspects of a healthy lifestyle: weight management and sleep improvement. Unlike most traditional weight loss programs that focus solely on diet and exercise, this approach integrates sleep health strategies, recognizing the vital role sleep plays in regulating metabolism and appetite. By addressing sleep issues, the program aims to enhance the effectiveness of weight loss strategies, potentially leading to more sustainable results. This holistic approach is particularly promising for individuals struggling with obesity, as it targets multiple factors contributing to weight gain.

What evidence suggests that the BWL+Sleep intervention might be effective for obesity?

Research has shown that combining weight loss efforts with good sleep habits can lead to better results. One study found that people who slept well were more likely to stick to their lifestyle changes, aiding in weight loss. Another study showed that losing at least 5% of starting weight improved both sleep length and quality. These findings suggest that focusing on sleep can enhance weight loss success. Therefore, this trial will evaluate the effectiveness of a Behavioral Weight Loss Program Plus Sleep Health Intervention, incorporating sleep strategies to potentially achieve better outcomes. ^{1 2 6 7 8}

Who Is on the Research Team?

Victoria Catenacci, MD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for children and adults struggling with obesity who are interested in losing weight. Participants should be willing to engage in a behavioral weight loss program that includes a sleep health component. Specific eligibility criteria details were not provided, so it's important to contact the study organizers for more information.

Inclusion Criteria

Physically Inactive: defined as <150 minutes per week of exercise at moderate intensity or greater and <60 min per day of total habitual physical activity at moderate intensity or greater over the past 3 months

No plans for extended travel (>2 weeks) within the next 12 months

Live or work within 30 minutes of the AHWC

Exclusion Criteria

I have had surgery or used a device to lose weight.

Diastolic blood pressure >100 mmHG, systolic blood pressure >160 mmHG, or resting heart rate >100 bpm as measured in duplicate on the screening visit after 5 minutes of rest in a seated position

Hematocrit, white blood cell count or platelets significantly outside the normal reference range as measured on the screening visit

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

3-4 months

Treatment

Participants receive a 6-month group-based behavioral weight loss intervention that incorporates strategies to improve sleep health

6 months

Visits at baseline, 3 months, and 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BWL+Sleep

Trial Overview The intervention being tested is a combination of behavioral weight loss strategies along with a sleep improvement program (BWL+Sleep). The goal is to see if this dual approach can lead to significant weight loss and better sleep quality over six months.

How Is the Trial Designed?

Group I: Behavioral Weight Loss Program Plus Sleep Health Intervention Experimental Treatment 1 Intervention

Participants will receive a 6-month group-based behavioral weight loss intervention that incorporates strategies to improve sleep health.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7914147/

The association between sleep health and weight change ... Our observational results indicate that better sleep health is associated with greater weight and fat loss among individuals enrolled in a ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07255287?term=heart+disease

Behavioral Weight Loss and Sleep Health Intervention This is a 6-month single-arm pilot and feasibility study designed to examine if a behavioral weight loss (BWL) intervention with an added sleep health ...

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/abs/pii/S0022316625005541

The Effect of Habitual Sleep Duration on Weight Loss ... Habitual long sleep duration is associated with reduced weight loss success and increased risk of attrition in a behavioral weight loss intervention. This trial ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4340776/

Effects of a Two-Year Behavioral Weight Loss Intervention ... Losing ≥ 5% of initial weight was associated with short-term improvements in sleep duration and sleep quality, as well as favorable short- and long-term changes ...

6. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/obr.70017

Examining the Role of Sleep in Body Weight Regulation ... The cornerstone of obesity treatment is a behavioral intervention promoting negative energy balance via a reduced-calorie diet and increased ...

7. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2788694

Effect of Sleep Extension on Objectively Assessed Energy ... Meaning The findings suggest that improving and maintaining adequate sleep duration could reduce weight and be a viable intervention for obesity ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5038135/

Effects on diet, activity and sleep behaviors in an at-risk ... The intervention resulted in significant reductions in fast food (p=0.007) but increases in difficulty staying awake (p=0.015).