Sleep Intervention for Obesity
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase < 1
Recruiting
Sponsor: University of Minnesota
Disqualifiers: Organ disorders, Pregnancy, Infant care, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?African American adults sleep less and obtain worse quality sleep compared to the national average, and emerging evidence links inadequate sleep with greater morbidity and mortality from chronic diseases such as diabetes, obesity, and cancer. To address this public health concern, the proposed research seeks to use a multi-method approach to adapt a sleep intervention for African American adults with overweight/obesity not meeting national sleep duration or physical activity recommendations. The overall goal of the project is to reduce cancer and obesity-related health disparities among African Americans.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the Sleep Intervention for Obesity treatment?
Research suggests that integrating sleep management with lifestyle changes like diet and exercise can help with weight loss. Additionally, improving sleep can boost self-confidence in sticking to healthy habits, which is important for losing weight.
12345Is the sleep intervention for obesity safe for humans?
The reviewed studies suggest that sleep interventions, including behavioral sleep interventions and sleep education programs, are generally safe for humans. These interventions have been used in various settings, such as group prenatal care and primary care, without reported safety concerns.
678910How is the sleep intervention treatment for obesity different from other treatments?
The sleep intervention for obesity is unique because it focuses on improving sleep patterns to help manage weight, unlike traditional treatments that primarily target diet and exercise. This approach addresses the hormonal imbalances and sleep disturbances that can contribute to obesity, offering a novel way to support weight loss.
27111213Eligibility Criteria
This trial is for African American adults aged 21-65 with a BMI of 25.0 to 40 kg/m2 who aren't very active, sleep ≤6 hours on average, and are not meeting physical activity guidelines. It's not for those with certain organ disorders, pregnant or recent mothers, or those with infants under one year old in the household.Inclusion Criteria
You do not meet the recommended level of physical activity.
Your body mass index (BMI) is between 25.0 and 40.
I am between 21 and 65 years old.
+2 more
Exclusion Criteria
Pregnant or less than 4 months postpartum
I have an infant under 1 year old living in my house.
I have a condition like COPD, heart rhythm problems, or stomach issues.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo a 4-week sleep extension intervention with weekly one-on-one contact to increase total sleep time by 60 minutes
4 weeks
4 visits (virtual)
Follow-up
Participants are monitored for satisfaction and adherence post-intervention
4 weeks
Participant Groups
The study aims to adapt a sleep intervention for African American adults who are overweight/obese and don't get enough sleep or exercise. The goal is to improve their health by reducing risks related to cancer and obesity through better sleep habits.
2Treatment groups
Experimental Treatment
Active Control
Group I: Sleep interventionExperimental Treatment1 Intervention
The sleep extension intervention is a 4-week intervention consisting of weekly one-on-one contact with the goal of increasing total sleep time by 60 minutes by the end of four weeks conducted by Dr. Wu or a trained counselor. The first session will last 60 minutes and the content will include psychoeducation about the importance of sleep, sleep guidelines and target setting, and basic sleep hygiene. Participants in this condition will receive hardcopy weekly daily diary worksheets, and receive an online version of the sleep daily diary every morning to complete via text messaging. Sessions 2-4 will be between 15-30 minutes where Dr. Wu or a trained counselor will review the sleep diary, problem solve barriers to weekly goals, and sleep promoting behaviors will be reinforced. Material that would be covered during a missed session will be included in the next session the participant attends.
Group II: Contact controlActive Control1 Intervention
The content of the contacts for this intervention condition will be based on the National Center for Healthy Housing's Healthy Homes program, a program designed by the UT School of Public Health. Participants in this condition will meet with Dr. Wu or a trained research staff member. They will meet through Zoom once a week for four sessions to go through each educational module. Sessions will conclude with the development of an action plan for participants. Staff will check in with participants regarding whether they were able to complete the tasks on their action plan, and if not, the reasons for this and potential strategies that may facilitate completion.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of MinnesotaMinneapolis, MN
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Who Is Running the Clinical Trial?
University of MinnesotaLead Sponsor
References
Erickson health coaching: An innovative approach for weight management in obese patients with obstructive sleep apnoea? [2019]Obstructive sleep apnoea (OSA) is a highly prevalent medical condition and amajor cardiovascular risk factor. Obesity is present in ∼70% of patients with OSA, nevertheless, continuous positive airway pressure (CPAP) ventilation - the gold standard therapy for moderate and severe OSA - has no appreciable long-term beneficial effects on obesity, body composition, energy metabolism, physical activities or the incidence of major cardiovascular events. Therefore, effective weight loss strategies in conjunction with CPAP therapy in OSA are critically needed. Since lifestyle interventions may positively impact body weight, there is a strong rationale to testing the hypothesis that Erikson coaching intervention as a form of lifestyle intervention to obese patients with OSA may increase their adherence to healthy lifestyle behaviour and thus result in weight reduction, improved body composition (reduction in %body fat) and improvements in glucose and lipid metabolism. There are three lines of evidence to justify testing this hypothesis: First, health coaching significantly facilitates uptake of healthy behaviours across a broad variety of chronic conditions; second, several randomized clinical trials suggested positive impact of health coaching on weight management and on cardiometabolic risk factors in overweight/obese otherwise healthy persons; third, Erickson coaching approach empowers the three key elements of health coaching (patient-centeredness, patient-determined goals, use of a self-discovery process) further, namely by introducing two other specific core elements into the coaching process: a) solution-focus and outcome frame, b) orientation at the patient-formulated positive outcomes (i.e., positive values resulting from behavioural change). Importantly, results of our recent pilot observational cohort study suggested that Erickson coaching is a powerful tool to address behavioural modification in obesity. In conclusion, testing our hypothesis may have significant clinical implications: if clinical randomized trials indicate that Erickson health coaching is an efficient approach to behavioural change and weight management in OSA then combining Erickson coaching with CPAP therapy may result in reductions in cardiovascular morbidity and mortality in these high-risk patients.
The better weight-better sleep study: a pilot intervention in primary care. [2018]To explore the feasibility of integrating sleep management interventions with dietary and exercise interventions for obesity in a 12-week randomized trial.
Nightly Variation in Sleep Influences Self-efficacy for Adhering to a Healthy Lifestyle: A Prospective Study. [2023]Self-efficacy, or the perceived capability to engage in a behavior, has been shown to play an important role in adhering to weight loss treatment. Given that adherence is extremely important for successful weight loss outcomes and that sleep and self-efficacy are modifiable factors in this relationship, we examined the association between sleep and self-efficacy for adhering to the daily plan. Investigators examined whether various dimensions of sleep were associated with self-efficacy for adhering to the daily recommended lifestyle plan among participants (N = 150) in a 12-month weight loss study.
Impact of lifestyle modifications on snoring and mild sleep apnoea patients. [2021]Behavioural modification through increasing nutritional awareness, along with customised dietary changes and education about physical inactivity, for obese snorers and mildly sleep apnoeic patients would help improve their quality of life.
A two-year weight reduction program in obese sleep apnea patients. [2021]To evaluate the effects of a 2-year weight reduction program on respiratory disturbances, arousal index, daytime sleepiness, metabolic status, and quality of life in obese patients with obstructive sleep apnea syndrome (OSAS).
Role of Sex and the Environment in Moderating Weight Gain Due to Inadequate Sleep. [2019]The growing prevalence of obesity, inadequate sleep and sleep disorders together with the negative impact of lack of sleep on overall health highlights the need for therapies targeted towards weight gain due to sleep loss.
An integrative review of sleep interventions and related clinical implications for obesity treatment in children. [2016]Evidence has shown correlations between obesity and sleep in children. The purpose of this review was to identify sleep interventions that could be utilized in primary care settings to prevent obesity in children.
Associations of short sleep duration with childhood obesity and weight gain: summary of a presentation to the National Academy of Science's Roundtable on Obesity Solutions. [2022]This article summarizes a presentation made in February 2017 as part of the National Academy of Sciences' Roundtable on Obesity Solutions webinar, "The Potential Role of Sleep in Obesity Prevention and Management: A Virtual Workshop." Briefly described are the patterns of childhood sleep duration in the United States, the state of the science relating insufficient sleep to overweight and obesity in infancy and early childhood, and the potential mechanisms for the association. Also discussed are intervention efforts to date. Despite research gaps, interventions aimed at increasing sleep quality and quantity may help prevent childhood obesity.
A Pilot Study of a Sleep Intervention Delivered through Group Prenatal Care to Overweight and Obese Women. [2020]We sought to investigate the feasibility of a behavioral sleep intervention for insomnia, delivered through group prenatal care and the relationship of this intervention to improvements in insomnia symptoms and sleep quality.
Sleep Health Promotion Interventions and Their Effectiveness: An Umbrella Review. [2021]Sleep is receiving increasing attention in public health. The aim of this umbrella review is to determine what non-pharmacological sleep health interventions have been evaluated among healthy populations, by examining target groups, settings, and effectiveness in improving sleep quality and duration. Comprehensive searches were conducted in five electronic databases (January 1975-February 2019), yielding 6505 records. Thirty-five articles were selected meeting the following eligibility criteria: (1) systematic reviews or meta-analyses of (2) sleep health interventions in (3) primarily healthy populations. Two reviewers independently screened for inclusion, extracted the data, and assessed the review quality. This umbrella review was registered with PROSPERO (CRD42019126291). Eleven intervention types were defined, and their effectiveness discussed. Substantial evidence demonstrated the effectiveness of later school start times, behavior change methods, and mind-body exercise. Other intervention types, including sleep education or relaxation techniques, demonstrated some promising impacts on sleep, but with less consistent evidence. Results were limited by high heterogeneity between studies, mixed results, and variable review quality. Nevertheless, this umbrella review is a first step towards understanding the current state of sleep health promotion and gives an overview of interventions across the lifespan.
Inadequate sleep & obesity: Breaking the vicious cycle. [2023]Poor sleep negatively affects hormones that govern the food reward system and can interfere with weight-loss programs. Obesity in turn restricts sleep. Which treatments have shown promise?
Sleep, nutrition, and physical activity interventions to prevent obesity in infancy: follow-up of the Prevention of Overweight in Infancy (POI) randomized controlled trial at ages 3.5 and 5 y. [2023]Our Prevention of Overweight in Infancy (POI) study suggested that a brief sleep intervention in infancy reduced the risk of obesity at age 2 y. In contrast, we observed no benefit from the nutrition and activity intervention.
Sleep, obesity, and weight loss in adults: is there a rationale for providing sleep interventions in the treatment of obesity? [2015]Rates of obesity and sleep disturbances are substantial in adults. A number of cross-sectional, longitudinal, and experimental studies have found that insufficient sleep and possibly longer sleep are associated with obesity and related eating patterns. Methodological discrepancies and limitations in the literature create ambiguity about the nature and potential mechanisms underlying these relationships. Insomnia and circadian patterns in eating and sleeping have also been examined in relation to weight. Although these studies are not as extensive as those examining sleep duration, the extant literature suggests possible associations between obesity and both insomnia (particularly when combined with short sleep duration) and circadian eating behaviours. However, research has only just begun to examine the benefits of combining sleep interventions with obesity treatment. The goal of the current review is to summarize research examining behavioural sleep patterns and disorders in relation to obesity, to discuss methodological considerations, and to provide an overview of studies examining whether addressing sleep disturbances can augment weight loss treatment effects. We conclude that future studies are needed that take into account sleep duration, sleep disorder co-morbidity, and chronobiology to explore the impact of sleep interventions on weight loss.