Feasibility Pilot Study: Adding a Sleep Health Intervention to a Behavioral Weight Loss Intervention

Primary Objective

The overall objective for this pilot study is to integrate evidence-based strategies to improve sleep health (SLEEP) within an established guidelines-based behavioral weight loss (BLW) curriculum (Colorado Weigh, CW) to create the BWL+SLEEP intervention, and to assess the feasibility and acceptability of the BWL+SLEEP intervention.

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Description

A 6-month behavioral weight loss (BWL) + sleep health (SLEEP) intervention . This will use a skills-based approach and cognitive behavioral strategies for lifestyle modification with a dietary focus on daily caloric restriction and increased physical activity. Group classes will be taught by a registered dietitian (RD) held weekly during weeks 0-13 and every two weeks during weeks 14-26. Participants will be given a calorie goal designed to produce a 30% energy deficit from baseline estimated energy needs for the duration of the 6-month intervention. Participants will also receive a recommendation to increase physical activity to 300 min/wk. Participants will also receive evidence-based strategies and recommendations for optimizing sleep health. Participants will receive a copy of their baseline actigraphy sleep data along with individualized recommendations for improving their sleep health. The Fitbit Inspire 2 will be utilized for self-monitoring daily physical activity and self-monitoring of sleep duration, timing, and quality.

Details
Age
Adult
Eligibility
- Age 18-55 years - Body Mass Index 25-40 kg/m2 - <100 minutes per week of exercise at moderate intensity or greater and <60 min per day of total habitual physical activity (i.e., work related, transportation related) at moderate intensity or greater, over the past 3 months. - No acute or chronic disease (cardiovascular disease (CVD), diabetes, pulmonary, gastrointestinal disorders, and orthopedic problems in particular). - No plans to relocate within the next 12 months. - No plans for extended travel (>2 weeks) within the next 12 months. - Live or work within 20 miles of the Anschutz Medical Campus - For Females: Not currently pregnant or lactating, Not pregnant within the past 6 months, Not planning to become pregnant in the next 12 months. Inclusion Criteria: - Age 18-55 years - Body Mass Index 25-40 kg/m2 - <100 minutes per week of exercise at moderate intensity or greater and <60 min per day of total habitual physical activity (i.e., work related, transportation related) at moderate intensity or greater, over the past 3 months. - No self-report of acute or chronic disease - No plans to relocate within the next 12 months. - No plans for extended travel (>2 weeks) within the next 12 months. - Live or work within 20 miles of the AHWC - Capable and willing to give informed consent, understand exclusion criteria, and accept the randomized group assignment. - Have a primary care physician (or are willing to establish care prior to study enrollment) No contraindications to exercise or limitations on ability to be physically active. - Agree to refrain from use of obesity pharmacotherapeutic agents during the 6 month pilot study. - Females: Not currently pregnant or lactating, Not pregnant within the past 6 months, Not planning to become pregnant in the next 12 months. Sexually active women of childbearing potential may be enrolled if they have had a tubal ligation or use a reliable means of contraception. Exclusion Criteria: - Diastolic blood pressure >100 mmHG, systolic blood pressure >160 mmHG, or resting heart rate >100 bpm - Diabetes - Undiagnosed hypo- or hyper-thyroid or history of uncontrolled thyroid disorder. - Hematocrit, white blood cell count or platelets significantly outside the normal reference range - Triglycerides >400 mg/dL - LDL cholesterol >200 mg/dL - Abnormal resting electrocardiogram - Presence or history of CVD, peripheral vascular disease, cerebrovascular disease, significant cardiac arrhythmias or cardiac valve disease, diabetes, uncontrolled hyper- or hypothyroidism, uncontrolled hypertension, cancer, HIV infection, significant gastrointestinal disorders, significant pulmonary disorders, significant renal, musculoskeletal, neurologic, hematologic, or psychiatric disease. - Significant gastrointestinal disorders including chronic malabsorptive conditions, active peptic ulcer disease, Crohns disease, Ulcerative Colitis, chronic diarrhea, or active gallbladder disease. - Chronic obstructive pulmonary disease (COPD), interstitial lung disease, cystic fibrosis, or uncontrolled asthma. - Chest pain, shortness of breath at rest or with mild exertion, syncope. - Primary sleep disorders including but not limited to insomnia, moderate or greater severity obstructive sleep apnea, periodic limb movements in sleep, restless leg syndrome. - Night-time shiftwork, rotating work, or other circadian disruptions and disorders - Regular use of prescription or over-the-counter medications known to affect sleep - Regular use of melatonin (greater than or equal to 2 days per week). - Regular use of prescription or over-the-counter medications known to affect appetite, weight, or energy metabolism - Regular use of systemic glucocorticoids. - Regular use of obesity pharmacotherapeutic agents within the last 6 months. - Previous obesity treatment with surgery or weight loss device - Current alcohol or substance abuse. - Nicotine use (current or quit in the past 6 months). - History of clinically diagnosed eating disorders including anorexia nervosa, bulimia, binge eating disorder. - Current severe depression or history of severe depression within the previous year - History of other significant psychiatric illness (e.g., psychosis, schizophrenia, mania, bipolar disorder) - Currently participating in or planning to participate in any formal weight loss programs, physical activity programs, or clinical trials. - Weight change ± 5 kg in past 3 months.
Locations

Anschutz Health and Wellness
Outpatient CTRC
University of Colorado Hospital

Principal Investigator
Photograph of Vicki Catenacci

Vicki Catenacci

Study ID

Protocol Number: 23-1317

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