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The investigators propose a randomized controlled clinical trial in 250 women with a history of early stage breast cancer who are overweight or obese with insomnia to test whether a brief, cognitive-behavioral intervention for insomnia (CBT-I) prior to behavioral weight loss (CBT-I+BWL) is superior to a sleep education control (EDU) condition followed by behavioral weight loss (EDU+BWL). The investigators will measure outcomes at baseline, 8 weeks (after completing CBT-I or EDU and prior to BWL), and at 3, 6, and 12 months.
The entire study will span a 14-month period and involves one video screening visit (V1) and 4 in-person assessment visits (V2-V5) and 27 video sessions (6 for sleep intervention or sleep control and 19 for BWL). After passing an initial phone screen, participants will be scheduled for in-depth screening (V1). The investigators will complete urine samples for pregnancy and substances, administer study measures, obtain weight, height, anthropometrics and randomize at in-person visit (V2). The overall framework of the BWL intervention is social cognitive theory (increasing self-efficacy and social support) with motivational interviewing (MI) as an approach to helping participants engage in established behavior change strategies (e.g. self-monitoring, stimulus control, goal setting, feedback, etc.) aimed at reducing dietary intake and increasing physical activity (PA). Body composition will be assessed by Dual Energy X-Ray Absorptiometry (DEXA), which measures total and regional fat, lean tissue and bone mass. The investigators will conduct DEXA scans at two time points (V1 \& V5).The investigators' primary endpoint is % total weight loss (TWL) at 12 months. The investigators will measure weight in light clothes without shoes, using a digital scale and height to the nearest 0.1 cm using a calibrated stadiometer, according to standardized procedures.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
Sidney Kimmel Comprehensive Cancer Center, the Avon Foundation Breast Center at Johns Hopkins
Baltimore, Maryland, United States
Johns Hopkins Bayview
Baltimore, Maryland, United States
Johns Hopkins Kimmel Cancer Center at Greenspring Station
Lutherville, Maryland, United States
Start Date
February 1, 2024
Primary Completion Date
December 31, 2028
Completion Date
December 31, 2028
Last Updated
February 23, 2026
250
ESTIMATED participants
Cognitive-Behavioral Therapy for Insomnia (CBT-I)
BEHAVIORAL
Sleep Education Control (EDU)
BEHAVIORAL
Lead Sponsor
Johns Hopkins University
Collaborators
NCT05372640
NCT05245812
Data Source & Attribution
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