NCT05780814

The Effects of Treating Insomnia on Behavioral Weight Loss Outcomes in Survivors of Breast Cancer

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Breast Cancer
• Insomnia
• Weight Gain

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive-Behavioral Therapy for Insomnia (CBT-I)	The CBT-I intervention is a 6-session intervention spread out over 8 weeks that combines education and behavioral techniques to reduce insomnia.
BEHAVIORAL	Sleep Education Control (EDU)	Subjects will be instructed to read and review select publications from the American Academy of Sleep Medicine

Timeline

• Start date: 2024-02-01
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2023-03-23
• Last updated: 2026-02-23

Locations

4 sites across 1 country: United States