Accepted for/Published in: JMIR Research Protocols
Date Submitted: Nov 16, 2023
Date Accepted: Apr 29, 2024
Behavioral Weight Loss Programs for Cancer Survivors throughout Maryland: Protocol for a Pragmatic Trial and Participant Characteristics
ABSTRACT
Background:
Clinical trials examining lifestyle interventions for weight loss in cancer survivors have been demonstrated to be safe, feasible, and effective. However, scalable weight loss programs are needed to support their widespread implementation.
Objective:
This study describes the study design, enrollment, and baseline characteristics of participants in the ASPIRE Study, a real-world, lifestyle-based, weight loss program for cancer survivors throughout Maryland.
Methods:
Participants were adults residing in Maryland with BMI ≥ 25 kg/m2 who reported diagnosis of a malignant solid tumor, completed curative treatment, and had no ongoing or planned cancer treatment. Enrollment criteria were kept to a minimum to increase generalizability. The primary recruitment source was the Johns Hopkins Health System electronic health records (EHR). Participants selected one of three remotely delivered weight loss programs: Self-Directed (SD), App-Supported (AS), or Coach-Supported (CS) program.
Results:
Recruitment was effective across all five geographic regions of Maryland. Targeted invitations using EHR accounted for 84.4% of the 340 participants enrolled. Of the 5,644 patients invited through EHR, 5.1% enrolled. Participants had a mean (standard deviation) age of 60.7(10.8) years, 74.7% were female, 55.9% identified as Non-Hispanic Black, 58.5% had a bachelor’s degree, and the average BMI was 34.1(5.9) kg/m2. The most common types of cancers were breast (49.4%), prostate (21.2%), and thyroid (8.5%). The SD program (n=91) included 25 participants who agreed to provide weights through a study scale; the AS program (n=142) included 108 individuals who agreed to provide weights; and the CS program included 107 participants.
Conclusions:
These results support EHR-based recruitment efforts as a pragmatic approach to reach and enroll cancer survivors into remotely delivered weight loss programs. Clinical Trial: ClinicalTrials.gov NCT04534309
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