Clinical trial NCT04534309: Behavioral Weight Loss Program for Cancer Survivors in Maryland
Official title: Behavioral Weight Loss for Overweight and Obese Cancer Survivors in Maryland: A Demonstration Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Prostate Cancer
Melanoma (Skin)
Endometrial Cancer
Gallbladder Cancer
Rectal Cancer
Kidney Cancer
Bladder Cancer
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: Maryland Cigarette Restitution Fund
First posted: 2020-09-01
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Behavioral Weight Loss for Overweight and Obese Cancer Survivors in Maryland: A Demonstration Project

Detailed description: The objective of the ASPIRE Project is to design, implement, and evaluate a real-world, lifestyle-based, support for overweight or obese cancer survivors in both urban and rural areas of Maryland. The project will provide three options of support to encourage lifestyle change to achieve and maintain a healthy weight for cancer survivors:

1. Self-Directed Weight Loss: educational materials only;
2. App-Directed Weight Loss: educational materials, weight loss app with weekly e-mail support; and
3. Coach-Directed Weight Loss: educational materials, weight loss app, weekly e-mail support and one-to-one weekly telephonic coach support.

Eligibility criteria: Inclusion Criteria:

* previously diagnosed with a malignant solid tumor,
* completed all required surgical, and/or chemotherapy and/or radiation curative intent therapy at least three months prior to enrollment,
* anticipated treatment-free life span of 12 months or longer.
* chemoprophylaxis with tamoxifen or aromatase inhibitors for breast cancer in women will be permitted
* anti- Luteinizing-hormone releasing therapy for prostate cancer in men will be permitted.
* BMI ≥ 25 kg/m2 (BMI ≥ 23 kg/m2 for Asians) and weight ≤ 400 lbs.
* have an email address for regular personal use

Additional criteria for participants in weight tracking (self-directed or app directed)

* willingness to record/transmit quarterly weights for 12 months

Additional criteria for App-Directed Program:

* willingness to change diet and increase physical activity and track weight, diet and physical activity
* have a smart phone for personal use
* sufficient data plan/Internet to support daily use of weight loss app\*

Additional Criteria for Coach-Directed Weight Loss Program

* willingness to lose weight by changing diet and physical activity habits
* willingness to track weight, diet and physical activity
* willingness to record/transmit quarterly weights for 12 months
* smart phone for personal use
* data plan/Internet to support daily use of weight loss app\*
* willingness to complete coaching calls (12 weekly calls and 3 monthly calls)
* sufficient call plan to support coaching calls

  * a corresponding website could be used, then daily Internet access is required for person use.

Exclusion Criteria:

* received any chemotherapy (unless anti-hormonal therapy) and/or radiation three months or less prior to the proposed program date
* women who are breastfeeding, pregnant, or planning pregnancy within the next year

Additional exclusion criteria for participants in weight tracking and/or Coach-Directed Program

* self-identification of uncontrolled concurrent medical condition likely to limit compliance with the program as determined by investigators.
* current involvement in another organized weight loss program
* current use of steroids or other medication known to affect body weight
* bariatric surgery scheduled within the next 6 months, or
* plan to move outside the continental US in the next 12 months

Primary outcomes:
measure: Weight change at 6 months in Coach-Directed Program
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Weight change at 6 months in Self-Directed and App-Directed Weight Loss Programs
timeFrame: Baseline and 6 months
Other outcomes:
measure: Program participation as assessed by participant enrollment
timeFrame: End of enrollment, up to 2 years
measure: Adoption of weight loss program activities as assessed by app use frequency
timeFrame: 6 months
measure: Implementation of weight loss program as assessed by a participant survey
timeFrame: 6 months
measure: Weight change at 12 months by program
timeFrame: Baseline and 12 months
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins ProHealth
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Jessica Yeh, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: