Behavioral Weight Loss Program for Cancer Survivors in Maryland

Breast Cancer Clinical Trial

— ASPIRE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04534309
• Other study ID #: IRB00229163
• Status: Completed
• Phase: N/A
• Start date: September 22, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: October 2023
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 340
• Est. completion date: June 30, 2023
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Breast Cancer
• Endometrial Cancer
• Endometrial Neoplasms
• Gallbladder Cancer
• Gallbladder Neoplasms
• Kidney Cancer
• Kidney Neoplasms
• Melanoma (Skin)
• Prostate Cancer
• Rectal Cancer
• Weight Loss

Intervention

Behavioral:
• Written Weight Loss Material
Participants will receive written weight loss material by email.
• Weight Loss App
Participants will receive written weight loss material as well as instructions for using a free weight loss app on their phone or computer.
• Behavioral Lifestyle Weight Loss Intervention (Coaching)
Participants will receive weekly coaching phone calls to encourage regular dietary, exercise, and self-monitoring practices which encourage gradual, healthy weight loss.

Locations

Country	Name	City	State
United States	Johns Hopkins ProHealth	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Maryland Cigarette Restitution Fund

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Program participation as assessed by participant enrollment	Examine the enrollment in each program as a measure of program participation.	End of enrollment, up to 2 years
Other	Adoption of weight loss program activities as assessed by app use frequency	Evaluate the "adoption" of the App-Directed Weight Loss Program and Coach-Directed Weight Loss Program by examining app-use frequency at six months.	6 months
Other	Implementation of weight loss program as assessed by a participant survey	Evaluate the implementation of the Coach-Directed Weight Loss Program through a participant survey.	6 months
Other	Weight change at 12 months by program	Evaluate the "maintenance" of the Self-Directed, App-Directed and Coach-Directed weight loss programs in a real world setting by examining weight change [in kilograms (kg)] at 12-months by program.	Baseline and 12 months
Primary	Weight change at 6 months in Coach-Directed Program	Evaluate the "effectiveness" of the Coach-Directed weight loss programs in a real world setting by examining weight change [in kilograms (kg)] at 6-months.	Baseline and 6 months
Secondary	Weight change at 6 months in Self-Directed and App-Directed Weight Loss Programs	Evaluate the "effectiveness" of the Self-Directed and App-Directed weight loss programs in a real world setting by examining weight change [in kilograms (kg)] at 6-months.	Baseline and 6 months