Back to resultsBehavioral Weight Loss Program for Cancer Survivors in Maryland (ASPIRE)
Primary Purpose
Breast Cancer, Prostate Cancer, Melanoma (Skin)
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Written Weight Loss Material
Weight Loss App
Behavioral Lifestyle Weight Loss Intervention (Coaching)
Sponsored by
About this trial
This is an interventional prevention trial for Breast Cancer
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
Sites / Locations
- Johns Hopkins ProHealth
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Self-Directed Weight Loss with year-long weight tracking
App-Directed Weight Loss with year-long weight tracking
Coach-Directed Weight Loss with year-long weight tracking
Arm Description
Written Weight Loss Material.
Smart phone Weight Loss App.
Behavioral Lifestyle Weight Loss Intervention with Smart phone Weight Loss App.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04534309
First Posted
August 26, 2020
Last Updated
October 9, 2023
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
Maryland Cigarette Restitution Fund
1. Study Identification
Unique Protocol Identification Number
NCT04534309
Brief Title
Behavioral Weight Loss Program for Cancer Survivors in Maryland
Acronym
ASPIRE
Official Title
Behavioral Weight Loss for Overweight and Obese Cancer Survivors in Maryland: A Demonstration Project
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
September 22, 2020 (Actual)
Primary Completion Date
December 15, 2022 (Actual)
Study Completion Date
June 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
Maryland Cigarette Restitution Fund
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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:
Self-Directed Weight Loss: educational materials only;
App-Directed Weight Loss: educational materials, weight loss app with weekly e-mail support; and
Coach-Directed Weight Loss: educational materials, weight loss app, weekly e-mail support and one-to-one weekly telephonic coach support.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Prostate Cancer, Melanoma (Skin), Endometrial Cancer, Gallbladder Cancer, Rectal Cancer, Kidney Cancer, Bladder Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
340 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Self-Directed Weight Loss with year-long weight tracking
Arm Type
Other
Arm Description
Written Weight Loss Material.
Arm Title
App-Directed Weight Loss with year-long weight tracking
Arm Type
Other
Arm Description
Smart phone Weight Loss App.
Arm Title
Coach-Directed Weight Loss with year-long weight tracking
Arm Type
Other
Arm Description
Behavioral Lifestyle Weight Loss Intervention with Smart phone Weight Loss App.
Intervention Type
Behavioral
Intervention Name(s)
Written Weight Loss Material
Intervention Description
Participants will receive written weight loss material by email.
Intervention Type
Behavioral
Intervention Name(s)
Weight Loss App
Intervention Description
Participants will receive written weight loss material as well as instructions for using a free weight loss app on their phone or computer.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Lifestyle Weight Loss Intervention (Coaching)
Intervention Description
Participants will receive weekly coaching phone calls to encourage regular dietary, exercise, and self-monitoring practices which encourage gradual, healthy weight loss.
Primary Outcome Measure Information:
Title
Weight change at 6 months in Coach-Directed Program
Description
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.
Time Frame
Baseline and 6 months
Secondary Outcome Measure Information:
Title
Weight change at 6 months in Self-Directed and App-Directed Weight Loss Programs
Description
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.
Time Frame
Baseline and 6 months
Other Pre-specified Outcome Measures:
Title
Program participation as assessed by participant enrollment
Description
Examine the enrollment in each program as a measure of program participation.
Time Frame
End of enrollment, up to 2 years
Title
Adoption of weight loss program activities as assessed by app use frequency
Description
Evaluate the "adoption" of the App-Directed Weight Loss Program and Coach-Directed Weight Loss Program by examining app-use frequency at six months.
Time Frame
6 months
Title
Implementation of weight loss program as assessed by a participant survey
Description
Evaluate the implementation of the Coach-Directed Weight Loss Program through a participant survey.
Time Frame
6 months
Title
Weight change at 12 months by program
Description
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.
Time Frame
Baseline and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica Yeh, Ph.D.
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins ProHealth
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21207
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Behavioral Weight Loss Program for Cancer Survivors in Maryland
We'll reach out to this number within 24 hrs