Behavioral Weight Loss Program for Cancer Survivors in Maryland (ASPIRE)

October 9, 2023 updated by: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

340

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21207
        • Johns Hopkins ProHealth

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Self-Directed Weight Loss with year-long weight tracking
Written Weight Loss Material.
Behavioral: Written Weight Loss Material
Participants will receive written weight loss material by email.
Other: App-Directed Weight Loss with year-long weight tracking
Smart phone Weight Loss App.
Behavioral: 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.
Other: Coach-Directed Weight Loss with year-long weight tracking
Behavioral Lifestyle Weight Loss Intervention with Smart phone Weight Loss App.
Behavioral: 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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight change at 6 months in Coach-Directed Program
Time Frame: Baseline and 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight change at 6 months in Self-Directed and App-Directed Weight Loss Programs
Time Frame: Baseline and 6 months
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Program participation as assessed by participant enrollment
Time Frame: End of enrollment, up to 2 years
Examine the enrollment in each program as a measure of program participation.
End of enrollment, up to 2 years
Adoption of weight loss program activities as assessed by app use frequency
Time Frame: 6 months
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
Implementation of weight loss program as assessed by a participant survey
Time Frame: 6 months
Evaluate the implementation of the Coach-Directed Weight Loss Program through a participant survey.
6 months
Weight change at 12 months by program
Time Frame: Baseline and 12 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

Maryland Cigarette Restitution Fund

Investigators

  • Principal Investigator: Jessica Yeh, Ph.D., Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 22, 2020

Primary Completion (Actual)

December 15, 2022

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

August 26, 2020

First Submitted That Met QC Criteria

August 26, 2020

First Posted (Actual)

September 1, 2020

Study Record Updates

Last Update Posted (Estimated)

October 10, 2023

Last Update Submitted That Met QC Criteria

October 9, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00229163

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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