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CompletedNCT04534309ASPIREUpdated Oct 10, 2023

Behavioral Weight Loss Program for Cancer Survivors in Maryland

An interventional study of Written Weight Loss Material and Weight Loss App in Breast Cancer, Prostate Cancer and Melanoma (Skin), sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-10.

Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
340
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.
02

Conditions studied

  • Breast Cancer
  • Prostate Cancer
  • Melanoma (Skin)
  • Endometrial Cancer
  • Gallbladder Cancer
  • Rectal Cancer
  • Kidney Cancer
  • Bladder Cancer
03

In context

Endometrial Neoplasms

1,325 studies on the registry are indexed under Endometrial Neoplasms; 447 are open to participants now.

This study's enrollment of 340 is above the median of 70 across 941 interventional studies indexed under Endometrial Neoplasms.

Browse Endometrial Neoplasms studies →

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins is the lead sponsor of 572 studies on the registry; 73 are open to participants now.

Of its 111 completed or terminated interventional studies of FDA-regulated products, 67 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
340 participants (actual)

Study arms

  • Other
    Self-Directed Weight Loss with year-long weight tracking

    Written Weight Loss Material.

    Behavioral: Written Weight Loss Material

  • Other
    App-Directed Weight Loss with year-long weight tracking

    Smart phone Weight Loss App.

    Behavioral: Weight Loss App

  • 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 · Behavioral: Behavioral Lifestyle Weight Loss Intervention (Coaching)

Interventions

  • BehavioralWritten Weight Loss Material

    Participants will receive written weight loss material by email.

  • BehavioralWeight 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.

  • BehavioralBehavioral 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline and 6 months

Secondary outcomes

  1. 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.

    Time frame: Baseline and 6 months

Other outcomes

  1. Program participation as assessed by participant enrollment

    Examine the enrollment in each program as a measure of program participation.

    Time frame: End of enrollment, up to 2 years

  2. 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.

    Time frame: 6 months

  3. 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.

    Time frame: 6 months

  4. 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.

    Time frame: Baseline and 12 months

07

Study locations

1 site
  • Johns Hopkins ProHealth
    Baltimore, Maryland 21207, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04534309
Lead sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
Maryland Cigarette Restitution Fund
Responsible party
Sponsor
First posted
Sep 1, 2020
Start date
Sep 22, 2020
Primary completion
Dec 15, 2022
Completion
Jun 30, 2023
Last update
Oct 10, 2023

Study contacts

Jessica Yeh, Ph.D.
principal investigator · Johns Hopkins University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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