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Completed

NCT Number: NCT04534309

Behavioral Weight Loss Program for Cancer Survivors in Maryland

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Written Weight Loss Material

Behavioral

Participants will receive written weight loss material by email.

Weight Loss App

Behavioral

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)

Behavioral

Participants will receive weekly coaching phone calls to encourage regular dietary, exercise, and self-monitoring practices which encourage gradual, healthy weight loss.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Other

Collaborators

  • Maryland Cigarette Restitution Fund

Registry information

Official study title

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

Acronym: ASPIRE

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Sep 1, 2020
Registry last updated
Oct 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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