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BRIEF TITLE: 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


  • Org Study ID: IRB00229163
  • Secondary ID:
  • NCT ID: NCT04534309
  • NCT Alias:
  • Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins - Other
  • Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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:

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.

Overal Status Start Date Phase Study Type
Recruiting September 22, 2020 N/A Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Weight change at 6 months in Coach-Directed Program

Primary Outcome 1 - Time Frame: Baseline and 6 months

Condition:

  • Breast Cancer
  • Prostate Cancer
  • Melanoma (Skin)
  • Endometrial Cancer
  • Gallbladder Cancer
  • Rectal Cancer
  • Kidney Cancer
  • Bladder 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
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Jessica Yeh, Ph.D.

Role: Principal Investigator

Affiliation: Johns Hopkins University

Overall Contact

Name: Jessica Yeh, Ph.D.

Phone: 410-281-6100

Email: hyeh1@jhmi.edu

Location

Facility Status Contact
Johns Hopkins ProHealth
Baltimore, Maryland 21207
United States
Recruiting Linda Bunyard
410-281-1600
aspirestudy@jhmi.edu