ASPIRE: Behavioral Weight Loss Program for Cancer Survivors in Maryland

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (Other)
Overall Status
Recruiting
CT.gov ID
NCT04534309
Collaborator
Maryland Cigarette Restitution Fund (Other)
300
Enrollment
1
Location
3
Arms
32.3
Anticipated Duration (Months)
9.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or DiseaseIntervention/TreatmentPhase
  • Behavioral: Written Weight Loss Material
  • Behavioral: Weight Loss App
  • Behavioral: Behavioral Lifestyle Weight Loss Intervention (Coaching)
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Behavioral Weight Loss for Overweight and Obese Cancer Survivors in Maryland: A Demonstration Project
Actual Study Start Date :
Sep 22, 2020
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

ArmIntervention/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.

Outcome Measures

Primary Outcome Measures

  1. Weight change at 6 months in Coach-Directed Program [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 Outcome Measures

  1. Weight change at 6 months in Self-Directed and App-Directed Weight Loss Programs [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 Outcome Measures

  1. Program participation as assessed by participant enrollment [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 [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 [6 months]

    Evaluate the implementation of the Coach-Directed Weight Loss Program through a participant survey.

  4. Weight change at 12 months by program [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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:
  • 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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Johns Hopkins ProHealthBaltimoreMarylandUnited States21207

Sponsors and Collaborators

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Maryland Cigarette Restitution Fund

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier:
NCT04534309
Other Study ID Numbers:
  • IRB00229163
First Posted:
Sep 1, 2020
Last Update Posted:
Oct 14, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 14, 2021