Behavioral Weight Loss Program for Cancer Survivors in Maryland

Not Applicable

Completed

• Conditions: Prostate Cancer; Gallbladder Cancer; Kidney Cancer; Bladder Cancer; Endometrial Cancer; Breast Cancer; Melanoma (Skin); Rectal Cancer
• Interventions: Behavioral: Written Weight Loss Material; Behavioral: Weight Loss App; Behavioral: Behavioral Lifestyle Weight Loss Intervention (Coaching)

• Registration Number: NCT04534309
• Lead Sponsor: 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.

Study Timeline

• Study First Submitted: 2020-08-26
• Study First Submitted QC: 2020-08-26
• Study First Posted: 2020-09-01
• Study Start: 2020-09-22
• Primary Completion: 2022-12-15
• Study Completion: 2023-06-30
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-09
• Last Update Posted: 2023-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 340

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self-Directed Weight Loss with year-long weight tracking	Written Weight Loss Material	Written Weight Loss Material.
App-Directed Weight Loss with year-long weight tracking	Weight Loss App	Smart phone Weight Loss App.
Coach-Directed Weight Loss with year-long weight tracking	Weight Loss App	Behavioral Lifestyle Weight Loss Intervention with Smart phone Weight Loss App.
Coach-Directed Weight Loss with year-long weight tracking	Behavioral Lifestyle Weight Loss Intervention (Coaching)	Behavioral Lifestyle Weight Loss Intervention with Smart phone Weight Loss App.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Johns Hopkins ProHealth; 🇺🇸 Baltimore, Maryland, United States