Behavioral Weight Loss for Cancer Survivors in Maryland: A Trial With Adaptive Interventions

Weight Loss Clinical Trial

— Helpline  

Official title:

Scaling up Behavioral Weight Loss Opportunities for Cancer Survivors With Overweight or Obesity in Maryland: A Randomized Trial With Adaptive Interventions (Helpline for Weight Loss)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06463249
• Other study ID #: IRB00403808
• Status: Recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: December 2027

Study information

• Verified date: June 2024
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: Jessica Yeh, PhD
• Phone: 410-614-4316
• Email: hyeh1[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of the HELPLINE Weight Loss Program is to determine the comparative effectiveness of two active multi-component, augmented interventions for cancer survivors with overweight or obesity who do not achieve early weight loss goal in the initial intervention period (termed, early non-responders). The core study design is randomized controlled trial with adaptive intervention.

1. CORE Helpline in all participants (first 2 months)

2. Extended Helpline in early responders (additional 6 months)

3. Enhanced Helpline in early non-responders (additional 6 months)

4. Intensive Helpline in early non-responders (additional 6 months)

Description:

All participants will receive

• written Johns Hopkins weight loss material

• instructions for using a smartphone weight loss app to keep track of food and exercise every day (either android or iPhone)

• a weekly weight loss tip by text message and email, and a text message on weight loss progress each week

• a research scale and specific instructions for verifying weights at 5 specific times over the next year.

The participants may also request two 20-minute phone calls during the first 2 months with a weight loss coach.

After the first 2 months, depending on weight loss progress, the participants will be assigned to another program which may include additional assistance for 6 more months.

Additional assistance may include scheduled phone calls with a Johns Hopkins weight loss coach each month, individualized emails from a Johns Hopkins weight loss coach, and the option for daily text message reminders.

After the first 8 months of assistance, the participants will continue the program on the participant's own for 4 more months and provide the study team with final weights 12 months after the start of the program.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Women and men ages 18 or older

• Able to complete all study requirements in English

• Have been previously diagnosed with a malignant solid tumor, completed the required surgical, and/or chemotherapy and/or radiation curative intent therapy at least three months prior to enrollment, and have an anticipated treatment-free life span of 12 months or longer. Chemoprophylaxis with tamoxifen or aromatase inhibitors for breast cancer in women and anti- luteinizing hormone-releasing hormone (LHRH) therapy for prostate cancer in men will be permitted.

• Have a BMI = 27 kg/m2 (BMI = 25 kg/m2 for Asians) and weight = 400 lbs.

• Have an email address for regular personal use

• Have a smartphone for personal use, and are willing to use the phone to read emails and text messages, and use an app

• Have adequate data plan and cell service to support daily use of weight loss app, receive text messages and to support coaching calls

• Are willing to record weekly weights

• Are willing to use a tracking app to log food and exercise daily

• Are willing to complete coaching calls as planned

• Are willing to prioritize weight loss efforts by making dietary changes and increasing physical activity

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

• 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 medications known to substantially affect body weight, including chronic oral steroids, Tirzepatide (Mounjaro™), and weight loss doses of other glucagon-like peptide 1 (GLP-1) agonists (e.g. Wegovy.)

• bariatric surgery scheduled within the next 12 months

• plan to move outside the continental United States in the next 12 months

• Weight loss or gain of >5.0% of body weight during 2 months prior to screening

Related Conditions & MeSH terms

• Body Weight
• Weight Loss

Intervention

Behavioral:
• CORE Helpline
All participants will receive the Core Helpline program (CORE) for 2 months, which includes written weight loss material, use of a smartphone app, weekly text messages and email reminders and 1 optional participant-initiated coaching call per month.
• Extended Helpline
Those who achieved 2% weight loss at 2-month, will continue to Extended Helpline, where the participants can continue receiving all CORE resources including1-on-1 coaching through 1 optional participant-initiated call per month for 6 months.
• Enhanced Helpline
Those who do not reach 2% weight loss at the end of 2 months will be randomized. Participants will continue to receive all CORE resources plus 1 optional participant-initiated call/month for 6 months. Additionally, the participants will receive 2 individualized coach-scripted feedback emails per month, and the option to receive daily text message reminders.
• Intensive Helpline
Those who do not reach 2% weight loss at the end of 2 months will be randomized. Participants will continue to receive all CORE resources plus 2 scheduled coaching calls/month for 6 months. Additionally, the participants will receive 2 individual coach-scripted feedback emails per month, and the option to receive daily text message reminders.

Locations

Country	Name	City	State
United States	Johns Hopkins ProHealth	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Maryland Cigarette Restitution Fund

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Weight (pounds) change from baseline to 2 months in all participants	Weight change for CORE Helpline over the first 2 months in all participants	2 months
Other	Within-program weight (pounds) changes from baseline to 5, 8, and 12 months in all programs	Weight change for each program over 12 months	12 months
Primary	Weight (pounds) changes at 8 months from 2-month between Enhanced Helpline and Intensive Helpline arms	Weight change for Enhanced Helpline and Intensive Helpline in early non-responders	8 months
Secondary	Weight (pounds) change at 5 and 12 months from 2-month between Enhanced Helpline and Intensive Helpline arms	Weight change for Enhanced Helpline and Intensive Helpline in early non-responders	12 months