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

Johns Hopkins Medicine

Status: Enrolling

Conditions: Weight Loss

Treatments: Behavioral: Enhanced Helpline; Behavioral: CORE Helpline; Behavioral: Intensive Helpline; Behavioral: Extended Helpline

Study type: Interventional

Funder types: Other

Identifiers

NCT06463249

IRB00403808

Details and patient eligibility

About

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)

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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200 participants in 4 patient groups

Intensive Helpline

Experimental group

Description:

Participants receive 2 scheduled coaching calls/month and individualized coach-scripted feedback via emails twice/month for 6 months.

Treatment:

Behavioral: Intensive Helpline

Behavioral: CORE Helpline

Enhanced Helpline

Active Comparator group

Description:

Participants receive 1 participant-initiated call/month. Additionally, the participants receive individualized coach-scripted feedback via emails twice/month for 6 months

Treatment:

Behavioral: CORE Helpline

Behavioral: Enhanced Helpline

Extended Helpline

Other group

Description:

Participants who achieved 2% weight loss at 2-month, will continue to Extended Helpline, where the participants can continue receiving 1-on-1 coaching through 1 participant-initiated calls per month for 6 months.

Treatment:

Behavioral: Extended Helpline

Behavioral: CORE Helpline

CORE Helpline

Other group

Description:

All participants will receive the CORE Helpline program for 2 months

Treatment:

Behavioral: CORE Helpline