Clinical trial NCT06463249: Behavioral Weight Loss for Cancer Survivors in Maryland: A Trial With Adaptive Interventions
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Weight Loss
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: Maryland Cigarette Restitution Fund
First posted: 2024-06-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: All participants will receive Core Helpline intervention in the first two months. If participants achieve 2% or more weight loss in two months (i.e. early responders), they will continue to the Extended Helpline. If participants do not achieve at least 2% of weight loss in two months (i.e. early non-responders), they will be randomized to one of two stepped-up interventions: Enhanced Helpline or Intensive Helpline.
Primary purpose: TREATMENT

Brief 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)

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Weight (pounds) changes at 8 months from 2-month between Enhanced Helpline and Intensive Helpline arms
timeFrame: 8 months
Secondary outcomes:
measure: Weight (pounds) change at 5 and 12 months from 2-month between Enhanced Helpline and Intensive Helpline arms
timeFrame: 12 months
Other outcomes:
measure: Weight (pounds) change from baseline to 2 months in all participants
timeFrame: 2 months
measure: Within-program weight (pounds) changes from baseline to 5, 8, and 12 months in all programs
timeFrame: 12 months
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins ProHealth
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Jessica Yeh, PhD
role: PRINCIPAL_INVESTIGATOR
References: