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

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

NCT ID: NCT06463249

Condition: Weight Loss

Conditions: Official terms:
Body Weight
Weight Loss

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Sequential Assignment

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

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: CORE Helpline
Description: 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.
Arm group label: CORE Helpline
Arm group label: Enhanced Helpline
Arm group label: Extended Helpline
Arm group label: Intensive Helpline

Intervention type: Behavioral
Intervention name: Extended Helpline
Description: 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.
Arm group label: Extended Helpline

Intervention type: Behavioral
Intervention name: Enhanced Helpline
Description: 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.
Arm group label: Enhanced Helpline

Intervention type: Behavioral
Intervention name: Intensive Helpline
Description: 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.
Arm group label: Intensive Helpline

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Johns Hopkins ProHealth

Address:
City: Baltimore
Zip: 21207
Country: United States

Status: Recruiting

Contact:
Last name: Linda Bunyard, MS, RD

Phone: 410-281-6168
Email: lbunyar1@jh.edu

Start date: June 17, 2024

Completion date: December 2027

Lead sponsor:
Agency: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Agency class: Other

Collaborator:
Agency: Maryland Cigarette Restitution Fund
Agency class: Other

Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06463249