RecruitingInterventional

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)

NCT ID: NCT06463249Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLast updated: 2025-07-20

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.

Arms & interventions

BehavioralCORE 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.
BehavioralExtended 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.
BehavioralEnhanced 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.
BehavioralIntensive 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.

Outcome measures

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
Time frame: 8 months

Secondary

Weight (pounds) change at 5 and 12 months from 2-month between Enhanced Helpline and Intensive Helpline arms
Time frame: 12 months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No

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

Study locations (1)

Johns Hopkins ProHealth

Baltimore, Maryland, 21207

Recruiting

Linda Bunyard, MS, RD · Contact

410-281-6168 lbunyar1@jh.edu