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NCT06463249 | RECRUITING | Weight Loss

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

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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)

Condition or disease

Weight Loss

Intervention/treatment

CORE Helpline

Extended Helpline

Enhanced Helpline

Intensive Helpline

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 200 participants
Masking : NONE
Primary Purpose : TREATMENT
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)
Actual Study Start Date : 2024-06-17
Estimated Primary Completion Date : 2026-12
Estimated Study Completion Date : 2027-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Behavioral Weight Loss for Cancer Survivors in Maryland: A Trial With Adaptive Interventions

Location Details

NCT06463249

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How to Participate

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Locations

RECRUITING

United States, Maryland

Johns Hopkins ProHealth

Baltimore, Maryland, United States, 21207