Clinical trial · Interventional
Behavioral Weight Loss for Cancer Survivors in Maryland: A Trial With Adaptive Interventions
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Weight Loss | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CORE Helpline | Behavioral | — | UNRESOLVED |
| Enhanced Helpline | Behavioral | — | UNRESOLVED |
| Extended Helpline | Behavioral | — | UNRESOLVED |
| Intensive Helpline | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Intensive Helpline
- description
- Participants receive 2 scheduled coaching calls/month and individualized coach-scripted feedback via emails twice/month for 6 months.
- interventionNames
- Behavioral: CORE Helpline
- Behavioral: Intensive Helpline
- type
- ACTIVE_COMPARATOR
- label
- Enhanced Helpline
- description
- Participants receive 1 participant-initiated call/month. Additionally, the participants receive individualized coach-scripted feedback via emails twice/month for 6 months
- interventionNames
- Behavioral: CORE Helpline
- Behavioral: Enhanced Helpline
- type
- OTHER
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available