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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT06463249
Status
Recruiting
Apply to this trial

Conditions

  • Weight Loss

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CORE Helpline — BEHAVIORAL
    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.
  • Extended Helpline — BEHAVIORAL
    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.
  • Enhanced Helpline — BEHAVIORAL
    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.
  • Intensive Helpline — BEHAVIORAL
    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.

Study Details

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)

Key Dates

Start date
Jun 17, 2024
Status verified
Jul 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Intensive Helpline
    Participants receive 2 scheduled coaching calls/month and individualized coach-scripted feedback via emails twice/month for 6 months.
  • Active Comparator: Enhanced Helpline
    Participants receive 1 participant-initiated call/month. Additionally, the participants receive individualized coach-scripted feedback via emails twice/month for 6 months
  • Other: Extended Helpline
    Participants who achieved 2% weight loss at 2-month, will continue to Extended Helpline, where the participants can continue receiving 1-on-1 coaching through 1 participant-initiated calls per month for 6 months.
  • Other: CORE Helpline
    All participants will receive the CORE Helpline program for 2 months

Primary Outcome Measure

Weight (pounds) changes at 8 months from 2-month between Enhanced Helpline and Intensive Helpline arms [ Time Frame: 8 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins ProHealthBaltimoreMaryland21207
Linda Bunyard, MS, RD
[email protected]
410-281-6168

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By research site
Johns Hopkins ProHealth· Baltimore, MD

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