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Behavioural Intervention

Behavioral Weight Loss for Obese Cancer Survivors (Helpline Trial)

N/A
Recruiting
Led By Jessica Yeh, PhD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have a BMI ≥ 27 kg/m2 (BMI ≥ 25 kg/m2 for Asians) and weight ≤ 400 lbs.
Have adequate data plan and cell service to support daily use of weight loss app, receive text messages and to support coaching calls
Must not have
Bariatric surgery scheduled within the next 12 months
Weight loss or gain of >5.0% of body weight during 2 months prior to screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to compare different weight loss programs for cancer survivors who are overweight or obese and did not lose enough weight in the initial phase of the intervention. The study will use a randomized controlled trial design

Who is the study for?
This trial is for cancer survivors living in Maryland who are overweight or obese and haven't had success with initial weight loss efforts. Participants should be early non-responders to the CORE Helpline intervention, which all participants receive for the first two months.
What is being tested?
The study tests two augmented interventions: Enhanced Helpline and Intensive Helpline, each lasting an additional six months. It aims to see which helps early non-responders lose weight more effectively after not meeting goals with just the CORE Helpline.
What are the potential side effects?
Since this trial involves behavioral interventions like helplines rather than medication, typical medical side effects are not expected. However, participants may experience stress or frustration if they do not achieve desired weight loss.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My BMI is over 27, or over 25 if I'm Asian, and I weigh less than or equal to 400 lbs.
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I have a good cell service and data plan for daily app use, texts, and coaching calls.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am scheduled for weight loss surgery within a year.
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My weight changed by more than 5% in the last 2 months.
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I am currently breastfeeding, pregnant, or planning to become pregnant soon.
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I am not taking medication that majorly affects my weight, like steroids or certain diabetes/weight loss drugs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Weight (pounds) changes at 8 months from 2-month between Enhanced Helpline and Intensive Helpline arms
Secondary study objectives
Weight (pounds) change at 5 and 12 months from 2-month between Enhanced Helpline and Intensive Helpline arms
Other study objectives
Weight (pounds) change from baseline to 2 months in all participants
Within-program weight (pounds) changes from baseline to 5, 8, and 12 months in all programs

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Intensive HelplineExperimental Treatment2 Interventions
Participants receive 2 scheduled coaching calls/month and individualized coach-scripted feedback via emails twice/month for 6 months.
Group II: Extended HelplineExperimental Treatment2 Interventions
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.
Group III: CORE HelplineExperimental Treatment1 Intervention
All participants will receive the CORE Helpline program for 2 months
Group IV: Enhanced HelplineActive Control2 Interventions
Participants receive 1 participant-initiated call/month. Additionally, the participants receive individualized coach-scripted feedback via emails twice/month for 6 months

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
570 Previous Clinical Trials
33,030 Total Patients Enrolled
1 Trials studying Obesity
30 Patients Enrolled for Obesity
Maryland Cigarette Restitution FundOTHER_GOV
8 Previous Clinical Trials
657 Total Patients Enrolled
Jessica Yeh, PhDPrincipal InvestigatorJohns Hopkins University
1 Previous Clinical Trials
121 Total Patients Enrolled
~133 spots leftby Dec 2026
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