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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

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

0 / 6Eligibility criteria met