Weight LossHelplineNCT06463249
Behavioral Weight Loss for Cancer Survivors in Maryland: A Trial With Adaptive Interventions
A study testing CORE Helpline, Extended Helpline and Enhanced Helpline in people with Weight Loss, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weight Loss
- What is being tested?
- CORE Helpline, Extended Helpline and Enhanced Helpline
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2024to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
- CORE Helpline in all participants (first 2 months)
- Extended Helpline in early responders (additional 6 months)
- Enhanced Helpline in early non-responders (additional 6 months)
- Intensive Helpline in early non-responders (additional 6 months)
Read the 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.
- Conditions
- Weight Loss
- Being tested
- CORE Helpline, Extended Helpline, Enhanced Helpline, Intensive Helpline
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CORE HelplineBehavioural
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 HelplineBehavioural
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 HelplineBehavioural
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 HelplineBehavioural
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 group | Role | What they receive |
|---|---|---|
| Intensive Helpline | Experimental | Participants receive 2 scheduled coaching calls/month and individualized coach-scripted feedback via emails twice/month for 6 months. Receives: Behavioral: CORE Helpline; Behavioral: Intensive Helpline |
| Enhanced Helpline | Active comparator | Participants receive 1 participant-initiated call/month. Additionally, the participants receive individualized coach-scripted feedback via emails twice/month for 6 months Receives: Behavioral: CORE Helpline; Behavioral: Enhanced Helpline |
| Extended Helpline | Other | 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. Receives: Behavioral: CORE Helpline; Behavioral: Extended Helpline |
| CORE Helpline | Other | All participants will receive the CORE Helpline program for 2 months Receives: Behavioral: CORE Helpline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight (pounds) changes at 8 months from 2-month between Enhanced Helpline and Intensive Helpline arms
Weight change for Enhanced Helpline and Intensive Helpline in early non-responders
Measured: 8 months
Secondary outcomes (1)
Weight (pounds) change at 5 and 12 months from 2-month between Enhanced Helpline and Intensive Helpline arms
Weight change for Enhanced Helpline and Intensive Helpline in early non-responders
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start17 Jun 2024
- Primary completionJul 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- All participants will receive Core Helpline intervention in the first two months. If participants achieve 2% or more weight loss in two months (i.e. early responders), they will continue to the Extended Helpline. If participants do not achieve at least 2% of weight loss in two months (i.e. early non-responders), they will be randomized to one of two stepped-up interventions: Enhanced Helpline or Intensive Helpline.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Maryland Cigarette Restitution Fund
- Responsible party
- Sponsor
- Investigators
- Jessica Yeh, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06463249
- Sponsor's protocol ID
- IRB00403808
- Acronym
- Helpline
- Status last verified
- Jul 2026
- First submitted
- 12 Jun 2024
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06463249
- Acronym / sponsor ID
- Helpline / IRB00403808
- Conditions
- Weight Loss
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Maryland Cigarette Restitution Fund
- Study start
- 17 Jun 2024 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 17 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- CORE Helpline in all participants (first 2 months)
- Extended Helpline in early responders (additional 6 months)
- Enhanced Helpline in early non-responders (additional 6 months)
- Intensive Helpline in early non-responders (additional 6 months)
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- All participants will receive Core Helpline intervention in the first two months. If participants achieve 2% or more weight loss in two months (i.e. early responders), they will continue to the Extended Helpline. If participants do not achieve at least 2% of weight loss in two months (i.e. early non-responders), they will be randomized to one of two stepped-up interventions: Enhanced Helpline or Intensive Helpline.
| Arm | Type | Receives |
|---|---|---|
| Intensive Helpline | Experimental | Behavioral: CORE Helpline, Behavioral: Intensive HelplineParticipants receive 2 scheduled coaching calls/month and individualized coach-scripted feedback via emails twice/month for 6 months. |
| Enhanced Helpline | Active comparator | Behavioral: CORE Helpline, Behavioral: Enhanced HelplineParticipants receive 1 participant-initiated call/month. Additionally, the participants receive individualized coach-scripted feedback via emails twice/month for 6 months |
| Extended Helpline | Other | Behavioral: CORE Helpline, Behavioral: Extended HelplineParticipants 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. |
| CORE Helpline | Other | Behavioral: CORE HelplineAll participants will receive the CORE Helpline program for 2 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (8 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CORE HelplineAll 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. | Behavioural | CORE Helpline, Enhanced Helpline, Extended Helpline, Intensive Helpline |
| Extended HelplineThose 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. | Behavioural | Extended Helpline |
| Enhanced HelplineThose 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. | Behavioural | Enhanced Helpline |
| Intensive HelplineThose 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. | Behavioural | Intensive Helpline |
Primary outcome
Weight (pounds) changes at 8 months from 2-month between Enhanced Helpline and Intensive Helpline arms
Time frame: 8 months
Weight change for Enhanced Helpline and Intensive Helpline in early non-responders
1 secondary outcome
Weight (pounds) change at 5 and 12 months from 2-month between Enhanced Helpline and Intensive Helpline arms
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Yeh, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CORE Helpline, Extended Helpline and Enhanced Helpline in people with Weight Loss, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (pounds) changes at 8 months from 2-month between Enhanced Helpline and Intensive Helpline arms (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.