Breast CancerASPIRENCT04534309
Behavioral Weight Loss Program for Cancer Survivors in Maryland
A study testing Written Weight Loss Material, Weight Loss App and Behavioral Lifestyle Weight Loss Intervention (Coaching) in people with Breast Cancer and Prostate Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
Behavioral Weight Loss for Overweight and Obese Cancer Survivors in Maryland: A Demonstration Project Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Prostate Cancer, Melanoma (Skin)
- What is being tested?
- Written Weight Loss Material, Weight Loss App and Behavioral Lifestyle Weight Loss Intervention (Coaching)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2020to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- previously diagnosed with a malignant solid tumor,
- completed all required surgical, and/or chemotherapy and/or radiation curative intent therapy at least three months prior to enrollment,
- anticipated treatment-free life span of 12 months or longer.
- chemoprophylaxis with tamoxifen or aromatase inhibitors for breast cancer in women will be permitted
- anti- Luteinizing-hormone releasing therapy for prostate cancer in men will be permitted.
- BMI ≥ 25 kg/m2 (BMI ≥ 23 kg/m2 for Asians) and weight ≤ 400 lbs.
Show all 22Show fewer
- have an email address for regular personal use
- Additional criteria for participants in weight tracking (self-directed or app directed)
- willingness to record/transmit quarterly weights for 12 months
- Additional criteria for App-Directed Program:
- willingness to change diet and increase physical activity and track weight, diet and physical activity
- have a smart phone for personal use
- sufficient data plan/Internet to support daily use of weight loss app*
- Additional Criteria for Coach-Directed Weight Loss Program
- willingness to lose weight by changing diet and physical activity habits
- willingness to track weight, diet and physical activity
- willingness to record/transmit quarterly weights for 12 months
- smart phone for personal use
- data plan/Internet to support daily use of weight loss app*
- willingness to complete coaching calls (12 weekly calls and 3 monthly calls)
- sufficient call plan to support coaching calls
- a corresponding website could be used, then daily Internet access is required for person use.
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
- Additional exclusion criteria for participants in weight tracking and/or Coach-Directed Program
- 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 steroids or other medication known to affect body weight
- bariatric surgery scheduled within the next 6 months, or
- plan to move outside the continental US in the next 12 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Behavioral Weight Loss for Overweight and Obese Cancer Survivors in Maryland: A Demonstration Project
Behavioral Weight Loss for Overweight and Obese Cancer Survivors in Maryland: A Demonstration Project
Read the detailed description
The objective of the ASPIRE Project is to design, implement, and evaluate a real-world, lifestyle-based, support for overweight or obese cancer survivors in both urban and rural areas of Maryland. The project will provide three options of support to encourage lifestyle change to achieve and maintain a healthy weight for cancer survivors:
- Self-Directed Weight Loss: educational materials only;
- App-Directed Weight Loss: educational materials, weight loss app with weekly e-mail support; and
- Coach-Directed Weight Loss: educational materials, weight loss app, weekly e-mail support and one-to-one weekly telephonic coach support.
- Conditions
- Breast Cancer, Prostate Cancer, Melanoma (Skin), Endometrial Cancer, Gallbladder Cancer, Rectal Cancer
- Being tested
- Written Weight Loss Material, Weight Loss App, Behavioral Lifestyle Weight Loss Intervention (Coaching)
- Medical subject headings
- Breast Neoplasms, Prostatic Neoplasms, Melanoma, Endometrial Neoplasms, Gallbladder Neoplasms, Rectal Neoplasms, Kidney Neoplasms, Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Written Weight Loss MaterialBehavioural
Participants will receive written weight loss material by email.
Weight Loss AppBehavioural
Participants will receive written weight loss material as well as instructions for using a free weight loss app on their phone or computer.
Behavioral Lifestyle Weight Loss Intervention (Coaching)Behavioural
Participants will receive weekly coaching phone calls to encourage regular dietary, exercise, and self-monitoring practices which encourage gradual, healthy weight loss.
| Study group | Role | What they receive |
|---|---|---|
| Self-Directed Weight Loss with year-long weight tracking | Other | Written Weight Loss Material. Receives: Behavioral: Written Weight Loss Material |
| App-Directed Weight Loss with year-long weight tracking | Other | Smart phone Weight Loss App. Receives: Behavioral: Weight Loss App |
| Coach-Directed Weight Loss with year-long weight tracking | Other | Behavioral Lifestyle Weight Loss Intervention with Smart phone Weight Loss App. Receives: Behavioral: Weight Loss App; Behavioral: Behavioral Lifestyle Weight Loss Intervention (Coaching) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight change at 6 months in Coach-Directed Program
Evaluate the "effectiveness" of the Coach-Directed weight loss programs in a real world setting by examining weight change [in kilograms (kg)] at 6-months.
Measured: Baseline and 6 months
Secondary outcomes (1)
Weight change at 6 months in Self-Directed and App-Directed Weight Loss Programs
Evaluate the "effectiveness" of the Self-Directed and App-Directed weight loss programs in a real world setting by examining weight change [in kilograms (kg)] at 6-months.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2020
- Study start22 Sep 2020
- Primary completion15 Dec 2022
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Maryland Cigarette Restitution Fund
- Responsible party
- Sponsor
- Investigators
- Jessica Yeh, Ph.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04534309
- Sponsor's protocol ID
- IRB00229163
- Acronym
- ASPIRE
- Status last verified
- Oct 2023
- First submitted
- 26 Aug 2020
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jerome GJ, Appel LJ, Bunyard L, Dalcin AT, Durkin N, Charleston JB, Kanarek NF, Carducci MA, Wang NY, Yeh HC. Behavioral Weight Loss Programs for Cancer Survivors Throughout Maryland: Protocol for a Pragmatic Trial and Participant Characteristics. JMIR Res Protoc. 2024 Jun 12;13:e54126. doi: 10.2196/54126.
PubMed 38865181
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Weight Loss for Overweight and Obese Cancer Survivors in Maryland: A Demonstration Project
- ClinicalTrials.gov ID
- NCT04534309
- Acronym / sponsor ID
- ASPIRE / IRB00229163
- Conditions
- Breast Cancer, Prostate Cancer, Melanoma (Skin), Endometrial Cancer, Gallbladder Cancer, Rectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Maryland Cigarette Restitution Fund
- Study start
- 22 Sep 2020 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 1 Sep 2020 (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.
Behavioral Weight Loss for Overweight and Obese Cancer Survivors in Maryland: A Demonstration Project
Detailed description
The objective of the ASPIRE Project is to design, implement, and evaluate a real-world, lifestyle-based, support for overweight or obese cancer survivors in both urban and rural areas of Maryland. The project will provide three options of support to encourage lifestyle change to achieve and maintain a healthy weight for cancer survivors:
- Self-Directed Weight Loss: educational materials only;
- App-Directed Weight Loss: educational materials, weight loss app with weekly e-mail support; and
- Coach-Directed Weight Loss: educational materials, weight loss app, weekly e-mail support and one-to-one weekly telephonic coach support.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Self-Directed Weight Loss with year-long weight tracking | Other | Behavioral: Written Weight Loss MaterialWritten Weight Loss Material. |
| App-Directed Weight Loss with year-long weight tracking | Other | Behavioral: Weight Loss AppSmart phone Weight Loss App. |
| Coach-Directed Weight Loss with year-long weight tracking | Other | Behavioral: Weight Loss App, Behavioral: Behavioral Lifestyle Weight Loss Intervention (Coaching)Behavioral Lifestyle Weight Loss Intervention with Smart phone Weight Loss App. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- previously diagnosed with a malignant solid tumor,
- completed all required surgical, and/or chemotherapy and/or radiation curative intent therapy at least three months prior to enrollment,
- anticipated treatment-free life span of 12 months or longer.
- chemoprophylaxis with tamoxifen or aromatase inhibitors for breast cancer in women will be permitted
- anti- Luteinizing-hormone releasing therapy for prostate cancer in men will be permitted.
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
- Additional exclusion criteria for participants in weight tracking and/or Coach-Directed Program
- 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
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 |
|---|---|---|
| Written Weight Loss MaterialParticipants will receive written weight loss material by email. | Behavioural | Self-Directed Weight Loss with year-long weight tracking |
| Weight Loss AppParticipants will receive written weight loss material as well as instructions for using a free weight loss app on their phone or computer. | Behavioural | App-Directed Weight Loss with year-long weight tracking, Coach-Directed Weight Loss with year-long weight tracking |
| Behavioral Lifestyle Weight Loss Intervention (Coaching)Participants will receive weekly coaching phone calls to encourage regular dietary, exercise, and self-monitoring practices which encourage gradual, healthy weight loss. | Behavioural | Coach-Directed Weight Loss with year-long weight tracking |
Primary outcome
Weight change at 6 months in Coach-Directed Program
Time frame: Baseline and 6 months
Evaluate the "effectiveness" of the Coach-Directed weight loss programs in a real world setting by examining weight change [in kilograms (kg)] at 6-months.
1 secondary outcome
Weight change at 6 months in Self-Directed and App-Directed Weight Loss Programs
Time frame: Baseline and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Derived from this study: PubMed 38865181Jerome GJ, Appel LJ, Bunyard L, Dalcin AT, Durkin N, Charleston JB, Kanarek NF, Carducci MA, Wang NY, Yeh HC. Behavioral Weight Loss Programs for Cancer Survivors Throughout Maryland: Protocol for a Pragmatic Trial and Participant Characteristics. JMIR Res Protoc. 2024 Jun 12;13:e54126. doi: 10.2196/54126.
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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, Ph.D. 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 Written Weight Loss Material, Weight Loss App and Behavioral Lifestyle Weight Loss Intervention (Coaching) in people with Breast Cancer and Prostate Cancer, 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 22 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: finished, as of the sponsor's last update on 10 Oct 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 change at 6 months in Coach-Directed Program (time frame: Baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04534309, which also lists 1 linked publication.
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 10 Oct 2023.