ObesityHELP PCNCT02960542
HELP Prevent Cancer Pilot Study
A study testing HELP Prevent Cancer Intervention in people with Obesity and Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
This pilot study is designed to adapt a community-based diabetes prevention program to reach adults at risk for cancer. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- What is being tested?
- HELP Prevent Cancer Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2017to 4 Apr 2018
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English Proficiency: Able to read/understand English at or above a level sufficient to comprehend recruitment and intervention materials.
- Body Mass Index: BMI > 25 kg/m2.
Who cannot join
- Weight Loss: Currently involved in a supervised program for weight loss.
- Medications: Use of insulin or other diabetes medications that would require additional medical monitoring during weight-loss; use of medications for weight loss or that may impact weight or glucometabolic function (e.g. corticosteroids).
- Recent History of Cardiovascular Disease: Clinical history of cardiovascular disease (CVD) occurring within the past 6 months, including myocardial infarction, angina, coronary revascularization, stroke, transient ischemic attack (TIA), carotid revascularization, peripheral arterial disease, and congestive heart failure.
- Hypertension: Uncontrolled high blood pressure: BP > 160/100. Persons can be re-screened after controlled.
- Pregnancy: Pregnancy, breast feeding, or planning pregnancy within 1 year.
- Other Chronic Conditions: Other chronic disease likely to limit lifespan to less than 2-3 years, including any cancer requiring treatment in past 5 years except non-melanoma skin cancer.
Trial locations and contacts
1 site in 1 country.
United States1 site
Danville Regional Medical Center
Danville, Virginia, 24541
About this study
Official title: Healthy Living Partnerships to Prevent Cancer (HELP PC) Pilot Study
This pilot study is designed to adapt a community-based diabetes prevention program to reach adults at risk for cancer.
Read the detailed description
The Healthy Living Partnerships to Prevent Diabetes (HELP PD) study successfully translated the Diabetes Prevention Program (DPP) weight-loss lifestyle intervention in Winston-Salem, North Carolina by delivering the intervention via a partnership between a local diabetes education program with lay community health workers. This study documented a 7% weight loss and 4 mg/dl decrease in fasting blood glucose in patients with prediabetes in 1 year at promote healthy weight loss (1-2 pounds per week). These lifestyle strategies significantly lower costs than the DPP. The HELP PD lifestyle intervention focuses on restricting calories (while improving dietary quality) and increasing physical activity to allow participants to achieve an energy deficient state to are essential to reduce risk for type 2 diabetes but also for a multitude of chronic diseases where excess body weight plays a critical role in the development and exacerbation of the disease. In light of the community-based partnership on which HELP PD was based and the relatively low costs of program administration, the HELP PD model has the potential to be a highly effective and sustainable long-term approach to cancer prevention as well. This pilot study will be the initial step to determine feasibility of implementing the Healthy Living Partnerships to Prevent Cancer (HELP PC) in the Dan River Region of Southern Virginia through a partnership between researchers and colleagues from Wake Forest Comprehensive Cancer Center, Virginia Polytechnic Institute and State University, Danville Hematology and Oncology at the Danville Regional Medical Center, Resource Center of Southern Virginia in Danville, and Danville Regional Medical Center. Wake Forest will serve as the lead site in this study.
- Being tested
- HELP Prevent Cancer Intervention
- Keywords
- lifestyle intervention, weight-loss
- Medical subject headings
- Obesity, Neoplasms, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HELP Prevent Cancer InterventionBehavioural
This Behavioral: Lifestyle Weigh Loss Intervention involves a dietary weight-loss program and an increase in caloric expenditure through moderate physical activity. The primary treatment objectives for the weight-loss component of the intervention will be to decrease caloric intake in a nutritionally sound manner so as to produce a weight-loss of .3 kg/week for a total weight loss of 5-7%. The primary objective for the physical activity component of the intervention will be to promote an increase in home-based energy expenditure to an eventual goal of 180 minutes/week.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle Weight Loss | Experimental | The Behavioral: HELP Prevent Cancer Intervention is a lifestyle intervention consisting of 24-weekly group meetings led by a community health worker and 3 individual sessions with a nutritionist/diabetes educator Receives: Behavioral: HELP Prevent Cancer Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment of 20 eligible study participants
Develop and evaluate a feasible referral system to facilitate participant enrollment into the HELP PC intervention (measured by number screened and enrolled)
Measured: 6 months
Retention of study participants
Measure retention to the HELP PC intervention (measured by number of participants attending the closeout visit after 26 weeks of intervention)
Measured: 6 months
Attendance at group sessions
Assess participant adherence to attending the HELP PC intervention sessions (measured by community health worker documentation of session attendance)
Measured: 6 months
Secondary outcomes (5)
Blood Pressure
Estimate the means and standard deviations at baseline and 6 months.
Measured: 6 months
Weight
Estimate the means and standard deviations at baseline and 6 months.
Measured: 6 months
Glucose
Estimate the means and standard deviations at baseline and 6 months.
Measured: 6 months
Insulin
Estimate the means and standard deviations at baseline and 6 months.
Measured: 6 months
Cholesterol
Estimate the means and standard deviations at baseline and 6 months.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2016 (estimated)
- Study start26 Jun 2017
- Primary completion4 Apr 2018
- Study completion4 Apr 2018
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 ObesityStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Virginia Polytechnic Institute and State University, Danville Regional Medical Center
- Responsible party
- Sponsor
- Investigators
- Mara Z Vitolins, DrPH MPH RDN, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02960542
- Sponsor's protocol ID
- IRB00039102
- Acronym
- HELP PC
- Status last verified
- Jun 2020
- First submitted
- 31 Oct 2016
- Last updated
- 19 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wise Thomas S, Blackwell Young C, Zoellner J, Brock DP, Isom S, Vitolins M. Feasibility of an Adapted Community-Based Lifestyle Intervention to Prevent Cancer in the Rural South: Healthy Living Partnerships to Prevent Cancer (HELP PC). J Cancer Educ. 2023 Apr;38(2):440-447. doi: 10.1007/s13187-022-02137-z. Epub 2022 Jan 25.
PubMed 35076863
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Living Partnerships to Prevent Cancer (HELP PC) Pilot Study
- ClinicalTrials.gov ID
- NCT02960542
- Acronym / sponsor ID
- HELP PC / IRB00039102
- Keywords
- lifestyle intervention, weight-loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Virginia Polytechnic Institute and State University, Danville Regional Medical Center
- Study start
- 26 Jun 2017 (actual)
- Primary completion
- 4 Apr 2018 (actual)
- Study completion
- 4 Apr 2018 (actual)
- First posted
- 9 Nov 2016 (estimated)
- 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.
This pilot study is designed to adapt a community-based diabetes prevention program to reach adults at risk for cancer.
Detailed description
The Healthy Living Partnerships to Prevent Diabetes (HELP PD) study successfully translated the Diabetes Prevention Program (DPP) weight-loss lifestyle intervention in Winston-Salem, North Carolina by delivering the intervention via a partnership between a local diabetes education program with lay community health workers. This study documented a 7% weight loss and 4 mg/dl decrease in fasting blood glucose in patients with prediabetes in 1 year at promote healthy weight loss (1-2 pounds per week). These lifestyle strategies significantly lower costs than the DPP. The HELP PD lifestyle intervention focuses on restricting calories (while improving dietary quality) and increasing physical activity to allow participants to achieve an energy deficient state to are essential to reduce risk for type 2 diabetes but also for a multitude of chronic diseases where excess body weight plays a critical role in the development and exacerbation of the disease. In light of the community-based partnership on which HELP PD was based and the relatively low costs of program administration, the HELP PD model has the potential to be a highly effective and sustainable long-term approach to cancer prevention as well. This pilot study will be the initial step to determine feasibility of implementing the Healthy Living Partnerships to Prevent Cancer (HELP PC) in the Dan River Region of Southern Virginia through a partnership between researchers and colleagues from Wake Forest Comprehensive Cancer Center, Virginia Polytechnic Institute and State University, Danville Hematology and Oncology at the Danville Regional Medical Center, Resource Center of Southern Virginia in Danville, and Danville Regional Medical Center. Wake Forest will serve as the lead site in this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle Weight Loss | Experimental | Behavioral: HELP Prevent Cancer InterventionThe Behavioral: HELP Prevent Cancer Intervention is a lifestyle intervention consisting of 24-weekly group meetings led by a community health worker and 3 individual sessions with a nutritionist/diabetes educator |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- English Proficiency: Able to read/understand English at or above a level sufficient to comprehend recruitment and intervention materials.
- Body Mass Index: BMI > 25 kg/m2.
Key exclusion criteria (6 listed)
- Weight Loss: Currently involved in a supervised program for weight loss.
- Medications: Use of insulin or other diabetes medications that would require additional medical monitoring during weight-loss; use of medications for weight loss or that may impact weight or glucometabolic function (e.g. corticosteroids).
- Recent History of Cardiovascular Disease: Clinical history of cardiovascular disease (CVD) occurring within the past 6 months, including myocardial infarction, angina, coronary revascularization, stroke, transient ischemic attack (TIA), carotid revascularization, peripheral arterial disease, and congestive heart failure.
- Hypertension: Uncontrolled high blood pressure: BP > 160/100. Persons can be re-screened after controlled.
- Pregnancy: Pregnancy, breast feeding, or planning pregnancy within 1 year.
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 |
|---|---|---|
| HELP Prevent Cancer InterventionThis Behavioral: Lifestyle Weigh Loss Intervention involves a dietary weight-loss program and an increase in caloric expenditure through moderate physical activity. The primary treatment objectives for the weight-loss component of the intervention will be to decrease caloric intake in a nutritionally sound manner so as to produce a weight-loss of .3 kg/week for a total weight loss of 5-7%. The primary objective for the physical activity component of the intervention will be to promote an increase in home-based energy expenditure to an eventual goal of 180 minutes/week. | Behavioural | Lifestyle Weight Loss |
Primary outcome
Recruitment of 20 eligible study participants
Time frame: 6 months
Develop and evaluate a feasible referral system to facilitate participant enrollment into the HELP PC intervention (measured by number screened and enrolled)
Retention of study participants
Time frame: 6 months
Measure retention to the HELP PC intervention (measured by number of participants attending the closeout visit after 26 weeks of intervention)
Attendance at group sessions
Time frame: 6 months
Assess participant adherence to attending the HELP PC intervention sessions (measured by community health worker documentation of session attendance)
5 secondary outcomes
Blood Pressure
Time frame: 6 months
Weight
Time frame: 6 months
Glucose
Time frame: 6 months
Insulin
Time frame: 6 months
Cholesterol
Time frame: 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 19 Jun 2020.
- Derived from this study: PubMed 35076863Wise Thomas S, Blackwell Young C, Zoellner J, Brock DP, Isom S, Vitolins M. Feasibility of an Adapted Community-Based Lifestyle Intervention to Prevent Cancer in the Rural South: Healthy Living Partnerships to Prevent Cancer (HELP PC). J Cancer Educ. 2023 Apr;38(2):440-447. doi: 10.1007/s13187-022-02137-z. Epub 2022 Jan 25.
- 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.
Mara Z Vitolins, DrPH MPH RDN principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HELP Prevent Cancer Intervention in people with Obesity and Cancer, run by Wake Forest University Health Sciences 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 2 inclusion and 6 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 19 Jun 2020. 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?
Recruitment of 20 eligible study participants (time frame: 6 months). The study lists 3 primary outcomes in all. 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 NCT02960542, 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 19 Jun 2020.