Blood PressureNCT03700710
Remote Dietary Counseling to Promote Healthy Diet and Blood Pressure
A study testing Self-Guided Approach and Dietitian-led Approach in people with Blood Pressure and High Blood Pressure, run by Geisinger Clinic at 2 sites in United States.
Trial summary
American College of Cardiology/American Heart Association (ACC/AHA) hypertension guidelines recommend lifestyle modification for patients with elevated blood pressure. While eating a Dietary Approaches to Stop Hypertension (DASH)-type diet, increasing physical activity, and weight loss have been shown to reduce blood… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure, High Blood Pressure, Dietary Modification
- What is being tested?
- Self-Guided Approach and Dietitian-led Approach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 187 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Jan 2019to 30 Jun 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 24-hour ambulatory SBP 120-160 mmHg
- BMI ≥ 25 kg/m2
- Access to a telephone
- Access to a computer or smartphone with internet access
- Complete dietary data entry for at least 5 out of 7 days during run-in period
- Enter weight into the platform during run-in period
Who cannot join
- Inability to understand English
- Myocardial infarction, stroke, or atherosclerotic cardiovascular disease procedure within last 6 months.
- Current treatment for malignancy
- Planned or previous bariatric surgery
- Pregnant, breast-feeding, or planned pregnancy prior to the end of participation
- Self-reported average consumption of > 21 alcoholic beverages per week or binge drinking.
Show all 11Show fewer
- Psychiatric hospitalization in past year
- Current symptoms of angina
- Planning to leave the area prior to end of the study
- Current participation in another clinical trial
- Principal investigator discretion (i.e. concerns about safety, compliance)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Geisinger Medical Center
Danville, Pennsylvania, 17822
Geisinger Wyoming Valley
Wilkes-Barre, Pennsylvania, 18711
About this study
Official title: Remote Dietary Counseling Using Web-based Tools to Promote Healthy Diet and Blood Pressure (Healthy BP)
American College of Cardiology/American Heart Association (ACC/AHA) hypertension guidelines recommend lifestyle modification for patients with elevated blood pressure. While eating a Dietary Approaches to Stop Hypertension (DASH)-type diet, increasing physical activity, and weight loss have been shown to reduce blood pressure, limited resources are available in the primary care setting to help patients make these changes.
In this study, the investigators will compare the efficacy of a self-guided vs. dietitian-led approach using web-based lifestyle modification tools to reduce weight, improve dietary quality, and lower blood pressure in overweight/obese adults with elevated blood pressure.
Read the detailed description
Goals that all participants will be instructed to target include: 1) weight loss >=3% at 3 months; 2) consume a healthier dietary pattern (high in fruits, vegetables, whole grains, low-fat dairy, vegetable/fish/poultry sources of protein, healthier sources of fat, and avoid sugar and salt); 3) reduce sodium intake to <2300 mg/d; 4) at least 180 min/wk of moderate-intensity physical activity.
- Being tested
- Self-Guided Approach, Dietitian-led Approach
- Keywords
- lifestyle modification, DASH diet, weight loss, exercise
- Medical subject headings
- Hypertension, Overweight, Obesity, Weight Loss, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Guided ApproachBehavioural
For a 12-week period, patients will be asked to access the web platform (Evolve, formerly BMIQ), review educational materials, and enter dietary information.
From January 2019 to February 2021, participants used an earlier version of the platform, which was used in tandem with LoseIt (www.loseit.com), a meal-logging app that integrated with the platform.
In February 2021, a platform update occurred (Evolve) where the core tenets of the program remained the same and included the dietary data entry directly on the platform.
Dietitian-led ApproachBehavioural
For a 12-week period, patients will be asked to access the web platform (Evolve, formerly BMIQ), review educational materials, and enter dietary information.
From January 2019 to February 2021, participants used an earlier version of the platform, which was used in tandem with LoseIt (www.loseit.com), a meal-logging app that integrated with the platform.
In February 2021, a platform update occurred (Evolve) where the core tenets of the program remained the same and included the dietary data entry directly on the platform.
Dietitians will access the web platform and provided personalized motivational interview phone calls on a weekly basis.
| Study group | Role | What they receive |
|---|---|---|
| Self-Guided Approach | Active comparator | In the self-guided arm, participants will receive access to web-based tools to help achieve healthy lifestyle changes to lower their blood pressure.
The web-based tools include: 1) a web-based food frequency questionnaire (Viocare FFQ), which will provide a snapshot of participants' dietary habits in the past 6 months as well as personalized recommendations for areas to improve; 2) access to an evidence-based program (Evolve, formerly BMIQ), which includes program materials for weight loss and leading a healthy lifestyle as well as the ability for capturing dietary data entry. Receives: Behavioral: Self-Guided Approach |
| Dietitian-led Approach | Experimental | In the dietitian-led arm, dietitian will use motivational interviewing in 15-30 minute telephone calls with participants.
The web-based tools include: 1) a web-based food frequency questionnaire (Viocare FFQ), which will provide a snapshot of participants' dietary habits in the past 6 months as well as personalized recommendations for areas to improve; 2) access to an evidence-based program (Evolve, formerly BMIQ), which includes program materials for weight loss and leading a healthy lifestyle as well as the ability for capturing dietary data entry.
The web platform will be used to share participant dietary and weight data with dietitians. Receives: Behavioral: Dietitian-led Approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 24-hour Systolic Blood Pressure
Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak)
Measured: Baseline to 12-week follow-up
Secondary outcomes (9)
Change in 24-hour diastolic blood pressure
Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak)
Measured: Baseline to 12-week follow-up
Change in Daytime Systolic Blood Pressure
Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak)
Measured: Baseline to 12-week follow-up
Change in Nighttime Systolic Blood Pressure
Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak)
Measured: Baseline to 12-week follow-up
Change in Daytime Diastolic Blood Pressure
Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak)
Measured: Baseline to 12-week follow-up
Change in Nighttime Diastolic Blood Pressure
Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak)
Measured: Baseline to 12-week follow-up
Change in Total Healthy Eating Index - 2015 score
Assessed by Viocare Food Frequency Questionnaire (score 0-100, 100=best possible score)
Measured: Baseline to 12-week follow-up
Change in Weight
Weight measured at baseline and 12-week visits without shoes
Measured: Baseline to 12-week follow-up
Change in Waist Circumference
Measured using a tape measure
Measured: Baseline to 12-week follow-up
Change in Physical Activity (metabolic equivalent of task [MET]-minute per week
Measured by International Physical Activity Questionnaire (IPAQ) Short Form
Measured: Baseline to 12-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start16 Jan 2019
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geisinger Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander Chang, MD, Principal investigator, Geisinger Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03700710
- Sponsor's protocol ID
- 2018-0433
- Status last verified
- Jul 2021
- First submitted
- 5 Oct 2018
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol, statistical analysis plan, informed consent form, analytic code, and clinical study report will be shared at the time of publication of the main trial results; these data will be deidentified. These data will be publicly available indefinitely.
Publications
Chang AR, Gummo L, Yule C, Bonaparte H, Collins C, Naylor A, Appel LJ, Juraschek SP, Bailey-Davis L. Effects of a Dietitian-Led, Telehealth Lifestyle Intervention on Blood Pressure: Results of a Randomized, Controlled Trial. J Am Heart Assoc. 2022 Oct 4;11(19):e027213. doi: 10.1161/JAHA.122.027213. Epub 2022 Sep 29.
PubMed 36172955Taher M, Yule C, Bonaparte H, Kwiecien S, Collins C, Naylor A, Juraschek SP, Bailey-Davis L, Chang AR. Telehealth versus self-directed lifestyle intervention to promote healthy blood pressure: a protocol for a randomised controlled trial. BMJ Open. 2021 Mar 3;11(3):e044292. doi: 10.1136/bmjopen-2020-044292.
PubMed 33658261
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Dietary Counseling Using Web-based Tools to Promote Healthy Diet and Blood Pressure (Healthy BP)
- ClinicalTrials.gov ID
- NCT03700710
- Acronym / sponsor ID
- 2018-0433
- Keywords
- lifestyle modification, DASH diet, weight loss, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- Study start
- 16 Jan 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 9 Oct 2018 (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.
American College of Cardiology/American Heart Association (ACC/AHA) hypertension guidelines recommend lifestyle modification for patients with elevated blood pressure. While eating a Dietary Approaches to Stop Hypertension (DASH)-type diet, increasing physical activity, and weight loss have been shown to reduce blood pressure, limited resources are available in the primary care setting to help patients make these changes.
In this study, the investigators will compare the efficacy of a self-guided vs. dietitian-led approach using web-based lifestyle modification tools to reduce weight, improve dietary quality, and lower blood pressure in overweight/obese adults with elevated blood pressure.
Detailed description
Goals that all participants will be instructed to target include: 1) weight loss >=3% at 3 months; 2) consume a healthier dietary pattern (high in fruits, vegetables, whole grains, low-fat dairy, vegetable/fish/poultry sources of protein, healthier sources of fat, and avoid sugar and salt); 3) reduce sodium intake to <2300 mg/d; 4) at least 180 min/wk of moderate-intensity physical activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-Guided Approach | Active comparator | Behavioral: Self-Guided ApproachIn the self-guided arm, participants will receive access to web-based tools to help achieve healthy lifestyle changes to lower their blood pressure. The web-based tools include: 1) a web-based food frequency questionnaire (Viocare FFQ), which will provide a snapshot of participants' dietary habits in the past 6 months as well as personalized recommendations for areas to improve; 2) access to an evidence-based program (Evolve, formerly BMIQ), which includes program materials for weight loss and leading a healthy lifestyle as well as the ability for capturing dietary data entry. |
| Dietitian-led Approach | Experimental | Behavioral: Dietitian-led ApproachIn the dietitian-led arm, dietitian will use motivational interviewing in 15-30 minute telephone calls with participants. The web-based tools include: 1) a web-based food frequency questionnaire (Viocare FFQ), which will provide a snapshot of participants' dietary habits in the past 6 months as well as personalized recommendations for areas to improve; 2) access to an evidence-based program (Evolve, formerly BMIQ), which includes program materials for weight loss and leading a healthy lifestyle as well as the ability for capturing dietary data entry. The web platform will be used to share participant dietary and weight data with dietitians. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 24-hour ambulatory SBP 120-160 mmHg
- BMI ≥ 25 kg/m2
- Access to a telephone
- Access to a computer or smartphone with internet access
- Complete dietary data entry for at least 5 out of 7 days during run-in period
Key exclusion criteria (11 listed)
- Inability to understand English
- Myocardial infarction, stroke, or atherosclerotic cardiovascular disease procedure within last 6 months.
- Current treatment for malignancy
- Planned or previous bariatric surgery
- Pregnant, breast-feeding, or planned pregnancy prior to the end of participation
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 |
|---|---|---|
| Self-Guided ApproachFor a 12-week period, patients will be asked to access the web platform (Evolve, formerly BMIQ), review educational materials, and enter dietary information. From January 2019 to February 2021, participants used an earlier version of the platform, which was used in tandem with LoseIt (www.loseit.com), a meal-logging app that integrated with the platform. In February 2021, a platform update occurred (Evolve) where the core tenets of the program remained the same and included the dietary data entry directly on the platform. | Behavioural | Self-Guided Approach |
| Dietitian-led ApproachFor a 12-week period, patients will be asked to access the web platform (Evolve, formerly BMIQ), review educational materials, and enter dietary information. From January 2019 to February 2021, participants used an earlier version of the platform, which was used in tandem with LoseIt (www.loseit.com), a meal-logging app that integrated with the platform. In February 2021, a platform update occurred (Evolve) where the core tenets of the program remained the same and included the dietary data entry directly on the platform. Dietitians will access the web platform and provided personalized motivational interview phone calls on a weekly basis. | Behavioural | Dietitian-led Approach |
Primary outcome
Change in 24-hour Systolic Blood Pressure
Time frame: Baseline to 12-week follow-up
Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak)
9 secondary outcomes
Change in 24-hour diastolic blood pressure
Time frame: Baseline to 12-week follow-up
Change in Daytime Systolic Blood Pressure
Time frame: Baseline to 12-week follow-up
Change in Nighttime Systolic Blood Pressure
Time frame: Baseline to 12-week follow-up
Change in Daytime Diastolic Blood Pressure
Time frame: Baseline to 12-week follow-up
Change in Nighttime Diastolic Blood Pressure
Time frame: Baseline to 12-week follow-up
Change in Total Healthy Eating Index - 2015 score
Time frame: Baseline to 12-week follow-up
Change in Weight
Time frame: Baseline to 12-week follow-up
Change in Waist Circumference
Time frame: Baseline to 12-week follow-up
Change in Physical Activity (metabolic equivalent of task [MET]-minute per week
Time frame: Baseline to 12-week follow-up
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 28 Jul 2021.
- Derived from this study: PubMed 36172955Chang AR, Gummo L, Yule C, Bonaparte H, Collins C, Naylor A, Appel LJ, Juraschek SP, Bailey-Davis L. Effects of a Dietitian-Led, Telehealth Lifestyle Intervention on Blood Pressure: Results of a Randomized, Controlled Trial. J Am Heart Assoc. 2022 Oct 4;11(19):e027213. doi: 10.1161/JAHA.122.027213. Epub 2022 Sep 29.
- Derived from this study: PubMed 33658261Taher M, Yule C, Bonaparte H, Kwiecien S, Collins C, Naylor A, Juraschek SP, Bailey-Davis L, Chang AR. Telehealth versus self-directed lifestyle intervention to promote healthy blood pressure: a protocol for a randomised controlled trial. BMJ Open. 2021 Mar 3;11(3):e044292. doi: 10.1136/bmjopen-2020-044292.
- Individual participant dataSharing planned: Yes. The study protocol, statistical analysis plan, informed consent form, analytic code, and clinical study report will be shared at the time of publication of the main trial results; these data will be deidentified. These data will be publicly available indefinitely.
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Behavior
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.
Alexander Chang, MD principal investigator
Geisinger Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Guided Approach and Dietitian-led Approach in people with Blood Pressure and High Blood Pressure, run by Geisinger Clinic at 2 sites 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 6 inclusion and 11 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 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Change in 24-hour Systolic Blood Pressure (time frame: Baseline to 12-week follow-up). 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 NCT03700710, which also lists 2 linked publications.
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 28 Jul 2021.