HypertensionDASH-4-TeensNCT00585832
Modifying Dietary Behavior in Adolescents With Elevated Blood Pressure
A study testing DASH-4-Teens and Routine Care in people with Hypertension and Pre-Hypertension, run by University of Cincinnati at 1 site in United States.
Trial summary
The purpose of this study is to examine the long term effects of a 24-week clinically-based behavioral nutrition intervention emphasizing the DASH diet compared to routine nutrition care on changing diet quality, blood pressure, hypertension status, and vascular function in adolescents with elevated blood pressure. Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- Hypertension, Pre-Hypertension
- What is being tested?
- DASH-4-Teens and Routine Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Oct 2014
- 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 11 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- diagnosed pre-hypertension or stage 1 hypertension
- 11-18 years of age
- newly enrolled in the hypertension center at the Cincinnati Children's Hospital Medical Center
Who cannot join
- stage 2 hypertension
- secondary hypertension
- are being treated with anti-hypertensive medications
- have received prior formalized diet therapy to managed their blood pressure
- have target organ damage (as defined by a left ventricular mass index >51
- diagnosed type 1 or 2 diabetes
Show all 12Show fewer
- use medications known to alter blood pressure
- are unwilling to stop use of vitamins, minerals or antacids
- do not speak English
- have a diagnosed eating disorder
- have a psychological or medical condition that may preclude them from full participation.
- do not have full medical clearance from a physician to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
The purpose of this study is to examine the long term effects of a 24-week clinically-based behavioral nutrition intervention emphasizing the DASH diet compared to routine nutrition care on changing diet quality, blood pressure, hypertension status, and vascular function in adolescents with elevated blood pressure.
Read the detailed description
Hypertension in youth is no longer a rare disease and the number of affected children and adolescents is growing with the evolving pediatric epidemic in the US. Hypertension tracks from adolescence into adulthood and has been linked with preclinical indicators of adverse cardiovascular events in adults. Early prevention and intervention efforts are needed to address this increasing public and individual health problem. Preliminary studies from our research group demonstrate promising short-term effects of a behavioral nutrition intervention emphasizing a diet high in fruits, vegetables and low fat dairy that is also low in fat and sodium (the DASH diet) on lowering blood pressure (BP) in adolescents. The purpose of this application is to extend these findings by examining the long term effects of an improved 24-week clinically based behavioral nutrition intervention emphasizing the DASH diet (the DASH-4-Teens intervention) compared to routine nutrition care intervention on changing diet quality, BP, hypertension status, and vascular function in adolescents with elevated blood pressure. Adolescents with diagnosed pre-hypertension and stage 1 hypertension will be randomly assigned to receive either the DASH-4-teens intervention or routine nutrition care. The DASH-4- Teens intervention will include individual in-person nutrition counseling sessions, behavioral counseling telephone calls, and mailings. Routine nutrition care will include individual in-person counseling sessions on guidelines consistent with the Fourth Pediatric Report of the National High Blood Pressure Education Program. Primary outcomes will be measured in both conditions at 6 months (post-treatment) and at 1 year follow-up. Adherence to treatment will be measured as diet-related goals met, counseling session attendance, and telephone call and food monitoring completion. Findings are expected to improve the treatment of hypertensive adolescents in the clinical setting and contribute to the enhancement of the cardiovascular health of this population.
- Conditions
- Hypertension, Pre-Hypertension
- Being tested
- DASH-4-Teens, Routine Care
- Keywords
- hypertension, pre-hypertension, adolescents, diet, vascular function
- Medical subject headings
- Hypertension, Prehypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DASH-4-TeensBehavioural
24-week behavioral nutrition intervention emphasizing a diet high in fruits, vegetables and low fat dairy foods and that is low in fat and sodium
Routine CareOther
individual in-person counseling sessions on guidelines consistent with the Fourth Pediatric Report of the National High Blood Pressure Education Program.
| Study group | Role | What they receive |
|---|---|---|
| DASH-4-Teens Intervention | Experimental | DASH-4-Teens Intervention is described in detail in Couch, SC et al. Hypertension 2021: 77:241-251. Receives: Behavioral: DASH-4-Teens |
| Routine Care | Other | Routine Care is described in detail in Couch, SC et al. Hypertension 2021: 77:241-251. Receives: Other: Routine Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure (BP)
BP measurements were performed with a mercury sphygmomanometer according to standardized procedures. BP was calculated from the average of 2 BP measurements. Systolic and diastolic BP z-scores were made based on established norms.
Measured: change from baseline BP at immediately post-treatment (6 months)
Secondary outcomes (2)
Vascular Function
Flow mediated dilation (FMD) of the brachial artery was assessed using B-mode ultrasound vascular imaging according to Corretti MS et al., (J Am Coll Cardiology 2002; 39: 257-265).
Measured: change from baseline at immediately post-treatment (6 months)
DASH dietary adherence
Dietary intake was assessed using 3 random 24 hour recalls (2 weekdays, 1 weekend day) collected in the 2 weeks before each assessment period using the validated multi-pass method. Recalls were collected from adolescents by telephone interview by trained dietitians using the Minnesota Nutrient Data Systems software (version 2.94, 2014). A DASH score was calculated according to Gunther et al (Hypertension 2009; 53: 6-12) modified to include a 10-point sodium component score. DASH score ranged from 0 to 90 with a higher score indicating greater DASH adherence.
Measured: change from baseline at immediately post-treatment (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2008 (estimated)
- Study startFeb 2008
- Primary completionOct 2013
- Study completionOct 2014
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 HypertensionStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe 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
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Sarah C. Couch, University of Cincinnati
- Investigators
- Sarah C Couch, Ph.D., Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00585832
- Sponsor's protocol ID
- R01HL088567
- Other IDs
- R01HL088567
- Acronym
- DASH-4-Teens
- Status last verified
- Jun 2022
- First submitted
- 27 Dec 2007
- Last updated
- 14 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: The data that support the findings of this study are available from the corresponding author upon reasonable request.
Publications
Couch SC, Saelens BE, Khoury PR, Dart KB, Hinn K, Mitsnefes MM, Daniels SR, Urbina EM. Dietary Approaches to Stop Hypertension Dietary Intervention Improves Blood Pressure and Vascular Health in Youth With Elevated Blood Pressure. Hypertension. 2021 Jan;77(1):241-251. doi: 10.1161/HYPERTENSIONAHA.120.16156. Epub 2020 Nov 16.
PubMed 33190559
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modifying Dietary Behavior in Adolescents With Elevated Blood Pressure
- ClinicalTrials.gov ID
- NCT00585832
- Acronym / sponsor ID
- DASH-4-Teens / R01HL088567
- Conditions
- Hypertension, Pre-Hypertension
- Keywords
- hypertension, pre-hypertension, adolescents, diet, vascular function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Feb 2008
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 3 Jan 2008 (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.
The purpose of this study is to examine the long term effects of a 24-week clinically-based behavioral nutrition intervention emphasizing the DASH diet compared to routine nutrition care on changing diet quality, blood pressure, hypertension status, and vascular function in adolescents with elevated blood pressure.
Detailed description
Hypertension in youth is no longer a rare disease and the number of affected children and adolescents is growing with the evolving pediatric epidemic in the US. Hypertension tracks from adolescence into adulthood and has been linked with preclinical indicators of adverse cardiovascular events in adults. Early prevention and intervention efforts are needed to address this increasing public and individual health problem. Preliminary studies from our research group demonstrate promising short-term effects of a behavioral nutrition intervention emphasizing a diet high in fruits, vegetables and low fat dairy that is also low in fat and sodium (the DASH diet) on lowering blood pressure (BP) in adolescents. The purpose of this application is to extend these findings by examining the long term effects of an improved 24-week clinically based behavioral nutrition intervention emphasizing the DASH diet (the DASH-4-Teens intervention) compared to routine nutrition care intervention on changing diet quality, BP, hypertension status, and vascular function in adolescents with elevated blood pressure. Adolescents with diagnosed pre-hypertension and stage 1 hypertension will be randomly assigned to receive either the DASH-4-teens intervention or routine nutrition care. The DASH-4- Teens intervention will include individual in-person nutrition counseling sessions, behavioral counseling telephone calls, and mailings. Routine nutrition care will include individual in-person counseling sessions on guidelines consistent with the Fourth Pediatric Report of the National High Blood Pressure Education Program. Primary outcomes will be measured in both conditions at 6 months (post-treatment) and at 1 year follow-up. Adherence to treatment will be measured as diet-related goals met, counseling session attendance, and telephone call and food monitoring completion. Findings are expected to improve the treatment of hypertensive adolescents in the clinical setting and contribute to the enhancement of the cardiovascular health of this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DASH-4-Teens Intervention | Experimental | Behavioral: DASH-4-TeensDASH-4-Teens Intervention is described in detail in Couch, SC et al. Hypertension 2021: 77:241-251. |
| Routine Care | Other | Other: Routine CareRoutine Care is described in detail in Couch, SC et al. Hypertension 2021: 77:241-251. |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- diagnosed pre-hypertension or stage 1 hypertension
- 11-18 years of age
- newly enrolled in the hypertension center at the Cincinnati Children's Hospital Medical Center
Key exclusion criteria (12 listed)
- stage 2 hypertension
- secondary hypertension
- are being treated with anti-hypertensive medications
- have received prior formalized diet therapy to managed their blood pressure
- have target organ damage (as defined by a left ventricular mass index >51
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 |
|---|---|---|
| DASH-4-Teens24-week behavioral nutrition intervention emphasizing a diet high in fruits, vegetables and low fat dairy foods and that is low in fat and sodium | Behavioural | DASH-4-Teens Intervention |
| Routine Careindividual in-person counseling sessions on guidelines consistent with the Fourth Pediatric Report of the National High Blood Pressure Education Program. | Other | Routine Care |
Primary outcome
Blood Pressure (BP)
Time frame: change from baseline BP at immediately post-treatment (6 months)
BP measurements were performed with a mercury sphygmomanometer according to standardized procedures. BP was calculated from the average of 2 BP measurements. Systolic and diastolic BP z-scores were made based on established norms.
2 secondary outcomes
Vascular Function
Time frame: change from baseline at immediately post-treatment (6 months)
DASH dietary adherence
Time frame: change from baseline at immediately post-treatment (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 14 Jun 2022.
- Results publication: PubMed 33190559Couch SC, Saelens BE, Khoury PR, Dart KB, Hinn K, Mitsnefes MM, Daniels SR, Urbina EM. Dietary Approaches to Stop Hypertension Dietary Intervention Improves Blood Pressure and Vascular Health in Youth With Elevated Blood Pressure. Hypertension. 2021 Jan;77(1):241-251. doi: 10.1161/HYPERTENSIONAHA.120.16156. Epub 2020 Nov 16.
- Individual participant dataSharing planned: Yes. The data that support the findings of this study are available from the corresponding author upon reasonable request.
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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.
Sarah C Couch, Ph.D. principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DASH-4-Teens and Routine Care in people with Hypertension and Pre-Hypertension, run by University of Cincinnati 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 3 inclusion and 12 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 14 Jun 2022. 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?
Blood Pressure (BP) (time frame: change from baseline BP at immediately post-treatment (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 NCT00585832, 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 14 Jun 2022.