HypertensionNCT00431288
A Nutrition Intervention to Lower Blood Pressure in Adolescents
A study testing diet high in fruits, vegetables, and dairy and Routine nutrition care in people with Hypertension, run by University of Cincinnati at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the efficacy of a 12-week, clinic-based, behavioral nutrition intervention emphasizing fruits, vegetables, and low fat dairy compared to routine nutrition care on changing diet quality and blood pressure post-treatment and at short-term follow-up in adolescents with… Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- Hypertension
- What is being tested?
- diet high in fruits, vegetables, and dairy and Routine nutrition care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2003to Jun 2006
- 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
- clinical diagnosis of prehypertension or stage 1 hypertension
- age 11-18 years
- english speaking
Who cannot join
- stage 2 or secondary hypertension
- target organ damage or symptomatic hypertension
- type 1 or 2 diabetes
- treated with anti-hypertensive medications or other blood pressure altering medications
- are unwilling to stop use of vitamins, minerals or antacids containing calcium or magnesium
- 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, 45229-3039
About this study
Official title: Efficacy of a Nutrition Intervention Emphasizing Fruits, Vegetables and Dairy to Lower Blood Pressure in Adolescents
The purpose of this study is to evaluate the efficacy of a 12-week, clinic-based, behavioral nutrition intervention emphasizing fruits, vegetables, and low fat dairy compared to routine nutrition care on changing diet quality and blood pressure post-treatment and at short-term follow-up in adolescents with hypertension.
Read the detailed description
Among youth, hypertension is no longer a rare disease, affecting about 7 million children and adolescents. Numbers are increasing with the evolving pediatric obesity epidemic in the US. More adolescents than children have primary hypertension, which tracks 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. The purpose of this project is to evaluate the immediate and sustained impact of a 3-month clinic-based behavioral nutrition intervention emphasizing a diet high in fruits, vegetables, and low fat dairy, and low in fat and sodium (the DASH intervention) versus routine nutrition care on changing diet quality and blood pressure in adolescents with pre-hypertension or hypertension. The DASH intervention will include a printed participant manual, 1 individual counseling session with a dietitian, 4 mailings and 10 telephone calls on behavioral strategies to promote dietary change. Routine care will include 1 individual counseling session with a dietitian on dietary guidelines consistent with those of the National High Blood Pressure Education Program. Adolescents with prehypertension or hypertension will be randomly assigned to the DASH intervention or routine nutrition care after pre-treatment assessment. Post-treatment and at 3-month follow-up, outcome measures will be assessed including dietary intake and blood pressure. Our expectations are that the DASH intervention will significantly improve dietary quality and blood pressure in adolescents with elevated blood pressure compared to that observed as a result of routine nutrition care. The findings from this study are expected to improve the manner in which hypertension among adolescents is being treated in the clinical setting and contribute to the enhancement of the cardiovascular health of the target population.
- Conditions
- Hypertension
- Being tested
- diet high in fruits, vegetables, and dairy, Routine nutrition care
- Keywords
- nutrition, adolescent nutrition, blood pressure, hypertension, diet therapy, patient education
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diet high in fruits, vegetables, and dairyBehavioural
Also called DASH dietary pattern
Routine nutrition careOther
Also called Routine Care
| Study group | Role | What they receive |
|---|---|---|
| DASH intervention | Experimental | The DASH diet used in this intervention was slightly modified from the original version of the DASH diet for adults to more closely conform to the unique nutritional needs of adolescents. Details of the intervention have been published (Couch, SC et al. J Pediatrics 2008; 152: 494-501) Receives: Behavioral: diet high in fruits, vegetables, and dairy |
| Routine Care | Other | Routine care did not deviate from the nutrition counseling that was routinely given to all new patients at the Cincinnati Children's Hypertension Clinic. Details of routine care have been published (Couch, SC et al. J Pediatrics 2008; 152: 494-501) Receives: Other: Routine nutrition care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) measurements were performed with a mercury sphygmomanometer according to standardized procedures. SBP and DBP were measured two times and averaged. SBP and DBP z-scores were determined from these average measurements based on established norms.
Measured: change from baseline BP at immediately post-treatment (3 months)
Secondary outcomes (1)
Diet quality Indicators
Dietary intake was assessed with 3, 24-hour recalls collected over a 2-week period (2 weekdays and 1 weekend day) before each assessment visit using the validated multi-pass method. Recalls were collected from the adolescent by telephone interview and coded by a trained research dietitian. Adolescents were trained in the use of a 2-dimensional food portion size model to enhance recall of different food volumes and dimensions. Food recalls were analyzed for selected nutrients and servings of fruits, vegetables, low fat dairy foods and high sodium and fat containing foods using the Minnesota Nutrient Data Systems software (version 5.0, 2003). Indicators of diet quality were recorded as average number of daily servings of fruits, vegetables, low fat dairy foods and high fat and sodium containing foods.
Measured: change from baseline diet quality indicators at immediately post-treatment (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2007 (estimated)
- Study startAug 2003
- Primary completionJun 2006
- Study completionJun 2006
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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- 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
- NCT00431288
- Sponsor's protocol ID
- AHA 0355332B
- Status last verified
- Sep 2023
- First submitted
- 1 Feb 2007
- Last updated
- 2 Oct 2023
- Results posted
- No
- Individual data sharing
- No
Publications
Couch SC, Saelens BE, Levin L, Dart K, Falciglia G, Daniels SR. The efficacy of a clinic-based behavioral nutrition intervention emphasizing a DASH-type diet for adolescents with elevated blood pressure. J Pediatr. 2008 Apr;152(4):494-501. doi: 10.1016/j.jpeds.2007.09.022. Epub 2007 Nov 5.
PubMed 18346503
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Nutrition Intervention Emphasizing Fruits, Vegetables and Dairy to Lower Blood Pressure in Adolescents
- ClinicalTrials.gov ID
- NCT00431288
- Acronym / sponsor ID
- AHA 0355332B
- Conditions
- Hypertension
- Keywords
- nutrition, adolescent nutrition, blood pressure, hypertension, diet therapy, patient education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- Aug 2003 (actual)
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 5 Feb 2007 (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 evaluate the efficacy of a 12-week, clinic-based, behavioral nutrition intervention emphasizing fruits, vegetables, and low fat dairy compared to routine nutrition care on changing diet quality and blood pressure post-treatment and at short-term follow-up in adolescents with hypertension.
Detailed description
Among youth, hypertension is no longer a rare disease, affecting about 7 million children and adolescents. Numbers are increasing with the evolving pediatric obesity epidemic in the US. More adolescents than children have primary hypertension, which tracks 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. The purpose of this project is to evaluate the immediate and sustained impact of a 3-month clinic-based behavioral nutrition intervention emphasizing a diet high in fruits, vegetables, and low fat dairy, and low in fat and sodium (the DASH intervention) versus routine nutrition care on changing diet quality and blood pressure in adolescents with pre-hypertension or hypertension. The DASH intervention will include a printed participant manual, 1 individual counseling session with a dietitian, 4 mailings and 10 telephone calls on behavioral strategies to promote dietary change. Routine care will include 1 individual counseling session with a dietitian on dietary guidelines consistent with those of the National High Blood Pressure Education Program. Adolescents with prehypertension or hypertension will be randomly assigned to the DASH intervention or routine nutrition care after pre-treatment assessment. Post-treatment and at 3-month follow-up, outcome measures will be assessed including dietary intake and blood pressure. Our expectations are that the DASH intervention will significantly improve dietary quality and blood pressure in adolescents with elevated blood pressure compared to that observed as a result of routine nutrition care. The findings from this study are expected to improve the manner in which hypertension among adolescents is being treated in the clinical setting and contribute to the enhancement of the cardiovascular health of the target population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DASH intervention | Experimental | Behavioral: diet high in fruits, vegetables, and dairyThe DASH diet used in this intervention was slightly modified from the original version of the DASH diet for adults to more closely conform to the unique nutritional needs of adolescents. Details of the intervention have been published (Couch, SC et al. J Pediatrics 2008; 152: 494-501) |
| Routine Care | Other | Other: Routine nutrition careRoutine care did not deviate from the nutrition counseling that was routinely given to all new patients at the Cincinnati Children's Hypertension Clinic. Details of routine care have been published (Couch, SC et al. J Pediatrics 2008; 152: 494-501) |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- clinical diagnosis of prehypertension or stage 1 hypertension
- age 11-18 years
- english speaking
Key exclusion criteria (6 listed)
- stage 2 or secondary hypertension
- target organ damage or symptomatic hypertension
- type 1 or 2 diabetes
- treated with anti-hypertensive medications or other blood pressure altering medications
- are unwilling to stop use of vitamins, minerals or antacids containing calcium or magnesium
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 |
|---|---|---|
| diet high in fruits, vegetables, and dairyAlso: DASH dietary pattern | Behavioural | DASH intervention |
| Routine nutrition careAlso: Routine Care | Other | Routine Care |
Primary outcome
Blood Pressure
Time frame: change from baseline BP at immediately post-treatment (3 months)
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) measurements were performed with a mercury sphygmomanometer according to standardized procedures. SBP and DBP were measured two times and averaged. SBP and DBP z-scores were determined from these average measurements based on established norms.
1 secondary outcome
Diet quality Indicators
Time frame: change from baseline diet quality indicators at immediately post-treatment (3 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 2 Oct 2023.
- Results publication: PubMed 18346503Couch SC, Saelens BE, Levin L, Dart K, Falciglia G, Daniels SR. The efficacy of a clinic-based behavioral nutrition intervention emphasizing a DASH-type diet for adolescents with elevated blood pressure. J Pediatr. 2008 Apr;152(4):494-501. doi: 10.1016/j.jpeds.2007.09.022. Epub 2007 Nov 5.
- 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.
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 diet high in fruits, vegetables, and dairy and Routine nutrition care in people with 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 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 2 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?
Blood Pressure (time frame: change from baseline BP at immediately post-treatment (3 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 NCT00431288, 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 2 Oct 2023.