Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000090617
Ethics application status
Approved
Date submitted
1/08/2005
Date registered
5/08/2005
Date last updated
5/08/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Activity, Diet and Blood Pressure Trial
Scientific title
A randomised phase III study to evaluate the effects of a lifestyle program in the treatment of hypertension to lower blood pressure and decrease antihypertensive drug needs.
Universal Trial Number (UTN)
Trial acronym
ADAPT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 170 0
Condition category
Condition code
Cardiovascular 190 190 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behavioural program promoting weight loss, a low-sodium DASH-type diet, high in fish, increased physical activity & reduced alcohol intake with 4 months intervention and follow-up at 1 and 3 years after completion of the intervention.
Intervention code [1] 91 0
Lifestyle
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 229 0
Blood pressure
Timepoint [1] 229 0
Primary outcome [2] 230 0
Requirements for antihypertensive drugs
Timepoint [2] 230 0
Secondary outcome [1] 516 0
Lipids
Timepoint [1] 516 0
Secondary outcome [2] 517 0
Glucose/insulin
Timepoint [2] 517 0
Secondary outcome [3] 518 0
Cognitive responses
Timepoint [3] 518 0
Secondary outcome [4] 519 0
Qualitative responses elicited in focus groups
Timepoint [4] 519 0

Eligibility
Key inclusion criteria
BMI>25 kg/m2, treated with one or two antihypertensive drugs for at least 3 months.
Minimum age
40 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Clinic BP > 160/90 mm Hg; consumption > 2 fish meals or 4 fish oil capsules per week; alcohol intake > 4 standard drinks/day for women and 6 standard drinks/day for men; drug- or insulin-treated diabetes; chronic renal failure (serum creatinine>120 umol/L); chronic liver disease; symptomatic cardiovascular disease < 3 months; other chronic debilitating disease; the use of antihypertensive drugs for indications other than hypertension, such as the use of beta blockers for arrhythmias

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central allocation by statistician
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random numbers
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Control group received usual care. None of the options under
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/01/2001
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 247 0
Government body
Name [1] 247 0
NH&MRC, FRDC
Country [1] 247 0
Australia
Primary sponsor type
Name
None
Address
Country
Secondary sponsor category [1] 188 0
None
Name [1] 188 0
None
Address [1] 188 0
Country [1] 188 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1048 0
University of Western Australia School of Medicine & Pharmacology
Ethics committee address [1] 1048 0
Ethics committee country [1] 1048 0
Australia
Date submitted for ethics approval [1] 1048 0
Approval date [1] 1048 0
Ethics approval number [1] 1048 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36150 0
Address 36150 0
Country 36150 0
Phone 36150 0
Fax 36150 0
Email 36150 0
Contact person for public queries
Name 9280 0
LJ Beilin
Address 9280 0
School of Medicine & Pharmacology
University of Western Australia
GPO Box X2213
Perth WA 6847
Country 9280 0
Australia
Phone 9280 0
+61 8 92240258
Fax 9280 0
+61 8 92240246
Email 9280 0
[email protected]
Contact person for scientific queries
Name 208 0
Valerie Burke
Address 208 0
School of Medicine & Pharmacology
University of Western Australia
GPO Box X2213
Perth WA 6847
Country 208 0
Australia
Phone 208 0
+61 8 92240276
Fax 208 0
+61 8 92240246
Email 208 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.