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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00128336




Registration number
NCT00128336
Ethics application status
Date submitted
8/08/2005
Date registered
9/08/2005
Date last updated
16/05/2016

Titles & IDs
Public title
The Heat Study: 2 Year Lifestyle Intervention in Overweight Women to Encourage Weight Management
Scientific title
The Heat Study: A 2-year Lifestyle Intervention in Overweight Women to Determine Optimal Approaches for Successful Maintenance of Weight Loss
Secondary ID [1] 0 0
03/173
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 0 0
Type 2 Diabetes Mellitus 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes
Diet and Nutrition 0 0 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - Lifestyle: diet and exercise intervention

Active Comparator: Nurse support -

Experimental: Intensive support -

Active Comparator: High carbohydrate diet -

Experimental: High mono-unsaturated fat diet -


Behaviour: Lifestyle: diet and exercise intervention
Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Weight
Timepoint [1] 0 0
2 years
Secondary outcome [1] 0 0
Body composition
Timepoint [1] 0 0
2 years
Secondary outcome [2] 0 0
Waist circumference and blood pressure
Timepoint [2] 0 0
2 years
Secondary outcome [3] 0 0
Lipid profile and glucose and insulin
Timepoint [3] 0 0
2 years
Secondary outcome [4] 0 0
Dietary intake
Timepoint [4] 0 0
2 years
Secondary outcome [5] 0 0
Physical fitness
Timepoint [5] 0 0
2 years
Secondary outcome [6] 0 0
Change in mood state
Timepoint [6] 0 0
2 years

Eligibility
Key inclusion criteria
- Female participants

- Aged 25 to 70

- Those who have intentionally lost more than or equal to 5% of initial body weight in
the previous 6 months will be recruited

- Objective evidence that volunteers were overweight or obese and have lost weight will
be obtained from doctors records
Minimum age
25 Years
Maximum age
70 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Presence of major illness including cancers

- Established cardiovascular disease or stroke

- Diabetes

- Gestational diabetes

- Renal disease

- Malabsorption disorders

- Thyroid disorders

- Major psychiatric disorders

- Taking weight loss medication or medications known to cause weight gain

- Planning a pregnancy in the next 2 years

- Those who do not intend to be in the area for the next 2 years

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2006
Sample size
Target
Accrual to date
Final
200
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Dunedin

Funding & Sponsors
Primary sponsor type
Other
Name
University of Otago
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Edgar National Centre for Diabetes Research
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this trial is to determine the most cost effective programme for overweight
and obese individuals to maintain weight loss over a 2 year period.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00128336
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kelly S Whiteford, MSc (Dist)
Address 0 0
University of Otago
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00128336