The Heat Study: 2 Year Lifestyle Intervention in Overweight Women to Encourage Weight Management
The Heat Study: A 2-year Lifestyle Intervention in Overweight Women to Determine Optimal Approaches for Successful Maintenance of Weight Loss
1 other identifier
interventional
200
1 country
1
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 obesity
Started May 2004
Typical duration for phase_3 obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 8, 2005
CompletedFirst Posted
Study publicly available on registry
August 9, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2006
CompletedMay 16, 2016
May 1, 2016
2.4 years
August 8, 2005
May 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Weight
2 years
Secondary Outcomes (6)
Body composition
2 years
Waist circumference and blood pressure
2 years
Lipid profile and glucose and insulin
2 years
Dietary intake
2 years
Physical fitness
2 years
- +1 more secondary outcomes
Study Arms (4)
Nurse support
ACTIVE COMPARATORIntensive support
EXPERIMENTALHigh carbohydrate diet
ACTIVE COMPARATORHigh mono-unsaturated fat diet
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Otagolead
- Edgar National Centre for Diabetes Researchcollaborator
Study Sites (1)
Department of Human Nutrition, University of Otago
Dunedin, 9001, New Zealand
Related Publications (1)
Dale KS, McAuley KA, Taylor RW, Williams SM, Farmer VL, Hansen P, Vorgers SM, Chisholm AW, Mann JI. Determining optimal approaches for weight maintenance: a randomized controlled trial. CMAJ. 2009 May 12;180(10):E39-46. doi: 10.1503/cmaj.080974.
PMID: 19433812DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kelly S Whiteford, MSc (Dist)
University of Otago
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD student
Study Record Dates
First Submitted
August 8, 2005
First Posted
August 9, 2005
Study Start
May 1, 2004
Primary Completion
October 1, 2006
Study Completion
October 1, 2006
Last Updated
May 16, 2016
Record last verified: 2016-05