ObesityPhase 3NCT00128336
The Heat Study: 2 Year Lifestyle Intervention in Overweight Women to Encourage Weight Management
A Phase 3 study testing Lifestyle: diet and exercise intervention in people with Obesity and Type 2 Diabetes Mellitus, run by University of Otago at 1 site in New Zealand.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Type 2 Diabetes Mellitus
- What is being tested?
- Lifestyle: diet and exercise intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteNew Zealand
- Study dates
- May 2004to Oct 2006
- Phase
- Phase 3
- 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 25 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Presence of major illness including cancers
- Established cardiovascular disease or stroke
- Diabetes
- Gestational diabetes
- Renal disease
- Malabsorption disorders
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
New Zealand1 site
Department of Human Nutrition, University of Otago
Dunedin, 9001
About this study
Official title: The Heat Study: A 2-year Lifestyle Intervention in Overweight Women to Determine Optimal Approaches for Successful Maintenance of Weight Loss
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.
Read the detailed description
Although short term weight loss is often achievable in overweight individuals, long term maintenance is generally poor. The researchers urgently need new information regarding the most cost effective programme(s) for maintenance of weight loss. This study will recruit 200 women and compare two approaches for providing support: one with intensive health professional support, the other peer group support facilitated by a research nurse with frequent 'weigh- ins'. The researchers will also compare two different diets one a high carbohydrate, high fibre, low glycaemic index diet versus one relatively high in monounsaturated fat and protein and low in glycaemic load.
- Conditions
- Obesity, Type 2 Diabetes Mellitus
- Being tested
- Lifestyle: diet and exercise intervention
- Keywords
- Weight, Diet, exercise, maintenance
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2, Body Weight, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle: diet and exercise interventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Nurse support | Active comparator | Not described Receives: Behavioral: Lifestyle: diet and exercise intervention |
| Intensive support | Experimental | Not described Receives: Behavioral: Lifestyle: diet and exercise intervention |
| High carbohydrate diet | Active comparator | Not described Receives: Behavioral: Lifestyle: diet and exercise intervention |
| High mono-unsaturated fat diet | Experimental | Not described Receives: Behavioral: Lifestyle: diet and exercise intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Measured: 2 years
Secondary outcomes (6)
Body composition
Measured: 2 years
Waist circumference and blood pressure
Measured: 2 years
Lipid profile and glucose and insulin
Measured: 2 years
Dietary intake
Measured: 2 years
Physical fitness
Measured: 2 years
Change in mood state
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2005 (estimated)
- Study startMay 2004
- Primary completionOct 2006
- Study completionOct 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 ObesityStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Otago
- Sponsor type
- University, hospital or other
- Collaborators
- Edgar National Centre for Diabetes Research
- Responsible party
- Principal investigator, Rachael Taylor, University of Otago
- Investigators
- Kelly S Whiteford, MSc (Dist), Principal investigator, University of Otago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00128336
- Sponsor's protocol ID
- 03/173
- Status last verified
- May 2016
- First submitted
- 8 Aug 2005
- Last updated
- 16 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19433812
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Heat Study: A 2-year Lifestyle Intervention in Overweight Women to Determine Optimal Approaches for Successful Maintenance of Weight Loss
- ClinicalTrials.gov ID
- NCT00128336
- Acronym / sponsor ID
- 03/173
- Conditions
- Obesity, Type 2 Diabetes Mellitus
- Keywords
- Weight, Diet, exercise, maintenance
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of OtagoUniversity, hospital or other
- Collaborators
- Edgar National Centre for Diabetes Research
- Study start
- May 2004
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 9 Aug 2005 (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 trial is to determine the most cost effective programme for overweight and obese individuals to maintain weight loss over a 2 year period.
Detailed description
Although short term weight loss is often achievable in overweight individuals, long term maintenance is generally poor. The researchers urgently need new information regarding the most cost effective programme(s) for maintenance of weight loss. This study will recruit 200 women and compare two approaches for providing support: one with intensive health professional support, the other peer group support facilitated by a research nurse with frequent 'weigh- ins'. The researchers will also compare two different diets one a high carbohydrate, high fibre, low glycaemic index diet versus one relatively high in monounsaturated fat and protein and low in glycaemic load.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Nurse support | Active comparator | Behavioral: Lifestyle: diet and exercise intervention |
| Intensive support | Experimental | Behavioral: Lifestyle: diet and exercise intervention |
| High carbohydrate diet | Active comparator | Behavioral: Lifestyle: diet and exercise intervention |
| High mono-unsaturated fat diet | Experimental | Behavioral: Lifestyle: diet and exercise intervention |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- Presence of major illness including cancers
- Established cardiovascular disease or stroke
- Diabetes
- Gestational diabetes
- Renal disease
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 |
|---|---|---|
| Lifestyle: diet and exercise intervention | Behavioural | High carbohydrate diet, High mono-unsaturated fat diet, Intensive support, Nurse support |
Primary outcome
Weight
Time frame: 2 years
6 secondary outcomes
Body composition
Time frame: 2 years
Waist circumference and blood pressure
Time frame: 2 years
Lipid profile and glucose and insulin
Time frame: 2 years
Dietary intake
Time frame: 2 years
Physical fitness
Time frame: 2 years
Change in mood state
Time frame: 2 years
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 16 May 2016.
- Derived from this study: PubMed 19433812Dale 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.
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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.
Kelly S Whiteford, MSc (Dist) principal investigator
University of Otago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lifestyle: diet and exercise intervention in people with Obesity and Type 2 Diabetes Mellitus, run by University of Otago at 1 site in New Zealand.
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 4 inclusion and 11 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 16 May 2016. 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 New Zealand. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Weight (time frame: 2 years). 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 NCT00128336, 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 16 May 2016.