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CompletedNCT00128336Updated May 16, 2016

The Heat Study: 2 Year Lifestyle Intervention in Overweight Women to Encourage Weight Management

A Phase 3 interventional study of Lifestyle: diet and exercise intervention in Obesity and Type 2 Diabetes Mellitus, sponsored by University of Otago. Completed at 1 site in New Zealand. Open to female participants aged 25 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-05-16.

Sponsored by University of Otago · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
25 Years to 70 Years
Sex
Female
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Study 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 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.

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Conditions studied

  • Obesity
  • Type 2 Diabetes Mellitus

Keywords

  • Weight
  • Diet
  • exercise
  • maintenance
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In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 200 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

University of Otago is the lead sponsor of 13 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

Exclusion criteria

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
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (actual)

Study arms

  • Active comparator
    Nurse support

    Behavioral: Lifestyle: diet and exercise intervention

  • Experimental
    Intensive support

    Behavioral: Lifestyle: diet and exercise intervention

  • Active comparator
    High carbohydrate diet

    Behavioral: Lifestyle: diet and exercise intervention

  • Experimental
    High mono-unsaturated fat diet

    Behavioral: Lifestyle: diet and exercise intervention

Interventions

  • BehavioralLifestyle: diet and exercise intervention
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What researchers measure

Primary outcomes

  1. Weight

    Time frame: 2 years

Secondary outcomes

  1. Body composition

    Time frame: 2 years

  2. Waist circumference and blood pressure

    Time frame: 2 years

  3. Lipid profile and glucose and insulin

    Time frame: 2 years

  4. Dietary intake

    Time frame: 2 years

  5. Physical fitness

    Time frame: 2 years

  6. Change in mood state

    Time frame: 2 years

07

Study locations

1 site
  • Department of Human Nutrition, University of Otago
    Dunedin, 9001, New Zealand
08

References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00128336
Lead sponsor
University of Otago
Collaborators
Edgar National Centre for Diabetes Research
Responsible party
Rachael Taylor (PhD student, University of Otago) — Principal investigator
First posted
Aug 9, 2005
Start date
May 2004
Primary completion
Oct 2006
Completion
Oct 2006
Last update
May 16, 2016

Study contacts

Kelly S Whiteford, MSc (Dist)
principal investigator · University of Otago

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.

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