Clinical trial NCT00128336: The Heat Study: 2 Year Lifestyle Intervention in Overweight Women to Encourage Weight Management
Official title: The Heat Study: A 2-year Lifestyle Intervention in Overweight Women to Determine Optimal Approaches for Successful Maintenance of Weight Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obesity
Type 2 Diabetes Mellitus
Keywords: Weight
Diet
exercise
maintenance
Lead sponsor: University of Otago
Sponsor class: OTHER
Collaborators: name: Edgar National Centre for Diabetes Research
First posted: 2005-08-09
Enrollment: 200
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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:

* 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

Primary outcomes:
measure: Weight
timeFrame: 2 years
Secondary outcomes:
measure: Body composition
timeFrame: 2 years
measure: Waist circumference and blood pressure
timeFrame: 2 years
measure: Lipid profile and glucose and insulin
timeFrame: 2 years
measure: Dietary intake
timeFrame: 2 years
measure: Physical fitness
timeFrame: 2 years
measure: Change in mood state
timeFrame: 2 years
Other outcomes:
Locations:
city: Dunedin
country: New Zealand
facility: Department of Human Nutrition, University of Otago
Study officials:
affiliation: University of Otago
name: Kelly S Whiteford, MSc (Dist)
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.