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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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00128336
Enrollment
200
Registered
2005-08-09
Start date
2004-05-31
Completion date
2006-10-31
Last updated
2016-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Type 2 Diabetes Mellitus

Keywords

Weight, Diet, exercise, maintenance

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.

Interventions

BEHAVIORALLifestyle: diet and exercise intervention

Sponsors

Edgar National Centre for Diabetes Research
CollaboratorOTHER
University of Otago
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
25 Years to 70 Years
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

* 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

Design outcomes

Primary

MeasureTime frame
Weight2 years

Secondary

MeasureTime frame
Waist circumference and blood pressure2 years
Lipid profile and glucose and insulin2 years
Body composition2 years
Physical fitness2 years
Change in mood state2 years
Dietary intake2 years

Countries

New Zealand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026