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

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus; Obesity

• Registration Number: NCT00128336
• Lead Sponsor: University of Otago

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.

Study Timeline

• Study Start: 2004-05
• Study First Submitted: 2005-08-08
• Study First Submitted QC: 2005-08-08
• Study First Posted: 2005-08-09
• Primary Completion: 2006-10
• Study Completion: 2006-10
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-12
• Last Update Posted: 2016-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Weight	2 years

Secondary Outcome Measures

Name	Time	Method
Lipid profile and glucose and insulin	2 years
Body composition	2 years
Waist circumference and blood pressure	2 years
Dietary intake	2 years
Physical fitness	2 years
Change in mood state	2 years

Trial Locations

Locations (1)

Department of Human Nutrition, University of Otago; 🇳🇿 Dunedin, New Zealand