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

University of Otago

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus; Obesity

Treatments: Behavioral: Lifestyle: diet and exercise intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT00128336

03/173

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: Female

Ages: 25 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 4 patient groups

Nurse support

Active Comparator group

Treatment:

Behavioral: Lifestyle: diet and exercise intervention

Intensive support

Experimental group

Treatment:

Behavioral: Lifestyle: diet and exercise intervention

High carbohydrate diet

Active Comparator group

Treatment:

Behavioral: Lifestyle: diet and exercise intervention

High mono-unsaturated fat diet

Experimental group

Treatment:

Behavioral: Lifestyle: diet and exercise intervention