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

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Heat Study: A 2-year Lifestyle Intervention in Overweight Women to Determine Optimal Approaches for Successful Maintenance of Weight Loss

Conditions
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Obesity, Type 2 Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Lifestyle: diet and exercise intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nurse support<br> | Behavioral: Lifestyle: diet and exercise intervention<br> <br> |
| Experimental: Intensive support<br> | Behavioral: Lifestyle: diet and exercise intervention<br> <br> |
| Active Comparator: High carbohydrate diet<br> | Behavioral: Lifestyle: diet and exercise intervention<br> <br> |
| Experimental: High mono-unsaturated fat diet<br> | Behavioral: Lifestyle: diet and exercise intervention<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition |  | 2 years | 
| Waist circumference and blood pressure |  | 2 years | 
| Lipid profile and glucose and insulin |  | 2 years | 
| Dietary intake |  | 2 years | 
| Physical fitness |  | 2 years | 
| Change in mood state |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Weight, Diet, exercise, maintenance