To determine the most cost effective programme for overweight and obese individuals to maintain weight loss over a 2 year period.

Condition	Intervention	Phase
Obesity Type 2 Diabetes	Behavior: Lifestyle: diet and exercise intervention	Phase III

Further Study Details: 

Primary Outcomes: weight at 2 years
Secondary Outcomes: Body composition changes over 2 years; Waist circumference and blood pressure changes over 2 years; Lipid profile and glucose and insulin changes over 2 years; Dietary intake changes over 2 years; Physical fitness at 2 years; Change in mood state over 2 years
Expected Total Enrollment:  200

Although short term weight loss is often achievable in overweight individuals, long term maintenance is generally poor. We 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’. We 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.

Ages Eligible for Study:  25 Years   -   70 Years,  Genders Eligible for Study:  Female

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

• Female participants
• Aged 25 to 70
• 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

New Zealand
      Department of Human Nutrition, University of Otago, Dunedin,  9001,  New Zealand

Study chairs or principal investigators

Kelly S Whiteford, MSc (Dist),  Principal Investigator,  University of Otago   

Study ID Numbers:  03/173
Last Updated:  August 8, 2005
Record first received:  August 8, 2005
ClinicalTrials.gov Identifier:  NCT00128336
Health Authority: New Zealand: Food Safety Authority
ClinicalTrials.gov processed this record on 2005-08-23