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

Sponsor

University of Otago (Other)

Overall Status

Completed

CT.gov ID

NCT00128336

Collaborator

Edgar National Centre for Diabetes Research (Other)

200

Enrollment

Location

Arms

Duration (Months)

6.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity Type 2 Diabetes Mellitus	Behavioral: Lifestyle: diet and exercise intervention	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2004

Actual Primary Completion Date :

Oct 1, 2006

Actual Study Completion Date :

Oct 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Nurse support	Behavioral: Lifestyle: diet and exercise intervention
Experimental: Intensive support	Behavioral: Lifestyle: diet and exercise intervention
Active Comparator: High carbohydrate diet	Behavioral: Lifestyle: diet and exercise intervention
Experimental: High mono-unsaturated fat diet	Behavioral: Lifestyle: diet and exercise intervention

Outcome Measures

Primary Outcome Measures

Weight [2 years]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts 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