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

Tracking Information

First Received Date ^ICMJE

August 8, 2005

Last Updated Date

September 8, 2005

Start Date ^ICMJE

May 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Weight at 2 years

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00128336 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Obesity
Type 2 Diabetes Mellitus

Intervention ^ICMJE

Behavioral: Lifestyle: diet and exercise intervention

Study Arms / Comparison Groups

Publications *

Dale KS, McAuley KA, Taylor RW, Williams SM, Farmer VL, Hansen P, Vorgers SM, Chisholm AW, Mann JI. Determining optimal approaches for weight maintenance: a randomized controlled trial. CMAJ. 2009 May 12;180(10):E39-46.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

200

Completion Date

October 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

25 Years to 70 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

New Zealand

Administrative Information

NCT ID ^ICMJE

NCT00128336

Responsible Party

Study ID Numbers ^ICMJE

03/173

Study Sponsor ^ICMJE

University of Otago

Collaborators ^ICMJE

Edgar National Centre for Diabetes Research

Investigators ^ICMJE

Principal Investigator:

Kelly S Whiteford, MSc (Dist)

University of Otago

Information Provided By

University of Otago

Verification Date

August 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP