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

This study is ongoing, but not recruiting participants.

First Received: August 8, 2005 Last Updated: September 8, 2005 History of Changes

Sponsor:	University of Otago
Collaborator:	Edgar National Centre for Diabetes Research
Information provided by:	University of Otago
ClinicalTrials.gov Identifier:	NCT00128336

Purpose

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	Intervention	Phase
Obesity Type 2 Diabetes Mellitus	Behavioral: Lifestyle: diet and exercise intervention	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Official Title:	The Heat Study: A 2-Year Lifestyle Intervention in Overweight Women to Determine Optimal Approaches for Successful Maintenance of Weight Loss

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diets Exercise and Physical Fitness Obesity Weight Control

U.S. FDA Resources

Further study details as provided by University of Otago:

Primary Outcome Measures:

Weight at 2 years

Secondary Outcome Measures:

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

Estimated Enrollment:	200
Study Start Date:	May 2004
Estimated Study Completion Date:	October 2006

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.

Eligibility

Ages Eligible for Study:	25 Years to 70 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00128336

Locations

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

Sponsors and Collaborators

University of Otago

Edgar National Centre for Diabetes Research

Investigators

Principal Investigator:

Kelly S Whiteford, MSc (Dist)

University of Otago

More Information

No publications provided by University of Otago

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Study ID Numbers:	03/173
Study First Received:	August 8, 2005
Last Updated:	September 8, 2005
ClinicalTrials.gov Identifier:	NCT00128336 History of Changes
Health Authority:	New Zealand: Food Safety Authority

Keywords provided by University of Otago:

Weight
Diet
exercise
maintenance

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Obesity
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus

Nutrition Disorders
Endocrine System Diseases
Overnutrition
Overweight
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on November 25, 2009