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

May 12, 2016 updated by: Rachael Taylor, University of Otago

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight
Time Frame: 2 years
2 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Otago

Collaborators

Edgar National Centre for Diabetes Research

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (Actual)

October 1, 2006

Study Completion (Actual)

October 1, 2006

Study Registration Dates

First Submitted

August 8, 2005

First Submitted That Met QC Criteria

August 8, 2005

First Posted (Estimate)

August 9, 2005

Study Record Updates

Last Update Posted (Estimate)

May 16, 2016

Last Update Submitted That Met QC Criteria

May 12, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03/173

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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