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

Primary Purpose

Obesity, Type 2 Diabetes Mellitus

Status

Completed

Phase

Phase 3

Locations

New Zealand

Study Type

Interventional

Intervention

Lifestyle: diet and exercise intervention

About this trial

This is an interventional treatment trial for Obesity focused on measuring Weight, Diet, exercise, maintenance

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Department of Human Nutrition, University of Otago

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

Nurse support

Intensive support

High carbohydrate diet

High mono-unsaturated fat diet

Arm Description

Outcomes

Primary Outcome Measures

Weight

Secondary Outcome Measures

Body composition

Waist circumference and blood pressure

Lipid profile and glucose and insulin

Dietary intake

Physical fitness

Change in mood state

Full Information

NCT ID

NCT00128336

First Posted

August 8, 2005

Last Updated

May 12, 2016

Sponsor

University of Otago

Collaborators

Edgar National Centre for Diabetes Research

1. Study Identification

Unique Protocol Identification Number

NCT00128336

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Completed

Study Start Date

May 2004 (undefined)

Primary Completion Date

October 2006 (Actual)

Study Completion Date

October 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Otago

Collaborators

Edgar National Centre for Diabetes Research

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Type 2 Diabetes Mellitus

Keywords

Weight, Diet, exercise, maintenance

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nurse support

Arm Type

Active Comparator

Arm Title

Intensive support

Arm Type

Experimental

Arm Title

High carbohydrate diet

Arm Type

Active Comparator

Arm Title

High mono-unsaturated fat diet

Arm Type

Experimental

Intervention Type

Behavioral

Intervention Name(s)

Lifestyle: diet and exercise intervention

Primary Outcome Measure Information:

Title

Weight

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Body composition

Time Frame

2 years

Title

Waist circumference and blood pressure

Time Frame

2 years

Title

Lipid profile and glucose and insulin

Time Frame

2 years

Title

Dietary intake

Time Frame

2 years

Title

Physical fitness

Time Frame

2 years

Title

Change in mood state

Time Frame

2 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kelly S Whiteford, MSc (Dist)

Organizational Affiliation

University of Otago

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Human Nutrition, University of Otago

City

Dunedin

ZIP/Postal Code

9001

Country

New Zealand

12. IPD Sharing Statement

Citations:

PubMed Identifier

19433812

Citation

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. doi: 10.1503/cmaj.080974.

Results Reference

derived

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

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