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

NCT ID: NCT00128336

Last Updated: 2016-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2006-10-31

Brief Summary

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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

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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.

Conditions

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Obesity Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nurse support

Group Type ACTIVE_COMPARATOR

Lifestyle: diet and exercise intervention

Intervention Type BEHAVIORAL

Intensive support

Group Type EXPERIMENTAL

Lifestyle: diet and exercise intervention

Intervention Type BEHAVIORAL

High carbohydrate diet

Group Type ACTIVE_COMPARATOR

Lifestyle: diet and exercise intervention

Intervention Type BEHAVIORAL

High mono-unsaturated fat diet

Group Type EXPERIMENTAL

Lifestyle: diet and exercise intervention

Intervention Type BEHAVIORAL

Interventions

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Lifestyle: diet and exercise intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Edgar National Centre for Diabetes Research

OTHER

Sponsor Role collaborator

University of Otago

OTHER

Sponsor Role lead

Responsible Party

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Rachael Taylor

PhD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kelly S Whiteford, MSc (Dist)

Role: PRINCIPAL_INVESTIGATOR

University of Otago

Locations

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Department of Human Nutrition, University of Otago

Dunedin, , New Zealand

Site Status

Countries

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New Zealand

References

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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.

Reference Type DERIVED
PMID: 19433812 (View on PubMed)

Other Identifiers

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03/173

Identifier Type: -

Identifier Source: org_study_id

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