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Completed

NCT Number: NCT00128336

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

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.

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Key information

Age range

25 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Department of Human Nutrition, University of Otago

Dunedin, 9001, New Zealand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle: diet and exercise intervention

Behavioral

Primary outcomes

  1. Weight

    Time frame: 2 years

Secondary outcomes

  1. Body composition

    Time frame: 2 years

  2. Waist circumference and blood pressure

    Time frame: 2 years

  3. Lipid profile and glucose and insulin

    Time frame: 2 years

  4. Dietary intake

    Time frame: 2 years

  5. Physical fitness

    Time frame: 2 years

  6. Change in mood state

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

University of Otago

Other

Collaborators

  • Edgar National Centre for Diabetes Research

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Aug 9, 2005
Registry last updated
May 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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