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

This study has been completed.
Sponsor:
Collaborator:
Edgar National Centre for Diabetes Research
Information provided by (Responsible Party):
Rachael Taylor, University of Otago
ClinicalTrials.gov Identifier:
NCT00128336
First received: August 8, 2005
Last updated: May 12, 2016
Last verified: May 2016
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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:


Further study details as provided by University of Otago:

Primary Outcome Measures:
  • Weight [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Body composition [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Waist circumference and blood pressure [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Lipid profile and glucose and insulin [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Dietary intake [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Physical fitness [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Change in mood state [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: May 2004
Study Completion Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Nurse support Behavioral: Lifestyle: diet and exercise intervention
Experimental: Intensive support Behavioral: Lifestyle: diet and exercise intervention
Active Comparator: High carbohydrate diet Behavioral: Lifestyle: diet and exercise intervention
Experimental: High mono-unsaturated fat diet Behavioral: Lifestyle: diet and exercise intervention

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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rachael Taylor, PhD student, University of Otago
ClinicalTrials.gov Identifier: NCT00128336     History of Changes
Other Study ID Numbers: 03/173 
Study First Received: August 8, 2005
Last Updated: May 12, 2016
Health Authority: New Zealand: Food Safety Authority

Keywords provided by University of Otago:
Weight
Diet
exercise
maintenance

Additional relevant MeSH terms:
Diabetes Mellitus
Overweight
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 27, 2016