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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00128336
• Other study ID #: 03/173
• Status: Completed
• Phase: Phase 3
• First received: August 8, 2005
• Last updated: May 12, 2016
• Start date: May 2004
• Est. completion date: October 2006

Study information

• Verified date: May 2016
• Source: University of Otago
• Contact: n/a
• Is FDA regulated: No
• Health authority: New Zealand: Food Safety Authority
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: October 2006
• Est. primary completion date: October 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 70 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Obesity
• Type 2 Diabetes Mellitus

Intervention

Behavioral:
• Lifestyle: diet and exercise intervention

Locations

Country	Name	City	State
New Zealand	Department of Human Nutrition, University of Otago	Dunedin

Sponsors (2)

Lead Sponsor	Collaborator
University of Otago	Edgar National Centre for Diabetes Research

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight		2 years	No
Secondary	Body composition		2 years	No
Secondary	Waist circumference and blood pressure		2 years	No
Secondary	Lipid profile and glucose and insulin		2 years	No
Secondary	Dietary intake		2 years	No
Secondary	Physical fitness		2 years	No
Secondary	Change in mood state		2 years	No