Lifestyle Intervention in Obese Non-diabetic Adults With a Family History of Diabetes.
The Effect of an 8-month Intensive Lifestyle Intervention on Hormonal Factors Regulating Food Intake in Obese, Non-diabetic Adults With a Family History of Diabetes.
2 other identifiers
interventional
66
1 country
1
Brief Summary
The aim of this study is to investigate weather gradual weight loss achieved with healthy lifestyle changes influence hormonal factors affecting appetite and blood glucose control in obese people without presence of diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable type-2-diabetes
Started Sep 2010
Typical duration for not_applicable type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 9, 2009
CompletedFirst Posted
Study publicly available on registry
October 12, 2009
CompletedStudy Start
First participant enrolled
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedDecember 5, 2012
December 1, 2012
2.1 years
October 9, 2009
December 4, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To estimate the correlation between weight loss over 8 months achieved through a programme of intensive lifestyle management and changes in GLP-1 production over the same period in obese without presence of diabetes but with family history of diabetes.
8 month lifestyle programme
Secondary Outcomes (1)
The secondary aim is to examine the changes in weight, cardiovascular risk factors and hormonal regulators of food intake and blood glucose metabolism.
8 months lifestyle programme
Study Arms (1)
Lifestyle programme.
EXPERIMENTAL8 month lifestyle programme.
Interventions
Dietary and lifestyle counselling (11 sessions), weekly exercise programme and 3 fasting blood samples at baseline, 4 and 8 months.
Eligibility Criteria
You may qualify if:
- BMI between 30-39.9kg/m2
- Family history of diabetes (self reported)
- Normal and impaired glucose tolerance
- Obtain informed consent
You may not qualify if:
- BMI less than 30kg/m2 or more than 39.9kg/m2
- Presence of diabetes or any other chronic disease or disability that might interfere with the study results
- Anti-obesity or any other prescription medications that may interfere with the study results
- Pregnancy
- Unable to converse competently in English as special arrangements would need to be made for such people and this would be impractical in a group setting
- Attending another weight management programme
- Patients who would be unable to attend at least 75% of the programme sessions for medical or other reasons
- Unable to provide informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Royal Bournemouth Hospital
Bournemouth, Dorset, BH7 7DW, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dr Joe Begley
The Royal Bournemouth Hospitals
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 9, 2009
First Posted
October 12, 2009
Study Start
September 1, 2010
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
December 5, 2012
Record last verified: 2012-12