NCT00991549

Brief Summary

This study compared the efficacy at one year of an interdisciplinary approach including individual counseling and group seminars versus group seminars alone to induce weight loss in subjects at high risk of developing type 2 diabetes. This study also compare if a participant's presence in small informative meeting groups as the only form of intervention is sufficient to induce a lifestyle change, thus inducing the weight loss needed for the prevention of the diseases associated with obesity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2004

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 8, 2009

Completed
Last Updated

October 8, 2009

Status Verified

October 1, 2009

Enrollment Period

2.8 years

First QC Date

October 7, 2009

Last Update Submit

October 7, 2009

Conditions

OverweightGlucose Intolerance

Keywords

overweightobesityglucose intolerancepre-diabetes

Outcome Measures

Primary Outcomes (5)

  • a weight loss of 7% in at least 19% of the subjects

    one year

  • reduced body weight of at least 5.6 kg in at least 25% of the subjects

    one year

  • an increase in the level of physical activity by at least 150 minutes per week in at least 29% of the subjects

    one year

  • a reduced daily caloric intake of at least 450 kcal/jour in at least 25% of the subjects

    one year

  • a reduced percentage of the calories introduced in the form of fat of at least 6.6%, in absolute value, in at least 25% of the subjects

    one year

Secondary Outcomes (5)

  • change in insulin sensitivity by HOMA

    one year

  • change in insulin secretion during an OGTT by deconvolution of plasma c-peptide

    one year

  • change in beta cell function by calculation of the disposition index

    one year

  • change in insulin-mediated suppression of plasma non-esterified fatty acids during an OGTT

    one year

  • relation between weight loss and change in insulin sensitivity, beta cell function, and insulin-mediated suppression of plasma non-esterified fatty acids

    one year

Study Arms (2)

1

EXPERIMENTAL

interdisciplinary weight loss intervention

Behavioral: interdisciplinary intervention or meeting-seminars

2

ACTIVE COMPARATOR

Small group seminars without interdisciplinary intervention

Behavioral: interdisciplinary intervention or meeting-seminars

Interventions

interdisciplinary intervention or meeting-seminarsBEHAVIORAL

one-year individualized interdisciplinary weight loss program vs. small group seminars on healthy lifestyle

12

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • pre diabetic state underlined by a marginal fasting glycemia between 6,1 and 6,9 mmol/L and/or a glucose intolerance with glucose confirmed by an OGTT 2 hours
  • overweight or obesity (BMI \> 27 kg/m² ; (Body Mass Index))
  • enlightened assent

You may not qualify if:

  • Impossibility to be present at the visits
  • Physical/motor incapacity (or other) making one unable and/or insecure to walk at a moderate to rapid speed of 6 min and more
  • Use of an anti-obesity treatment during the last 3 months
  • Bariatric Surgery in the past
  • Planned Pregnancy
  • Pacemaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de Recherche Clinique (CRC), Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Location

Related Publications (1)

  • Gagnon C, Brown C, Couture C, Kamga-Ngande CN, Hivert MF, Baillargeon JP, Carpentier AC, Langlois MF. A cost-effective moderate-intensity interdisciplinary weight-management programme for individuals with prediabetes. Diabetes Metab. 2011 Nov;37(5):410-8. doi: 10.1016/j.diabet.2011.01.003. Epub 2011 Apr 13.

    PMID: 21489843DERIVED

MeSH Terms

Conditions

OverweightGlucose IntoleranceObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperglycemiaGlucose Metabolism DisordersMetabolic Diseases

Study Officials

  • Marie-France Langlois, MD

    Medecine department, Division of endocrinology, CHUS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 7, 2009

First Posted

October 8, 2009

Study Start

December 1, 2004

Primary Completion

October 1, 2007

Study Completion

January 1, 2008

Last Updated

October 8, 2009

Record last verified: 2009-10

Locations

CA(1)