NCT01006213

Brief Summary

Overall mortality, such as that caused by cardiovascular disease, increases as weight increases. In the Framingham Study, it was shown that obesity is a cardiovascular risk factor independent of other risk factors such as type 2 diabetes mellitus, dyslipidemia and smoking. Objectives:

  1. 1.To determine whether a group motivational intervention is more effective than the standard intervention for treatment of overweight and obesity and most importantly to maintain the attained weight loss on a permanent basis.
  2. 2.To assess whether this intervention is more effective than reducing cardiovascular risk factors (lipid profile, apo B-100, apo A-1, fibrinogen, C-reactive protein, hypertension, diabetes mellitus) associated with overweight and obesity, and the overall cardiovascular risk in these patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2008

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 30, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 2, 2009

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

November 2, 2009

Status Verified

October 1, 2009

Enrollment Period

Same day

First QC Date

October 30, 2009

Last Update Submit

October 30, 2009

Conditions

OverweightObesity

Keywords

Motivational Intervention

Outcome Measures

Primary Outcomes (1)

  • If a group of motivational intervention, together with current clinical practice, is more efficient than the latter in the treatment of overweight and obesity

    two years

Secondary Outcomes (1)

  • Observe whether this intervention is more effective for reducing cardiovascular risk factors (lipid profile, apo B-100, apo A-1, fibrinogen, reactive protein C, hypertension, diabetes mellitus)

    two years

Study Arms (1)

Lifestyle counseling vs motivational intervention

EXPERIMENTAL
Behavioral: Motivational intervention

Interventions

Motivational interventionBEHAVIORAL

Two groups will be established in geographically separate areas, one of which will receive the group motivational intervention (intervention group) and the other will receive standard follow-up (control group)

Lifestyle counseling vs motivational intervention

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Overweight (BMI\>25) and obese (BMI\>30) patients of both sexes, registered in the medical history (MH) or newly diagnosed.
  • Aged between 30 and 70 years
  • Agreement to participate in the study

You may not qualify if:

  • Patients with severe clinical pathology (bedridden, dementia, advanced neoplasia, etc.)
  • Patients with secondary obesity (hypothyroidism, Cushing's disease, etc).
  • Patients with severe sensorial disorders capable of interfering with the motivational intervention
  • Patients with serious psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abs Florida Sur

L'Hospitalet de Llobregat, BARCELONA, 08905, Spain

RECRUITING

Related Publications (3)

  • Rodriguez-Cristobal JJ, Alonso-Villaverde C, Panisello JM, Trave-Mercade P, Rodriguez-Cortes F, Marsal JR, Pena E. Effectiveness of a motivational intervention on overweight/obese patients in the primary healthcare: a cluster randomized trial. BMC Fam Pract. 2017 Jun 20;18(1):74. doi: 10.1186/s12875-017-0644-y.

    PMID: 28633627DERIVED

  • Rodriguez Cristobal JJ, Alonso-Villaverde Grote C, Trave Mercade P, Perez Santos JM, Pena Sendra E, Munoz Lloret A, Fernandez Perez C, Bleda Fernandez D; EFAP group. Randomised clinical trial of an intensive intervention in the primary care setting of patients with high plasma fibrinogen in the primary prevention of cardiovascular disease. BMC Res Notes. 2012 Mar 1;5:126. doi: 10.1186/1756-0500-5-126.

    PMID: 22381072DERIVED

  • Rodriguez Cristobal JJ, Panisello Royo JM, Alonso-Villaverde Grote C, Perez Santos JM, Munoz Lloret A, Rodriguez Cortes F, Trave Mercade P, Benavides Marquez F, Marti de la Morena P, Gonzalez Burgillos MJ, Delclos Baulies M, Bleda Fernandez D, Quillama Torres E; IMOAP Group. Group motivational intervention in overweight/obese patients in primary prevention of cardiovascular disease in the primary healthcare area. BMC Fam Pract. 2010 Mar 18;11:23. doi: 10.1186/1471-2296-11-23.

    PMID: 20298557DERIVED

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

JUAN JOSE RODRIGUEZ-CRISTOBAL, DR

CONTACT

003493261167221002jrc@comb.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 30, 2009

First Posted

November 2, 2009

Study Start

January 1, 2008

Primary Completion

January 1, 2008

Study Completion

December 1, 2010

Last Updated

November 2, 2009

Record last verified: 2009-10

Locations

ES(1)