NCT02703129

Brief Summary

Migraine is a common medical condition. Several studies suggest that obesity and/or weight gain are risk factors for aggravating migraine course, especially increase the frequency of headache episodes. The aim of the current study was to evaluate whether nutritional intervention would be able to improve clinical parameters (as assessed by MIDAS and HIT) of patients with migraine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2010

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

February 5, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 9, 2016

Completed
Last Updated

March 9, 2016

Status Verified

March 1, 2016

Enrollment Period

2.9 years

First QC Date

February 5, 2016

Last Update Submit

March 3, 2016

Conditions

Migraine

Keywords

MigraineDiet qualityNutritional interventionSeverity of diseaseDepressive symptoms

Outcome Measures

Primary Outcomes (2)

  • Change in clinical parameters of migraine patients by nutritional intervention in the last month.

    Migraine impact/severity in the last month was assessed by HIT-6.

    4 weeks

  • Change in clinical parameters of migraine patients by nutritional intervention in the last three month.

    Migraine impact/severity in the last three month was assessed by MIDAS.

    12 weeks

Secondary Outcomes (2)

  • Change in diet quality of migraine patients by nutritional intervention assessed with the Brazilian Healthy Eating Index - Revised (BHEI-R)

    12 weeks

  • Change in depressive symptoms in migraine patients by nutritional intervention assessed with the Beck Depression Inventory (BDI)

    12 weeks

Study Arms (1)

Nutritional intervention

EXPERIMENTAL

Women with the diagnosis of migraine received individualized diet meal plan and nutritional orientations for three months according to their nutritional diagnosis

Other: Nutritional intervention

Interventions

Nutritional interventionOTHER

Women with the diagnosis of migraine received individualized diet meal plan and nutritional orientations for three months according to their nutritional diagnosis

Nutritional intervention

Eligibility Criteria

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

You may qualify if:

  • Women;
  • Older than 18 years;
  • Migraine diagnosis;
  • Agree to sign the informed consent.

You may not qualify if:

  • Patients with headaches not characterized as migraine;
  • Pregnant or lactating women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ambulatório Bias Fortes

Belo Horizonte, Minas Gerais, 30130-100, Brazil

Location

MeSH Terms

Conditions

Migraine DisordersDepression

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesBehavioral SymptomsBehavior

Study Officials

  • Adaliene VM Ferreira, PhD

    Federal University of Minas Gerais

    STUDY DIRECTOR

  • Aline Bárbara P Costa, Ms

    Federal University of Minas Gerais

    STUDY CHAIR

  • Antônio L Teixeira, PhD

    Federal University of Minas Gerais

    PRINCIPAL INVESTIGATOR

  • Laís B Martins, Ms

    Federal University of Minas Gerais

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

February 5, 2016

First Posted

March 9, 2016

Study Start

January 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

March 9, 2016

Record last verified: 2016-03

Locations

BR(1)