NCT02247635

Brief Summary

The metabolic syndrome is a group of cardiometabolic risk factors that reflect a sedentary lifestyle and the excessive intake of food among the risk factors that comprise it are located the obesity, hyperglycemia, dyslipidemia and hypertension. It has been observed that the interventions of lifestyle changes that promote weight loss through the practice of physical activity and intake of a hypocaloric diet, reduce the prevalence of chronic diseases such as Metabolic syndrome. Adherence is defined as the extent to which a person's behaviour - taking medication, following a diet, and/or executing lifestyle changes, corresponds with agreed recommendations from a health care provider. The World Health Organization has estimated that in developing countries, as in Mexico, less than 27% of people with chronic diseases will continue treatment as directed. Adherence to treatment of chronic disease is a multifactorial problem that includes not only patient-related barriers, but also providers of health services and social security systems themselves. Furthermore, as WHO has pointed out, as increasing prevalence of chronic non-adherence to treatment will become a global problem even more serious. The purpose of this study is develop and implement a methodology to overcome barriers affecting adherence to treatment of women over 20 years with non-communicable diseases such as metabolic syndrome (diabetes , hypertension and dyslipidemia) evaluating its impact through various quantitative indicators such as weight loss or metabolic syndrome prevalence. This study will include two phases:

  1. 1.Phase 1. Design. Qualitative methodology was used primarily to identify the barriers faced by individuals to adhere to treatment. From this methodology, we developed a tool to assess adherence to treatment of subjects with these conditions and then an intervention to improve it.
  2. 2.Phase 2. Implementation of intervention (24 weeks). To recruite a group of 180 overweight and two of the following comorbidities: diabetes mellitus, dyslipidemia or hypertension. All study subjects will be randomized to a control group and intervention. The control group will receive a medical traditional clinical care. The intervention group will receive a lifestyle treatment with behavioral intervention to improve adherence for improve eating behaviors, physical activity and metabolic control.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Nov 2008

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

November 1, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

September 17, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 25, 2014

Completed
Last Updated

November 3, 2014

Status Verified

October 1, 2014

Enrollment Period

6 months

First QC Date

September 17, 2014

Last Update Submit

October 30, 2014

Conditions

ObesityDiabetesHigh Blood PressureDyslipidemia

Keywords

Treatment adherenceBehavioral model of health careHealthy lifestyleChronic metabolic diseasesMetabolic syndromeObesity

Outcome Measures

Primary Outcomes (1)

  • Reduction in the prevalence of metabolic syndrome (obesity, diabetes, hypertension, dyslipidemia)

    To first week(basal), 12 weeks after recruiting (intermediate) and 24 weeks after recruiting (final evaluation)

    24 weeks

Secondary Outcomes (4)

  • Reduction of hyperglycemia

    24 weeks

  • Weight loss

    24 weeks

  • Reduction of high blood pressure

    24 weeks

  • Reduction of hypercholesterolemia

    24 weeks

Study Arms (2)

Conventional medical treatment

NO INTERVENTION

Based on the clinical guidelines of the Ministry of Health, medical treatment was provided and consisted in counseling for chronic diseases such as obesity, hyperglycemia, hypertension, dyslipidemia

Healthy lifestyle and adherence

ACTIVE COMPARATOR

1\) Maintain a caloric restriction of 500kcal in overweight adults, 2) Have a total fat intake \<30% (including cholesterol and trans fat), 3) A total intake of complex carbohydrates for 50%, 3) 30g fiber, 4) Perform at least 30 minutes of moderate physical activity at least 5 days a week; 5) Maintain education and behavioral therapy changes in your lifestyle.

Behavioral: Healthy lifestyle and adherence

Interventions

Healthy lifestyle and adherenceBEHAVIORAL

Behavioral intervention to improve adherence to treatment and 1) Maintain a caloric restriction of 500kcal in overweight adults, 2) Have a total fat intake \<30% (including cholesterol and trans fat), 3) A total intake of complex carbohydrates for 50%, 3) 30g fiber, 4) Perform at least 30 minutes of moderate physical activity at least 5 days a week; 5) Maintain education and behavioral therapy changes in your lifestyle. The model consists of monthly visits to the doctor, nutritionist and psychologist, for screening cardiometabolic risk factors, to know limitations on treatment adherence, to start intervention to evaluate reasons for success or failure, to evaluate and maintain motivation to adherence to diet, physical activity and medication and long-term care

Healthy lifestyle and adherence

Eligibility Criteria

Age20 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women from 19 to 65 years old
  • Body mass index ≥ 25.0 - ≤39.9 or abdominal obesity
  • With previous medical diagnosis:
  • high fasting glucose
  • high blood pressure
  • dyslipidemia.

You may not qualify if:

  • Currently pregnant or breast-feeding.
  • Anxiety and depression significantly.
  • Consumption of alcohol or smoking significantly.
  • Taking anorexigenic or other weight-loss drugs (Xenical)
  • Pregnant or breastfeeding
  • Have polycystic ovary syndrome,
  • Kidney failure
  • Hypothyroidism,
  • Cancer,
  • Anxiety or depression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mexican National Institute of Public Health

Cuernavaca, Morelos, 62100, Mexico

Location

MeSH Terms

Conditions

ObesityDiabetes MellitusHypertensionDyslipidemiasTreatment Adherence and ComplianceMetabolic Syndrome

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular DiseasesLipid Metabolism DisordersHealth BehaviorBehaviorInsulin ResistanceHyperinsulinism

Study Officials

  • Simón Barquera, PhD

    Mexican National Institute of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Research in Nutrition Policy and Programs.

Study Record Dates

First Submitted

September 17, 2014

First Posted

September 25, 2014

Study Start

November 1, 2008

Primary Completion

May 1, 2009

Study Completion

August 1, 2010

Last Updated

November 3, 2014

Record last verified: 2014-10

Locations

ME(1)