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Effect of a Nutritional Intervention That Incorporates the Transtheoretical Model

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ClinicalTrials.gov Identifier: NCT03296722
Recruitment Status : Completed
First Posted : September 28, 2017
Last Update Posted : February 7, 2019
Sponsor:
Information provided by (Responsible Party):
LILIA CASTILLO MARTINEz, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Brief Summary:
Cardiovascular diseases are the main responsible for the global burden of disease for non-communicable diseases. Its treatment and prevention is aimed at generating changes in the habits of life; however, the percentages of non-adherence are very high. The objective of the study was to evaluate the effect of a nutritional intervention in patients with cardiovascular risk that incorporates the transtheoretical model and motivational interviews on the progression in the stages of change to improve adherence to healthy eating. Methods: the investigators included 105 patients who came to the first time at clinical nutrition service in external consultation of National Institute of Medical Sciences and Nutrition Salvador Zubirán, were randomized to intervention group or control group and the stage of change of the transtheoretical model, presence or absence of anxiety and depression, anthropometry, blood pressure, physical activity, and food frequency, to determine the quality and quantity of food intake, were evaluated. Used X² and t-test for the comparison of baseline data between groups and repeated measures ANOVA to assess differences in post-intervention.

Condition or disease Intervention/treatment Phase
Adherence to Fad Diet (Symptom) Behavioral: The Transtheoretical Model Not Applicable

Detailed Description:

The investigators included 105 patients that were randomized to intervention group or control group. The control group comprised 41 patients, that continued with the usual intervention of Clinical Nutrition Service in external consultation, attending once a month to receive nutritional intervention with the prescription of a hypocaloric diet on the part of the nutritionist. And the intervention group made up of 42 patients using the TM and MI through sessions group and sessions individual with topics of healthy eating habits taught by a nutritionist, physical activity and exercise manual taught by a physical therapist, preparation of healthy food with menu taught by graduates in gastronomy and confrontation of barriers given by a psychologist.

Both groups had a monthly monitoring for 3 months. The diet that was prescribed to the intervention group was with the characteristics of the DASH diet, according to the most recent international guides of the ACC and AHA, for the reduction of cardiovascular risk.

Once included in the study were applied to the following questionnaires to identify the stage of change according to the TM; Hospital Anxiety and Depression Scale (HAD) to evaluate the presence of anxiety and depression; 24-hours recall of multiple steps; Food consumption frequency to determine the quantity and quality of food intake and the Rapid Assessment Physical Activity Scale (RAPA), to determine the type, duration and intensity of physical activity of the subject. In addition, we measured weight, height, waist circumference, hip, and blood pressure.

Finally were described and analyzed each of the variables according to the visits in which patients were cited.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Effect of a Nutritional Intervention That Incorporates the Transtheoretical Model of Motivation to Change in Healthy Eating in Patients With Cardiovascular Risk Factors: a Randomized Controlled Trial
Actual Study Start Date : January 18, 2016
Actual Primary Completion Date : December 13, 2016
Actual Study Completion Date : April 28, 2017

Arm Intervention/treatment
No Intervention: Control group
The control group comprised 41 patients, which was to go once a month to receive nutritional intervention with the prescription of a hypocaloric diet on the part of the nutritionist. The control group had a monthly monitoring for 3 months.
Experimental: Intervention group
The intervention group made up of 42 patients using the transtheoretical model and MI through sessions group and sessions individual with topics of healthy eating habits taught by a nutritionist, physical activity and exercise manual taught by a physical therapist, preparation of healthy food with menu taught by graduates in gastronomy and confrontation of barriers given by a psychologist. The intervention group had a monthly monitoring for 3 months. The diet that was prescribed to the intervention group was with the characteristics of the DASH diet.
Behavioral: The Transtheoretical Model
Intervention with the Transtheoretical Model, through group and individual sessions with topics of healthy eating habits taught by a dietician, physical activity and exercise manual taught by a physical therapist, preparation of healthy food with menu taught by graduates in gastronomy, confrontation of barriers given by a psychologist. This group had a monthly monitoring during 3 months. The food plan that was prescribed to the intervention group was with the characteristics of the DASH diet, according to the most recent international guides of the ACC and AHA, for the reduction of cardiovascular risk.




Primary Outcome Measures :
  1. Weight [ Time Frame: 3 months ]
    Weight loss



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  • Men and women volunteers over the age of 18 years. Referees for first time of the various specialties and subspecialties of the INCMNSZ.
  • They have e-mail, telephone or personal cell phones.
  • Which could go one time every month to consultation.

Submitted at least 2 of the following comorbidities:

  • Overweight or obese (BMI ≥ 25kg/m2)
  • DM2 with pharmacological treatment, but without treatment with insulin.
  • Hypertension (≥140/90 mmHg) with or without medication
  • Waist circumference greater than 80 cm women and greater than 90 cm men
  • Hypertriglyceridemia (>150 mg/dl), HDL-cholesterol <40 mg/dl in men and <50 mg/dl in women. Were selected those that have two or more cardiovascular risk factors (obesity, hypertension, DM2 or dyslipidemia.

Exclusion criteria

  • Diagnosis of major depression
  • Cancer
  • Human immunodeficiency virus (HIV)
  • Acute and chronic diseases such as renal failure (GFR ˂ 30 ml/min/1.21m2)
  • Disease of liver and/or heart failure
  • Respiratory disease
  • Bariatric surgery
  • Morbid obesity (BMI ≥40 kg/m2).

Responsible Party: LILIA CASTILLO MARTINEz, Professor, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier: NCT03296722     History of Changes
Other Study ID Numbers: NC002
First Posted: September 28, 2017    Key Record Dates
Last Update Posted: February 7, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No