Adherence to Fad Diet (Symptom)NCT03296722
Effect of a Nutritional Intervention That Incorporates the Transtheoretical Model
A study testing The Transtheoretical Model in people with Adherence to Fad Diet (Symptom), run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Adherence to Fad Diet (Symptom)
- What is being tested?
- The Transtheoretical Model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- 18 Jan 2016to 28 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
About this study
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
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.
Read the 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.
- Conditions
- Adherence to Fad Diet (Symptom)
- Being tested
- The Transtheoretical Model
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Transtheoretical ModelBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | 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. |
| Intervention group | Experimental | 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. Receives: Behavioral: The Transtheoretical Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Weight loss
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2017
- Study start18 Jan 2016
- Primary completion13 Dec 2016
- Study completion28 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adherence to Fad Diet (Symptom)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LILIA CASTILLO MARTINEz, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03296722
- Sponsor's protocol ID
- NC002
- Status last verified
- Feb 2019
- First submitted
- 2 Sep 2017
- Last updated
- 7 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03296722
- Acronym / sponsor ID
- NC002
- Conditions
- Adherence to Fad Diet (Symptom)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUniversity, hospital or other
- Study start
- 18 Jan 2016 (actual)
- Primary completion
- 13 Dec 2016 (actual)
- Study completion
- 28 Apr 2017 (actual)
- First posted
- 28 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –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. |
| Intervention group | Experimental | Behavioral: The Transtheoretical ModelThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- Overweight or obese (BMI ≥ 25kg/m2)
- DM2 with pharmacological treatment, but without treatment with insulin.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Transtheoretical ModelIntervention 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. | Behavioural | Intervention group |
Primary outcome
Weight
Time frame: 3 months
Weight loss
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2019.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing The Transtheoretical Model in people with Adherence to Fad Diet (Symptom), run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2019; AzTrials last refreshed its copy on 6 Nov 2026.