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EFFECTIVENESS OF A TRIPLE NUTRITIONAL INTERVENTION AND PHYSICAL IN PREDIABETIC PATIENRS

ConditionDiabetes
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-70
SponsorBioaraba Health Research Institute

About this trial

Diabetes represents a substantial burden on health care systems. People with prediabetes IGT (impaired glucose tolerance) or IFG (impaired fasting glucose) are at high risk of developing diabetes, and up to 50% progress to diabetes within 5 years.

OBJECTIVE: To evaluate the effectiveness of a triple intervention (physical activity and ordered healthy diet) to improve glycosylated hemoglobin control in prediabetic patients.

MATERIAL AND METHODOLOGY: Randomized, open, controlled clinical trial with routine clinical practice (health advice for physical activity and healthy diet). Study population: obese or overweight patients of the OSI Araba aged 35-70 years who are in the contemplation stage.

Response assessment: Primary variable: glycosylated hemoglobin; Secondary variables: Body Mass Index (BMI) (kg/cm2); blood pressure (mm Hg); satisfaction questionnaire score; physical exercise index (IPAQ) (METs). Statistical analysis: The analysis of the main variable (change in HbA1c at 6 months between both groups) will be assessed by analysis of covariance, ANCOVA, adjusting for baseline HbA1c. Sample size: 41 patients per arm (+30% to cover losses to follow-up).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • A TRIPLE INTERVENTION NUTRITION AND PHYSICAL ACTIVITY

    Combination product

    Intervention group: Health advice and triple intervention: 15 ml apple cider vinegar diluted in a glass of water before meals, order in the sequence of meals (sequence of food intake: first vegetables, second proteins, third fats and finally carbohydrates) and physical activity immediately after meals. Description of all interventions: Patients in both groups: all patients will receive health advice on sports practice from the WHO, Osakidetza and the Basque Government.

Treatment groups

82 Participants
are divided into 2 treatment groups
Group A: INTERVENTIONAL GROUPExperimental treatment 1 intervention
Group B: CONTROL GROUPNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Glycated hemoglobin (HbA1c)

Glycated hemoglobin (HbA1c)

Time frame
At baseline, 3 and 6 months

Secondary outcomes

1

BMI (kg/cm2)

BMI (kg/cm2)

Time frame
At baseline, 3 and 6 months
2

Satisfaction of patients

Score in the satisfaction questionnaire

Time frame
At 6 months
3

Physical exercise index

Physical exercise index (IPAQ)

Time frame
At baseline, 3 and 6 months
4

Compliance with the triple dietary intervention

Compliance with the triple dietary intervention

Time frame
At 3 and 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bioaraba Health Research Institute

Lead sponsor

Osakidetza

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: