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Prevention of Diabetes in Overweight/Obese Preadolescent Children

NCT03027726 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2020-11-20

No results posted yet for this study

Summary

Background: The global pandemic obesity has led to increased risk for prediabetes and type 2 diabetes (T2D).

Objectives: (i) To evaluate the effect of a 22 weeks multidisciplinary intervention program including exercise on T2D risk in pre-adolescents with high risk to develop T2D, and (ii) To identify the profile of microRNA in circulating exosomes and in blood peripheral mononuclear cells in pre-adolescents with high risk to develop T2D and its response to a multidisciplinary intervention program including exercise.

Conditions

  • Overweight Children With Type 2 Diabetes Risk

Interventions

BEHAVIORAL

lifestyle and psycho-educational program

The family-based healthy lifestyle education and psychological education program will be followed once every two weeks (11 sessions over 22 weeks) for 90 minutes (45 minutes in the healthy lifestyle education program and 45 minutes in the psycho-educational intervention). The sessions of the healthy lifestyle education and psycho-educational interventions will be developed simultaneously and delivered to both parents (or caregivers) and children, separately. The family-based healthy lifestyle education program will be conducted by experienced nutritionists and the psycho-educational program by experienced psychologists in behavior changes

OTHER

Exercise plus lifestyle and psycho-educational program

The intervention group will attend the same lifestyle education and psycho-educational program plus the exercise program. The exercise group will do exercise 3 days/week, 90 minutes per session, over a 22-week period. The program will be offered to the families five days per week to choose a total of three days/week. Sessions will be designed and supervised by exercise specialists. The duration of training sessions will be 90 minutes of exercise, including warm-up, moderate to vigorous aerobic activities, and strength exercises

Sponsors & Collaborators

  • Ministerio de Economía y Competitividad, Spain

    collaborator OTHER_GOV

  • Universidad Pública de Navarra

    collaborator OTHER

  • University of the Basque Country (UPV/EHU)

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-07
Primary Completion
2018-09-15
Completion
2018-09-15

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03027726 on ClinicalTrials.gov