<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03234946</url>
  </required_header>
  <id_info>
    <org_study_id>2145</org_study_id>
    <nct_id>NCT03234946</nct_id>
  </id_info>
  <brief_title>Effect of the CAIPaDi Care Model in Relatives of Patients With Type 2 Diabetes Mellitus</brief_title>
  <acronym>CAIPaDi</acronym>
  <official_title>Effect of the CAIPaDi Care Model in Relatives of Patients With Type 2 Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Mexican National Institute of Public Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Diabetes is a chronic disease that requires long-term lifestyle changes that may affect the&#xD;
      whole family. Hence, during the last decade, studies have focused mainly in the role of the&#xD;
      members of the family and their influence in life quality or clinical outcomes of patients&#xD;
      with diabetes. Therefore, the delivery of education only to the patients with type 2 diabetes&#xD;
      mellitus may restrict the expectations of success in achieving the necessary modifications in&#xD;
      lifestyle.&#xD;
&#xD;
      Objectives: To assess the effect of the CAIPaDi (Centre of Comprehensive Care for the&#xD;
      Patients with Diabetes) program interventions on various health indicators relatives of&#xD;
      patients with type 2 diabetes mellitus.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Diabetes mellitus is one of the most challenging health issues of our time, the percentage of&#xD;
      adults with this disease tripled in Mexico between 1993 and 2012; In 1993 the prevalence was&#xD;
      6.7% (cases previously diagnosed 4.6% and diagnosed during the survey 2.1%), whereas in 2012,&#xD;
      the prevalence was 14.4% (7.3% previously diagnosed and 7.1% diagnosed during the survey)&#xD;
      Identifying individuals at risk for developing diabetes and implementing prevention&#xD;
      strategies is the optimal solution. Carbohydrate intolerance and impaired fasting glucose&#xD;
      raise the risk of developing diabetes up to 20 times compared to those with normal levels of&#xD;
      HbA1C and a progression rate to diabetes of 10% per year in the absence of any intervention.&#xD;
&#xD;
      Randomized studies have shown that progression from impaired fasting glucose and glucose&#xD;
      intolerance to type 2 diabetes mellitus and its complications can be prevented by&#xD;
      interventions focused on changes in lifestyle. This contributed to the implementation of new&#xD;
      guidelines for the management of prediabetes, emphasizing the importance of timely&#xD;
      interventions in this condition, which may be the most cost-effective alternative to avoid&#xD;
      complications.&#xD;
&#xD;
      One of the most important studies in primary diabetes prevention, the Diabetes Prevention&#xD;
      Program (DPP), provided scientific evidence on the prevention and delay in the onset of&#xD;
      diabetes in high-risk individuals, with a 58% risk reduction through lifestyle modifications,&#xD;
      such as reduced fat and calorie intake, increased physical activity up to at least 150&#xD;
      minutes per week and loss of 5-7% of body weight.&#xD;
&#xD;
      Another multicenter, randomized trial, the Finnish Diabetes Prevention Study (DPS), showed&#xD;
      that type 2 diabetes is preventable with lifestyle multidisciplinary interventions, with a&#xD;
      58% risk reduction similar to that of the DPP study in the group who received intensive&#xD;
      treatment, compared to the control group, even significant changes were observed in metabolic&#xD;
      parameters one and three years afterwards.&#xD;
&#xD;
      In addition, a randomized, multicenter study in the city of Da Qing, China, with a population&#xD;
      of 110,660 participants, demonstrated that diet and / or exercise lead to a significant&#xD;
      decrease in the incidence of diabetes over a 6-year period in patients with carbohydrate&#xD;
      intolerance, with an incidence of 67.7% in the control group, 43.8% in the group undergoing&#xD;
      dietary changes and 46% in the diet and exercise group.&#xD;
&#xD;
      Family history of diabetes is an independent risk factor for having the disease and provides&#xD;
      information for the screening of individuals at risk and even represents an even more&#xD;
      sensitive indicator than the presence of obesity.&#xD;
&#xD;
      Diabetes is a chronic disease that involves changes in the patient's lifestyle that can&#xD;
      affect the whole family. During the last decade, studies have focused mainly on the role of&#xD;
      family members and their influence on the quality of life or clinical course of patients with&#xD;
      diabetes. Therefore, providing education only to the individual diagnosed with type 2&#xD;
      diabetes could restrict the chances of success in achieving the necessary changes in&#xD;
      lifestyle.&#xD;
&#xD;
      Some studies have shown that the familial nature of type 2 diabetes is manifested by the&#xD;
      presence of insulin resistance in first-degree relatives without diabetes, while others have&#xD;
      revealed B-cell dysfunction, it seems that both insulin resistance and a diminished B-cell&#xD;
      compensation are the family metabolic phenotype of type 2 diabetes mellitus. This highlights&#xD;
      the importance of providing diabetes education not only to the patient, but also to their&#xD;
      relatives, especially those who already have additional risk factors or prediabetes.&#xD;
&#xD;
      In cross-sectional studies of diabetes, social support has been associated with a better&#xD;
      glycemic control in type 2 diabetes and is positively related to overall health status and&#xD;
      lifestyle changes. Additionally, the health status of family members of patients attending&#xD;
      the sessions has been demonstrated, and social and family support in general is positively&#xD;
      linked to health status and transcendental changes in lifestyle.&#xD;
&#xD;
      These findings are justified by the results of the second multinational study, Diabetes&#xD;
      Attitudes, Wishes and Needs (DAWN2TM), in which the disease was studied from the perspective&#xD;
      of family members, patients and health professionals. Family members who deemed a greater&#xD;
      responsibility for the management of diabetes had a lower quality of life and higher levels&#xD;
      of disease impact and perceived burden, while less responsibility for the management of&#xD;
      diabetes perceived by the patient's family members and an effective collaboration among them&#xD;
      correlates with improved psychological well-being and quality of life for family members.&#xD;
&#xD;
      Diabetes is associated with a sense of social disadvantage and stress not only in patients&#xD;
      with diabetes but also in the members of their family, so there is a need to foster a larger&#xD;
      network of family support through educational programs and to involve them in the treatment&#xD;
      of the illness.&#xD;
&#xD;
      To date there are no studies that accurately analyze the impact of social support on&#xD;
      maintaining lifestyle changes in a supportive group setting.&#xD;
&#xD;
      The study Families United analyzed the effect of social support in the prevention of&#xD;
      diabetes, which has proved to be important for its management and even for other diseases&#xD;
      such as obesity, it has been used to convey information regarding prevention of diabetes to&#xD;
      minority and high-risk groups in communities.&#xD;
&#xD;
      The social context in which the patient carries out self-care activities determines its&#xD;
      success, so that obstructive behaviors such as sabotage or underestimating the patient's&#xD;
      effort or hampering their self-care are associated with a greater HbA1C and a reduction of&#xD;
      motivation and adherence to treatment, diet plan and exercise.&#xD;
&#xD;
      Despite the high prevalence of obstructive behaviors among relatives of patients with&#xD;
      diabetes, few interventions focus on the negative aspects of family interactions.&#xD;
&#xD;
      Family support behaviors or sabotage in diabetes have been independently associated with&#xD;
      adherence to self-care behavior and glycemic control among adults with diabetes and low&#xD;
      sociocultural level. DAWN-II found that more than one-third of family members wish to be more&#xD;
      involved in managing the patient's disease.&#xD;
&#xD;
      A study was conducted in 2013 based on socio-cognitive theory, which focuses on the influence&#xD;
      of the social environment (family members) on changes in health habits to overcome barriers&#xD;
      to self-management of diabetes and improve self-efficacy. With a population of 36 patients&#xD;
      and 37 relatives, with a duration of 14.6 months. The intervention consisted of 2 family&#xD;
      sessions and 8 weekly group educational sessions for participants and their families. It was&#xD;
      possible to demonstrate positive effects on systolic blood pressure, knowledge of diabetes,&#xD;
      self-efficacy, self-management of general and specific diet, glucose monitoring, foot care,&#xD;
      fruit and vegetable consumption and physical and mental components associated with quality of&#xD;
      life in the participants. There was also a significant improvement in BMI and knowledge of&#xD;
      diabetes in family members, suggesting that a culturally-tailored diabetes education program&#xD;
      provides a significant benefit to both Hispanic patients with diabetes and their families. In&#xD;
      addition, it has been observed that total family involvement in diabetes education helps to&#xD;
      increase knowledge, attitude and practice scores in patients with type 2 diabetes mellitus&#xD;
      and to improve their quality of life, with significant effects on glycemic control and&#xD;
      weight.&#xD;
&#xD;
      For this reason, a collaborative therapeutic partnership between the patient, his family and&#xD;
      health care providers is essential, encouraging family members to participate in programs to&#xD;
      avoid patient isolation, maintaining family cohesion and promoting health behaviors that&#xD;
      reduce the risk and early onset of diabetes in family members.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">June 19, 2017</start_date>
  <completion_date type="Anticipated">June 19, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 19, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Relatives of CAIPaDi patients that present on their initial evaluation either overweight, obesity, hypertension, glucose intolerance and/or secondary dyslipidemia will be invited to participate.&#xD;
Those who accept will require to attend the center twice. On the first visit, an anthropometric evaluation and laboratory studies will be performed; an oral glucose tolerance (OGTT) test will be carried out if the glucose value is over 100 mg/dl. If the OGTT results are abnormal, the individual will be included in the study sample.&#xD;
Those who have an abnormal OGTT and are included in the study sample will be randomized into two groups.&#xD;
The change of the main variables (weight, waist circumference, serum glucose, glycated hemoglobin, blood pressure, triglycerides and non-HDL cholesterol) will be assessed 3 months later, along with the effect on patients with diabetes parameters.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Glycated hemoglobin</measure>
    <time_frame>1 year</time_frame>
    <description>60% of patients with a glycated hemoglobin of &lt;5.8</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body Mass Index</measure>
    <time_frame>1 year</time_frame>
    <description>Difference of 2kg/m2 between groups</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serum glucose</measure>
    <time_frame>1 year</time_frame>
    <description>&lt;126 mg/dl</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Non-HDL cholesterol</measure>
    <time_frame>1 year</time_frame>
    <description>&lt;160</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Triglycerides</measure>
    <time_frame>1 year</time_frame>
    <description>&lt;150</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>1 year</time_frame>
    <description>&lt;140/90 mmHg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight loss</measure>
    <time_frame>1 year</time_frame>
    <description>5% reduction of basal weight</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist circumference</measure>
    <time_frame>1 year</time_frame>
    <description>5 cm reduction of basal waist circumference</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety and Depression Scale (HAD)</measure>
    <time_frame>1 year</time_frame>
    <description>score of &lt;7 points</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minutes of exercise per day</measure>
    <time_frame>1 year</time_frame>
    <description>&gt;30 minutes of exercise per day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Steps per day</measure>
    <time_frame>1 year</time_frame>
    <description>&gt;10,000 steps per day</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">97</enrollment>
  <condition>Metabolic Syndrome</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Relatives of patients with diabetes who will only attend sessions at the center along with the patients on all the interventions of the center (except psychology and psychiatry), receiving instructions from each area on the first and fourth visit. When the patient with diabetes is in the psychology or psychiatry consultation, the relative will also be evaluated in these areas in an analogue form.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Relatives who will receive multidisciplinary care at the center The subjects from group B will be asked to be accompanied by another relative. If they accept, they will be included as a patient of the CAIPaDi program to receive all the interventions of the second, third and fourth visits in an individual form, without following the patient with diabetes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CAIPaDi</intervention_name>
    <description>Patients are attended in 1 day by 9 specialists (endocrinologist, diabetes educators, nutritionist, psychologist, physical activity specialist, foot care and ophthalmologist). They are attended in 4 monthly visits. After the initial phase, patients come back to the Center at 1 and 2 years for evaluation and reinforcement</description>
    <arm_group_label>Group B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Being a relative of a patient of CAIPaDi&#xD;
&#xD;
          -  Fasting glucose of &lt;125 mg/dl&#xD;
&#xD;
          -  Serum glucose of &lt;199 mg/dl 2 hours after a glucose load of 75 gr&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of diabetes&#xD;
&#xD;
          -  Smoking&#xD;
&#xD;
          -  Who has any disabling or priority health condition other than prevention of diabetes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ana C García Ulloa, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Grade A Specialized Physician</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Instituto Nacional de Salud Pública</name>
      <address>
        <city>Cuernavaca</city>
        <state>Morelos</state>
        <zip>62100</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán</name>
      <address>
        <city>Mexico City</city>
        <zip>14000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <reference>
    <citation>Villalpando S, Shamah-Levy T, Rojas R, Aguilar-Salinas CA. Trends for type 2 diabetes and other cardiovascular risk factors in Mexico from 1993-2006. Salud Publica Mex. 2010;52 Suppl 1:S72-9. doi: 10.1590/s0036-36342010000700011.</citation>
    <PMID>20585732</PMID>
  </reference>
  <reference>
    <citation>Aguilar Salinas CA, Gómez Diaz RA, Gomez Perez FJ. Type 2 diabetes in Mexico: Main Challenges and possible solutions. Revista ALAD 19(4): 146-161, 2011.</citation>
  </reference>
  <reference>
    <citation>Schinckus L, Van den Broucke S, Housiaux M; Diabetes Literacy Consortium. Assessment of implementation fidelity in diabetes self-management education programs: a systematic review. Patient Educ Couns. 2014 Jul;96(1):13-21. doi: 10.1016/j.pec.2014.04.002. Epub 2014 Apr 21.</citation>
    <PMID>24795074</PMID>
  </reference>
  <reference>
    <citation>Machado Bonfante H, da Costa Avila M, Miranda Marcon L, Andrade Pedrosa C, de Oliveira Goncalves Prince Soares H, Fonseca Reis L, Pereira Mendonca U, dos Reis Barreiros A, Porto Araújo de Andrade M. Prediabetes: Clinical Relevance of an Important Risk Marker. Revista Brasileira de Cièncias Médicas e da Saúde 3(3):1-5, 2015.</citation>
  </reference>
  <reference>
    <citation>Perez Siwik V, Kutob RM, Ritenbaugh C, Aickin M, Gordon JS. Families United/Familias Unidas: development and implementation of a family-based group office visit model for the primary prevention of type 2 diabetes. Diabetes Educ. 2012 Nov-Dec;38(6):811-21. doi: 10.1177/0145721712461533. Epub 2012 Sep 26.</citation>
    <PMID>23019237</PMID>
  </reference>
  <reference>
    <citation>Diabetes Prevention Program (DPP) Research Group. The Diabetes Prevention Program (DPP): description of lifestyle intervention. Diabetes Care. 2002 Dec;25(12):2165-71. doi: 10.2337/diacare.25.12.2165.</citation>
    <PMID>12453955</PMID>
  </reference>
  <reference>
    <citation>Lindstrom J, Louheranta A, Mannelin M, Rastas M, Salminen V, Eriksson J, Uusitupa M, Tuomilehto J; Finnish Diabetes Prevention Study Group. The Finnish Diabetes Prevention Study (DPS): Lifestyle intervention and 3-year results on diet and physical activity. Diabetes Care. 2003 Dec;26(12):3230-6. doi: 10.2337/diacare.26.12.3230.</citation>
    <PMID>14633807</PMID>
  </reference>
  <reference>
    <citation>Pan XR, Li GW, Hu YH, Wang JX, Yang WY, An ZX, Hu ZX, Lin J, Xiao JZ, Cao HB, Liu PA, Jiang XG, Jiang YY, Wang JP, Zheng H, Zhang H, Bennett PH, Howard BV. Effects of diet and exercise in preventing NIDDM in people with impaired glucose tolerance. The Da Qing IGT and Diabetes Study. Diabetes Care. 1997 Apr;20(4):537-44. doi: 10.2337/diacare.20.4.537.</citation>
    <PMID>9096977</PMID>
  </reference>
  <reference>
    <citation>Hariri S, Yoon PW, Qureshi N, Valdez R, Scheuner MT, Khoury MJ. Family history of type 2 diabetes: a population-based screening tool for prevention? Genet Med. 2006 Feb;8(2):102-8. doi: 10.1097/01.gim.0000200949.52795.df.</citation>
    <PMID>16481893</PMID>
  </reference>
  <reference>
    <citation>Kovacs Burns K, Holt RI, Nicolucci A, Lucisano G, Skovlund SE, Comaschi M, Vallis M, Peyrot M. Correlates of psychological outcomes among family members of people with diabetes in the second Diabetes Attitudes, Wishes and Needs (DAWN2() ) study. Diabet Med. 2016 Sep;33(9):1184-93. doi: 10.1111/dme.13136. Epub 2016 May 26.</citation>
    <PMID>27086909</PMID>
  </reference>
  <reference>
    <citation>Shi M, Xu MY, Liu ZL, Duan XY, Zhu YB, Shi HM, Jiang B, Zhang XM, Yu XH. Effectiveness of family involvement in newly diagnosed type 2 diabetes patients: a follow-up study. Patient Educ Couns. 2016 May;99(5):776-82. doi: 10.1016/j.pec.2015.12.018. Epub 2015 Dec 30.</citation>
    <PMID>26763869</PMID>
  </reference>
  <reference>
    <citation>Arslanian SA, Bacha F, Saad R, Gungor N. Family history of type 2 diabetes is associated with decreased insulin sensitivity and an impaired balance between insulin sensitivity and insulin secretion in white youth. Diabetes Care. 2005 Jan;28(1):115-9. doi: 10.2337/diacare.28.1.115.</citation>
    <PMID>15616243</PMID>
  </reference>
  <reference>
    <citation>Herman WH, Hoerger TJ, Brandle M, Hicks K, Sorensen S, Zhang P, Hamman RF, Ackermann RT, Engelgau MM, Ratner RE; Diabetes Prevention Program Research Group. The cost-effectiveness of lifestyle modification or metformin in preventing type 2 diabetes in adults with impaired glucose tolerance. Ann Intern Med. 2005 Mar 1;142(5):323-32. doi: 10.7326/0003-4819-142-5-200503010-00007.</citation>
    <PMID>15738451</PMID>
  </reference>
  <reference>
    <citation>Hu J, Wallace DC, McCoy TP, Amirehsani KA. A family-based diabetes intervention for Hispanic adults and their family members. Diabetes Educ. 2014 Jan-Feb;40(1):48-59. doi: 10.1177/0145721713512682. Epub 2013 Nov 18.</citation>
    <PMID>24248832</PMID>
  </reference>
  <reference>
    <citation>Mayberry LS, Harper KJ, Osborn CY. Family behaviors and type 2 diabetes: What to target and how to address in interventions for adults with low socioeconomic status. Chronic Illn. 2016 Sep;12(3):199-215. doi: 10.1177/1742395316644303. Epub 2016 Apr 19.</citation>
    <PMID>27099387</PMID>
  </reference>
  <reference>
    <citation>Kutob RM, Siwik VP, Aickin M, Ritenbaugh C. Families United/Familias Unidas: family group office visits to reduce risk factors for type 2 diabetes. Diabetes Educ. 2014 Mar-Apr;40(2):191-201. doi: 10.1177/0145721714520722. Epub 2014 Jan 24.</citation>
    <PMID>24464087</PMID>
  </reference>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>July 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <last_update_submitted>June 17, 2021</last_update_submitted>
  <last_update_submitted_qc>June 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Diabetes</keyword>
  <keyword>Family</keyword>
  <keyword>Impaired fasting-glucose</keyword>
  <keyword>Carbohydrate intolerance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    <mesh_term>Metabolic Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03234946
org study id: 2145
nct id: NCT03234946
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Diabetes is a chronic disease that requires long-term lifestyle changes that may affect the
      whole family. Hence, during the last decade, studies have focused mainly in the role of the
      members of the family and their influence in life quality or clinical outcomes of patients
      with diabetes. Therefore, the delivery of education only to the patients with type 2 diabetes
      mellitus may restrict the expectations of success in achieving the necessary modifications in
      lifestyle.

      Objectives: To assess the effect of the CAIPaDi (Centre of Comprehensive Care for the
      Patients with Diabetes) program interventions on various health indicators relatives of
      patients with type 2 diabetes mellitus.
Diabetes mellitus is one of the most challenging health issues of our time, the percentage of
      adults with this disease tripled in Mexico between 1993 and 2012; In 1993 the prevalence was
      6.7% (cases previously diagnosed 4.6% and diagnosed during the survey 2.1%), whereas in 2012,
      the prevalence was 14.4% (7.3% previously diagnosed and 7.1% diagnosed during the survey)
      Identifying individuals at risk for developing diabetes and implementing prevention
      strategies is the optimal solution. Carbohydrate intolerance and impaired fasting glucose
      raise the risk of developing diabetes up to 20 times compared to those with normal levels of
      HbA1C and a progression rate to diabetes of 10% per year in the absence of any intervention.

      Randomized studies have shown that progression from impaired fasting glucose and glucose
      intolerance to type 2 diabetes mellitus and its complications can be prevented by
      interventions focused on changes in lifestyle. This contributed to the implementation of new
      guidelines for the management of prediabetes, emphasizing the importance of timely
      interventions in this condition, which may be the most cost-effective alternative to avoid
      complications.

      One of the most important studies in primary diabetes prevention, the Diabetes Prevention
      Program (DPP), provided scientific evidence on the prevention and delay in the onset of
      diabetes in high-risk individuals, with a 58% risk reduction through lifestyle modifications,
      such as reduced fat and calorie intake, increased physical activity up to at least 150
      minutes per week and loss of 5-7% of body weight.

      Another multicenter, randomized trial, the Finnish Diabetes Prevention Study (DPS), showed
      that type 2 diabetes is preventable with lifestyle multidisciplinary interventions, with a
      58% risk reduction similar to that of the DPP study in the group who received intensive
      treatment, compared to the control group, even significant changes were observed in metabolic
      parameters one and three years afterwards.

      In addition, a randomized, multicenter study in the city of Da Qing, China, with a population
      of 110,660 participants, demonstrated that diet and / or exercise lead to a significant
      decrease in the incidence of diabetes over a 6-year period in patients with carbohydrate
      intolerance, with an incidence of 67.7% in the control group, 43.8% in the group undergoing
      dietary changes and 46% in the diet and exercise group.

      Family history of diabetes is an independent risk factor for having the disease and provides
      information for the screening of individuals at risk and even represents an even more
      sensitive indicator than the presence of obesity.

      Diabetes is a chronic disease that involves changes in the patient's lifestyle that can
      affect the whole family. During the last decade, studies have focused mainly on the role of
      family members and their influence on the quality of life or clinical course of patients with
      diabetes. Therefore, providing education only to the individual diagnosed with type 2
      diabetes could restrict the chances of success in achieving the necessary changes in
      lifestyle.

      Some studies have shown that the familial nature of type 2 diabetes is manifested by the
      presence of insulin resistance in first-degree relatives without diabetes, while others have
      revealed B-cell dysfunction, it seems that both insulin resistance and a diminished B-cell
      compensation are the family metabolic phenotype of type 2 diabetes mellitus. This highlights
      the importance of providing diabetes education not only to the patient, but also to their
      relatives, especially those who already have additional risk factors or prediabetes.

      In cross-sectional studies of diabetes, social support has been associated with a better
      glycemic control in type 2 diabetes and is positively related to overall health status and
      lifestyle changes. Additionally, the health status of family members of patients attending
      the sessions has been demonstrated, and social and family support in general is positively
      linked to health status and transcendental changes in lifestyle.

      These findings are justified by the results of the second multinational study, Diabetes
      Attitudes, Wishes and Needs (DAWN2TM), in which the disease was studied from the perspective
      of family members, patients and health professionals. Family members who deemed a greater
      responsibility for the management of diabetes had a lower quality of life and higher levels
      of disease impact and perceived burden, while less responsibility for the management of
      diabetes perceived by the patient's family members and an effective collaboration among them
      correlates with improved psychological well-being and quality of life for family members.

      Diabetes is associated with a sense of social disadvantage and stress not only in patients
      with diabetes but also in the members of their family, so there is a need to foster a larger
      network of family support through educational programs and to involve them in the treatment
      of the illness.

      To date there are no studies that accurately analyze the impact of social support on
      maintaining lifestyle changes in a supportive group setting.

      The study Families United analyzed the effect of social support in the prevention of
      diabetes, which has proved to be important for its management and even for other diseases
      such as obesity, it has been used to convey information regarding prevention of diabetes to
      minority and high-risk groups in communities.

      The social context in which the patient carries out self-care activities determines its
      success, so that obstructive behaviors such as sabotage or underestimating the patient's
      effort or hampering their self-care are associated with a greater HbA1C and a reduction of
      motivation and adherence to treatment, diet plan and exercise.

      Despite the high prevalence of obstructive behaviors among relatives of patients with
      diabetes, few interventions focus on the negative aspects of family interactions.

      Family support behaviors or sabotage in diabetes have been independently associated with
      adherence to self-care behavior and glycemic control among adults with diabetes and low
      sociocultural level. DAWN-II found that more than one-third of family members wish to be more
      involved in managing the patient's disease.

      A study was conducted in 2013 based on socio-cognitive theory, which focuses on the influence
      of the social environment (family members) on changes in health habits to overcome barriers
      to self-management of diabetes and improve self-efficacy. With a population of 36 patients
      and 37 relatives, with a duration of 14.6 months. The intervention consisted of 2 family
      sessions and 8 weekly group educational sessions for participants and their families. It was
      possible to demonstrate positive effects on systolic blood pressure, knowledge of diabetes,
      self-efficacy, self-management of general and specific diet, glucose monitoring, foot care,
      fruit and vegetable consumption and physical and mental components associated with quality of
      life in the participants. There was also a significant improvement in BMI and knowledge of
      diabetes in family members, suggesting that a culturally-tailored diabetes education program
      provides a significant benefit to both Hispanic patients with diabetes and their families. In
      addition, it has been observed that total family involvement in diabetes education helps to
      increase knowledge, attitude and practice scores in patients with type 2 diabetes mellitus
      and to improve their quality of life, with significant effects on glycemic control and
      weight.

      For this reason, a collaborative therapeutic partnership between the patient, his family and
      health care providers is essential, encouraging family members to participate in programs to
      avoid patient isolation, maintaining family cohesion and promoting health behaviors that
      reduce the risk and early onset of diabetes in family members.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Relatives of CAIPaDi patients that present on their initial evaluation either overweight, obesity, hypertension, glucose intolerance and/or secondary dyslipidemia will be invited to participate.
Those who accept will require to attend the center twice. On the first visit, an anthropometric evaluation and laboratory studies will be performed; an oral glucose tolerance (OGTT) test will be carried out if the glucose value is over 100 mg/dl. If the OGTT results are abnormal, the individual will be included in the study sample.
Those who have an abnormal OGTT and are included in the study sample will be randomized into two groups.
The change of the main variables (weight, waist circumference, serum glucose, glycated hemoglobin, blood pressure, triglycerides and non-HDL cholesterol) will be assessed 3 months later, along with the effect on patients with diabetes parameters.
primary purpose: Prevention
masking: None (Open Label)
measure: Glycated hemoglobin
time frame: 1 year
description: 60% of patients with a glycated hemoglobin of <5.8
measure: Body Mass Index
time frame: 1 year
description: Difference of 2kg/m2 between groups
measure: Serum glucose
time frame: 1 year
description: <126 mg/dl
measure: Non-HDL cholesterol
time frame: 1 year
description: <160
measure: Triglycerides
time frame: 1 year
description: <150
measure: Blood pressure
time frame: 1 year
description: <140/90 mmHg
measure: Weight loss
time frame: 1 year
description: 5% reduction of basal weight
measure: Waist circumference
time frame: 1 year
description: 5 cm reduction of basal waist circumference
measure: Hospital Anxiety and Depression Scale (HAD)
time frame: 1 year
description: score of <7 points
measure: Minutes of exercise per day
time frame: 1 year
description: >30 minutes of exercise per day
measure: Steps per day
time frame: 1 year
description: >10,000 steps per day
arm group label: Group A
arm group type: No Intervention
description: Relatives of patients with diabetes who will only attend sessions at the center along with the patients on all the interventions of the center (except psychology and psychiatry), receiving instructions from each area on the first and fourth visit. When the patient with diabetes is in the psychology or psychiatry consultation, the relative will also be evaluated in these areas in an analogue form.
arm group label: Group B
arm group type: Experimental
description: Relatives who will receive multidisciplinary care at the center The subjects from group B will be asked to be accompanied by another relative. If they accept, they will be included as a patient of the CAIPaDi program to receive all the interventions of the second, third and fourth visits in an individual form, without following the patient with diabetes.
intervention type: Behavioral
intervention name: CAIPaDi
description: Patients are attended in 1 day by 9 specialists (endocrinologist, diabetes educators, nutritionist, psychologist, physical activity specialist, foot care and ophthalmologist). They are attended in 4 monthly visits. After the initial phase, patients come back to the Center at 1 and 2 years for evaluation and reinforcement
arm group label: Group B
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Ana C García Ulloa, MD
role: Principal Investigator
affiliation: Grade A Specialized Physician
facility: 
facility: 
country: Mexico
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PMID: 20585732
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PMID: 24795074
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PMID: 23019237
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PMID: 12453955
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PMID: 14633807
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PMID: 9096977
citation: Hariri S, Yoon PW, Qureshi N, Valdez R, Scheuner MT, Khoury MJ. Family history of type 2 diabetes: a population-based screening tool for prevention? Genet Med. 2006 Feb;8(2):102-8. doi: 10.1097/01.gim.0000200949.52795.df.
PMID: 16481893
citation: Kovacs Burns K, Holt RI, Nicolucci A, Lucisano G, Skovlund SE, Comaschi M, Vallis M, Peyrot M. Correlates of psychological outcomes among family members of people with diabetes in the second Diabetes Attitudes, Wishes and Needs (DAWN2() ) study. Diabet Med. 2016 Sep;33(9):1184-93. doi: 10.1111/dme.13136. Epub 2016 May 26.
PMID: 27086909
citation: Shi M, Xu MY, Liu ZL, Duan XY, Zhu YB, Shi HM, Jiang B, Zhang XM, Yu XH. Effectiveness of family involvement in newly diagnosed type 2 diabetes patients: a follow-up study. Patient Educ Couns. 2016 May;99(5):776-82. doi: 10.1016/j.pec.2015.12.018. Epub 2015 Dec 30.
PMID: 26763869
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PMID: 15738451
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PMID: 24464087
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Metabolic Syndrome
sharing ipd: Undecided