Corazon de la Familia (Heart of the Family)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03196024|
Recruitment Status : Recruiting
First Posted : June 22, 2017
Last Update Posted : November 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Risk Reduction Behavior Diabetes Mellitus, Type 2 Cardiovascular Diseases||Behavioral: Family-focused intervention arm Behavioral: Individual-focused intervention arm||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||440 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||We will conduct a randomized controlled trial with Hispanic family dyads using a 2-group design (Corazón de la Familia active intervention versus control condition) to test effects of a type 2 diabetes and CVD risk reduction intervention at 3 (short-term) and 12 (long-term) months. For dyads randomized to the active intervention, the participant with 2 or more CVD or type 2 diabetes risk factors (index participant) and their co-participating family member will attend 8 sessions that provide type 2 diabetes and CVD risk reduction and lifestyle modification education. For dyads randomized to the control condition, only the index participant will attend 8 educational lifestyle modification sessions. Participants in both groups will receive monthly follow up phone calls up through 12 months post-baseline. The sessions for both the intervention and the control group and the monthly post-intervention phone calls will be provided by community health workers.|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Masking Description:||Participants, community health workers, and assessors are blinded to which arm is the active intervention and which arm is the active comparator. Participants, community health workers, and assessors will be blinded to hypotheses regarding group differences and will be informed that both groups are intervention groups and that we are examining how well both intervention types perform.|
|Official Title:||A Randomized Controlled Trial to Examine a Healthy Lifestyle Intervention With Families to Prevent Cardiovascular Disease and Type 2 Diabetes in Hispanics/Latinos|
|Actual Study Start Date :||October 5, 2017|
|Estimated Primary Completion Date :||July 31, 2021|
|Estimated Study Completion Date :||July 31, 2021|
Experimental: Family-focused intervention arm
Family-focused intervention arm: Educational sessions will be provided to family pairs that include participants who are at-risk for type 2 diabetes or CVD and their co-participating family member.
Behavioral: Family-focused intervention arm
Family pairs including an individual family member at-risk for type 2 diabetes or CVD and a co-participating family member will be enrolled in the study. After completing baseline data they will be randomly selected to participate in one of the two study arms. For the family-focused arm, the family pair will attend 8 2-hour weekly educational sessions about type 2 diabetes and CVD risk reducing lifestyle behaviors. The sessions will be presented by community health workers (CHWs) in Spanish to groups of 5 to 6 family pairs. Following completion of the sessions, data will be collected from the family pairs. CHWs will call monthly to provide information and support through the end of the 12-month period at which time data will be collected from the family pairs.
Active Comparator: Individual-focused intervention arm
Individual-focused intervention arm: Educational sessions will be provided to the individual members of the family pairs who are at-risk for type 2 diabetes or CVD.
Behavioral: Individual-focused intervention arm
Family pairs including an individual family member at-risk for type 2 diabetes or CVD and co-participating family member will be enrolled in the study. After completing baseline data pairs will be randomly selected to participate in one of two interventions. For the individual-focused intervention, the at-risk individual will attend 8 weekly 2-hour education sessions on type 2 diabetes and CVD risk reducing lifestyle behaviors. Sessions will be presented by CHWs in Spanish to groups of 10 to 12 individuals. Following completion of sessions, data will be collected from the individuals. CHWs will call monthly to provide information and support through the end of the 12-month period at which time data will be collected from the at-risk individuals and their co-participating family members.
- Change in body mass index (BMI) [ Time Frame: Baseline, 3 months, and 12 months ]BMI based on measurements of weight and height and calculated as kg/m2
- Change in blood pressure [ Time Frame: Baseline, 3 months, and 12 months ]Blood pressure assessed using calibrated sphygmomanometry
- Change in lipid profile [ Time Frame: Baseline, 3 months, and 12 months ]Lipid profile includes LDL-cholesterol, HDL-cholesterol and triglycerides measured using point-of-care testing obtained by fingerstick.
- Change in hemoglobin A1c (HbA1c) [ Time Frame: Baseline, 3 months, and 12 months ]HbA1c measured using point-of-care testing obtained by fingerstick.
- Change in level of physical activity [ Time Frame: Baseline, 3 months, and 12 months ]Physical activity will be measured using the International Physical Activity Questionnaire (IPAQ) to assess the number of days in the last 7 days that the participant engaged in vigorous or moderate physical activity and confirmed by comparing responses to number of daily steps over 7 days assessed with a Fitbit
- Change in diet quality [ Time Frame: Baseline, 3 months, and 12 months ]Diet quality will be measured using the Food Frequency Questionnaire
- Change in tobacco use [ Time Frame: Baseline, 3 months, and 12 months ]Urine cotinine levels will be used to assess tobacco use
- Support for healthy behaviors [ Time Frame: Baseline, 3 months, and 12 months ]Self report of experience of social support for healthy behaviors
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03196024
|Contact: Gia Mudd-Martin, PhD, RN||859-257-4204||Gia.Mudd@uky.edu|
|Contact: Rosa Martin||859-323-4305||Rosa.Martin@uky.edu|
|United States, Kentucky|
|University of Kentucky||Recruiting|
|Lexington, Kentucky, United States, 40536-0232|
|Contact: Gia Mudd-Martin, PhD, RN 859-494-7073 Gia.Mudd@uky.edu|
|Contact: Rosa Martin 859-323-4305 Rosa.Martin@uky.edu|
|Principal Investigator:||Gia Mudd-Martin, PhD, RN||University of Kentucky|
|Study Director:||Rosa Martin||University of Kentucky|