Corazon de la Familia (Heart of the Family)

NCT03196024 | Completed

• 1 other identifier: 1R01NR016262-01A1
• Study Type: interventional
• Target: 526
• Locations: 1 country
• Sites: 1

Brief Summary

The Corazón de la Familia study is a randomized controlled trial to examine the effects of a novel family-focused lifestyle modification intervention to reduce risk for type 2 diabetes and cardiovascular disease (CVD) among Hispanics/Latinos. Facilitated by community health workers, the family-focused intervention engages two members of a family in an educational program addressing lifestyle behaviors to support sustained engagement in healthy lifestyles among Hispanics with high risk for type 2 diabetes or CVD. In this study, we will conduct a randomized controlled trial using a 2-group design and compare the short-term and long-term impact of the family-focused active intervention to an individual-focused control condition on biological and behavioral type 2 diabetes and CVD risk factors. Furthermore, we will examine outcomes of participants in the family-focused intervention to determine how each family member's engagement in healthy lifestyle behaviors and level of support for the other family member's engagement in healthy lifestyle behaviors affects their own and their partner's outcomes.

Conditions

Risk Reduction Behavior; Diabetes Mellitus, Type 2; Cardiovascular Diseases

Keywords

Diabetes; CVD; Lifestyle; Hispanic; Promotora; Diabetes Mellitus, Type 2; Cardiovascular Diseases; Risk Reduction Behavior; Hispanic Americans; Latinos; Community Health Workers

Outcome Measures

Primary Outcomes (7)

• Change in body mass index (BMI)

  BMI based on measurements of weight and height and calculated as kg/m2

  Baseline, 3 months, and 12 months

• Change in blood pressure

  Blood pressure assessed using calibrated sphygmomanometry

  Baseline, 3 months, and 12 months

• Change in lipid profile

  Lipid profile includes LDL-cholesterol, HDL-cholesterol and triglycerides measured using point-of-care testing obtained by fingerstick.

  Baseline, 3 months, and 12 months

• Change in hemoglobin A1c (HbA1c)

  HbA1c measured using point-of-care testing obtained by fingerstick.

  Baseline, 3 months, and 12 months

• Change in level of physical activity

  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

  Baseline, 3 months, and 12 months

• Change in diet quality

  Diet quality will be measured using the Food Frequency Questionnaire

  Baseline, 3 months, and 12 months

• Change in tobacco use

  Urine cotinine levels will be used to assess tobacco use

  Baseline, 3 months, and 12 months

Secondary Outcomes (1)

• Support for healthy behaviors

  Baseline, 3 months, and 12 months

Study Arms (2)

Family-focused intervention arm

EXPERIMENTAL

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

Individual-focused intervention arm

ACTIVE COMPARATOR

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

Interventions

Family-focused intervention arm BEHAVIORAL

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.

Family-focused intervention arm

Individual-focused intervention arm BEHAVIORAL

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.

Individual-focused intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• We are enrolling family dyads, or 2 family members, one of whom is at-risk for type 2 diabetes or cardiovascular disease and the second of whom is a co-participating family member who may or may not be at risk for type 2 diabetes or cardiovascular disease.
• Is Hispanic or Latino
• Is 18 years of age and older
• Is a primary Spanish speaker
• Has two or more risk factors for type 2 diabetes or cardiovascular disease including:
• clinical diagnosis of hypertension;
• clinical diagnosis of hyperlipidemia;
• clinical diagnosis of prediabetes;
• overweight or obese (body mass index ≥ 25 kg/m2);
• is a current cigarette smoker;
• male 45 years of age or older or female 55 years of age or older;
• family history in first degree relative of type 2 diabetes or cardiovascular disease; or
• is a female with a history of gestational diabetes mellitus or polycystic ovary syndrome.
• Plan to be in Kentucky and Is willing to participate in the study for the next 12 months
• Is 18 years of age and older

You may not qualify if:

• Dyads will be excluded if one or both dyad members have any of the following:
• Have cognitive impairment that preclude them from understanding the consent process, answering questionnaires, or participating in the intervention;
• Have a major psychiatric (e.g., schizophrenia) condition;
• Are pregnant or nursing or plan on becoming pregnant within the next year since dietary needs will be different.
• Have known coronary artery or cerebrovascular disease;
• Have a diagnosis of type 1 or type 2 diabetes;
• Have medical contraindications to participate in a lifestyle intervention that includes unsupervised physical activity and weight loss

Sponsors & Collaborators

• Gia Mudd: lead
• National Institute of Nursing Research (NINR): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536-0232, United States

Location

MeSH Terms

Conditions

Risk Reduction Behavior; Diabetes Mellitus, Type 2; Cardiovascular Diseases; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Behavior; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Gia Mudd-Martin, PhD, RN

  University of Kentucky

  PRINCIPAL INVESTIGATOR

• Rosa Martin

  University of Kentucky

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor/Investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 20, 2017
• First Posted: June 22, 2017
• Study Start: October 5, 2017
• Primary Completion: December 23, 2023
• Study Completion: December 23, 2023
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: De-identified data from this study will be made available after completion of analyses for primary and secondary outcomes, and publications and research presentations that address the specific aims and major secondary analyses of the study.
• Access Criteria: De-identified data from this study will be submitted to the Inter-university Consortium for Political and Social Research (ICPSR), a unit of the Institute for Social Research at the University of Michigan.All de-identified data housed by ICPSR are available to over 759 member institutions as well as to other institutions and individuals. Should access to data from this study be restricted to member institutions, the PI will, on request, provide the de-identified dataset and accompanying documentation to requesters.

Locations

US (1)