Lifestyle Intervention for Cardiovascular Disease and Type 2 Diabetes
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Gia Mudd
Disqualifiers: Cognitive impairment, Major psychiatric, Pregnancy, Coronary artery, Diabetes, others
No Placebo Group
Trial Summary
What is the purpose of this trial?Rural populations in the U.S. are disproportionately burdened by cardiovascular disease and type 2 diabetes. Lifestyle modification interventions are needed that support long-term engagement in risk-reducing health behaviors. This trial will study the effects of a family-focused, lifestyle intervention that is culturally tailored for use with rural Hispanic and non-Hispanic adults. If successful, this community-based intervention has significant potential for broad dissemination to reduce cardiovascular disease and type 2 diabetes health disparities in rural U.S. communities.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It focuses on lifestyle changes, so it's best to discuss your medications with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment for cardiovascular disease and type 2 diabetes?
Research shows that family-based interventions, especially those culturally tailored, can improve self-management and reduce distress in individuals with type 2 diabetes. These interventions have shown sustained improvements in diet and exercise management, which are crucial for managing diabetes and potentially beneficial for cardiovascular health.
12345Is the lifestyle intervention for cardiovascular disease and type 2 diabetes safe for humans?
The studies on family-based lifestyle interventions for diabetes, particularly among Latino families, suggest that these interventions are generally safe. They focus on education, social support, and self-management, which are non-invasive and promote healthy behaviors.
12346How is the Family Dyad Intervention treatment different from other treatments for cardiovascular disease and type 2 diabetes?
The Family Dyad Intervention is unique because it involves the patient's family in the treatment process, focusing on family engagement, empowerment, and support to improve lifestyle habits and manage health conditions. This approach is culturally tailored and emphasizes the role of family dynamics in promoting health, which is different from traditional individual-focused treatments.
12378Eligibility Criteria
This trial is for adults over 18 living in rural Kentucky, with internet access and at risk for type 2 diabetes or cardiovascular disease. Participants must speak English or Spanish and may include a family member who lives nearby. Those with cognitive impairments, major psychiatric conditions, pregnancy, or known heart diseases are excluded.Inclusion Criteria
Inclusion criteria for the co-participating family member if primary participant is randomly selected to participate with a family member: Is 18 years of age and older, Is a primary Spanish or English speaker, Lives in the same household or in close proximity (no further than 25 miles distance) to the primary participant, Has internet access, Is willing to participate in the study for the next 12 months
I have two or more risk factors for type 2 diabetes or heart disease.
I am a rural-dwelling adult at risk for type 2 diabetes or heart disease, and I have a family member who can join if needed.
+6 more
Exclusion Criteria
I do not have heart or brain vessel disease, diabetes, and can safely do physical activities and lose weight.
Both the main participant and their family member cannot have trouble understanding information, answering questions, or taking part in the study. They also cannot have serious mental health conditions, be pregnant, nursing, or planning to get pregnant soon because their dietary needs will be different.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Intervention
Participants receive eight weekly educational sessions focused on self-management of risk factors and engagement in healthy behaviors for risk reduction
8 weeks
8 visits (virtual)
Follow-up
Community health workers follow up with participants once a month by phone to monitor long-term impact on type 2 diabetes and CVD risk factors
12 months
12 visits (virtual)
Participant Groups
The study tests a culturally tailored lifestyle intervention aimed at reducing the risk of cardiovascular disease and type 2 diabetes among rural Hispanic and non-Hispanic families. It involves educational sessions comparing individual versus family dyad participation.
2Treatment groups
Experimental Treatment
Active Control
Group I: Family Dyad ArmExperimental Treatment1 Intervention
An index participant with 2 or more risk factors for cardiovascular disease or type 2 diabetes and a co-participating family member will together attend 8 weekly educational sessions focused on self-management of risk factors and engagement in healthy behaviors for risk reduction. The dyadic intervention sessions also incorporate family-focused throughout each session to encourage dyadic support.
Group II: Active Control ArmActive Control1 Intervention
An index participant with 2 or more risk factors for cardiovascular disease or type 2 diabetes who is randomized to this arm will attend 8 weekly educational sessions focused on self-management of risk factors and engagement in healthy behaviors for risk reduction. The index participant will attend the sessions as an individual and will receive standard individual-focused lifestyle modification education.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
2201 Regency Rd.Lexington, KY
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Who Is Running the Clinical Trial?
Gia MuddLead Sponsor
National Institute of Nursing Research (NINR)Collaborator
References
Preventing diabetes in Latino families: A protocol for a randomized control trial. [2023]Latino families are disproportionately affected by type 2 diabetes (T2D) and lifestyle intervention is the first-line approach for preventing T2D. The purpose of this study is to test the efficacy of a culturally-grounded lifestyle intervention that prioritizes health promotion and diabetes prevention for Latino families. The intervention is guided by a novel Family Diabetes Prevention Model, leveraging the family processes of engagement, empowerment, resilience, and cohesion to orient the family system towards health.
Partnering With Families to Refine and Expand a Diabetes Intervention for Mexican Americans. [2021]The purpose of this study was to refine and expand a culturally tailored individual-level diabetes self-management intervention to a family-level intervention.
Effects of a Family-based Diabetes Intervention on Behavioral and Biological Outcomes for Mexican American Adults. [2023]Purpose The purpose of the study was to investigate the effects of a family-based self-management support intervention for adults with type 2 diabetes (T2DM). Methods Using a 2-group, experimental repeated measures design, 157 dyads (participant with T2DM and family member) were randomly assigned to an intervention (education, social support, home visits, and telephone calls) or a wait list control group. Data were collected at baseline, postintervention (3 months), and 6 months postintervention. A series of 2 × 3 repeated measures ANOVAs were used to test the hypotheses with interaction contrasts to assess immediate and sustained intervention effects. Results Significant changes over time were reported in diet self-management, exercise self-management, total self-management, diabetes self-efficacy for general health and total diabetes self-efficacy, physician distress, regimen distress, interpersonal distress, and total distress. There were likewise sustained effects for diet self-management, total self-management, diabetes self-efficacy for general health, total self-efficacy, physician distress, regimen distress, and interpersonal distress. Conclusions Results support and extend prior research documenting the value of culturally relevant family-based interventions to improve diabetes self-management and substantiate the need for intensive, longer, tailored interventions to achieve glycemic control.
The Juntos Pilot Study: A Diabetes Management Intervention for Latino Caregiving Dyads. [2020]The purpose of this study was to design a culturally sensitive dyad-level diabetes intervention to improve glycemic control for older Latino adults with type 2 diabetes.
Challenges and Lessons Learned in the Development and Implementation of a Couples-Focused Telephone Intervention for Adults with Type 2 Diabetes: The Diabetes Support Project. [2021]BACKGROUND: Type 2 diabetes (T2DM) studies report that marital/family support relates to glycemic control, adherence and quality-of-life. Yet, there are few reports of couples-focused interventions. PURPOSE: To describe the challenges faced and lessons learned in the implementation of a theoretically-based, couples intervention. METHODS: 350 couples (one partner has T2DM in poor glycemic control) are randomized to a couples intervention, individual intervention, or enhanced usual care. All contacts are by telephone, to increase reach. OUTCOMES: medical (e.g. glycemic control), psychosocial (e.g. diabetes distress), and behavioral (e.g. regimen adherence). Challenges in recruitment, assessment and intervention with couples are described, with suggestions about how to address them. RESULTS: Findings concerning the efficacy and cost-effectiveness of the couples intervention, its effect on partners, and possible mechanisms of demonstrated changes, are anticipated in 2013. CONCLUSIONS: Interventionists need specific skills to work with couples to promote communal coping and increase the likelihood of an efficacious couples intervention.
Dyadic collaboration in shared health behavior change: the effects of a randomized trial to test a lifestyle intervention for high-risk Latinas. [2022]This study sought to evaluate the feasibility of a pilot, dyad-based lifestyle intervention, the Unidas por la Vida program, for improving weight loss and dietary intake among high-risk Mexican American mothers who have Type 2 diabetes and their overweight/obese adult daughters.
Effect of a family and interdisciplinary intervention to prevent T2D: randomized clinical trial. [2020]Lifestyle changes can reduce the risk of T2D; however, no study has evaluated the effect of a lifestyle intervention involving patients´ family. The aim of this study was to compare the impact of an interdisciplinary family (FI) Vs individual intervention (II) on glucose metabolism, insulin resistance (IR), pancreatic β-cell function and cardiovascular risk markers in patients with prediabetes, as well as to measure the impact on their families' metabolic risk.
Evaluation of an adapted version of the Diabetes Prevention Program for low- and middle-income countries: A cluster randomized trial to evaluate "Lifestyle Africa" in South Africa. [2023]Low- and middle-income countries (LMICs) are experiencing major increases in diabetes and cardiovascular conditions linked to overweight and obesity. Lifestyle interventions such as the United States National Diabetes Prevention Program (DPP) developed in high-income countries require adaptation and cultural tailoring for LMICs. The objective of this study was to evaluate the efficacy of "Lifestyle Africa," an adapted version of the DPP tailored for an underresourced community in South Africa compared to usual care.