Unidas Por la Vida: A Healthy Lifestyle Intervention for High-risk Latina Dyads

NCT ID: NCT02741037

Last Updated: 2023-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 710 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2021-07-31

Brief Summary

Mexican American women have significantly elevated rates of obesity and type 2 diabetes. The proposed study tests a novel intervention that capitalizes on an existing important family dyad (mothers and their adult daughters) to foster clinically significant and long-lasting health behavior change. If found to effective, this intervention strategy has great potential to address health disparities in this, and other, at-risk populations.

Detailed Description

Approximately half of Mexican-American women report having a sedentary lifestyle, and nearly 78% are overweight or obese. Compared to women in all other ethnic groups, Mexican-American women have the highest lifetime risk of type 2 diabetes. The development of culturally appropriate lifestyle interventions for this population is an urgent priority, and the proposed study accordingly will investigate a novel dyadic intervention designed to improve health behaviors and promote weight loss in two at-risk members of the same family: mothers with type 2 diabetes and their overweight/obese adult daughters who are at risk for developing diabetes. The intervention, Unidas por la Vida (United for Life), capitalizes on the importance of the family in Latino culture to mobilize an existing family dyad as a source of mutual support that is likely to foster greater and longer-lasting health behavior change. The study builds on a successful pilot study (R34 DK083500) that established the feasibility and acceptability of this dyadic behavioral lifestyle intervention in a high-risk sample of Mexican-American family members who share a risk for diabetes and its complications. The 16-week intervention was modeled after the Diabetes Prevention Program (DPP), but was adapted for use with mother daughter pairs and to be community-based and, thus, more easily accessible to low-income Latinas. Preliminary data from the Unidas pilot study indicated that the dyadic intervention promoted significant weight loss. The proposed study extends the successful pilot study to: 1) target weight loss > 5% of baseline body weight and to foster maintenance using a tapered intervention, 2) add comparison groups that permit evaluation of the improvement uniquely associated with the partner intervention, and 3) assess theoretically derived mediators of the intervention. Participants (N=460 mother-adult daughter dyads) will be randomized into one of three conditions: 1) dyadic (mother-daughter) participation in a Unidas partner intervention (Arm 1); 2) individual participation (mothers alone; unrelated daughters alone) in a Unidas individual intervention (Arm 2); and 3) mother-daughter dyad in a usual care only condition (Arm 3).

Conditions

Diabetes; Obesity; Overweight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Dyadic lifestyle intervention

Mothers and daughters participate in the Unidas partner intervention together.

Group Type: EXPERIMENTAL

Dyadic lifestyle intervention

Intervention Type: BEHAVIORAL

Dyadic lifestyle intervention: The dyadic behavioral lifestyle intervention was modeled after the Diabetes Prevention Program (DPP), and was adapted to make it more easily accessible to low-income Latinas. In addition, this intervention arm has a dyadic component to examine the effectiveness of mothers and daughters engaging in the lifestyle intervention together as partners. Participants also will receive usual care.

Usual Care

Intervention Type: OTHER

Usual Care: Mother and daughter participants will receive Usual Care.

Individual lifestyle intervention

Mothers participate in the Unidas intervention alone, without their related daughters. Unrelated daughters participate in the Unidas intervention alone without their related mothers.

Group Type: EXPERIMENTAL

Individual lifestyle intervention

Intervention Type: BEHAVIORAL

Individual lifestyle intervention: The individual behavioral lifestyle intervention was modeled after the Diabetes Prevention Program, and was adapted to make it more easily accessible to low-income Latinas. Mothers participate in the Unidas intervention alone, without their related daughters. Unrelated daughters participate in the Unidas intervention alone without their related mothers. Participants also will receive usual care.

Usual Care

Intervention Type: OTHER

Usual Care: Mother and daughter participants will receive Usual Care.

Usual Care

Mothers and daughters receive usual care.

Group Type: OTHER

Usual Care

Intervention Type: OTHER

Usual Care: Mother and daughter participants will receive Usual Care.

Interventions

Dyadic lifestyle intervention

Dyadic lifestyle intervention: The dyadic behavioral lifestyle intervention was modeled after the Diabetes Prevention Program (DPP), and was adapted to make it more easily accessible to low-income Latinas. In addition, this intervention arm has a dyadic component to examine the effectiveness of mothers and daughters engaging in the lifestyle intervention together as partners. Participants also will receive usual care.

Intervention Type: BEHAVIORAL

Individual lifestyle intervention

Individual lifestyle intervention: The individual behavioral lifestyle intervention was modeled after the Diabetes Prevention Program, and was adapted to make it more easily accessible to low-income Latinas. Mothers participate in the Unidas intervention alone, without their related daughters. Unrelated daughters participate in the Unidas intervention alone without their related mothers. Participants also will receive usual care.

Intervention Type: BEHAVIORAL

Usual Care

Usual Care: Mother and daughter participants will receive Usual Care.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Mothers:

1. Are Mexican-American

2. Are age 18 and older

3. Have a body mass index (BMI) between 25 kg/m2 and 43 kg/m2.

4. Are diagnosed with type 2 diabetes

5. Live within a 25 mile radius of your adult daughter

6. Are fluent in either Spanish or English as your primary language

7. Are able to understand and sign an informed consent

Adult daughters:

1. Are Mexican-American

2. Are age 18 and older

3. Have a body mass index (BMI) between 25 kg/m2 and 43 kg/m2.

4. Live within a 25 mile radius of your mother

5. Are fluent in either Spanish or English as your primary language

6. Are able to understand and sign an informed consent

Exclusion Criteria

1. Are male

2. Have a visual or hearing impairment, documented psychiatric and/or life-threatening illness that precludes the ability to participate in a weight loss program and/or provide consent.

3. Are a mother with diabetes who is not able to start an exercise regimen or are likely to be injured (e.g., have uncontrolled high blood pressure).

4. Are pregnant or become pregnant during the course of the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

AltaMed Health Services Corporation

OTHER

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: collaborator

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Dara Sorkin

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dara H Sorkin, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Karen S Rook, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

References

Sorkin DH, Rook KS, Campos B, Marquez B, Solares J, Mukamel DB, Marcus B, Kilgore D, Dow E, Ngo-Metzger Q, Nguyen DV, Biegler K. Rationale and study protocol for Unidas por la Vida (United for Life): A dyadic weight-loss intervention for high-risk Latina mothers and their adult daughters. Contemp Clin Trials. 2018 Jun;69:10-20. doi: 10.1016/j.cct.2018.03.013. Epub 2018 Mar 26.

Reference Type: DERIVED

PMID: 29597006 (View on PubMed)

Other Identifiers

20097225

Identifier Type: -

Identifier Source: org_study_id