Unidas Por la Vida: A Healthy Lifestyle Intervention for High-risk Latina Dyads
1 other identifier
interventional
710
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes
Started Jan 2016
Longer than P75 for not_applicable diabetes
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 31, 2016
CompletedFirst Posted
Study publicly available on registry
April 18, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2021
CompletedAugust 21, 2023
August 1, 2023
5.5 years
March 31, 2016
August 16, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Longitudinal % change in body weight
The study will compare longitudinal % change in body weight across the three study arms.
6, 12, and 18 months
Secondary Outcomes (4)
Longitudinal change in dietary intake
6, 12, and 18 months
Longitudinal change in physical activity
6, 12, and 18 months
Longitudinal change in interpersonal processes
6, 12, and 18 months
Longitudinal change in mother-daughter processes of mutual influence
6, 12, and 18 months
Study Arms (3)
Dyadic lifestyle intervention
EXPERIMENTALMothers and daughters participate in the Unidas partner intervention together.
Individual lifestyle intervention
EXPERIMENTALMothers participate in the Unidas intervention alone, without their related daughters. Unrelated daughters participate in the Unidas intervention alone without their related mothers.
Usual Care
OTHERMothers and daughters receive usual care.
Interventions
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.
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: Mother and daughter participants will receive Usual Care.
Eligibility Criteria
You may qualify if:
- Mothers:
- Are Mexican-American
- Are age 18 and older
- Have a body mass index (BMI) between 25 kg/m2 and 43 kg/m2.
- Are diagnosed with type 2 diabetes
- Live within a 25 mile radius of your adult daughter
- Are fluent in either Spanish or English as your primary language
- Are able to understand and sign an informed consent
- Adult daughters:
- Are Mexican-American
- Are age 18 and older
- Have a body mass index (BMI) between 25 kg/m2 and 43 kg/m2.
- Live within a 25 mile radius of your mother
- Are fluent in either Spanish or English as your primary language
- Are able to understand and sign an informed consent
You may not qualify if:
- Are male
- 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.
- 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).
- Are pregnant or become pregnant during the course of the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, Irvinelead
- AltaMed Health Services Corporationcollaborator
- University of California, San Diegocollaborator
Related Publications (1)
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.
PMID: 29597006DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dara H Sorkin, Ph.D.
University of California, Irvine
- PRINCIPAL INVESTIGATOR
Karen S Rook, Ph.D.
University of California, Irvine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
March 31, 2016
First Posted
April 18, 2016
Study Start
January 1, 2016
Primary Completion
July 1, 2021
Study Completion
July 1, 2021
Last Updated
August 21, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share