Clinical trial NCT02741037: Unidas Por la Vida: A Healthy Lifestyle Intervention for High-risk Latina Dyads
Official title: Unidas Por la Vida: A Healthy Lifestyle Intervention for High-risk Latina Dyads
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Obesity
Overweight
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: AltaMed Health Services Corporation
name: University of California, San Diego
First posted: 2016-04-18
Enrollment: 710
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

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.

Primary outcomes:
measure: Longitudinal % change in body weight
timeFrame: 6, 12, and 18 months
Secondary outcomes:
measure: Longitudinal change in dietary intake
timeFrame: 6, 12, and 18 months
measure: Longitudinal change in physical activity
timeFrame: 6, 12, and 18 months
measure: Longitudinal change in interpersonal processes
timeFrame: 6, 12, and 18 months
measure: Longitudinal change in mother-daughter processes of mutual influence
timeFrame: 6, 12, and 18 months
Other outcomes:
Locations:
Study officials:
affiliation: University of California, Irvine
name: Dara H Sorkin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Irvine
name: Karen S Rook, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.