DiabetesNCT02741037
Unidas Por la Vida: A Healthy Lifestyle Intervention for High-risk Latina Dyads
A study testing Dyadic lifestyle intervention and Individual lifestyle intervention in people with Diabetes and Obesity, run by University of California, Irvine.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Diabetes, Obesity, Overweight
- What is being tested?
- Dyadic lifestyle intervention and Individual lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 710 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 15Show fewer
- 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
Who cannot join
- 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.
About this study
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.
Read the 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
- Being tested
- Dyadic lifestyle intervention, Individual lifestyle intervention, Usual Care
- Medical subject headings
- Diabetes Mellitus, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dyadic lifestyle interventionBehavioural
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 interventionBehavioural
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 CareOther
Usual Care: Mother and daughter participants will receive Usual Care.
| Study group | Role | What they receive |
|---|---|---|
| Dyadic lifestyle intervention | Experimental | Mothers and daughters participate in the Unidas partner intervention together. Receives: Behavioral: Dyadic lifestyle intervention; Other: Usual Care |
| Individual lifestyle intervention | Experimental | Mothers participate in the Unidas intervention alone, without their related daughters. Unrelated daughters participate in the Unidas intervention alone without their related mothers. Receives: Behavioral: Individual lifestyle intervention; Other: Usual Care |
| Usual Care | Other | Mothers and daughters receive usual care. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Longitudinal % change in body weight
The study will compare longitudinal % change in body weight across the three study arms.
Measured: 6, 12, and 18 months
Secondary outcomes (4)
Longitudinal change in dietary intake
The study will examine whether changes in dietary intake are greatest among women in the partner intervention, compared to women in an individual intervention or in usual care, and to examine whether changes in dietary intake mediate the effects of the intervention on weight status and maintenance. Dietary intake will be measured with the Spanish version of the 2005 Block Food Frequency Questionnaire (FFQ). This instrument assesses portion sizes and frequency of consumption of over 100 food items, including foods selected for their cultural appropriateness for Mexican Americans to provide validated estimates of energy intake (total kilocalories) and macronutrient intake (including fat, carbohydrates and dietary fiber).
Measured: 6, 12, and 18 months
Longitudinal change in physical activity
The study will examine whether changes in physical activity are greatest among women in the partner intervention, compared to women in an individual intervention or in usual care, and to examine whether changes in physical activity mediate the effects of the intervention on weight status and maintenance. The 7-day physical activity recall (PAR) will be used to assess physical activity at each study time point. Participants will be asked to estimate the number of hours spent each day (starting with the current day and working backwards) in sleep and in moderate, hard, and very hard physical activities.
Measured: 6, 12, and 18 months
Longitudinal change in interpersonal processes
The study will examine whether changes in theoretically-derived mediating mechanisms, such as interpersonal processes, are greatest among women in the partner intervention, compared to women in the individual intervention or in usual care to examine whether changes in these processes mediate the effects of the intervention on dietary intake and in physical activity. Well-established methods of social network and social exchange assessment will be used to obtain detailed information about the involvement of participants' social network members in health-related social support, social control, and/or social undermining. Participants will be asked to identify social network members who have helped them make healthy lifestyle changes (social support), have prompted or urged them to do more to make such changes (social control), and/or have interfered (intentionally or unintentionally) with their efforts to make such changes (social undermining).
Measured: 6, 12, and 18 months
Longitudinal change in mother-daughter processes of mutual influence
The study will examine actor-partner interdependence models to explore group differences in mother-daughter processes of mutual influence across the study arms, with this mutual influence expected to be greater and more strongly related to the primary and secondary outcomes for women in the partner intervention, compared to women in the individual intervention or in usual care.
Measured: 6, 12, and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2016 (estimated)
- Study startJan 2016
- Primary completionJul 2021
- Study completionJul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 710 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- AltaMed Health Services Corporation, University of California, San Diego
- Responsible party
- Principal investigator, Dara Sorkin, University of California, Irvine
- Investigators
- Dara H Sorkin, Ph.D., Principal investigator, University of California, IrvineKaren S Rook, Ph.D., Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02741037
- Sponsor's protocol ID
- 20097225
- Status last verified
- Aug 2023
- First submitted
- 31 Mar 2016
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 29597006
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unidas Por la Vida: A Healthy Lifestyle Intervention for High-risk Latina Dyads
- ClinicalTrials.gov ID
- NCT02741037
- Acronym / sponsor ID
- 20097225
- Conditions
- Diabetes, Obesity, Overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 710 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- AltaMed Health Services Corporation, University of California, San Diego
- Study start
- Jan 2016 (actual)
- Primary completion
- Jul 2021 (actual)
- Study completion
- Jul 2021 (actual)
- First posted
- 18 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dyadic lifestyle intervention | Experimental | Behavioral: Dyadic lifestyle intervention, Other: Usual CareMothers and daughters participate in the Unidas partner intervention together. |
| Individual lifestyle intervention | Experimental | Behavioral: Individual lifestyle intervention, Other: Usual CareMothers participate in the Unidas intervention alone, without their related daughters. Unrelated daughters participate in the Unidas intervention alone without their related mothers. |
| Usual Care | Other | Other: Usual CareMothers and daughters receive usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dyadic lifestyle interventionDyadic 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. | Behavioural | Dyadic lifestyle intervention |
| Individual lifestyle interventionIndividual 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. | Behavioural | Individual lifestyle intervention |
| Usual CareUsual Care: Mother and daughter participants will receive Usual Care. | Other | Dyadic lifestyle intervention, Individual lifestyle intervention, Usual Care |
Primary outcome
Longitudinal % change in body weight
Time frame: 6, 12, and 18 months
The study will compare longitudinal % change in body weight across the three study arms.
4 secondary outcomes
Longitudinal change in dietary intake
Time frame: 6, 12, and 18 months
Longitudinal change in physical activity
Time frame: 6, 12, and 18 months
Longitudinal change in interpersonal processes
Time frame: 6, 12, and 18 months
Longitudinal change in mother-daughter processes of mutual influence
Time frame: 6, 12, and 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Derived from this study: PubMed 29597006Sorkin 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.
- Individual participant dataSharing planned: No
Related trials for Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dara H Sorkin, Ph.D. principal investigator
University of California, Irvine
Karen S Rook, Ph.D. principal investigator
University of California, Irvine
Questions about this trial
What is this clinical trial studying?
A study testing Dyadic lifestyle intervention and Individual lifestyle intervention in people with Diabetes and Obesity, run by University of California, Irvine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Longitudinal % change in body weight (time frame: 6, 12, and 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02741037, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.