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AzTrials

Prediabetic StateUNITEDNCT03527641

United for Health: Type 2 Diabetes Prevention in Latino Teens

A study testing CookingMatters, Parent Education and Physical Activity in people with Prediabetic State and Insulin Resistance, run by Colorado State University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study pilots the feasibility and acceptability of a family-based lifestyle intervention for decreasing diabetes risk called "Salud sin Barreras" (meaning, "Health without Barriers") delivered in the community to Latino teens at risk for type 2 diabetes. Read more about this study

Who is it for?
Ages 12 to 15 years
What is being tested?
CookingMatters, Parent Education and Physical Activity
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesUnited States
Study dates
1 May 2018to 30 Apr 2019
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 12 to 15 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Age 12-15 years
  • Identify as Hispanic/Latino
  • English speaking
  • At-risk for T2D by virtue of current BMI ≥ 85th percentile for age and sex by CDC 2000 standards and ≥ 1 first or second degree biological relative with T2D, prediabetes, or gestational diabetes
  • Currently a Salud Family Health Center patient or willing to become a patient of Salud Family Health Center (required to complete medical assessments at Salud)

Who cannot join

  • Major medical problem, including type 1 diabetes or T2D
  • Reported psychiatric disorder that would impede compliance in the opinion of the investigators
  • Started use of medication affecting mood or body weight, such as stimulants or anti-depressants within the past 3 months
  • Any medical issues that could be acutely worsened by exercise such as severe or uncontrolled asthma or musculoskeletal problems
  • Self-reported pregnancy in girls

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Colorado State University

    Fort Collins, Colorado, 80523

  • Salud Family Health Center

    Fort Collins, Colorado, 80524

Other trials in United States

About this study

Official title: Unidos Por la Salud/United for Health: Innovative Community-Academic Partnership for Type 2 Diabetes Prevention

This study pilots the feasibility and acceptability of a family-based lifestyle intervention for decreasing diabetes risk called "Salud sin Barreras" (meaning, "Health without Barriers") delivered in the community to Latino teens at risk for type 2 diabetes. This program combines traditional lifestyle intervention to change eating and physical activity with learning mindfulness-based stress reduction tools. We also are exploring how Salud sin Barreras lowers stress and improves insulin resistance in Latino teens, as compared to lifestyle-only intervention, the "La Vida Saludable" (meaning, the Healthy Living Program; HeLP).

Read the detailed description

This study is a comparative effectiveness pilot trial to evaluate the feasibility and acceptability of a 12-session community-delivered, family-based type 2 diabetes preventative lifestyle intervention, delivered over 6 weeks, that includes mindfulness-based stress reduction training - "Salud sin Barreras" (meaning, "Health without Barriers") - in up to 50 Hispanic/Latino adolescents who are at-risk for developing type 2 diabetes. We also will estimate the effectiveness of Salud sin Barreras for lowering perceived stress and improving insulin resistance as compared to a time-matched lifestyle-only intervention, the "La Vida Saludable" (meaning, the Healthy Living Program; HeLP) in Hispanic/Latino adolescents at-risk for type 2 diabetes. In addition, we will estimate the impact of the Salud sin Barreras program, relative to HeLP, on the secondary outcomes of mindfulness, depressive symptoms, disinhibited eating behavior, sleep quality, physical activity, cortisol, and perceived impact of discrimination.

Being tested
CookingMatters, Parent Education, Physical Activity, Health Education, Mindfulness-based Stress Reduction
Medical subject headings
Prediabetic State, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CookingMattersBehavioural

    Nutrition education and hands-on cooking lessons for the whole family

  • Parent EducationBehavioural

    Parenting, physical activity and nutrition education, and family health education for parents

  • Physical ActivityBehavioural

    Physical fitness activities for teens

  • Health EducationBehavioural

    Also called Hey Durham

    Health knowledge curriculum for adolescents

  • Mindfulness-based Stress ReductionBehavioural

    Also called Learning to Breathe

    Adolescent mindfulness curriculum

  • Brief Mindfulness InterventionBehavioural

    Also called Learning to Breathe, Parent Education

    Parent-based education and experiential learning of mindfulness-based tools

Study groups in NCT03527641
Study groupRoleWhat they receive
Salud sin Barreras, Health without BarriersExperimentalSalud sin Barreras is a manualized community-delivered program tailored for Latino families and their adolescent children at-risk for type 2 diabetes. Salud sin Barreras is based upon a lifestyle intervention called the Healthy Living Program (HeLP), which includes 6 weekly 2-hour nutrition/cooking sessions and 6 weekly 2-hour Multidisciplinary Sessions that include parent education on nutrition, fitness, goal-setting, parenting, and a brief mindfulness curriculum, a teen group physical fitness class, and a teen mindfulness curriculum called Learning 2 BREATHe. In between sessions, participants are encouraged to practice brief mindfulness skills in their daily lives and to complete the "homework" assignments, such as an audio-guided body scan. Participants have access to home-practice audio-recordings and will be queried about their completion of home-practice assignments.
Receives: Behavioral: CookingMatters; Behavioral: Parent Education; Behavioral: Physical Activity; Behavioral: Mindfulness-based Stress Reduction; Behavioral: Brief Mindfulness Intervention
La Vida Saludable, Healthy LivingActive comparatorThe Health Living Program (HeLP) is a manualized community-delivered program tailored specifically for Latino families and children at-risk for adult obesity. HeLP includes 6 weekly 2-hour nutrition/cooking sessions and 6 weekly 2-hour Multidisciplinary Sessions, that include parent education on nutrition, fitness, goal-setting, and parenting, a teen group physical fitness class, and a teen health knowledge curriculum derived from a health education curriculum called Hey DURHAM.
Receives: Behavioral: CookingMatters; Behavioral: Parent Education; Behavioral: Physical Activity; Behavioral: Health Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of Recruitment/Enrollment

    Feasibility of recruitment/enrollment for community-based family lifestyle intervention for Latino teens at-risk for type 2 diabetes as measured by number of qualifying participants following screening

    Measured: Up to 12 week period preceding the start of the intervention

  2. Treatment Acceptability Questionnaire

    Survey adapted from the Treatment Acceptability Questionnaire to assess acceptability and satisfaction with program participation; items are rated on a scale ranging from 1-5 with higher scores reflecting more positive acceptability

    Measured: 6 weeks

  3. Perceived Stress Scale

    Survey assessing perceptions of stress; the total score, calculated as the sum of all items, ranges from 0 to 60, with higher values reflecting more perceived stress

    Measured: 6 months

  4. Homeostasis model assessment of insulin resistance (HOMA-IR)

    Poor sensitivity of insulin to respond to and regulate glucose (blood sugar) as estimated from fasting glucose and insulin values

    Measured: 6 months

Secondary outcomes (7)

  1. Mindful Attention Awareness Scale

    Survey assessing propensity for present-moment attention; a total score is calculated as the sum of all items with a possible range of 15-90, with higher scores reflecting greater mindfulness (positive outcome) and lower scores, less mindfulness (worse outcome)

    Measured: 6 months

  2. Center for Epidemiologic Studies-Depression Scale

    Survey measure of symptoms of depression; a total score is calculated as the sum of all items with a possible range of 0-60, with higher scores reflecting more depressive symptoms

    Measured: 6 months

  3. Emotional Eating Scale Adapted for Children and Adolescents

    Survey measure of eating in response to negative emotions; subscales include eating in response to depression, eating in response to anger/anxiety/frustration, and eating in response to boredom with subscales calculated as the average of items; subscales range from 1-5 with higher scores indicating more emotional eating

    Measured: 6 months

  4. Actigraph GT3x Sleep Time

    Total sleep time as assessed by wrist-worn accelerometry

    Measured: 6 months

  5. Actigraph GT3x Physical Activity

    Total amount of minutes spent in light, moderate, and vigorous activity as assessed by wrist-worn accelerometry

    Measured: 6 months

  6. Cortisol

    Stress hormone as assessed by salivary swab

    Measured: 6 weeks

  7. Everyday Discrimination Scale

    Survey assessing perceived impact of discrimination; a total score is calculated from the sum of all items, with the total score ranging from 1 to 54, with higher scores indicating higher levels of perceived discrimination

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2018
  2. Study start1 May 2018
  3. Primary completion30 Apr 2019
  4. Study completion30 Apr 2019

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants are assigned to one of two or more group conditions in parallel for the duration of the study - (1) Salud sin Barreras or (2) La Vida Saludable. Both of these programs meet for 6 weeks, twice per week for 12 total 2-hour sessions. Youth are assessed at baseline, post-treatment, and 6-month follow-up.
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03527641
Sponsor's protocol ID
16-6568
Acronym
UNITED
Status last verified
Aug 2019
First submitted
23 Apr 2018
Last updated
26 Aug 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing CookingMatters, Parent Education and Physical Activity in people with Prediabetic State and Insulin Resistance, run by Colorado State University at 2 sites in United States.

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 5 inclusion and 5 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 26 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Feasibility of Recruitment/Enrollment (time frame: Up to 12 week period preceding the start of the intervention). The study lists 4 primary outcomes in all. 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 NCT03527641.

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 26 Aug 2019.

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