OverweightLucesNCT02771951
Clinical/Behavioral Approach to Overweight in Latino Youth
A study testing "Lights of Change" in people with Overweight and Pediatric Obesity, run by San Diego State University at 1 site in United States.
Trial summary
This randomized controlled trial tests the efficacy of a culturally and linguistically appropriate, evidence-based intervention to slow weight gain or promote weight loss among overweight 6-9 year old Mexican-American children. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Overweight, Pediatric Obesity
- What is being tested?
- "Lights of Change"
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 297 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Mar 2016
- 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 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Self-identify as Latino
- Have made a clinic visit within past 24 months prior to enrollment in study
- Have a BMI % for age/gender between 75 - 99.9th
- Plan on living in target area for following 18 months
- Have transportation to participating clinic
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Institute for Behavioral and Community Health at San Diego State University
San Diego, California, 92123
About this study
Official title: Clinical/Behavioral Approach to Overweight in Latino Youth: Luces de Cambio
This randomized controlled trial tests the efficacy of a culturally and linguistically appropriate, evidence-based intervention to slow weight gain or promote weight loss among overweight 6-9 year old Mexican-American children.
Read the detailed description
Overweight and obesity is a serious problem for Mexican-American children, due in part to poverty, acculturation, genetic predisposition or other factors. Clinic-based weight control studies have shown promise, but often include convenience samples with few or no Latino children. This randomized controlled trial tests the efficacy of a culturally and linguistically appropriate, evidence-based intervention to lower Body Mass Index (BMI) or slow weight gain among overweight 6-9 year old Mexican-American children randomly sampled from a large (36,192 pediatric patients) community clinic providing services to low and medium income families in a US-Mexico border community (San Ysidro, CA). Intervention and measurement design and selection are based on a "Socioecological Model for Latino Health Promotion". Children and their parents will be randomly assigned to either a Special Intervention (SI) or Usual Care (UC) group. The SI group will participate in the following behavior change activities based on Prevention Plus and Structured Weight Management approaches:
- classes providing culturally-sensitive health education regarding healthy eating, increasing physical activity, decreasing sedentary behaviors, and effective parenting behaviors to model and reinforce children's health behaviors, instruction on how to modify both social and structural aspects of the home environment, and skills-building to navigate community resources;
- clinical visits with a Health Educator and Mid-Level Provider (MLP);
- family visits with primary care providers (PCP); and
- phone calls to reinforce goal setting.
The UC group will receive standard health education for childhood obesity already provided by the community clinic. The primary outcome for the study is child BMI, which along with other changes in physical outcomes, child health behaviors and parenting behaviors will be evaluated at four time-points (baseline, 6-, 12-, and 18-months). The primary hypothesis is that the SI group will demonstrate lower mean BMI than the UC group at the end of a 6 month intervention with a maximum difference occurring at 12 months, and will sustain this difference for an additional six months (18 months after baseline). Secondary aims include examining intervention effects on children's energy balance, physical activity levels, sedentary behavior and parenting strategies related to their children's health behaviors.
- Conditions
- Overweight, Pediatric Obesity
- Being tested
- "Lights of Change", Usual Care
- Keywords
- Childhood, Obesity
- Medical subject headings
- Overweight, Pediatric Obesity, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Lights of Change"Behavioural
Usual CareBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Special Intervention | Experimental | Study participants randomized to receive Special Intervention receive a series of 7 group classes taught by trained clinic health educators; a series of phone calls; clinical visits with a mid-level provider; and a series of 6 booster group classes over 1 year. Receives: Behavioral: "Lights of Change" |
| Usual Care | Placebo comparator | Study participants randomized to receive Usual Care receive up to 2 visits with a usual care health educator over 1 year. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2016 (estimated)
- Study startApr 2010
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 297 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Elder, San Diego State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02771951
- Sponsor's protocol ID
- SanDiegoStateU
- Acronym
- Luces
- Status last verified
- May 2016
- First submitted
- 9 May 2016
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical/Behavioral Approach to Overweight in Latino Youth: Luces de Cambio
- ClinicalTrials.gov ID
- NCT02771951
- Acronym / sponsor ID
- Luces / SanDiegoStateU
- Conditions
- Overweight, Pediatric Obesity
- Keywords
- Childhood, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 297 participants (actual)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 13 May 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.
This randomized controlled trial tests the efficacy of a culturally and linguistically appropriate, evidence-based intervention to slow weight gain or promote weight loss among overweight 6-9 year old Mexican-American children.
Detailed description
Overweight and obesity is a serious problem for Mexican-American children, due in part to poverty, acculturation, genetic predisposition or other factors. Clinic-based weight control studies have shown promise, but often include convenience samples with few or no Latino children. This randomized controlled trial tests the efficacy of a culturally and linguistically appropriate, evidence-based intervention to lower Body Mass Index (BMI) or slow weight gain among overweight 6-9 year old Mexican-American children randomly sampled from a large (36,192 pediatric patients) community clinic providing services to low and medium income families in a US-Mexico border community (San Ysidro, CA). Intervention and measurement design and selection are based on a "Socioecological Model for Latino Health Promotion". Children and their parents will be randomly assigned to either a Special Intervention (SI) or Usual Care (UC) group. The SI group will participate in the following behavior change activities based on Prevention Plus and Structured Weight Management approaches:
- classes providing culturally-sensitive health education regarding healthy eating, increasing physical activity, decreasing sedentary behaviors, and effective parenting behaviors to model and reinforce children's health behaviors, instruction on how to modify both social and structural aspects of the home environment, and skills-building to navigate community resources;
- clinical visits with a Health Educator and Mid-Level Provider (MLP);
- family visits with primary care providers (PCP); and
- phone calls to reinforce goal setting.
The UC group will receive standard health education for childhood obesity already provided by the community clinic. The primary outcome for the study is child BMI, which along with other changes in physical outcomes, child health behaviors and parenting behaviors will be evaluated at four time-points (baseline, 6-, 12-, and 18-months). The primary hypothesis is that the SI group will demonstrate lower mean BMI than the UC group at the end of a 6 month intervention with a maximum difference occurring at 12 months, and will sustain this difference for an additional six months (18 months after baseline). Secondary aims include examining intervention effects on children's energy balance, physical activity levels, sedentary behavior and parenting strategies related to their children's health behaviors.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Special Intervention | Experimental | Behavioral: "Lights of Change"Study participants randomized to receive Special Intervention receive a series of 7 group classes taught by trained clinic health educators; a series of phone calls; clinical visits with a mid-level provider; and a series of 6 booster group classes over 1 year. |
| Usual Care | Placebo comparator | Behavioral: Usual CareStudy participants randomized to receive Usual Care receive up to 2 visits with a usual care health educator over 1 year. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Self-identify as Latino
- Have made a clinic visit within past 24 months prior to enrollment in study
- Have a BMI % for age/gender between 75 - 99.9th
- Plan on living in target area for following 18 months
- Have transportation to participating clinic
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| "Lights of Change" | Behavioural | Special Intervention |
| Usual Care | Behavioural | Usual Care |
Primary outcome
Body Mass Index
Time frame: 1 year
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 13 May 2016.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Lights of Change" in people with Overweight and Pediatric Obesity, run by San Diego State University at 1 site 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 0 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 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
Body Mass Index (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 May 2016.