Childhood ObesityNCT04261985
A Mobile Phone Based Pilot Intervention to Prevent Obesity in Latino Preschool Children
A study testing healthy weight behaviors supported by web-based mobile phone application in people with Childhood Obesity and Parenting, run by University of California, Los Angeles at 1 site in United States.
Trial summary
To pilot a stand-alone mobile phone intervention with Latino caregivers of 2- to 5-year olds, using a prospective control group design, to assess feasibility and preliminary effect sizes on children's BMI changes (primary outcome) and dietary and physical activity changes (secondary outcomes) at 6 months… Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity, Parenting, Mobile Phone Use
- What is being tested?
- healthy weight behaviors supported by web-based mobile phone application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2020to 1 Jul 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- adult male or female caregiver
- self-identifies as an individual of Latino descent
- has a child or grandchild 2-5 years of age (relationship does not have to be biological but caregiver is a legal guardian)
- lives with or cares for child/grandchild at least 20 hours/week
- is fluent in English or Spanish
- has the ability to participate in the mHealth intervention (ability determined by using a Subject Comprehension and Participation Assessment Tool)
- agrees to complete baseline, 1-, and 6-month post-baseline surveys and have adult and child height and weight measured.
Who cannot join
- child has a failure to thrive diagnosis
- medical complications associated with their weight status such as Prader-Willi Syndrome
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA David Geffen School of Medicine
Los Angeles, California, 90095
About this study
To pilot a stand-alone mobile phone intervention with Latino caregivers of 2- to 5-year olds, using a prospective control group design, to assess feasibility and preliminary effect sizes on children's BMI changes (primary outcome) and dietary and physical activity changes (secondary outcomes) at 6 months post-baseline, in preparation for a larger randomized trial to evaluate the intervention's efficacy.
Read the detailed description
The investigators will pilot an mHealth intervention using a prospective control group design with 66 caregiver-child dyads (33 intervention and 33 comparison) recruited from two community based agencies in East Los Angeles. Fidelity and feasibility will be assessed. Pre- and post- intervention data (child dietary, physical activity, and media viewing behaviors and BMI z-scores) will be collected to estimate preliminary effect sizes and standard deviations. The mHealth intervention has been informed by a previous feasibility study and focus groups with Latino caregivers of 2- to 5-year old children. This mHealth childhood obesity intervention specifically targets Latino mothers, fathers, and grandmothers of 2- to 5-year olds. The intervention focuses on parenting skills, dietary, physical activity, and media-viewing behaviors consistent with American Academy of Pediatrics guidelines.
- Conditions
- Childhood Obesity, Parenting, Mobile Phone Use
- Being tested
- healthy weight behaviors supported by web-based mobile phone application
- Medical subject headings
- Pediatric Obesity, Cell Phone Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
healthy weight behaviors supported by web-based mobile phone applicationBehavioural
Chorus is a mobile phone platform that provides texting, a web application, and an online community for mHealth interventions.Content is created using existing templates to insert text, images, pictures, audio, video clips, or any combination of these. Users interface with Chorus by clicking a hyperlink embedded in a text message sent to their phone to then access web-based interactions via prompts and clicks. Content was created in English and Spanish.
| Study group | Role | What they receive |
|---|---|---|
| Mobile Phone Obesity Intervention | Active comparator | Approximately 30 caregiver-child dyads will be randomized into the intervention arm. Every week for 4 weeks, caregivers will receive 4 interactive multi-media phone prompts to support the intervention's targeted topics. Each mobile phone prompt starts with a 140-character text with an embedded link. Clicking on the link navigates caregivers to a web-based application with interactive content that includes images, text, videos, and prompts. Each week, caregivers will share their goal/s, perceived barriers, questions, tips and strategies that may be helpful to other participants. Each week, caregivers will also receive strategies, and individual and group feedback on changing unhealthy behaviors. Receives: Behavioral: healthy weight behaviors supported by web-based mobile phone application |
| Control | No intervention | Approximately 30 caregiver-child dyads will be randomized into the control (no intervention) arm. Every week for 4 weeks, these caregivers will receive 4 interactive multi-media phone prompts around managing common illness in young children (i.e. fever, vomiting, constipation, etc.) Each mobile phone prompt will start with a 140-character text with an embedded link. Clicking on the link navigates caregivers to a web-based application with interactive content that includes images, text, videos, and prompts. Each week, caregivers will share questions and strategies that may be helpful to other participants. Each week, caregivers will also receive tips and group feedback based on group questions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Weight
Child pounds measured using participant weight measured on a digital scale (calibrated with 5kg weight before each measurement) to the nearest 0.1 pounds
Measured: 6-months post baseline
Secondary outcomes (1)
Caregiver Weight in Pounds
Caregiver pounds measured using participant weight measured on a digital scale (calibrated with 5kg weight before each measurement) to the nearest 0.1 pounds
Measured: 6-months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start8 Jun 2020
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a prospective control group design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Alma Guerrero, MD, MPH, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04261985
- Sponsor's protocol ID
- 1R21HD096298-01A1
- Other IDs
- 1R21HD096298-01A1
- Status last verified
- Oct 2024
- First submitted
- 3 Feb 2020
- Last updated
- 16 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mobile Phone Based Pilot Intervention to Prevent Obesity in Latino Preschool Children
- ClinicalTrials.gov ID
- NCT04261985
- Acronym / sponsor ID
- 1R21HD096298-01A1
- Conditions
- Childhood Obesity, Parenting, Mobile Phone Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 8 Jun 2020 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 10 Feb 2020 (actual)
- Results
- Posted 16 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To pilot a stand-alone mobile phone intervention with Latino caregivers of 2- to 5-year olds, using a prospective control group design, to assess feasibility and preliminary effect sizes on children's BMI changes (primary outcome) and dietary and physical activity changes (secondary outcomes) at 6 months post-baseline, in preparation for a larger randomized trial to evaluate the intervention's efficacy.
Detailed description
The investigators will pilot an mHealth intervention using a prospective control group design with 66 caregiver-child dyads (33 intervention and 33 comparison) recruited from two community based agencies in East Los Angeles. Fidelity and feasibility will be assessed. Pre- and post- intervention data (child dietary, physical activity, and media viewing behaviors and BMI z-scores) will be collected to estimate preliminary effect sizes and standard deviations. The mHealth intervention has been informed by a previous feasibility study and focus groups with Latino caregivers of 2- to 5-year old children. This mHealth childhood obesity intervention specifically targets Latino mothers, fathers, and grandmothers of 2- to 5-year olds. The intervention focuses on parenting skills, dietary, physical activity, and media-viewing behaviors consistent with American Academy of Pediatrics guidelines.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- a prospective control group design
| Arm | Type | Receives |
|---|---|---|
| Mobile Phone Obesity Intervention | Active comparator | Behavioral: healthy weight behaviors supported by web-based mobile phone applicationApproximately 30 caregiver-child dyads will be randomized into the intervention arm. Every week for 4 weeks, caregivers will receive 4 interactive multi-media phone prompts to support the intervention's targeted topics. Each mobile phone prompt starts with a 140-character text with an embedded link. Clicking on the link navigates caregivers to a web-based application with interactive content that includes images, text, videos, and prompts. Each week, caregivers will share their goal/s, perceived barriers, questions, tips and strategies that may be helpful to other participants. Each week, caregivers will also receive strategies, and individual and group feedback on changing unhealthy behaviors. |
| Control | No intervention | –Approximately 30 caregiver-child dyads will be randomized into the control (no intervention) arm. Every week for 4 weeks, these caregivers will receive 4 interactive multi-media phone prompts around managing common illness in young children (i.e. fever, vomiting, constipation, etc.) Each mobile phone prompt will start with a 140-character text with an embedded link. Clicking on the link navigates caregivers to a web-based application with interactive content that includes images, text, videos, and prompts. Each week, caregivers will share questions and strategies that may be helpful to other participants. Each week, caregivers will also receive tips and group feedback based on group questions. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- adult male or female caregiver
- self-identifies as an individual of Latino descent
- has a child or grandchild 2-5 years of age (relationship does not have to be biological but caregiver is a legal guardian)
- lives with or cares for child/grandchild at least 20 hours/week
- is fluent in English or Spanish
Key exclusion criteria (2 listed)
- child has a failure to thrive diagnosis
- medical complications associated with their weight status such as Prader-Willi Syndrome
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 |
|---|---|---|
| healthy weight behaviors supported by web-based mobile phone applicationChorus is a mobile phone platform that provides texting, a web application, and an online community for mHealth interventions.Content is created using existing templates to insert text, images, pictures, audio, video clips, or any combination of these. Users interface with Chorus by clicking a hyperlink embedded in a text message sent to their phone to then access web-based interactions via prompts and clicks. Content was created in English and Spanish. | Behavioural | Mobile Phone Obesity Intervention |
Primary outcome
Child Weight
Time frame: 6-months post baseline
Child pounds measured using participant weight measured on a digital scale (calibrated with 5kg weight before each measurement) to the nearest 0.1 pounds
1 secondary outcome
Caregiver Weight in Pounds
Time frame: 6-months post-intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 healthy weight behaviors supported by web-based mobile phone application in people with Childhood Obesity and Parenting, run by University of California, Los Angeles 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 7 inclusion and 2 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 16 Oct 2024. 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. 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?
Yes. Results are posted in the registry (first posted 16 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Child Weight (time frame: 6-months post baseline). 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 16 Oct 2024.