Pediatric ObesityNCT06565455
Growing Healthy Children and Families in Rural Arkansas
A study testing Growing Healthy Children and Families in Rural Arkansas in people with Pediatric Obesity and Health Behavior, Risky, run by University of Arkansas at 1 site in United States.
Trial summary
Childhood obesity is a national problem with racial and ethnic disparities specifically among Hispanic children. The primary purpose of this study is to develop and implement a culturally appropriate healthy eating intervention called Growing Healthy Children and Families in Rural Arkansas. Specific Aim (SA) 1. Read more about this study
- Who is it for?
- Ages 7 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obesity, Health Behavior, Risky
- What is being tested?
- Growing Healthy Children and Families in Rural Arkansas
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 7 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Aged 18 to 45 years old
- Living in the United States for at least one year
- At least one child aged 7 to 12 years old, and
- English and/or Spanish speaker
Who cannot join
- Unable to read or write in English or Spanish.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
Childhood obesity is a national problem with racial and ethnic disparities specifically among Hispanic children. The primary purpose of this study is to develop and implement a culturally appropriate healthy eating intervention called Growing Healthy Children and Families in Rural Arkansas.
Specific Aim (SA) 1. To develop a culturally appropriate healthy eating promotion intervention (Growing Healthy Children and Families in Rural Arkansas) in collaboration with Hispanic churches and their congregants.
Read more
SA2. To conduct the Growing Healthy Children and Families in Rural Arkansas intervention in eight churches (four churches in the intervention vs four in the control/attention group), and to assess the feasibility and acceptability of implementing the intervention.
SA3. To assess the impact of the Growing Healthy Children and Families in Rural Arkansas intervention on healthy food preparation (mothers) and intake of fruits and vegetables (child).
The investigators will compare between the intervention group (16 mother-child dyads) versus the control/attention group (16 mother-child dyad) to see if the intervention is effective in improving diet quality and changing cooking behaviors.
Participants will:
- Participate in cooking workshops and one to one learning activities
- Report on diet and physical activity
- Will measure fruit and vegetable intake
Read the detailed description
The primary purpose of this study is to develop and implement a culturally appropriate healthy eating intervention called Growing Healthy Children and Families in Rural Arkansas , to be delivered in the home and church setting by lay Community Health workers (CHW).
Specific Aim (SA) 1. To develop a culturally appropriate healthy eating promotion intervention (Growing Healthy Children and Families in Rural Arkansas ) in collaboration with Hispanic churches and their congregants (formative).
SA2. To conduct the Growing Healthy Children and Families in Rural Arkansas intervention in eight churches (four churches in the intervention vs four in the control/attention group), and to assess the feasibility and acceptability of implementing the intervention (implementation).
SA3. To assess the impact of the Growing Healthy Children and Families in Rural Arkansas intervention on healthy food preparation (mothers) and intake of fruits and vegetables (child).
To achieve Aim 1, Healthy eating culturally adapted modules will be developed from existing sources The healthy eating modules will consist of: Cause and long-term consequences of childhood obesity, Importance of hydration , Physical Activity, Recommended meal portions and meal planning, Sugar Smart, Ultra-processed foods, Fruits and vegetables.
The investigators will recruit up to 15 women to participate in focus groups (FGs) to participate in an iterative process of culturally adapting the healthy eating modules. FGs will be audio-recorded on Zoom or on an encrypted iPad, and professionally transcribed for data analysis. A moderator will lead the FGs, and a note taker will be present during the FGs.
To achieve aim 2, the investigators will recruit and train 10 lay CHWs to deliver the intervention. Priest, pastors, sisters, and/or church staff will approach women who are active in the church setting to discuss the program goals and assess their interest in becoming CHWs. The training will consist of learning the 7 learning modules, and how to effect and motivate behavior change.
Hispanic mother and-child dyads will be recruited to participate in the Growing Healthy Children and Families in Rural Arkansas intervention via word or mouth from priests, sisters, and church staff and via fliers being posted in the churches. The objective is to recruit a total of 16 mother-child dyad, for the intervention group and 16 mother-child dyads for the control/attention group. The total sample, size will be 64 participants.
Randomization will occur at the level of the church. Each dyad will be assigned to either the Growing Healthy Children and Families in Rural Arkansas intervention group or the control group. The Growing Healthy Children and Families in Rural Arkansas intervention group will be implemented at home by the lay CHW bi-weekly for 14 weeks. Participants within the Growing Healthy Children and Families in Rural Arkansas intervention will also attend two Cooking Demonstrations/Tasting Workshops. The workshops will be led by the CHW Specialist, and the dietitian. The workshops are projected to last 2-3 hrs. 60 minutes for teaching nutrition facts, healthy ingredient selection, portion sizes, and the nutritional value of typical Hispanic dishes. The remaining 60-90 minutes will be dedicated to cooking.
The control group will receive seven bi-weekly messaging videos for 12 weeks via Facebook/whatsApp. The messaging videos will last 5-15 minutes and will be delivered in Spanish or English. The topics of the messaging videos are as follows: Mental health issues that affect the Hispanic community, childhood vaccinations Cord blood banking, recommended adult vaccinations, common childhood diseases, dental care for adults and children common behavioral problems in children.
To achieve Aim 3, the investigators will test differences between the intervention and control groups. To determine if there is a change in food preparation in the home setting by the participant (mother) the investigators will measure home cooking quality at T0, and T1. The instrument to evaluate if there is a difference after implementation of the Growing Healthy Children and Families in Rural Arkansas intervention is the HCQ2. To assess if there is a change in intake of fruits and vegetables, in children that participated in the Growing Healthy Children and Families in Rural Arkansas intervention and the control/attention group the investigators will use the Veggie Meter and the Block FFQ at T0 and T1.
The investigators will use descriptive statistics to describe our sample and to make comparisons between the intervention and control/attention group. For the primary outcomes, of changes in dietary behaviors at the family level and change in diet quality, the investigators will use pre-post data (T0 and TI). Secondary outcomes of consumption of fruits and vegetables, consumption of sugar drinks, and physical activity, will be analyzed by using an analysis of covariance (ANCOVA) model from baseline T0, to T1 in children and mothers in both groups.
Data analysis of the FGs qualitative data: FGs transcripts will be uploaded to MAXQDA software for data management and to analyze the transcripts. The investigators will use Rapid analytical techniques to code and uncover themes in the transcripts.
- Conditions
- Pediatric Obesity, Health Behavior, Risky
- Being tested
- Growing Healthy Children and Families in Rural Arkansas
- Keywords
- Healthy Diet, Community Health, Faith Based Organizations, Cultural Adaptation
- Medical subject headings
- Pediatric Obesity, Health Risk Behaviors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Growing Healthy Children and Families in Rural ArkansasBehavioural
The intervention will consist of seven healthy eating culturally developed modules, which will be implemented/delivered in the participants home and two cooking demonstration/tasting workshops for the participants in the intervention group (mothers in the church setting and individual and collective goal settings for the intervention group.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Seven healthy eating modules, delivered by Community Health Workers (CHW) in the home setting, for 14 weeks. Plus two to three cooking demonstration in the church setting. Receives: Behavioral: Growing Healthy Children and Families in Rural Arkansas |
| Control/Attention Group | No intervention | Five video recordings via Facebook/WhatsApp for three months. Video topics: * Mental Health * Cord Blood Banking * Dental Care * Immunizations * Behavioral Problems in Children |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in dietary behavior
Evaluated via eating habits as reported through the Food Frequency Questionnaire
Measured: Baseline (T0), Week 22 (T1)
Change in diet quality - Food Frequency Questionnaire
Evaluated based on eating habits reported through the Food Frequency Questionnaire
Measured: Baseline (T0), Week 22 (T1)
Change in diet quality - Healthy Cooking Questionnaire-2
Evaluated based on eating habits reported through the Healthy Cooking Questionnaire-2
Measured: Baseline (T0), Week 22 (T1)
Secondary outcomes (3)
Consumption of fruits and vegetables
Evaluated through the Veggie Meter measures
Measured: Baseline (T0), Week 22 (T1)
Consumption of sugary drinks
Evaluated through the FFQ
Measured: Baseline (T0), Week 22 (T1)
Physical activity
Evaluated through the PA Screener
Measured: Baseline (T0), Week 22 (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start2 Feb 2026
- Primary completion31 May 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martha Rojo, PhD, Principal investigator, UAMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06565455
- Sponsor's protocol ID
- 297627
- Status last verified
- Oct 2026
- First submitted
- 14 Aug 2024
- Last updated
- 27 Oct 2026
- Results posted
- No
- 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 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growing Healthy Children and Families in Rural Arkansas
- ClinicalTrials.gov ID
- NCT06565455
- Acronym / sponsor ID
- 297627
- Conditions
- Pediatric Obesity, Health Behavior, Risky
- Keywords
- Healthy Diet, Community Health, Faith Based Organizations, Cultural Adaptation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- 31 May 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Aug 2024 (actual)
- 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.
Childhood obesity is a national problem with racial and ethnic disparities specifically among Hispanic children. The primary purpose of this study is to develop and implement a culturally appropriate healthy eating intervention called Growing Healthy Children and Families in Rural Arkansas.
Specific Aim (SA) 1. To develop a culturally appropriate healthy eating promotion intervention (Growing Healthy Children and Families in Rural Arkansas) in collaboration with Hispanic churches and their congregants.
SA2. To conduct the Growing Healthy Children and Families in Rural Arkansas intervention in eight churches (four churches in the intervention vs four in the control/attention group), and to assess the feasibility and acceptability of implementing the intervention.
SA3. To assess the impact of the Growing Healthy Children and Families in Rural Arkansas intervention on healthy food preparation (mothers) and intake of fruits and vegetables (child).
The investigators will compare between the intervention group (16 mother-child dyads) versus the control/attention group (16 mother-child dyad) to see if the intervention is effective in improving diet quality and changing cooking behaviors.
Participants will:
- Participate in cooking workshops and one to one learning activities
- Report on diet and physical activity
- Will measure fruit and vegetable intake
Detailed description
The primary purpose of this study is to develop and implement a culturally appropriate healthy eating intervention called Growing Healthy Children and Families in Rural Arkansas , to be delivered in the home and church setting by lay Community Health workers (CHW).
Specific Aim (SA) 1. To develop a culturally appropriate healthy eating promotion intervention (Growing Healthy Children and Families in Rural Arkansas ) in collaboration with Hispanic churches and their congregants (formative).
SA2. To conduct the Growing Healthy Children and Families in Rural Arkansas intervention in eight churches (four churches in the intervention vs four in the control/attention group), and to assess the feasibility and acceptability of implementing the intervention (implementation).
SA3. To assess the impact of the Growing Healthy Children and Families in Rural Arkansas intervention on healthy food preparation (mothers) and intake of fruits and vegetables (child).
To achieve Aim 1, Healthy eating culturally adapted modules will be developed from existing sources The healthy eating modules will consist of: Cause and long-term consequences of childhood obesity, Importance of hydration , Physical Activity, Recommended meal portions and meal planning, Sugar Smart, Ultra-processed foods, Fruits and vegetables.
The investigators will recruit up to 15 women to participate in focus groups (FGs) to participate in an iterative process of culturally adapting the healthy eating modules. FGs will be audio-recorded on Zoom or on an encrypted iPad, and professionally transcribed for data analysis. A moderator will lead the FGs, and a note taker will be present during the FGs.
To achieve aim 2, the investigators will recruit and train 10 lay CHWs to deliver the intervention. Priest, pastors, sisters, and/or church staff will approach women who are active in the church setting to discuss the program goals and assess their interest in becoming CHWs. The training will consist of learning the 7 learning modules, and how to effect and motivate behavior change.
Hispanic mother and-child dyads will be recruited to participate in the Growing Healthy Children and Families in Rural Arkansas intervention via word or mouth from priests, sisters, and church staff and via fliers being posted in the churches. The objective is to recruit a total of 16 mother-child dyad, for the intervention group and 16 mother-child dyads for the control/attention group. The total sample, size will be 64 participants.
Randomization will occur at the level of the church. Each dyad will be assigned to either the Growing Healthy Children and Families in Rural Arkansas intervention group or the control group. The Growing Healthy Children and Families in Rural Arkansas intervention group will be implemented at home by the lay CHW bi-weekly for 14 weeks. Participants within the Growing Healthy Children and Families in Rural Arkansas intervention will also attend two Cooking Demonstrations/Tasting Workshops. The workshops will be led by the CHW Specialist, and the dietitian. The workshops are projected to last 2-3 hrs. 60 minutes for teaching nutrition facts, healthy ingredient selection, portion sizes, and the nutritional value of typical Hispanic dishes. The remaining 60-90 minutes will be dedicated to cooking.
The control group will receive seven bi-weekly messaging videos for 12 weeks via Facebook/whatsApp. The messaging videos will last 5-15 minutes and will be delivered in Spanish or English. The topics of the messaging videos are as follows: Mental health issues that affect the Hispanic community, childhood vaccinations Cord blood banking, recommended adult vaccinations, common childhood diseases, dental care for adults and children common behavioral problems in children.
To achieve Aim 3, the investigators will test differences between the intervention and control groups. To determine if there is a change in food preparation in the home setting by the participant (mother) the investigators will measure home cooking quality at T0, and T1. The instrument to evaluate if there is a difference after implementation of the Growing Healthy Children and Families in Rural Arkansas intervention is the HCQ2. To assess if there is a change in intake of fruits and vegetables, in children that participated in the Growing Healthy Children and Families in Rural Arkansas intervention and the control/attention group the investigators will use the Veggie Meter and the Block FFQ at T0 and T1.
The investigators will use descriptive statistics to describe our sample and to make comparisons between the intervention and control/attention group. For the primary outcomes, of changes in dietary behaviors at the family level and change in diet quality, the investigators will use pre-post data (T0 and TI). Secondary outcomes of consumption of fruits and vegetables, consumption of sugar drinks, and physical activity, will be analyzed by using an analysis of covariance (ANCOVA) model from baseline T0, to T1 in children and mothers in both groups.
Data analysis of the FGs qualitative data: FGs transcripts will be uploaded to MAXQDA software for data management and to analyze the transcripts. The investigators will use Rapid analytical techniques to code and uncover themes in the transcripts.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Growing Healthy Children and Families in Rural ArkansasSeven healthy eating modules, delivered by Community Health Workers (CHW) in the home setting, for 14 weeks. Plus two to three cooking demonstration in the church setting. |
| Control/Attention Group | No intervention | –Five video recordings via Facebook/WhatsApp for three months. Video topics: * Mental Health * Cord Blood Banking * Dental Care * Immunizations * Behavioral Problems in Children |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 to 45 years old
- Living in the United States for at least one year
- At least one child aged 7 to 12 years old, and
- English and/or Spanish speaker
Key exclusion criteria (1 listed)
- Unable to read or write in English or Spanish.
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 |
|---|---|---|
| Growing Healthy Children and Families in Rural ArkansasThe intervention will consist of seven healthy eating culturally developed modules, which will be implemented/delivered in the participants home and two cooking demonstration/tasting workshops for the participants in the intervention group (mothers in the church setting and individual and collective goal settings for the intervention group. | Behavioural | Intervention Group |
Primary outcome
Changes in dietary behavior
Time frame: Baseline (T0), Week 22 (T1)
Evaluated via eating habits as reported through the Food Frequency Questionnaire
Change in diet quality - Food Frequency Questionnaire
Time frame: Baseline (T0), Week 22 (T1)
Evaluated based on eating habits reported through the Food Frequency Questionnaire
Change in diet quality - Healthy Cooking Questionnaire-2
Time frame: Baseline (T0), Week 22 (T1)
Evaluated based on eating habits reported through the Healthy Cooking Questionnaire-2
3 secondary outcomes
Consumption of fruits and vegetables
Time frame: Baseline (T0), Week 22 (T1)
Consumption of sugary drinks
Time frame: Baseline (T0), Week 22 (T1)
Physical activity
Time frame: Baseline (T0), Week 22 (T1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- 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.
Martha Rojo, PhD principal investigator
UAMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Growing Healthy Children and Families in Rural Arkansas in people with Pediatric Obesity and Health Behavior, Risky, run by University of Arkansas 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 4 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Changes in dietary behavior (time frame: Baseline (T0), Week 22 (T1)). The study lists 3 primary outcomes in all. 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 27 Oct 2026.