Health BehaviorNCT05419557

Buen Provecho!: A Virtual Family-Based Intervention to Promote Health

A study testing Virtual Family-Based Healthy Plate Club in people with Health Behavior and Diet, Healthy, run by Inova Health Care Services at 1 site 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

The purpose of this pilot study is to compare the effectiveness of an expanded virtual educational program at modifying knowledge, self-efficacy, and behaviors when compared to traditional in-office counseling for guardians of children who are obese or overweight. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Health Behavior, Diet, Healthy, Childhood Obesity
What is being tested?: Virtual Family-Based Healthy Plate Club
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 42 participants
Where: 1 siteUnited States
Study dates: 17 Aug 2022to 31 Jan 2023
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Child is clients at community clinic
Child between the ages 6-12 years
Child has a BMI percentage greater than 85%
Primary parent or guardian is > 18 years of age
Family identifies as Hispanic and Spanish is one of the primary languages spoken in the home
Children will be living with the primary guardian or parent for the duration of the program
Access to the internet
Parent or guardian is willing to commit to engaging in the 12 week program

Who cannot join

Family plans to change location within the year
During initial screening for the study, the study PI determines that the intervention may exacerbate existing medical conditions of the child or the family.

Trial locations and contacts

1 site in 1 country.

United States1 site

HealthWorks for Northern Virginia
Leesburg, Virginia, 20176

Other trials in United States

About this study

Read the detailed description

Rationale: Obesity rates are significantly higher among Hispanic youth in the United States, disproportionately putting these children at an increased risk for obesity-related diseases such as hypertension, dyslipidemia, and impaired glucose tolerance. While virtual programming offers an innovative option for pediatric weight management, limited data exists on the efficacy of virtual interventions for this population and their guardians (parents / caregivers).

Objectives: The purpose of this pilot study is to compare the effectiveness of an expanded virtual educational program (expanded -Inova Healthy Plate Club, x-IHPC) at modifying knowledge, self-efficacy, and behaviors when compared to traditional in-office counseling for guardians of children who are obese or overweight.

Study Design: In order to test the effectiveness of the x-IHPC intervention, outcomes from participants in this pilot study will be compared with outcomes from a comparison group of similar participants who receive standard nutrition counseling during their regularly scheduled check-ups. The team will enroll 25 children in the x-IHPC intervention and the same number in the comparison group (n=50). Both groups will receive standard in-office counseling, but the intervention group will also receive the x-IHPC.

Study Methodology: The comparison group receives standard, in-office counseling at visits 1, 3-months and 6-months. The intervention group receives standard in-office counseling at the same intervals, and also participates in a 12-week x-IHPC developed by a dietician curriculum specialist. In addition, a key pillar of this study is identifying and training Community Health Workers (CHWs) to be Spanish-speaking facilitators of the x-IHPC and utilizing community engagement strategies. Training these CHWs and including them in designing the x-IHPC curriculum, will ensure that the programming is culturally appropriate; includes local features that relate directly to the community's needs; and enables study facilitators to respond effectively to the questions and learning needs of the parents and children involved in the program.

Statistical Methodology:

To examine the research question, a longitudinal analysis using generalized estimating equations (GEE) will be conducted to assess if mean differences exist on dietary measures, screen time, sleep quality, physical activity and guardian self-efficacy and confidence between the intervention and comparison groups while accounting for the correlation among the repeated measurements and controlling for covariates.

Conditions: Health Behavior, Diet, Healthy, Childhood Obesity
Being tested: Virtual Family-Based Healthy Plate Club
Medical subject headings: Health Behavior, Pediatric Obesity

What participants receive

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

Virtual Family-Based Healthy Plate ClubBehavioural
IHPC provides produce boxes, nutrition and meal-preparation, education, and supportive counseling to address barriers related to obtaining produce and food. The intervention provides participants with a bi-weekly produce box for 12 weeks and helps families identify sustainable ways to obtain vegetables once the produce boxes end. The CHW will support families by coaching them on how to prepare these unfamiliar vegetables, give tips on finding sales at grocery stores, as well as by navigation to food assistance sites including food pantries. Parents will learn strategies to increase vegetable consumption by addressing perceived barriers - such as the child doesn't like vegetables. Curriculum will also include topics such as how to increase physical activity and reduce screen time.

Study groups in NCT05419557
Study group	Role	What they receive
Intervention	Active comparator	12 week virtual family-based health eating program Receives: Behavioral: Virtual Family-Based Healthy Plate Club
Comparison	No intervention	Standard in-office counseling about diet

What is being measured

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

Count of Participants Who Consumed Vegetables With Their Dinner Meal More Than 5 Days Per Week
Days per week child ate vegetables with dinner meal, post intervention Measured with a food frequency questionnaire, question: "Think about all the foods your child ate at your dinner/supper meal and snacks in the past week. On how many days did your child eat vegetables for the dinner meal?" Answer options: 1, Never | 2, 1-3 days | 3, 1-2 days | 4, 3-4 days | 5, 5-6 days | 6, Every day (Higher score indicates increased vegetable consumption)
Measured: 3 months post-study intervention
Count of Guardians Who Reported Being Confident or Very Confident That They Could Increase the Number of Vegetables the Child Eats Each Week
Guardians who reported being Confident or Very Confident that they could increase the number of vegetables the child eats each week As measured by guardian self-efficacy and confidence questions related to modifiable lifestyle behaviors on a likert scale Question: How confident do you feel that you can increase the number of vegetables your child eats each week? Likert Scale: 1, Not confident = It is impossible for me to do this | 2, Somewhat confident = Maybe I can do this | 3, Confident = I think I can do this | 4, Very confident = I can absolutely do this (Higher score indicates better outcome than lower score on Likert scale)
Measured: 3 months post-study intervention

Timeline

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

17 Aug 202231 Jan 2023

First posted15 Jun 2022
Study start17 Aug 2022
Primary completion31 Jan 2023
Study completion31 Jan 2023

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 Health BehaviorStudies 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: Non-randomised
Intervention model: Parallel groups
Model description: concurrent groups
Masking: None (open label)
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05419557
Sponsor's protocol ID: U21-12-4630
Status last verified: Jul 2024
First submitted: 10 Jun 2022
Last updated: 8 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Buen Provecho!: A Virtual Family-Based Intervention to Promote Health
ClinicalTrials.gov ID: NCT05419557
Acronym / sponsor ID: U21-12-4630
Conditions: Health Behavior, Diet, Healthy, Childhood Obesity
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: Inova Health Care ServicesUniversity, hospital or other
Study start: 17 Aug 2022 (actual)
Primary completion: 31 Jan 2023 (actual)
Study completion: 31 Jan 2023 (actual)
First posted: 15 Jun 2022 (actual)
Results: Posted 8 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Statistical Methodology:

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: concurrent groups

Arm	Type	Receives
Intervention	Active comparator	Behavioral: Virtual Family-Based Healthy Plate Club12 week virtual family-based health eating program
Comparison	No intervention	–Standard in-office counseling about diet

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Child is clients at community clinic
Child between the ages 6-12 years
Child has a BMI percentage greater than 85%
Primary parent or guardian is > 18 years of age
Family identifies as Hispanic and Spanish is one of the primary languages spoken in the home

Key exclusion criteria (2 listed)

Family plans to change location within the year
During initial screening for the study, the study PI determines that the intervention may exacerbate existing medical conditions of the child or the family.

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
Virtual Family-Based Healthy Plate ClubIHPC provides produce boxes, nutrition and meal-preparation, education, and supportive counseling to address barriers related to obtaining produce and food. The intervention provides participants with a bi-weekly produce box for 12 weeks and helps families identify sustainable ways to obtain vegetables once the produce boxes end. The CHW will support families by coaching them on how to prepare these unfamiliar vegetables, give tips on finding sales at grocery stores, as well as by navigation to food assistance sites including food pantries. Parents will learn strategies to increase vegetable consumption by addressing perceived barriers - such as the child doesn't like vegetables. Curriculum will also include topics such as how to increase physical activity and reduce screen time.	Behavioural	Intervention

Primary outcome

Count of Participants Who Consumed Vegetables With Their Dinner Meal More Than 5 Days Per Week
Time frame: 3 months post-study intervention
Days per week child ate vegetables with dinner meal, post intervention Measured with a food frequency questionnaire, question: "Think about all the foods your child ate at your dinner/supper meal and snacks in the past week. On how many days did your child eat vegetables for the dinner meal?" Answer options: 1, Never | 2, 1-3 days | 3, 1-2 days | 4, 3-4 days | 5, 5-6 days | 6, Every day (Higher score indicates increased vegetable consumption)
Count of Guardians Who Reported Being Confident or Very Confident That They Could Increase the Number of Vegetables the Child Eats Each Week
Time frame: 3 months post-study intervention
Guardians who reported being Confident or Very Confident that they could increase the number of vegetables the child eats each week As measured by guardian self-efficacy and confidence questions related to modifiable lifestyle behaviors on a likert scale Question: How confident do you feel that you can increase the number of vegetables your child eats each week? Likert Scale: 1, Not confident = It is impossible for me to do this | 2, Somewhat confident = Maybe I can do this | 3, Confident = I think I can do this | 4, Very confident = I can absolutely do this (Higher score indicates better outcome than lower score on Likert scale)

Results and safety

Results posted to the registry on 8 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention	22	11
Comparison	20	16

Primary outcome: Count of Participants Who Consumed Vegetables With Their Dinner Meal More Than 5 Days Per Week

Time frame: 3 months post-study intervention. Count of participants. Unit: Participants

Measure	Intervention n = 11	Comparison n = 16
Value	9	5

Intervention vs Comparison: Odds Ratio (OR): 8.5 (95% CI 1.3 to 54.6), p = 0.02, Regression, Logistic

Primary outcome: Count of Guardians Who Reported Being Confident or Very Confident That They Could Increase the Number of Vegetables the Child Eats Each Week

Time frame: 3 months post-study intervention. Count of participants. Unit: Participants

Measure	Intervention n = 11	Comparison n = 16
Value	7	5

Intervention vs Comparison: Odds Ratio (OR): 9.98 (95% CI 1.55 to 64.25), p = 0.015, Regression, Logistic

Adverse events

Time frame: Adverse Events were monitored over 3 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention	0 of 11 (0%)	0 of 11 (0%)	0 of 11
Comparison	0 of 16 (0%)	0 of 16 (0%)	0 of 16

Limitations and caveats (from the sponsor): The study relied on self-reported measures of behaviors, which are subject to recall bias and social desirability bias and in addition we relied on reports from guardians about their child. The study had a relatively short follow-up period limiting our understanding of the long-term sustainability of intervention. The study sample was limited to a specific cultural group, which limits the generalizability of the findings to other cultural contexts.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 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 Virtual Family-Based Healthy Plate Club in people with Health Behavior and Diet, Healthy, run by Inova Health Care Services 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 8 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 8 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 8 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?

Count of Participants Who Consumed Vegetables With Their Dinner Meal More Than 5 Days Per Week (time frame: 3 months post-study intervention). The study lists 2 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 NCT05419557.

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 8 Oct 2024.