Healthy LifestyleNCT05019339
HomeStyles-2: Shaping HOME Environments and LifeSTYLES to Prevent Childhood Obesity in SNAP-Education
A study testing Healthy HomeStyles and Eat Healthy Be Active in people with Healthy Lifestyle and Home Environment Related Disease, run by University of Florida at 1 site in United States.
Trial summary
Childhood obesity prevention efforts are needed in the United States, especially for families with low income. Educating parents and caregivers on simple lifestyle and affordable home environment changes is an effective strategy to improve health outcomes for the entire family. Read more about this study
- Who is it for?
- Ages 18 to 110 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Lifestyle, Home Environment Related Disease, Child Behavior
- What is being tested?
- Healthy HomeStyles and Eat Healthy Be Active
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 247 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2021to 30 Apr 2023
- 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 18 to 110 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- SNAP-Ed-eligible (i.e., eligible for or receiving SNAP benefits, household income at or below 200% Federal Poverty Guidelines, or living in communities with significant (50% or greater) low-income population)
- Parent or caregiver of a least 1 child aged 6 to 11 years
- Have regular Internet and/or telephone access
- Can read and comprehend English or Spanish
- Reside in study catchment area (i.e., Florida)
- Have not previously participated in nutrition education series using the attention control curriculum
Who cannot join
- Does not fit inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Childhood obesity prevention efforts are needed in the United States, especially for families with low income. Educating parents and caregivers on simple lifestyle and affordable home environment changes is an effective strategy to improve health outcomes for the entire family. Therefore, the purpose of this study is to determine whether HomeStyles-2, a nutrition education and childhood obesity prevention program for families with children in middle childhood (ages 6 to 11 years), motivates parents to shape their home environments and weight-related lifestyle practices to be more supportive of optimal health and weight status of their children aged 6-11 years more so than those in the control condition. The study will include the experimental group and an attention control group who will engage in a nutrition education program, Eat Healthy Be Active, that is equal in nonspecific treatment effects but does not overlap on topics covered in HomeStyles-2. This study will be implemented in Florida's Supplemental Nutrition Assistance Program-Education (SNAP-Ed) program, which provides nutrition education and obesity prevention supports for individuals with low income who are receiving or eligible for SNAP benefits. Nutrition Educators will be randomized to the experimental or attention control condition, and will lead participants through virtual, group-based nutrition education series. The following data will be collected: sociodemographic characteristics of the participant and child; child and parent health status; parent weight-related cognitions; weight-related behaviors of the participant and child; and weight-related characteristics of the home environment. Enrollment for this study will begin late-2021.
Read the detailed description
The aim of the HomeStyles-2 for SNAP-Ed families RCT is to determine whether HomeStyles-2 enables and motivates SNAP-Ed parents and child caregivers (e.g., guardians) to shape their home environments and weight-related lifestyle practices to be more supportive of optimal health and weight status of their children aged 6-11 years than those in the control condition. The study will be a two-arm, cluster randomized trial and will follow the CONSORT guidelines extension for cluster trials. Individual counties or groups of small counties operate as a single division with one individual who supervises the SNAP-Ed Nutrition Educators assigned to that division. Every participating division will function as a cluster in the study. Half of the Nutrition Educators in each cluster that choose to participate in the study will be randomized and trained to only deliver the experimental treatment and the other half the control intervention. Eligible participants will be recruited by Nutrition Educators through existing SNAP-Ed community partnerships.
Once identified, eligible individuals will be screened for eligibility, consented, and complete the baseline survey with a trained research assistant over the phone. Participants who complete the baseline survey and meet survey plausibility checks will be enrolled in the study. Their assignment to experimental or attention control condition is dependent upon the Nutrition Educator's random assignment to teach experimental or attention control curriculum. Recruitment materials and the bona fide treatment to be delivered to the attention control group are designed to blind participant assignment to study condition.
Participants will complete a six-week virtual nutrition education program, with each weekly session lasting approximately 30 minutes. Nutrition Educators will conduct the sessions over video conferencing software (e.g., Zoom). Participants will receive intervention materials by mail before the first class of the series and will have electronic access to the materials through a free learning management system. After the six-week virtual nutrition education program, participants will be invited to take the post survey over the telephone with a trained research assistant. Approximately 4 to 10 weeks after participants complete the post survey, they will be invited to take the follow-up survey to assess longer-term intervention effects.
Participant progress through the RCT will be monitored by tracking attendance at each educational session. Trained research assistants and SNAP-Ed staff will be available to answer questions throughout the study. Participants will receive modest stipends that increase in value after they complete each survey.
The HomeStyles-2 experimental group intervention materials (i.e., "Healthy" HomeStyles-2) were designed to be congruent with White House and IOM recommendations for home-centered obesity prevention interventions and critical elements for effective interventions (e.g., interventions are positive, culturally sensitive, supportive of parent-child interaction and child development; develop realistic, effective plans that empower families). HomeStyles-2 for middle childhood intervention materials provide intensive, interactive, fun, non-judgmental opportunities for parents to shape their home environments and lifestyle practices to protect child health. They also promote positive strategies and changes that adults can control in their environments to reduce risk of excessive weight gain in their middle childhood youth. Key factors contributing to childhood obesity that can be suitably addressed in the home environment with middle childhood kids identified for inclusion in the intervention materials were selected using systematic literature reviews and input from experts in childhood obesity prevention. The topics that emerged and will be covered in the SNAP-Ed arm of the study include inadequate intake of fruits and vegetables, infrequent family meals, excessive consumption of sugar-sweetened beverages, large portion sizes, and irregular breakfast consumption. An additional factor was children's limited food preparation skills.
The attention control group will receive a different but bona fide, credible treatment at the same time as the experimental group. The control condition will provide information distinct from the "active" ingredient in the experimental intervention, while still aligning with the description of the study recruitment materials (i.e., to build happier, healthier families) and adhering to the regulations governing educational content of SNAP-Ed programming. The control condition materials are from the SNAP-Ed Eat Healthy, Be Active program and were adapted to match the experimental intervention in number of sessions, length of sessions, 4-page informational guide, goal-setting activity, and incentive items.
To adapt the experimental and control programs for virtual delivery, a Microsoft PowerPoint presentation and script was created for each of the educational sessions. The scripts include suggested questions and opportunities for Nutrition Educators to use to actively engage participants in the session, such as by speaking, typing questions and comments in the chat box, or using emojis to register reactions.
The study survey, "Home Obesogenicity Measure of EnvironmentS"-Families with School-age Kids (HOMES-FSAK), will be used to collect baseline, post, and follow-up data in the HomeStyles-2 RCT. The Social Cognitive Theory along with the key concepts addressed in the HomeStyles-2 guides provided the framework for identification of cognitions, behaviors, and aspects of the home environment to be assessed. The survey will collect sociodemographic characteristics of the participant and child; child and participant health status; parent weight-related cognitions; weight-related behaviors of the parent and child; and weight-related characteristics of the home environment.
- Conditions
- Healthy Lifestyle, Home Environment Related Disease, Child Behavior, Cognitive Change, Child Obesity, Parenting
- Being tested
- Healthy HomeStyles, Eat Healthy Be Active
- Medical subject headings
- Child Behavior, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy HomeStylesBehavioural
Comparison of 2 educational interventions
Eat Healthy Be ActiveBehavioural
Comparison of 2 educational interventions
| Study group | Role | What they receive |
|---|---|---|
| Healthy HomeStyles | Experimental | Six-week virtual, group nutrition education series using the HomeStyles-2 experimental curriculum administered through SNAP-Ed. This curriculum addresses factors affecting school-aged children's health and nutritional status: inadequate intake of fruits and vegetables, infrequent family meals, excessive consumption of sugar-sweetened beverages, large portion sizes, and irregular breakfast consumption. Receives: Behavioral: Healthy HomeStyles |
| Eat Healthy Be Active | Active comparator | Six-week virtual, group nutrition education series using the Eat Healthy Be Active attention control curriculum administered through SNAP-Ed. This curriculum addresses factors affecting overall health and nutritional status: limiting nutrients of concern (saturated fat, sodium, and added sugars), eating healthy while dining out, eating healthy on a budget, losing weight and keeping it off, understanding nutrition facts labels, and being physically active. Receives: Behavioral: Eat Healthy Be Active |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant weight-related behaviors
Participant dietary intake and physical activity behaviors
Measured: Baseline up to follow-up (~4 weeks after post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start19 Nov 2021
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy LifestyleStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Model description
- experimental group and attention control group
- Masking
- None (open label)
- Enrolment
- 247 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Agriculture (USDA)
- Responsible party
- Sponsor
- Investigators
- Karla Shelnutt, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05019339
- Sponsor's protocol ID
- IRB201700192
- Status last verified
- May 2023
- First submitted
- 11 Aug 2021
- Last updated
- 1 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carman K, O'Neal LJ, Byrd-Bredbenner C, Olfert MD, Shelnutt KP. HomeStyles-2 for SNAP-Ed families with children in middle childhood: Cluster randomized trial protocol. Contemp Clin Trials. 2022 Jun;117:106771. doi: 10.1016/j.cct.2022.106771. Epub 2022 Apr 27.
PubMed 35489646
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HomeStyles-2: Shaping HOME Environments and LifeSTYLES to Prevent Childhood Obesity in SNAP-Education
- ClinicalTrials.gov ID
- NCT05019339
- Acronym / sponsor ID
- IRB201700192
- Conditions
- Healthy Lifestyle, Home Environment Related Disease, Child Behavior, Cognitive Change, Child Obesity, Parenting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 247 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- United States Department of Agriculture (USDA)
- Study start
- 19 Nov 2021 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 24 Aug 2021 (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 prevention efforts are needed in the United States, especially for families with low income. Educating parents and caregivers on simple lifestyle and affordable home environment changes is an effective strategy to improve health outcomes for the entire family. Therefore, the purpose of this study is to determine whether HomeStyles-2, a nutrition education and childhood obesity prevention program for families with children in middle childhood (ages 6 to 11 years), motivates parents to shape their home environments and weight-related lifestyle practices to be more supportive of optimal health and weight status of their children aged 6-11 years more so than those in the control condition. The study will include the experimental group and an attention control group who will engage in a nutrition education program, Eat Healthy Be Active, that is equal in nonspecific treatment effects but does not overlap on topics covered in HomeStyles-2. This study will be implemented in Florida's Supplemental Nutrition Assistance Program-Education (SNAP-Ed) program, which provides nutrition education and obesity prevention supports for individuals with low income who are receiving or eligible for SNAP benefits. Nutrition Educators will be randomized to the experimental or attention control condition, and will lead participants through virtual, group-based nutrition education series. The following data will be collected: sociodemographic characteristics of the participant and child; child and parent health status; parent weight-related cognitions; weight-related behaviors of the participant and child; and weight-related characteristics of the home environment. Enrollment for this study will begin late-2021.
Detailed description
The aim of the HomeStyles-2 for SNAP-Ed families RCT is to determine whether HomeStyles-2 enables and motivates SNAP-Ed parents and child caregivers (e.g., guardians) to shape their home environments and weight-related lifestyle practices to be more supportive of optimal health and weight status of their children aged 6-11 years than those in the control condition. The study will be a two-arm, cluster randomized trial and will follow the CONSORT guidelines extension for cluster trials. Individual counties or groups of small counties operate as a single division with one individual who supervises the SNAP-Ed Nutrition Educators assigned to that division. Every participating division will function as a cluster in the study. Half of the Nutrition Educators in each cluster that choose to participate in the study will be randomized and trained to only deliver the experimental treatment and the other half the control intervention. Eligible participants will be recruited by Nutrition Educators through existing SNAP-Ed community partnerships.
Once identified, eligible individuals will be screened for eligibility, consented, and complete the baseline survey with a trained research assistant over the phone. Participants who complete the baseline survey and meet survey plausibility checks will be enrolled in the study. Their assignment to experimental or attention control condition is dependent upon the Nutrition Educator's random assignment to teach experimental or attention control curriculum. Recruitment materials and the bona fide treatment to be delivered to the attention control group are designed to blind participant assignment to study condition.
Participants will complete a six-week virtual nutrition education program, with each weekly session lasting approximately 30 minutes. Nutrition Educators will conduct the sessions over video conferencing software (e.g., Zoom). Participants will receive intervention materials by mail before the first class of the series and will have electronic access to the materials through a free learning management system. After the six-week virtual nutrition education program, participants will be invited to take the post survey over the telephone with a trained research assistant. Approximately 4 to 10 weeks after participants complete the post survey, they will be invited to take the follow-up survey to assess longer-term intervention effects.
Participant progress through the RCT will be monitored by tracking attendance at each educational session. Trained research assistants and SNAP-Ed staff will be available to answer questions throughout the study. Participants will receive modest stipends that increase in value after they complete each survey.
The HomeStyles-2 experimental group intervention materials (i.e., "Healthy" HomeStyles-2) were designed to be congruent with White House and IOM recommendations for home-centered obesity prevention interventions and critical elements for effective interventions (e.g., interventions are positive, culturally sensitive, supportive of parent-child interaction and child development; develop realistic, effective plans that empower families). HomeStyles-2 for middle childhood intervention materials provide intensive, interactive, fun, non-judgmental opportunities for parents to shape their home environments and lifestyle practices to protect child health. They also promote positive strategies and changes that adults can control in their environments to reduce risk of excessive weight gain in their middle childhood youth. Key factors contributing to childhood obesity that can be suitably addressed in the home environment with middle childhood kids identified for inclusion in the intervention materials were selected using systematic literature reviews and input from experts in childhood obesity prevention. The topics that emerged and will be covered in the SNAP-Ed arm of the study include inadequate intake of fruits and vegetables, infrequent family meals, excessive consumption of sugar-sweetened beverages, large portion sizes, and irregular breakfast consumption. An additional factor was children's limited food preparation skills.
The attention control group will receive a different but bona fide, credible treatment at the same time as the experimental group. The control condition will provide information distinct from the "active" ingredient in the experimental intervention, while still aligning with the description of the study recruitment materials (i.e., to build happier, healthier families) and adhering to the regulations governing educational content of SNAP-Ed programming. The control condition materials are from the SNAP-Ed Eat Healthy, Be Active program and were adapted to match the experimental intervention in number of sessions, length of sessions, 4-page informational guide, goal-setting activity, and incentive items.
To adapt the experimental and control programs for virtual delivery, a Microsoft PowerPoint presentation and script was created for each of the educational sessions. The scripts include suggested questions and opportunities for Nutrition Educators to use to actively engage participants in the session, such as by speaking, typing questions and comments in the chat box, or using emojis to register reactions.
The study survey, "Home Obesogenicity Measure of EnvironmentS"-Families with School-age Kids (HOMES-FSAK), will be used to collect baseline, post, and follow-up data in the HomeStyles-2 RCT. The Social Cognitive Theory along with the key concepts addressed in the HomeStyles-2 guides provided the framework for identification of cognitions, behaviors, and aspects of the home environment to be assessed. The survey will collect sociodemographic characteristics of the participant and child; child and participant health status; parent weight-related cognitions; weight-related behaviors of the parent and child; and weight-related characteristics of the home environment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- experimental group and attention control group
| Arm | Type | Receives |
|---|---|---|
| Healthy HomeStyles | Experimental | Behavioral: Healthy HomeStylesSix-week virtual, group nutrition education series using the HomeStyles-2 experimental curriculum administered through SNAP-Ed. This curriculum addresses factors affecting school-aged children's health and nutritional status: inadequate intake of fruits and vegetables, infrequent family meals, excessive consumption of sugar-sweetened beverages, large portion sizes, and irregular breakfast consumption. |
| Eat Healthy Be Active | Active comparator | Behavioral: Eat Healthy Be ActiveSix-week virtual, group nutrition education series using the Eat Healthy Be Active attention control curriculum administered through SNAP-Ed. This curriculum addresses factors affecting overall health and nutritional status: limiting nutrients of concern (saturated fat, sodium, and added sugars), eating healthy while dining out, eating healthy on a budget, losing weight and keeping it off, understanding nutrition facts labels, and being physically active. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- SNAP-Ed-eligible (i.e., eligible for or receiving SNAP benefits, household income at or below 200% Federal Poverty Guidelines, or living in communities with significant (50% or greater) low-income population)
- Parent or caregiver of a least 1 child aged 6 to 11 years
- Have regular Internet and/or telephone access
- Can read and comprehend English or Spanish
- Reside in study catchment area (i.e., Florida)
Key exclusion criteria (1 listed)
- Does not fit inclusion criteria
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 HomeStylesComparison of 2 educational interventions | Behavioural | Healthy HomeStyles |
| Eat Healthy Be ActiveComparison of 2 educational interventions | Behavioural | Eat Healthy Be Active |
Primary outcome
Participant weight-related behaviors
Time frame: Baseline up to follow-up (~4 weeks after post-intervention)
Participant dietary intake and physical activity behaviors
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 1 Jun 2023.
- Derived from this study: PubMed 35489646Carman K, O'Neal LJ, Byrd-Bredbenner C, Olfert MD, Shelnutt KP. HomeStyles-2 for SNAP-Ed families with children in middle childhood: Cluster randomized trial protocol. Contemp Clin Trials. 2022 Jun;117:106771. doi: 10.1016/j.cct.2022.106771. Epub 2022 Apr 27.
- 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.
Karla Shelnutt, PhD principal investigator
University of Florida
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 HomeStyles and Eat Healthy Be Active in people with Healthy Lifestyle and Home Environment Related Disease, run by University of Florida 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 6 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: finished, as of the sponsor's last update on 1 Jun 2023. 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?
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?
Participant weight-related behaviors (time frame: Baseline up to follow-up (~4 weeks after post-intervention)). 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 NCT05019339, which also lists 1 linked publication.
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 1 Jun 2023.