Diet HabitNCT05885581
"Grow Well: Addressing Childhood Obesity in Low-income Families"
A study testing Arm A Grow Well and Arm B Healthy Steps in people with Diet Habit, run by University of California, Riverside at 1 site in United States.
Trial summary
This research uses community based participatory research (CBPR) to engage low-income Latinx families in research to pilot test an adapted nutrition education program compared to an existing nutrition education program. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diet Habit
- What is being tested?
- Arm A Grow Well and Arm B Healthy Steps
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2023to 28 Feb 2024
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Identify as Latina Mothers with infant who identified as caregivers.
- 18 years or older.
- Speak English, Spanish or Purépecha.
- Mother (biological, adoptive, foster) of an infant ages 4 months or younger, who had a normal birth weight (greater than or equal to 5. lbs., 8 oz.)
- Live in Inland Southern California.
- Income eligible (mothers or their children) for government programs such as WIC, Early Head Start, MediCal, CalFresh and similar programs.
- Willing to have a community health worker enter your home to provide 30-45 minute in person sessions once per month over 6 months.
- Have another caregiver 18 years or older who participates in at least 3 hours of care per week and agrees to participate in the home sessions.
Who cannot join
- Individual not willing to sign informed consent.
- Unable to speak English, Spanish or Perepecha.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Grow Well/Crecer Bien: Addressing Childhood Obesity in Low-income Families
This research uses community based participatory research (CBPR) to engage low-income Latinx families in research to pilot test an adapted nutrition education program compared to an existing nutrition education program. The goal of the research is to provide nutrition education on healthy infant feeding to reduce risk for early childhood obesity. The prevalence of obesity in early life remains unacceptably high, especially among low-income children, most are ethnic minorities. Marked ethnic disparities are evident by two years of age, which suggests that existing interventions are not adequate. This project, which focuses on an-at-risk child population, has great potential to address our nation's growing crisis of childhood obesity, which can dramatically improve the health of millions of low-income children, their families, and their future children.
Read the detailed description
This research will implement and evaluate an existing healthy infant feeding intervention, Healthy Beginnings, which was developed for English-speaking low-income mothers in Australia and delivered by public health nurses via in-home visits. The investigator will test the efficacy of an adapted version of this intervention in comparison to the original intervention.
Aim 1. Pilot test an adapted nutrition education program of, compared to the original program curriculum.
● Using a pilot randomized control trial with 30 mother-infant-caregiver triad (15 intervention, 15 control) determine the feasibility, acceptability, and preliminary efficacy of the adapted intervention compared to the original intervention.
The investigator hypothesize that the adapted intervention will be feasible, acceptable to study participants, and efficacious in addressing feeding styles and practices and caregivers' role in infant feeding. The investigator anticipate that the intervention will be feasible to deliver and acceptable to mothers' participants and caregivers' participants, and that the mother's participants-infant-caregiver triads randomized to intervention with the adapted Healthy Beginnings curriculum compared to the treatment as usual control group will demonstrate greater improvements in outcomes (i.e., infant feeding knowledge and use of recommended feeding practices) after 6 months compared to the control group.
- Conditions
- Diet Habit
- Being tested
- Arm A Grow Well, Arm B Healthy Steps
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm A Grow WellOther
Also called Intervention
- the preliminary efficacy of the adapted intervention on mothers' and caregivers' infant feeding knowledge, use of recommended feeding practices, and infant anthropometric measurement outcomes.
- the feasibility of implementing the intervention and its acceptability among mothers and caregivers.
- the feasibility of collecting infant anthropometric data.
Arm B Healthy StepsOther
Also called Control Group
Group B: Healthy Steps and will receive the Healthy Steps curriculum or treatment as usual as this is the curriculum commonly shared during well baby visits (n= 15 mother-infant-caregiver triad).
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Grow Well and will receive the adapted Healthy Beginnings Curriculum (n= 15 mother-infant-caregiver triad) determine the feasibility, acceptability, and preliminary efficacy of the adapted intervention. The intervention will be on mothers' and caregivers' infant feeding knowledge, use of recommended feeding practices, and infant anthropometric measurement outcomes. Receives: Other: Arm A Grow Well |
| Group B: | Active comparator | Group B will receive the Healthy Steps curriculum or treatment as usual as this is the curriculum commonly shared during well baby visits (n= 15 mother-infant-caregiver triad). Receives: Other: Arm B Healthy Steps |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of the adapted intervention on mothers' and caregivers' infant.
It will include an intervention and control group and will be carried out over 6 months or 24 weeks and will involve 30 mother-infant-caregiver triads. Pretest and posttest surveys will be collected at baseline (week 1), and at six months follow up (week 24).
Measured: 0 months (infant birth) to one year
Data Collection-Infant Feeding Practices
The survey will collect data on infant feeding practices using the validated Infant Feeding Scale Questionnaire (Thompson et al., 2009). It questionnaire is designed to assess maternal attitude towards infant feeding methods and to predict breastfeeding intention and exclusivity. The scale is composed of 17 items with a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree).The measurements of unit will be in fluid ounces.
Measured: 0 months (infant birth) to one year
Data collection-anthropometric data
The study team members will collect anthropometric data, weight, length, and body fat composition from infants at the beginning and end of the study period. The infant body fat composition using fat calipers; Skinfolds (mm) Triceps (mm); Subscapular (mm); Liver (mm); Flank(mm); Thigh (mm)
Measured: 0 months (infant birth) to one year
Data collection-anthropometric data
The study team members will collect anthropometric data, weight, length, and body fat composition from infants at the beginning and end of the study period. The infant weight using Body measurements: Child Weight (kg)
Measured: 0 months (infant birth) to one year
Data collection-anthropometric data
The study team members will collect anthropometric data, weight, length, and body fat composition from infants at the beginning and end of the study period. The infant length using an infant measuring device that infants lay on, and body fat composition using fat calipers. Length (cm).
Measured: 0 months (infant birth) to one year
Data collection-sociodemographic questions
The study team members will collect data Socio-demographic variables include, for example, age, sex, education, migration background and ethnicity, religious affiliation, marital status, household, employment, and income.
Measured: 0 months (infant birth) to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start5 Apr 2023
- Primary completion28 Feb 2024
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet HabitStudies 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
- Single group
- Model description
- The goal of the research is to provide nutrition education on healthy infant feeding to reduce risk for early childhood obesity. The prevalence of obesity in early life remains unacceptably high, especially among low-income children, most are ethnic minorities. Marked ethnic disparities are evident by two years of age, which suggests that existing interventions are not adequate. Early prevention is critical, especially for low-income children. This project, which focuses on an-at-risk child population, has great potential to address our nation's growing crisis of childhood obesity, which can dramatically improve the health of millions of low-income children, their families, and their future children.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Riverside
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05885581
- Sponsor's protocol ID
- UCRiverside
- Status last verified
- May 2024
- First submitted
- 13 Apr 2023
- Last updated
- 9 May 2024
- Results posted
- 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 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Grow Well/Crecer Bien: Addressing Childhood Obesity in Low-income Families
- ClinicalTrials.gov ID
- NCT05885581
- Acronym / sponsor ID
- UCRiverside
- Conditions
- Diet Habit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University of California, RiversideUniversity, hospital or other
- Study start
- 5 Apr 2023 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 2 Jun 2023 (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.
This research uses community based participatory research (CBPR) to engage low-income Latinx families in research to pilot test an adapted nutrition education program compared to an existing nutrition education program. The goal of the research is to provide nutrition education on healthy infant feeding to reduce risk for early childhood obesity. The prevalence of obesity in early life remains unacceptably high, especially among low-income children, most are ethnic minorities. Marked ethnic disparities are evident by two years of age, which suggests that existing interventions are not adequate. This project, which focuses on an-at-risk child population, has great potential to address our nation's growing crisis of childhood obesity, which can dramatically improve the health of millions of low-income children, their families, and their future children.
Detailed description
This research will implement and evaluate an existing healthy infant feeding intervention, Healthy Beginnings, which was developed for English-speaking low-income mothers in Australia and delivered by public health nurses via in-home visits. The investigator will test the efficacy of an adapted version of this intervention in comparison to the original intervention.
Aim 1. Pilot test an adapted nutrition education program of, compared to the original program curriculum.
● Using a pilot randomized control trial with 30 mother-infant-caregiver triad (15 intervention, 15 control) determine the feasibility, acceptability, and preliminary efficacy of the adapted intervention compared to the original intervention.
The investigator hypothesize that the adapted intervention will be feasible, acceptable to study participants, and efficacious in addressing feeding styles and practices and caregivers' role in infant feeding. The investigator anticipate that the intervention will be feasible to deliver and acceptable to mothers' participants and caregivers' participants, and that the mother's participants-infant-caregiver triads randomized to intervention with the adapted Healthy Beginnings curriculum compared to the treatment as usual control group will demonstrate greater improvements in outcomes (i.e., infant feeding knowledge and use of recommended feeding practices) after 6 months compared to the control group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- The goal of the research is to provide nutrition education on healthy infant feeding to reduce risk for early childhood obesity. The prevalence of obesity in early life remains unacceptably high, especially among low-income children, most are ethnic minorities. Marked ethnic disparities are evident by two years of age, which suggests that existing interventions are not adequate. Early prevention is critical, especially for low-income children. This project, which focuses on an-at-risk child population, has great potential to address our nation's growing crisis of childhood obesity, which can dramatically improve the health of millions of low-income children, their families, and their future children.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Arm A Grow WellGrow Well and will receive the adapted Healthy Beginnings Curriculum (n= 15 mother-infant-caregiver triad) determine the feasibility, acceptability, and preliminary efficacy of the adapted intervention. The intervention will be on mothers' and caregivers' infant feeding knowledge, use of recommended feeding practices, and infant anthropometric measurement outcomes. |
| Group B: | Active comparator | Other: Arm B Healthy StepsGroup B will receive the Healthy Steps curriculum or treatment as usual as this is the curriculum commonly shared during well baby visits (n= 15 mother-infant-caregiver triad). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Identify as Latina Mothers with infant who identified as caregivers.
- 18 years or older.
- Speak English, Spanish or Purépecha.
- Mother (biological, adoptive, foster) of an infant ages 4 months or younger, who had a normal birth weight (greater than or equal to 5. lbs., 8 oz.)
- Live in Inland Southern California.
Key exclusion criteria (2 listed)
- Individual not willing to sign informed consent.
- Unable to speak English, Spanish or Perepecha.
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 |
|---|---|---|
| Arm A Grow WellAlso: Intervention1. the preliminary efficacy of the adapted intervention on mothers' and caregivers' infant feeding knowledge, use of recommended feeding practices, and infant anthropometric measurement outcomes. 2. the feasibility of implementing the intervention and its acceptability among mothers and caregivers. 3. the feasibility of collecting infant anthropometric data. | Other | Group A |
| Arm B Healthy StepsAlso: Control GroupGroup B: Healthy Steps and will receive the Healthy Steps curriculum or treatment as usual as this is the curriculum commonly shared during well baby visits (n= 15 mother-infant-caregiver triad). | Other | Group B: |
Primary outcome
Efficacy of the adapted intervention on mothers' and caregivers' infant.
Time frame: 0 months (infant birth) to one year
It will include an intervention and control group and will be carried out over 6 months or 24 weeks and will involve 30 mother-infant-caregiver triads. Pretest and posttest surveys will be collected at baseline (week 1), and at six months follow up (week 24).
Data Collection-Infant Feeding Practices
Time frame: 0 months (infant birth) to one year
The survey will collect data on infant feeding practices using the validated Infant Feeding Scale Questionnaire (Thompson et al., 2009). It questionnaire is designed to assess maternal attitude towards infant feeding methods and to predict breastfeeding intention and exclusivity. The scale is composed of 17 items with a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree).The measurements of unit will be in fluid ounces.
Data collection-anthropometric data
Time frame: 0 months (infant birth) to one year
The study team members will collect anthropometric data, weight, length, and body fat composition from infants at the beginning and end of the study period. The infant body fat composition using fat calipers; Skinfolds (mm) Triceps (mm); Subscapular (mm); Liver (mm); Flank(mm); Thigh (mm)
Data collection-anthropometric data
Time frame: 0 months (infant birth) to one year
The study team members will collect anthropometric data, weight, length, and body fat composition from infants at the beginning and end of the study period. The infant weight using Body measurements: Child Weight (kg)
Data collection-anthropometric data
Time frame: 0 months (infant birth) to one year
The study team members will collect anthropometric data, weight, length, and body fat composition from infants at the beginning and end of the study period. The infant length using an infant measuring device that infants lay on, and body fat composition using fat calipers. Length (cm).
Data collection-sociodemographic questions
Time frame: 0 months (infant birth) to one year
The study team members will collect data Socio-demographic variables include, for example, age, sex, education, migration background and ethnicity, religious affiliation, marital status, household, employment, and income.
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 9 May 2024.
- 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 Arm A Grow Well and Arm B Healthy Steps in people with Diet Habit, run by University of California, Riverside 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 9 May 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?
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?
Efficacy of the adapted intervention on mothers' and caregivers' infant. (time frame: 0 months (infant birth) to one year). The study lists 6 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 9 May 2024.