ObesityPECO1-LTFNCT05424471
Preventing Early Childhood Obesity, Part 1: Long-term Follow-up
A study testing Family Spirit Nurture (FSN) in people with Obesity and Water; Lack of, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
Trial summary
This study extends follow up on of Native American (NA) mothers and their children (now age 3-5 years) enrolled in the 1:1 randomized controlled trial of the Family Spirit Nurture (FSN) intervention designed to prevent early childhood obesity (PECO 1). Read more about this study
- Who is it for?
- Ages 13 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Water; Lack of, Childhood Obesity
- What is being tested?
- Family Spirit Nurture (FSN)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2021to 15 Aug 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 13 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Mother/child dyads who enrolled, participated in/completed the initial PECO 1 study (followed mother/infant dyads through 12 months of age).
- Willingness to fully participate.
Who cannot join
- Inability to participate in full intervention or evaluation (e.g., planned move, etc.)
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Center for American Indian Health
Shiprock, New Mexico, 87420
About this study
Official title: Preventing Early Childhood Obesity, Part 1: Family Spirit Nurture, 3-9 Months, Long-term Follow-up
This study extends follow up on of Native American (NA) mothers and their children (now age 3-5 years) enrolled in the 1:1 randomized controlled trial of the Family Spirit Nurture (FSN) intervention designed to prevent early childhood obesity (PECO 1). The investigators will examine whether positive FSN impacts on sugar sweetened beverage (SSB) consumption and healthy growth in the first year of life were sustained. The investigators will also examine the effects of the emergency COVID-19 water solutions on water insecurity, early childhood SSB consumption, and growth, and explore how COVID-19 affected child feeding patterns and weight status either through changes in maternal mental health or household food access.
Read the detailed description
Primary Aims
Aim 1. Determine the longer-term effectiveness of the brief FSN intervention on reducing SSB consumption, increasing water intake, and promoting healthy growth status up to 5 years of age.
Aim 2. Examine the impact of point-of-use (POU) water filters, employed as COVID-19 emergency water response efforts, on water insecurity, children's water intake and SSB consumption with or without previous FSN intervention. Positive findings would provide leverage to promote water solutions and water equity.
Secondary Aims
Secondary Aim 1. Determine whether providing a booster lesson at 4 years of age targeting age appropriate parental feeding practices, snack routines, avoidance of SSBs and increased water intake impacts SSB consumption and water intake between 4 and 4.5 years of age and child growth between 4 and 5 years of age.
Secondary Aim 2. Describe how COVID-19 affected child feeding patterns and weight status either through maternal depression and anxiety or changes in food access.
This follow-up study will builds upon a 1:1 randomized controlled trial of the Family Spirit Nurture (FSN) intervention designed to prevent early childhood obesity (PECO 1).
Methods:
A long-term follow-up evaluation will be conducted with n=110 of the randomized mother-child dyads (90% of the participants that completed the PECO 1 study) when the children are between 4 - 5 years of age.
Eligible participants will complete a 4 year follow-up assessment after reconsent when the children are 4 years of age. All participants will maintain their randomization status and receive one age appropriate lesson specific to their study group. The intervention group (n=55) will receive one FSN lesson focused on age-appropriate parental feeding practices, including snack routines, avoidance of SSBs, and increased water intake. The control group (n=55) will receive one injury prevention lesson focused on vehicle safety. An endline follow-up assessment will be completed by all reconsented participants after three months of the 4 year follow-up assessment. Maternal and child medical chart review will be conducted by trained study staff after the child turns 5 years old. Medical chart reviews will collect data on maternal BMI (as a possible moderator of child growth) and child growth.
During the COVID-19 pandemic as part of the emergency response on the Navajo Nation, a subset of study participants who previously reported water insecurity (n=50) received point-of-use (POU) water filters. Water filters were evenly distributed between the intervention (n=25) and control groups (n=25).
Study implementation will include three phases:
Phase 1 (Reconsent, Reenroll, and 4 year Follow-up Assessment):
Study staff will re-approach randomized mother/child dyads when the child is 4 years of age to complete the informed consent process for the follow-up component. Participants will maintain their original randomization status and complete a 4 year follow-up assessment that consists of a mixed-methods approach.
Phase 2 (Booster Lesson):
Local FHCs, trained and employed by Johns Hopkins, will deliver either the intervention (1- FSN lesson) or the control condition (1- Vehicle-Safety Lesson) shortly after the 4 year follow-up assessment when the child is 4 years of age. With participant permission, lesson visits will be audio recorded for quality assurance, using digital audio recorders. A random 10% of audio recordings will be reviewed and rated to ensure fidelity to the curriculum and to facilitate staff training and supervision.
Phase 3 (Endline Follow-up Assessment and Medical Chart Reviews):
Three months after the 4 year follow-up assessment, participants will complete an endline follow-up assessment. The endline follow-up assessment will be the same assessment battery as the 4 year follow-up assessment. Maternal and child medical chart reviews will be conducted by trained study staff after the child is 5 years of age. Weight and height data will be collected from child's medical charts (birth through 5 years of age). Data may be collected any time during the 5th year of life as timing of the five year check up can vary. Maternal BMI will be collected from maternal medical chart reviews as a possible moderator of child growth.
- Conditions
- Obesity, Water; Lack of, Childhood Obesity, Feeding Behavior, Mother-Child Relations, Dietary Habits
- Being tested
- Family Spirit Nurture (FSN), Control Group - Vehicle Safety
- Keywords
- Sugar Sweetened Beverages
- Medical subject headings
- Obesity, Pediatric Obesity, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Spirit Nurture (FSN)Behavioural
The FSN intervention lesson is taught to participants previously randomized into the FSN intervention group during the PECO 1 study. Intervention group participants receive 1 Family Spirit Nurture lesson taught by Family Health Coaches. Mothers will receive the 1 - 45 minute lesson within 1-2 weeks of completing the 4-year Follow-up Assessment. The lesson focuses on age-appropriate parental feeding practices, including snack routines, avoidance of SSBs and promotion of water consumption. The lesson is highly visual and interactive, and incorporates cultural teachings related to child feeding and nutrition that support aims. The Family Health Coaches also provide social support and will facilitate referrals to community resources.
Control Group - Vehicle SafetyOther
Also called Vehicle Safety
The control (vehicle safety) lesson is taught to participants previously randomized into the control group during the PECO 1 study. Control group participants receive 1 - 30 minute lesson with vehicle safety information, taught by Family Health Coaches. Mothers will receive the lesson within 1-2 weeks of completing the 4-year Follow-up Assessment. The Family Health Coaches also provide social support and will facilitate referrals to community resources.
| Study group | Role | What they receive |
|---|---|---|
| Family Spirit Nurture (FSN) | Experimental | Intervention group participants receive 1 Family Spirit Nurture lesson taught by Family Health Coaches. Mothers will receive the lesson within 1-2 weeks of completing the 4-year Follow-up Assessment. The lesson focuses on age-appropriate parental feeding practices, including snack routines, avoidance of SSBs and promotion of water consumption. The lesson is highly visual and interactive, and incorporates cultural teachings related to child feeding and nutrition that support aims. The Family Health Coaches also provide social support and will facilitate referrals to community resources. Receives: Behavioral: Family Spirit Nurture (FSN) |
| Control Vehicle Safety | Other | Control group participants receive 1 lesson with vehicle safety information, taught by Family Health Coaches. Mothers will receive the lesson within 1-2 weeks of completing the 4-year Follow-up Assessment. The Family Health Coaches also provide social support and will facilitate referrals to community resources. Receives: Other: Control Group - Vehicle Safety |
What is being measured
The primary outcome is the main question the study is designed to answer.
Group differences in children's mean BMI z-scores over time as assessed through child weight and length/height measurements through 5 years of age.
Child weight (to the nearest ounce) and recumbent length/height (to the nearest 1/8 inch) will be extracted through medical chart review. Measurements will be taken by healthcare providers. Measurements will be used to calculate BMI z-scores using age- and sex-specific World Health Organization (WHO) Child Growth Standards.
Measured: Birth to 5 years of age
Group differences in sugar sweetened beverage (SSB) consumption & water intake.
Mothers were asked about SSB initiation and frequency among infants between 3 months and 12 months of age in the Preventing Early Childhood Obesity, Part 1: Family Spirit Nurture, 3-9 Months study using an an adapted version of the Pre-School-Aged Beverage Intake Questionnaire (BEVQ-15). We will continue to use the age appropriate Pre-School-Aged BEVQ-15 to assess child's SSB consumption and water intake between 4 and 5 years of age. This data will be examined for between group differences in SSB consumption and water intake through 5 years of age.
Measured: 3 months to 5 years of age
Examine whether point-of-use (POU) water filters impact water security, and/or moderate intervention impact on water intake and SSB consumption.
Examine the impact of point-of-use (POU) water filters, employed as COVID-19 emergency water response efforts, on water insecurity. Examine study group differences in water intake and SSB consumption with and without POU water filters.
Measured: 3 to 5 years of age
Secondary outcomes (2)
Between study group differences, post booster lesson, in age appropriate parental feeding practices, snack routines, avoidance of SSBs and increased water intake.
Age appropriate parental feeding practices, snack routines, avoidance of SSBs and increased water intake impacts SSB consumption and water intake between 4 and 4.5 years of age will be measured by the Toddler BEV-Q and Child Feeding Styles Questionnaire. Child growth between 4 and 5 years of age will be assessed by weight and length/height measurements from medical chart reviews.
Measured: Up to 5 years of age
Within study group comparison of pre-/during- COVID-19 child feeding practices, snack routines, SSB consumption and water intake and examination of associations with maternal depression and anxiety, and changes in food access.
COVID-19 Impact Questionnaire will be used to assess how the COVID-19 pandemic has affected participants' lives, access to basic needs and healthcare, child feeding practices and childcare support. The Toddler BEV-Q and Child Feeding Styles Questionnaire will be used to assess child feeding practices, snack routines, SSB consumption and water intake. Maternal depression will be assessed by the CES-D and anxiety will be assessed by PROMIS Anxiety 8-item scale.
Measured: 5 years postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start1 May 2021
- Primary completion31 Mar 2023
- Study completion15 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe 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
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Allison Barlow, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05424471
- Sponsor's protocol ID
- 7476 /MOD994
- Acronym
- PECO1-LTF
- Status last verified
- Aug 2023
- First submitted
- 26 Apr 2022
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Early Childhood Obesity, Part 1: Family Spirit Nurture, 3-9 Months, Long-term Follow-up
- ClinicalTrials.gov ID
- NCT05424471
- Acronym / sponsor ID
- PECO1-LTF / 7476 /MOD994
- Conditions
- Obesity, Water; Lack of, Childhood Obesity, Feeding Behavior, Mother-Child Relations, Dietary Habits
- Keywords
- Sugar Sweetened Beverages
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 21 Jun 2022 (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 study extends follow up on of Native American (NA) mothers and their children (now age 3-5 years) enrolled in the 1:1 randomized controlled trial of the Family Spirit Nurture (FSN) intervention designed to prevent early childhood obesity (PECO 1). The investigators will examine whether positive FSN impacts on sugar sweetened beverage (SSB) consumption and healthy growth in the first year of life were sustained. The investigators will also examine the effects of the emergency COVID-19 water solutions on water insecurity, early childhood SSB consumption, and growth, and explore how COVID-19 affected child feeding patterns and weight status either through changes in maternal mental health or household food access.
Detailed description
Primary Aims
Aim 1. Determine the longer-term effectiveness of the brief FSN intervention on reducing SSB consumption, increasing water intake, and promoting healthy growth status up to 5 years of age.
Aim 2. Examine the impact of point-of-use (POU) water filters, employed as COVID-19 emergency water response efforts, on water insecurity, children's water intake and SSB consumption with or without previous FSN intervention. Positive findings would provide leverage to promote water solutions and water equity.
Secondary Aims
Secondary Aim 1. Determine whether providing a booster lesson at 4 years of age targeting age appropriate parental feeding practices, snack routines, avoidance of SSBs and increased water intake impacts SSB consumption and water intake between 4 and 4.5 years of age and child growth between 4 and 5 years of age.
Secondary Aim 2. Describe how COVID-19 affected child feeding patterns and weight status either through maternal depression and anxiety or changes in food access.
This follow-up study will builds upon a 1:1 randomized controlled trial of the Family Spirit Nurture (FSN) intervention designed to prevent early childhood obesity (PECO 1).
Methods:
A long-term follow-up evaluation will be conducted with n=110 of the randomized mother-child dyads (90% of the participants that completed the PECO 1 study) when the children are between 4 - 5 years of age.
Eligible participants will complete a 4 year follow-up assessment after reconsent when the children are 4 years of age. All participants will maintain their randomization status and receive one age appropriate lesson specific to their study group. The intervention group (n=55) will receive one FSN lesson focused on age-appropriate parental feeding practices, including snack routines, avoidance of SSBs, and increased water intake. The control group (n=55) will receive one injury prevention lesson focused on vehicle safety. An endline follow-up assessment will be completed by all reconsented participants after three months of the 4 year follow-up assessment. Maternal and child medical chart review will be conducted by trained study staff after the child turns 5 years old. Medical chart reviews will collect data on maternal BMI (as a possible moderator of child growth) and child growth.
During the COVID-19 pandemic as part of the emergency response on the Navajo Nation, a subset of study participants who previously reported water insecurity (n=50) received point-of-use (POU) water filters. Water filters were evenly distributed between the intervention (n=25) and control groups (n=25).
Study implementation will include three phases:
Phase 1 (Reconsent, Reenroll, and 4 year Follow-up Assessment):
Study staff will re-approach randomized mother/child dyads when the child is 4 years of age to complete the informed consent process for the follow-up component. Participants will maintain their original randomization status and complete a 4 year follow-up assessment that consists of a mixed-methods approach.
Phase 2 (Booster Lesson):
Local FHCs, trained and employed by Johns Hopkins, will deliver either the intervention (1- FSN lesson) or the control condition (1- Vehicle-Safety Lesson) shortly after the 4 year follow-up assessment when the child is 4 years of age. With participant permission, lesson visits will be audio recorded for quality assurance, using digital audio recorders. A random 10% of audio recordings will be reviewed and rated to ensure fidelity to the curriculum and to facilitate staff training and supervision.
Phase 3 (Endline Follow-up Assessment and Medical Chart Reviews):
Three months after the 4 year follow-up assessment, participants will complete an endline follow-up assessment. The endline follow-up assessment will be the same assessment battery as the 4 year follow-up assessment. Maternal and child medical chart reviews will be conducted by trained study staff after the child is 5 years of age. Weight and height data will be collected from child's medical charts (birth through 5 years of age). Data may be collected any time during the 5th year of life as timing of the five year check up can vary. Maternal BMI will be collected from maternal medical chart reviews as a possible moderator of child growth.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family Spirit Nurture (FSN) | Experimental | Behavioral: Family Spirit Nurture (FSN)Intervention group participants receive 1 Family Spirit Nurture lesson taught by Family Health Coaches. Mothers will receive the lesson within 1-2 weeks of completing the 4-year Follow-up Assessment. The lesson focuses on age-appropriate parental feeding practices, including snack routines, avoidance of SSBs and promotion of water consumption. The lesson is highly visual and interactive, and incorporates cultural teachings related to child feeding and nutrition that support aims. The Family Health Coaches also provide social support and will facilitate referrals to community resources. |
| Control Vehicle Safety | Other | Other: Control Group - Vehicle SafetyControl group participants receive 1 lesson with vehicle safety information, taught by Family Health Coaches. Mothers will receive the lesson within 1-2 weeks of completing the 4-year Follow-up Assessment. The Family Health Coaches also provide social support and will facilitate referrals to community resources. |
Who may qualify
- Ages
- 13 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Mother/child dyads who enrolled, participated in/completed the initial PECO 1 study (followed mother/infant dyads through 12 months of age).
- Willingness to fully participate.
Key exclusion criteria (1 listed)
- Inability to participate in full intervention or evaluation (e.g., planned move, etc.)
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 |
|---|---|---|
| Family Spirit Nurture (FSN)The FSN intervention lesson is taught to participants previously randomized into the FSN intervention group during the PECO 1 study. Intervention group participants receive 1 Family Spirit Nurture lesson taught by Family Health Coaches. Mothers will receive the 1 - 45 minute lesson within 1-2 weeks of completing the 4-year Follow-up Assessment. The lesson focuses on age-appropriate parental feeding practices, including snack routines, avoidance of SSBs and promotion of water consumption. The lesson is highly visual and interactive, and incorporates cultural teachings related to child feeding and nutrition that support aims. The Family Health Coaches also provide social support and will facilitate referrals to community resources. | Behavioural | Family Spirit Nurture (FSN) |
| Control Group - Vehicle SafetyAlso: Vehicle SafetyThe control (vehicle safety) lesson is taught to participants previously randomized into the control group during the PECO 1 study. Control group participants receive 1 - 30 minute lesson with vehicle safety information, taught by Family Health Coaches. Mothers will receive the lesson within 1-2 weeks of completing the 4-year Follow-up Assessment. The Family Health Coaches also provide social support and will facilitate referrals to community resources. | Other | Control Vehicle Safety |
Primary outcome
Group differences in children's mean BMI z-scores over time as assessed through child weight and length/height measurements through 5 years of age.
Time frame: Birth to 5 years of age
Child weight (to the nearest ounce) and recumbent length/height (to the nearest 1/8 inch) will be extracted through medical chart review. Measurements will be taken by healthcare providers. Measurements will be used to calculate BMI z-scores using age- and sex-specific World Health Organization (WHO) Child Growth Standards.
Group differences in sugar sweetened beverage (SSB) consumption & water intake.
Time frame: 3 months to 5 years of age
Mothers were asked about SSB initiation and frequency among infants between 3 months and 12 months of age in the Preventing Early Childhood Obesity, Part 1: Family Spirit Nurture, 3-9 Months study using an an adapted version of the Pre-School-Aged Beverage Intake Questionnaire (BEVQ-15). We will continue to use the age appropriate Pre-School-Aged BEVQ-15 to assess child's SSB consumption and water intake between 4 and 5 years of age. This data will be examined for between group differences in SSB consumption and water intake through 5 years of age.
Examine whether point-of-use (POU) water filters impact water security, and/or moderate intervention impact on water intake and SSB consumption.
Time frame: 3 to 5 years of age
Examine the impact of point-of-use (POU) water filters, employed as COVID-19 emergency water response efforts, on water insecurity. Examine study group differences in water intake and SSB consumption with and without POU water filters.
2 secondary outcomes
Between study group differences, post booster lesson, in age appropriate parental feeding practices, snack routines, avoidance of SSBs and increased water intake.
Time frame: Up to 5 years of age
Within study group comparison of pre-/during- COVID-19 child feeding practices, snack routines, SSB consumption and water intake and examination of associations with maternal depression and anxiety, and changes in food access.
Time frame: 5 years postpartum
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 21 Aug 2023.
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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.
Allison Barlow principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Spirit Nurture (FSN) in people with Obesity and Water; Lack of, run by Johns Hopkins Bloomberg School of Public Health 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 2 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 21 Aug 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?
Group differences in children's mean BMI z-scores over time as assessed through child weight and length/height measurements through 5 years of age. (time frame: Birth to 5 years of age). 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 21 Aug 2023.