Childhood Obesity PreventionNCT04179565
Healthy Children, Healthy Families: Parents Making A Difference
A study testing Healthy Children Healthy Families in people with Childhood Obesity Prevention, run by Cornell University.
Trial summary
The impacts of Healthy Children, Healthy Families: Parents Making a Difference! (HCHF) on how low-income parents enrolled in the Expanded Food and Nutrition Education Program use effective parenting practices to influence children's healthy eating and active play behavior will be investigated, as compared to a delayed… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity Prevention
- What is being tested?
- Healthy Children Healthy Families
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 391 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 31 Dec 2019
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
- Inclusion Criteria: Parents/caregivers with young children 3-5 years old
- Exclusion Criteria: Any person who does not have children who are 3-5 years old
About this study
Official title: Healthy Children, Healthy Families: Parents Making A Difference: A Randomized Controlled Trial
The impacts of Healthy Children, Healthy Families: Parents Making a Difference! (HCHF) on how low-income parents enrolled in the Expanded Food and Nutrition Education Program use effective parenting practices to influence children's healthy eating and active play behavior will be investigated, as compared to a delayed intervention control group.
Read the detailed description
The Healthy Children, Healthy Families: Parents Making a Difference! (HCHF) curriculum is a Cornell curriculum for parents and caregivers focusing on the behaviors most likely to help children avoid unhealthy weight gain. These behaviors include drinking water or milk instead of sweetened beverages, eating more vegetables and fruits, playing actively, eating fewer high-fat and high-sugar foods, limiting screen time, and having sensible serving sizes. The 8-session curriculum uses a learner-centered dialogue approach, hands-on activities and role plays. The study will include 300 participants with young children 3-5 years old in Head Start and childcare programs in New York City using a randomized control design. In period 1 (9 weeks), half the groups will receive HCHF education (immediate education, IE) and half will serve as controls, receiving no education (delayed education, DE). In period 2 (9 weeks), DE will receive education; IE will receive no education and be followed longitudinally for periods 2 and 3. In period 3 (16 weeks), neither group will receive education and both will be followed longitudinally. Data will be collected at each time point using validated measures, including the HCHF Checklist developed by the investigators and complementary measures that assess parenting feeding practices, food behavior in parents, food behavior in children, and parent self-efficacy around obesity prevention behaviors. It is hypothesized that change pre- to post- HCHF will be greater than control groups, and changes in behavior will be retained post-education.
- Conditions
- Childhood Obesity Prevention
- Being tested
- Healthy Children Healthy Families
- Keywords
- childhood obesity, parenting practices, food and physical activity
- Medical subject headings
- Pediatric Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Children Healthy FamiliesBehavioural
The Healthy Children, Healthy Families: Parents Making a Difference! intervention was developed by the investigators for low-income parents and caregivers focusing on the behaviors most likely to help children avoid unhealthy weight gain.
| Study group | Role | What they receive |
|---|---|---|
| Immediate intervention | Active comparator | The immediate education (IE) group will receive the intervention, Healthy Children, Healthy Families: Parents Making a Difference! in period 1. In period 2, IE will receive no education and will be followed longitudinally for periods 2 and 3. Receives: Behavioral: Healthy Children Healthy Families |
| Delayed intervention | Active comparator | The delayed education (DE) group will serve as controls in period 1, receiving no intervention. In period 2, the treatments will cross over, so DE will receive the Healthy Children, Healthy Families: Parents Making a Difference! intervention. Receives: Behavioral: Healthy Children Healthy Families |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healthy Children, Healthy Families Checklist
The checklist is a 16-item instrument that assesses parents'/caregivers' parenting and personal practices around food and physical activity, as well as the target child's food and physical activity practices. The checklist asks parents to report frequency (per day/week/month) of practices on 5-point Likert-type scales. The constructs measure parent diet quality and physical activity, child diet quality and physical activity, and parenting practices. Each question on the instrument is converted to a numeric value, 1 for the least desirable to 5 for most desirable response. The values for the entire instrument are summed (range 1 - 80 - only those checklists with at least one response are included) and divided by the number of items with a response (0 - 16), resulting in a mean score range of 0 - 5. The questions within each sub-scale are handled in the same way, with a sub-scale range of 0 - 5.
Measured: up to 8 months
Comprehensive Feeding Practices Questionnaire (CFPQ)
Six sub-scales (24 items) aligned with the learning objectives of the intervention, were selected from the original CFPQ. The constructs assessed by the sub-scales include encouraging balance and variety, use of food as reward, parent allowing child to control eating, parental modeling, parental pressure for child to consume more food, and home environment. Response options for 6 items include frequency on a Likert-type scale (never to always) and for 18 items include a Likert scale (strongly disagree to strongly agree). Each response is converted to a numeric value, 1 for the least desirable to 5 for the most desirable option. These values are then summed (range 0 - 120) and divided by the number of items with a response, resulting in a mean scale score range of 0 - 5. The items within each sub-scale are handled in the same way, with the sub-scale ranges of 0 - 5.
Measured: up to 8 months
Secondary outcomes (3)
Parental self-efficacy
Four items were selected assessing parental efficacy for influencing behaviors addressed in the interventions: child's physical activity; and fruit, vegetable, and sugar sweetened beverage intake. The item responses included a 5-point Likert-type scale (not sure to extremely sure). Each question is converted to a numeric value, 1 for the least to 5 for the most desirable. These values are summed (range 0 - 20) and divided by the number of items with a response (0 - 4), resulting in a mean scale score range of 0 - 5.
Measured: up to 8 months
Food frequency of sugar sweetened beverages and foods
Five items were selected from a 10-item instrument; selected items specifically focus on sugar-sweetened beverages and foods with added sugars. Parents report the number of times per day the child consumes each. Based on initial responses, a scoring system was devised that assigned 7 for a response of zero intake (most desirable) to 1 for a response of >2.5 times per day (least desirable). The response values are then summed (range 0 - 35) and divided by 5, resulting in a mean scale score range of 0 - 7.
Measured: up to 8 months
Parent food choice behaviors
Two scales are used from the Food Behavior Checklist to assess parents' self-reported food intake of fruits and vegetables (9 items) and overall diet quality (4 items). Nine items have Likert-type responses with 8 being never to always (scored 1 - 4), and one being poor to excellent (scored 1-5), with the higher score being most desirable in all cases. The responses to two items are no or yes, scored 1 or 5 respectively. Two items ask for number of servings consumed per day and are assigned the value provided. The fruit and vegetable 9-item scale response values are summed (range = 1 - (26+sum of 2 frequency responses). The diet quality 4-item scale response values are summed (range 1 - 17). The sum for each scale is divided by the number of items in the scale resulting in a mean scale score range of 0-7 for the 9-item scale and 0-4.25 for the 4-item scale.
Measured: up to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start1 Jan 2017
- Primary completion30 Aug 2018
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (87)Papers the sponsor has linked to this study.
- Other trials for Childhood Obesity PreventionStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 391 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jamie S Dollahite, Principal investigator, Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04179565
- Sponsor's protocol ID
- CornellU
- Status last verified
- Mar 2022
- First submitted
- 7 Sep 2018
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Publications
Skinner AC, Perrin EM, Skelton JA. Prevalence of obesity and severe obesity in US children, 1999-2014. Obesity (Silver Spring). 2016 May;24(5):1116-23. doi: 10.1002/oby.21497.
PubMed 27112068Hurley KM, Cross MB, Hughes SO. A systematic review of responsive feeding and child obesity in high-income countries. J Nutr. 2011 Mar;141(3):495-501. doi: 10.3945/jn.110.130047. Epub 2011 Jan 26.
PubMed 21270360Golley RK, Hendrie GA, Slater A, Corsini N. Interventions that involve parents to improve children's weight-related nutrition intake and activity patterns - what nutrition and activity targets and behaviour change techniques are associated with intervention effectiveness? Obes Rev. 2011 Feb;12(2):114-30. doi: 10.1111/j.1467-789X.2010.00745.x.
PubMed 20406416Skouteris H, McCabe M, Swinburn B, Newgreen V, Sacher P, Chadwick P. Parental influence and obesity prevention in pre-schoolers: a systematic review of interventions. Obes Rev. 2011 May;12(5):315-28. doi: 10.1111/j.1467-789X.2010.00751.x.
PubMed 20492538Arnold, C.G. and Sobal, J. 2000. Food practices and nutrition knowledge after graduation from the Expanded Food and Nutrition Education Program (EFNEP). J Nutr Educ Behav. 32:130-138.
Auld G, Baker S, Conway L, Dollahite J, Lambea MC, McGirr K. Outcome effectiveness of the widely adopted EFNEP curriculum Eating Smart-Being Active. J Nutr Educ Behav. 2015 Jan-Feb;47(1):19-27. doi: 10.1016/j.jneb.2014.07.001. Epub 2014 Sep 26.
PubMed 25267324Baral R, Davis GC, Blake S, You W, Serrano E. Using national data to estimate average cost effectiveness of EFNEP outcomes by state/territory. J Nutr Educ Behav. 2013 Mar;45(2):183-7. doi: 10.1016/j.jneb.2012.04.015. Epub 2012 Dec 2.
PubMed 23211510Brink, M.S. 2000. Expanded food and nutrition education program: A precedent-setting program. Easy Writer Publications.
Dollahite J, Kenkel D, Thompson CS. An economic evaluation of the expanded food and nutrition education program. J Nutr Educ Behav. 2008 May-Jun;40(3):134-43. doi: 10.1016/j.jneb.2007.08.011.
PubMed 18457781Dollahite JS, Pijai EI, Scott-Pierce M, Parker C, Trochim W. A randomized controlled trial of a community-based nutrition education program for low-income parents. J Nutr Educ Behav. 2014 Mar-Apr;46(2):102-9. doi: 10.1016/j.jneb.2013.09.004. Epub 2013 Nov 20.
PubMed 24268300Agriculture, U.S.D.o., Research, E.a.E., and Scientist, O.o.t.C. 2012. Nutrition and Childhood Obesity Science White Paper.
Baranowski T, Cerin E, Baranowski J. Steps in the design, development and formative evaluation of obesity prevention-related behavior change trials. Int J Behav Nutr Phys Act. 2009 Jan 21;6:6. doi: 10.1186/1479-5868-6-6.
PubMed 19159476Ventura AK, Birch LL. Does parenting affect children's eating and weight status? Int J Behav Nutr Phys Act. 2008 Mar 17;5:15. doi: 10.1186/1479-5868-5-15.
PubMed 18346282Lent M, Hill TF, Dollahite JS, Wolfe WS, Dickin KL. Healthy children, healthy families: parents making a difference! A curriculum integrating key nutrition, physical activity, and parenting practices to help prevent childhood obesity. J Nutr Educ Behav. 2012 Jan-Feb;44(1):90-2. doi: 10.1016/j.jneb.2011.02.011. Epub 2011 Sep 6. No abstract available.
PubMed 21900051Dickin KL, Hill TF, Dollahite JS. Practice-based evidence of effectiveness in an integrated nutrition and parenting education intervention for low-income parents. J Acad Nutr Diet. 2014 Jun;114(6):945-950. doi: 10.1016/j.jand.2013.09.029. Epub 2013 Dec 4.
PubMed 24315130
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Children, Healthy Families: Parents Making A Difference: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04179565
- Acronym / sponsor ID
- CornellU
- Conditions
- Childhood Obesity Prevention
- Keywords
- childhood obesity, parenting practices, food and physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 391 participants (actual)
- Lead sponsor
- Cornell UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 27 Nov 2019 (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.
The impacts of Healthy Children, Healthy Families: Parents Making a Difference! (HCHF) on how low-income parents enrolled in the Expanded Food and Nutrition Education Program use effective parenting practices to influence children's healthy eating and active play behavior will be investigated, as compared to a delayed intervention control group.
Detailed description
The Healthy Children, Healthy Families: Parents Making a Difference! (HCHF) curriculum is a Cornell curriculum for parents and caregivers focusing on the behaviors most likely to help children avoid unhealthy weight gain. These behaviors include drinking water or milk instead of sweetened beverages, eating more vegetables and fruits, playing actively, eating fewer high-fat and high-sugar foods, limiting screen time, and having sensible serving sizes. The 8-session curriculum uses a learner-centered dialogue approach, hands-on activities and role plays. The study will include 300 participants with young children 3-5 years old in Head Start and childcare programs in New York City using a randomized control design. In period 1 (9 weeks), half the groups will receive HCHF education (immediate education, IE) and half will serve as controls, receiving no education (delayed education, DE). In period 2 (9 weeks), DE will receive education; IE will receive no education and be followed longitudinally for periods 2 and 3. In period 3 (16 weeks), neither group will receive education and both will be followed longitudinally. Data will be collected at each time point using validated measures, including the HCHF Checklist developed by the investigators and complementary measures that assess parenting feeding practices, food behavior in parents, food behavior in children, and parent self-efficacy around obesity prevention behaviors. It is hypothesized that change pre- to post- HCHF will be greater than control groups, and changes in behavior will be retained post-education.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate intervention | Active comparator | Behavioral: Healthy Children Healthy FamiliesThe immediate education (IE) group will receive the intervention, Healthy Children, Healthy Families: Parents Making a Difference! in period 1. In period 2, IE will receive no education and will be followed longitudinally for periods 2 and 3. |
| Delayed intervention | Active comparator | Behavioral: Healthy Children Healthy FamiliesThe delayed education (DE) group will serve as controls in period 1, receiving no intervention. In period 2, the treatments will cross over, so DE will receive the Healthy Children, Healthy Families: Parents Making a Difference! intervention. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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 Children Healthy FamiliesThe Healthy Children, Healthy Families: Parents Making a Difference! intervention was developed by the investigators for low-income parents and caregivers focusing on the behaviors most likely to help children avoid unhealthy weight gain. | Behavioural | Delayed intervention, Immediate intervention |
Primary outcome
Healthy Children, Healthy Families Checklist
Time frame: up to 8 months
The checklist is a 16-item instrument that assesses parents'/caregivers' parenting and personal practices around food and physical activity, as well as the target child's food and physical activity practices. The checklist asks parents to report frequency (per day/week/month) of practices on 5-point Likert-type scales. The constructs measure parent diet quality and physical activity, child diet quality and physical activity, and parenting practices. Each question on the instrument is converted to a numeric value, 1 for the least desirable to 5 for most desirable response. The values for the entire instrument are summed (range 1 - 80 - only those checklists with at least one response are included) and divided by the number of items with a response (0 - 16), resulting in a mean score range of 0 - 5. The questions within each sub-scale are handled in the same way, with a sub-scale range of 0 - 5.
Comprehensive Feeding Practices Questionnaire (CFPQ)
Time frame: up to 8 months
Six sub-scales (24 items) aligned with the learning objectives of the intervention, were selected from the original CFPQ. The constructs assessed by the sub-scales include encouraging balance and variety, use of food as reward, parent allowing child to control eating, parental modeling, parental pressure for child to consume more food, and home environment. Response options for 6 items include frequency on a Likert-type scale (never to always) and for 18 items include a Likert scale (strongly disagree to strongly agree). Each response is converted to a numeric value, 1 for the least desirable to 5 for the most desirable option. These values are then summed (range 0 - 120) and divided by the number of items with a response, resulting in a mean scale score range of 0 - 5. The items within each sub-scale are handled in the same way, with the sub-scale ranges of 0 - 5.
3 secondary outcomes
Parental self-efficacy
Time frame: up to 8 months
Food frequency of sugar sweetened beverages and foods
Time frame: up to 8 months
Parent food choice behaviors
Time frame: up to 8 months
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 22 Mar 2022.
- Background: PubMed 27112068Skinner AC, Perrin EM, Skelton JA. Prevalence of obesity and severe obesity in US children, 1999-2014. Obesity (Silver Spring). 2016 May;24(5):1116-23. doi: 10.1002/oby.21497.
- Background: PubMed 21270360Hurley KM, Cross MB, Hughes SO. A systematic review of responsive feeding and child obesity in high-income countries. J Nutr. 2011 Mar;141(3):495-501. doi: 10.3945/jn.110.130047. Epub 2011 Jan 26.
- Background: PubMed 20406416Golley RK, Hendrie GA, Slater A, Corsini N. Interventions that involve parents to improve children's weight-related nutrition intake and activity patterns - what nutrition and activity targets and behaviour change techniques are associated with intervention effectiveness? Obes Rev. 2011 Feb;12(2):114-30. doi: 10.1111/j.1467-789X.2010.00745.x.
- Background: PubMed 20492538Skouteris H, McCabe M, Swinburn B, Newgreen V, Sacher P, Chadwick P. Parental influence and obesity prevention in pre-schoolers: a systematic review of interventions. Obes Rev. 2011 May;12(5):315-28. doi: 10.1111/j.1467-789X.2010.00751.x.
- BackgroundArnold, C.G. and Sobal, J. 2000. Food practices and nutrition knowledge after graduation from the Expanded Food and Nutrition Education Program (EFNEP). J Nutr Educ Behav. 32:130-138.
- Background: PubMed 25267324Auld G, Baker S, Conway L, Dollahite J, Lambea MC, McGirr K. Outcome effectiveness of the widely adopted EFNEP curriculum Eating Smart-Being Active. J Nutr Educ Behav. 2015 Jan-Feb;47(1):19-27. doi: 10.1016/j.jneb.2014.07.001. Epub 2014 Sep 26.
- Background: PubMed 23211510Baral R, Davis GC, Blake S, You W, Serrano E. Using national data to estimate average cost effectiveness of EFNEP outcomes by state/territory. J Nutr Educ Behav. 2013 Mar;45(2):183-7. doi: 10.1016/j.jneb.2012.04.015. Epub 2012 Dec 2.
- BackgroundBrink, M.S. 2000. Expanded food and nutrition education program: A precedent-setting program. Easy Writer Publications.
- Background: PubMed 18457781Dollahite J, Kenkel D, Thompson CS. An economic evaluation of the expanded food and nutrition education program. J Nutr Educ Behav. 2008 May-Jun;40(3):134-43. doi: 10.1016/j.jneb.2007.08.011.
- Background: PubMed 24268300Dollahite JS, Pijai EI, Scott-Pierce M, Parker C, Trochim W. A randomized controlled trial of a community-based nutrition education program for low-income parents. J Nutr Educ Behav. 2014 Mar-Apr;46(2):102-9. doi: 10.1016/j.jneb.2013.09.004. Epub 2013 Nov 20.
- BackgroundAgriculture, U.S.D.o., Research, E.a.E., and Scientist, O.o.t.C. 2012. Nutrition and Childhood Obesity Science White Paper.
- Background: PubMed 19159476Baranowski T, Cerin E, Baranowski J. Steps in the design, development and formative evaluation of obesity prevention-related behavior change trials. Int J Behav Nutr Phys Act. 2009 Jan 21;6:6. doi: 10.1186/1479-5868-6-6.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available.
Related trials for Childhood Obesity Prevention
Recruiting
National Childhood Obesity Prevention Programme BE FIT 24
Childhood Obesity
Enrolling by invitation
Impact of a Playful Family Education Strategy With ICT on Childhood Obesity Prevention
Pediatric Obesity, Childhood Obesity
Recruiting
Cities for Better Health Childhood Obesity Prevention Initiative in JAPAN
Quality of Life (QOL), Nutrition
Enrolling by invitation
EFFECT OF A ONLINE NUTRITION EDUCATION PROGRAM IN PRESCHOOLER'S FAMILIES ON THEIR ADHERENCE TO THE MEDITERRANEAN DIET
Prevention of Childhood Obesity, Community Health Education
RecruitingPhase 2/3
Food-Body-Mind Intervention (16 Weeks)
Mental Health Wellness, Emotional Problem
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.
Jamie S Dollahite principal investigator
Cornell University
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Children Healthy Families in people with Childhood Obesity Prevention, run by Cornell University.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Healthy Children, Healthy Families Checklist (time frame: up to 8 months). 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 NCT04179565, which also lists 87 linked publications.
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 22 Mar 2022.