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Healthy Children, Healthy Families: Parents Making A Difference

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04179565
Recruitment Status : Active, not recruiting
First Posted : November 27, 2019
Last Update Posted : November 27, 2019
Sponsor:
Information provided by (Responsible Party):
Jamie Dollahite, Cornell University

Brief 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 intervention control group.

Condition or disease Intervention/treatment Phase
Childhood Obesity Prevention Behavioral: Healthy Children Healthy Families Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Healthy Children, Healthy Families: Parents Making A Difference: A Randomized Controlled Trial
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : August 30, 2018
Estimated Study Completion Date : December 31, 2019

Arm Intervention/treatment
Active Comparator: Immediate intervention
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.
Behavioral: Healthy Children Healthy Families
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.

Active Comparator: Delayed intervention
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.
Behavioral: Healthy Children Healthy Families
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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Parental self-efficacy [ Time Frame: up to 8 months ]
    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.

  2. Food frequency of sugar sweetened beverages and foods [ Time Frame: up to 8 months ]
    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.

  3. Parent food choice behaviors [ Time Frame: up to 8 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04179565


Sponsors and Collaborators
Cornell University
Investigators
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Principal Investigator: Jamie S Dollahite Cornell University

Publications:
Arnold, 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.
Brink, M.S. 2000. Expanded food and nutrition education program: A precedent-setting program. Easy Writer Publications.
Agriculture, U.S.D.o., Research, E.a.E., and Scientist, O.o.t.C. 2012. Nutrition and Childhood Obesity Science White Paper.
U.S. Department of Agriculture (USDA) & Federal Nutrition Services (FNS). 2016. SNAP-Ed Strategies & Interventions: An obesity Prevention Toolkit for States. Available from:https://snaped.fns.usda.gov/sites/default/files/uploads/NCCORSNAPEdToolkit2016UpdateApril2016FINAL.pdf.
Woodward-Lopez, G., Ritchie, L.D., Gerstein, D.E., and Crawford, P.B. 2006. Obesity: Dietary and developmental influences. Boca Raton: CRC Press.
Whitaker, R.C.. 2004. A Review of Household Behaviors for Preventing Obesity in Children. Mathematica Policy Research, Inc.: Princeton, NJ.
Ontai, L., Ritchie, L.D., Williams, S.T., Young, T., and Townsend, M.S. 2009. Guiding family-based obesity prevention efforts in low-income children in the United States. Part I: What determinants do we target? Int J Child Adolesc health. 2:20-30.
Rhee, K. 2008. Childhood overweight and the relationship between parent behaviors, parenting style ' and family functioning. Annals of the American Academy of Political and Social Science. 615:12-37.
Koplan, J.P., Liverman, C.T., Kraak, V.I., and Wisham, S.L. 2007. Progress in preventing childhood obesity: how do we measure up? : National Academies Press Washington, DC.
Davison, K.K. 2004. Activity-related support from parents, peers, and siblings and adolescents' physical activity: are there gender differences? J Phys Act Health. 1:363-376.
New York State Department of Health. 2016. Eat Well Play hard in Child Care Settings. Available from: http://www.health.ny.gov/prevention/nutrition/cacfp/ewphccs.
Gabor V, Cates S, Gleason S, Long V, Aponte Clarke G, Blitstein J. 2012. SNAP education and evaluation (wave I): final report. Available from: http://www.fns.usda.gov/ snap-education-and-evaluation-study-wave-i.
Food Trust. 2007. Kindergarten Initiative: A Healthy Start to a Healthy Life, 2007: Philadelphia PA: A Report of the Food Trust.
Food Trust. 2010. Intervention: The Kindergarten Initiative. Available from: http://centertrt.org/content/docs/intervention_documents/intervention_templates/kindergarten_intitiative_template.pdf.
National Heart, Lung, and Blood Institute. 2016. We Can! Ways to Enhance Children's Activity & Nutrition. Available from: http://www.nhlbi.nih.gov/health/educational/wecan/
Grutzmacher, S. 2013. Text2BHealthy: A case study of planning, implementing, and evaluating a targeted text-based nutrition education program 141st APHA Annual Meeting and Exposition. APHA.
Arnold, 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. 32:130-138.
Amstutz, M.K., Dixon, D.L. 1986. Dietary changes resulting from the Expanded Food and Nutrition Education Program. J Nutr Educ. 18:55-60.
Nierman, L.G., A longitudinal study of the retention of foods and nutrition knowledge and practices of participants from the Michigan Expanded Food and Nutrition Education Program, 1986, Michigan State University: East Lansing, MI.
Wardlaw, M. and Baker, S. 2012. Long-term evaluation of EFNEP and SNAP-Ed. Forum Fam Consum Issues.17 (2) Retrieved from http://ncsu. edu/ffci/publications/2012/v17-n2-2012-summer-fall/wardl.
Norris, J. 2003. From Telling to Teaching: A Dialogue Approach to Adult Learning. Featuring a Step-by-step Workshop Design Model that Will Transform You, Your Teaching, and Your Learners! North Myrtle Beach, NC: Learning By Dialogue.
Bandura, A. 1986. Social Foundations of Thought and Action: A Social Cognitive Theory. Prentice-Hall, Inc.
Ryan, R.M., Patrick, H., Deci, E.L., and Williams, G.C. 2008. Facilitating health behaviour change and its maintenance: Interventions based on self-determination theory. European Health Psychologist. 10:2-5.
Raudsepp, L. and Viira, R. 2000. Influence of parents' and siblings' physical activity on activity levels of adolescents. Eur J Phys Educ. 5:169-178.
Satter, E. 2005. Your Child's Weight: Helping Without Harming. Madison, WI: Kelcy Press.
Brustad. 1993. Who will go out and play? Parental and psychological influences on children's attraction to physical activity. Pediatr Exerc Sci. 5:210-223.
Hearn, M., T., B., J., B., Doyle, C., Smith, M., Lin, L.S., and Resnicow, K. 1998. Environmental influences on dietary behavior among children: availability and accessibility of fruit and vegetables enable consumption. J Health Educ. 29:26-32.
U.S. Department of Agriculture (USDA), Nutrition Evaluation Reporting System (NEERS5), 2009, Cooperative State Research, Education, and Extension Service, USDA.

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Responsible Party: Jamie Dollahite, Professor, Cornell University
ClinicalTrials.gov Identifier: NCT04179565    
Other Study ID Numbers: CornellU
First Posted: November 27, 2019    Key Record Dates
Last Update Posted: November 27, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: 2020
Access Criteria: Data access requests will be reviewed by investigators within the Division of Nutritional Sciences at Cornell who were not involved in the study. Requestors will be required to sign a data access agreement.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jamie Dollahite, Cornell University:
childhood obesity
parenting practices
food and physical activity
Additional relevant MeSH terms:
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Pediatric Obesity
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms