NCT03957148

Brief Summary

Sugar-sweetened beverages and over consumption of 100% fruit juice add unneeded calories to the diets of children, potentially leading to overweight. As children's diets are extensions of their parent's behaviors, the investigators propose to implement a nutrition education intervention based on the Information-Motivation-Behavioral Skills (IMB) behavior change model using parents as the primary agent of change. This project will evaluate an intervention to reduce sugar-sweetened beverages in preschool children from low-resource families. The proposed research uses a randomized control group design involving 20 parents of 3-5-year-old children at 20 sites (n=400) over 3 years. The investigators will randomly assign sites to two experimental conditions: 1) 10-week sugar-sweetened beverage intervention and 2) 10-week sham education control. Data collection for the two groups will be conducted at baseline and 1 weeks and 6 months post intervention. Measures to be collected include and IMB survey, home beverage inventory (HBI), weekend food recall, and anthropometrics. Education programs will be available to all parents at sites through interactive display boards with 5-10-minute lessons. Each semester 8 students (n=32) will enroll in an experiential course aimed at increasing students' cultural competency. For 10 weeks, students will attend classroom training and spend 2 hours twice a week at sites implementing the nutrition education program.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
484

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 7, 2008

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 19, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 19, 2014

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

May 13, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 21, 2019

Completed
Last Updated

September 26, 2019

Status Verified

September 1, 2019

Enrollment Period

6.5 years

First QC Date

May 13, 2019

Last Update Submit

September 24, 2019

Conditions

Keywords

Sugar sweetened beverages,childhood obesitypreschool children

Outcome Measures

Primary Outcomes (2)

  • Availability of sugar-sweetened beverages for the child in the home

    Inventory of all beverages in the home exclusive of alcohol .

    Baseline compared to one month, three months and six month post initiation of intervention.

  • Child consumption of sugar-sweetened beverages.

    Parent records of food intake for two weekend days of their children cross checked with an Inventory of all beverages in the home, exclusive of alcohol.

    Baseline compared to one month, three months and six month post initiation of intervention.

Study Arms (2)

SSB Education

EXPERIMENTAL

The SSB reduction intervention consists of 10-weeks of targeted, brief interactions with parents when they come to pick up their children for a center-based early childcare program. The sessions will be twice per week.

Behavioral: Sugar-sweetened beverage reduction education for preschool children

Food Safety Education

SHAM COMPARATOR

The sham control (food safety education) consists of 10-weeks of targeted, brief interactions with parents when they come to pick up their children for a center-based early childcare program. The sessions will be twice per week.

Behavioral: Sugar-sweetened beverage reduction education for preschool children

Interventions

Participants in the SSB-IMB program will receive 10 weeks of SSB related nutrition education at their child's preschool. Each week a different lesson pertaining to parental information, motivation, or behavioral skills related to SSBs will be presented via an interactive display board. Twice a week, two student educators will stand by display boards for two hours and deliver the lessons that will last 5-10 minutes with each parent. These displays will include an activity for parents to apply knowledge and skills learned during the short lesson. Educators will also provide parents with informational handouts pertaining to each lesson to reinforce concepts learned. Display board education is flexible, so that if a parent arrives while another parent is receiving education, the second educator can begin the lesson with the new parent. Multiple parents can participate in a lesson at the same time. Groups of 2-3 parents can review the lesson together, learning from each other.

Food Safety EducationSSB Education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Parent-child dyads where the children attend a center-based early childcare center in Hartford, CT that is part of the City of Hartford sponsored School Readiness Network.
  • Easy access to a telephone

You may not qualify if:

  • If more than two children are eligible, the oldest child would be part of the study.
  • Children with medical issues that restrict normal eating.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UConn Health

Farmington, Connecticut, 06030, United States

Location

Related Publications (11)

  • Anderson CB, Hughes SO, Fisher JO, Nicklas TA. Cross-cultural equivalence of feeding beliefs and practices: the psychometric properties of the child feeding questionnaire among Blacks and Hispanics. Prev Med. 2005 Aug;41(2):521-31. doi: 10.1016/j.ypmed.2005.01.003.

    PMID: 15917048BACKGROUND
  • Birch LL, Fisher JO, Grimm-Thomas K, Markey CN, Sawyer R, Johnson SL. Confirmatory factor analysis of the Child Feeding Questionnaire: a measure of parental attitudes, beliefs and practices about child feeding and obesity proneness. Appetite. 2001 Jun;36(3):201-10. doi: 10.1006/appe.2001.0398.

    PMID: 11358344BACKGROUND
  • Conway JM, Ingwersen LA, Vinyard BT, Moshfegh AJ. Effectiveness of the US Department of Agriculture 5-step multiple-pass method in assessing food intake in obese and nonobese women. Am J Clin Nutr. 2003 May;77(5):1171-8. doi: 10.1093/ajcn/77.5.1171.

    PMID: 12716668BACKGROUND
  • Fisher WA, Fisher JD, Harman J, Suls J, Wallston KA. The information-motivation-behavior skills model: A general social psychological approach to understanding and promoting health behavior. IN: Social Psychological Foundations of Health and Illness. Hoboken, NJ, Blackwell Publishing 2003:82-106.

    BACKGROUND
  • Gibson RS. Principles of Nutritional Assessment. (2nd ed.). NY: Oxford University Press, 2005.

    BACKGROUND
  • Malik VS, Schulze MB, Hu FB. Intake of sugar-sweetened beverages and weight gain: a systematic review. Am J Clin Nutr. 2006 Aug;84(2):274-88. doi: 10.1093/ajcn/84.1.274.

    PMID: 16895873BACKGROUND
  • Nielsen SJ, Popkin BM. Changes in beverage intake between 1977 and 2001. Am J Prev Med. 2004 Oct;27(3):205-10. doi: 10.1016/j.amepre.2004.05.005.

    PMID: 15450632BACKGROUND
  • Nord M, Andrews M, Carlson S. 2005 Household Food Security in the United States (ERR29) Washington, DC: USDA Economic Research Service, 2006.

    BACKGROUND
  • Powers SW, Chamberlin LA, van Schaick KB, Sherman SN, Whitaker RC. Maternal feeding strategies, child eating behaviors, and child BMI in low-income African-American preschoolers. Obesity (Silver Spring). 2006 Nov;14(11):2026-33. doi: 10.1038/oby.2006.237.

    PMID: 17135620BACKGROUND
  • Research Triangle Institute. SUDAAN (Version 9.0.0) Research Triangle, NC: Research Triangle Institute, 2004.

    BACKGROUND
  • Goodell LS, Pierce MB, Amico KR, Ferris AM. Parental information, motivation, and behavioral skills correlate with child sweetened beverage consumption. J Nutr Educ Behav. 2012 May-Jun;44(3):240-5. doi: 10.1016/j.jneb.2010.07.012. Epub 2011 Jun 1.

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ann M Ferris, PhD

    UConn Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The efficacy of the Information Motivation Behavior (IMB) behavior-change model articulated to child sugar sweetened beverage (SSB) consumption will be assessed using a randomized, pretest-posttest control group design involving approximately 400 primary caretakers of 3-5-year old children in 20 sites over a 3-year period. These sites will be randomly assigned to two experimental conditions: 10 sites will receive a 10-week SSB education intervention and 10 sites will be assigned to the control group and will receive 10 weeks of alternative nutrition education not related to SSB. Although the investigators expect the program to be widely implemented, the team will select 20 parents from each site to participate in the research study. Random assignment of sites to experimental conditions will be achieved using a random numbers table. Data collection for the two groups will be conducted at baseline (prior to education implementation) and at 1 week and 6 months post-intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor emerita Medicine and Public Health

Study Record Dates

First Submitted

May 13, 2019

First Posted

May 21, 2019

Study Start

May 7, 2008

Primary Completion

October 19, 2014

Study Completion

October 19, 2014

Last Updated

September 26, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations