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Effectiveness of an IMB-based Intervention for Reducing Sweetened Beverages Consumption in Preschool Children

Primary Purpose

Childhood Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sugar-sweetened beverage reduction education for preschool children
Sponsored by
UConn Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Childhood Obesity focused on measuring Sugar sweetened beverages,, childhood obesity, preschool children

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

  • UConn Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

SSB Education

Food Safety Education

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Availability of sugar-sweetened beverages for the child in the home
Inventory of all beverages in the home exclusive of alcohol .
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.

Secondary Outcome Measures

Full Information

First Posted
May 13, 2019
Last Updated
September 24, 2019
Sponsor
UConn Health
Collaborators
University of Connecticut
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1. Study Identification

Unique Protocol Identification Number
NCT03957148
Brief Title
Effectiveness of an IMB-based Intervention for Reducing Sweetened Beverages Consumption in Preschool Children
Official Title
Effectiveness of an Information-Motivation-Behavior Skills (IMB)-Based Intervention for Reducing Sugar-Sweetened Beverage (SSB) Consumption in Preschool Children
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
May 7, 2008 (Actual)
Primary Completion Date
October 19, 2014 (Actual)
Study Completion Date
October 19, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UConn Health
Collaborators
University of Connecticut

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
BACKGROUND. Sugar sweetened beverages (SSB), including sodas, fruit drinks, nectars, and ice teas, make up the largest source of added sugar in the American diet. Fruit juices and fruit drinks alone contribute 17-18% of the energy in children's diets. For young children, beverage consumption depends on beverages available and served at home by parents. Consequently, the most effective pathway for reducing SSBs in pre-school children must target the parent as the agent of change. The IMB model is the theoretical foundation for behavior change in this project. Unlike other behavior change models, IMB incorporates three major constructs that theoretically interact, leading to the outcome behavior. Each construct of IMB (information, motivation, and behavioral skills) includes subconstructs as a basis for tailoring the model to an individual health-related behavior. RESEARCH DESIGN AND METHODS. The proposed design allows for 2 sets of systematic comparisons that will address the major study hypotheses: 1) analysis of the differences in outcomes between intervention and control groups at baseline, 1-week post-intervention and 6 months post-intervention; and 2) analysis of the IMB factors that mediate the impact of the intervention on the key outcome measures. Participants in the intervention will receive 10 weeks of SSB-related nutrition education at their child's preschool or daycare. Twice a week, two student educators will be available to parents (both research participants and casual observers) at each site for 2 hours during the typical afternoon pick-up. Each week a different lesson pertaining to parental information, motivation, or behavioral skills related to SSB will be presented via an interactive display board. Lessons will last 5 to 10 minutes, as parents realistically only have this amount of time to stop at an educational board before or after picking up their child. 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. In addition, the program will include educational flyers and posters for site promotion. All materials to be developed will be culturally sensitive, available in English and Spanish, and appropriate for this low-literacy population. Target Population. Twenty Hartford area center or school based early childcare centers serving primarily low-income, minority families will be recruited to participate in the study. Sample Size. Investigators estimated a target sample size of 400 to provide enough stability in the parameter estimates and power to detect effects in the major set of analysis for the current research. Based on our previous efforts in conducting preschool based prevention research, the investigators expect follow-up retention rates to be 75%. Families who move or leave the site during the study will be retained for analysis. Recruitment. Two weeks prior to baseline data collection, researchers will begin participant recruitment. The investigators have experience with recruitment in preschools. The researchers will obtain parent written consent and child verbal assent prior to individual involvement in the study. Data Collection. Procedures used to collect data from parents and children will be identical across all 3 time points: baseline (1 week prior to intervention), 1-week post-intervention, and 6 months post-intervention. At each point, two periods of data collection will occur: 1) at a prearranged meeting at the child's day care, researchers will take anthropometric measurements, administer the IMB, Parent Attitude Toward Nutrition and Child Health, and Food Security questionnaires, and train the parent on the food record and HBI; 2) on the following Monday, the researcher will call the parent to collect data from the HBI and conduct the 48 hour food recall aided by the food record. Since the HBI and food recall will be completed over the phone, participants must have access to a telephone. The 1 week and 6-month follow-up assessments will repeat collection of all data gathered at baseline. Instruments and Measures IMB Survey. A structured researcher-administered survey instrument will be used to assess parental information, motivation, and behavioral skills related to their child's SSB and demographic characteristics. A sum of construct items will create the final score for the three construct indices (Information, Motivation, and Behavioral Skills). Home Beverage Inventory. Using the HBI journal as a guide, participants will record all non-alcoholic beverages in their home, including liquids, powders, concentrates, teas, coffees, sweeteners, and syrups. They will look for beverages throughout their home but will be reminded to specifically look in their freezer, refrigerator, cabinets, pantries, cupboards, counters, and closets. Participants will report the beverage brand, type, flavor, size, container, and number of containers for each drink. The interviewer will record the HBI, as reported by participants, while using probes to ensure clarity and completeness. Analysts will use data collected from the HBI to calculate the availability of sugar sweetened beverages in the home via numbers of containers and number of types of beverages available. Weekend Food Recall. The investigators will collect food and beverage consumption data for two weekend days when the parent will be controlling the food supply and aware of their child's full-day intake and will use a multi-pass food recall aided by a food record. A researcher will phone each parent on Monday to conduct the food recall using a modified United States Department of Agriculture (USDA) multi-pass protocol Parental Attitudes Toward Nutrition and Child Health Questionnaire. This interviewer-administered questionnaire will be composed of nutrition and health related constructs whose items have demonstrated empirical validity in our study population, such as parent perceived feeding responsibility and monitoring of food intake from the modified version of the Child Feeding Questionnaire and parent feeding control from the Parental Feeding Style Questionnaire. Food Security Questionnaire. The researchers will measure household food security using the validated USDA Food Security Module which consists of 18 questions that ask with increasing severity about a household's experiences with getting enough food. Anthropometric Measurements. Parent and child heights will be measured in stocking feet using a stadiometer using standard protocols. Parent and child weights will be obtained using an electronic self-calibrating digital scale using standard procedures. Body mass index (BMI) will be used as a measure of adiposity in parents and children. Data Analysis. Data analysis plans for the research questions listed on page 1 and 2 are presented below. Because this study utilizes a randomized multisite design in which participants are nested within daycare sites, scientific tests of the effectiveness of the intervention will be performed in a series of regression models using SUDAAN, a proprietary statistical package developed by the Research Triangle Institute. SUDAAN was developed to address generic problems in the analysis of hierarchical data structures, that is, data in which characteristics of one unit of analysis (e.g., individuals) are nested within, and vary among, larger units (e.g., social groups or contexts). Descriptive Analysis. Before substantive issues regarding the efficacy of the SSB intervention are examined, the evaluators will perform analyses to determine the comparability of the intervention and control groups. This will enable us to determine the adequacy of the randomization in terms of demographic characteristics and outcomes of interest. The researchers will perform one-way ANOVAs (for continuous baseline characteristics) and chi-square tests (for categorical baseline characteristics) in SUDAAN to explore differences among the 2 groups. Subsequent analyses will statistically adjust for any differences in the composition of the intervention and control groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
Sugar sweetened beverages,, childhood obesity, preschool children

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
484 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SSB Education
Arm Type
Experimental
Arm Description
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.
Arm Title
Food Safety Education
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Sugar-sweetened beverage reduction education for preschool children
Intervention Description
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.
Primary Outcome Measure Information:
Title
Availability of sugar-sweetened beverages for the child in the home
Description
Inventory of all beverages in the home exclusive of alcohol .
Time Frame
Baseline compared to one month, three months and six month post initiation of intervention.
Title
Child consumption of sugar-sweetened beverages.
Description
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.
Time Frame
Baseline compared to one month, three months and six month post initiation of intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: If more than two children are eligible, the oldest child would be part of the study. Children with medical issues that restrict normal eating.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann M Ferris, PhD
Organizational Affiliation
UConn Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
UConn Health
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15917048
Citation
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.
Results Reference
background
PubMed Identifier
11358344
Citation
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.
Results Reference
background
PubMed Identifier
12716668
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
Citation
Gibson RS. Principles of Nutritional Assessment. (2nd ed.). NY: Oxford University Press, 2005.
Results Reference
background
PubMed Identifier
16895873
Citation
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.
Results Reference
background
PubMed Identifier
15450632
Citation
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. Erratum In: Am J Prev Med. 2005 May;28(4):413.
Results Reference
background
Citation
Nord M, Andrews M, Carlson S. 2005 Household Food Security in the United States (ERR29) Washington, DC: USDA Economic Research Service, 2006.
Results Reference
background
PubMed Identifier
17135620
Citation
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.
Results Reference
background
Citation
Research Triangle Institute. SUDAAN (Version 9.0.0) Research Triangle, NC: Research Triangle Institute, 2004.
Results Reference
background
PubMed Identifier
21636326
Citation
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.
Results Reference
result

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Effectiveness of an IMB-based Intervention for Reducing Sweetened Beverages Consumption in Preschool Children

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