Feeding, Fun, and Families Study (FFF)

August 22, 2018 updated by: Temple University

Reducing Solid Fat and Added Sugar Intakes in Low-income Preschoolers Through Environmental and Behavioral Portion Size Strategies

To develop and evaluate the efficacy of Feeding Fun and Families (FFF), a nutrition education intervention for low-income mothers emphasizing authoritative food parenting skills, on preschool aged children's energy intakes from solid fats and added sugars (SoFAS), using a randomized controlled trial conducted in a clinic-based setting.

FFF will result in lower child SoFAS intakes compared to a no-treatment control group at the end of the 12 week intervention (primary outcome), adjusted for baseline values.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Feeding Fun and Families (FFF) taught mothers authoritative parenting skills for reducing children's exposure to and intake of daily energy from SoFAS. FFF was developed and rigorously testing a contextually sensitive, state-of-the art nutrition education program for low-income mothers emphasizing parenting skills. This project represents the first systematic research to translate, from bench-to-bedside, the basic behavioral science on child portion size to clinic-based and then community level nutrition education programming. FFF is a nutrition education intervention emphasizing the "hows" of parenting around feeding young children. Authoritative parenting strategies will target the family food environment, mothers' own eating behaviors, and their child feeding practices. Based on previous research, strategies will attempt to reduce SoFAS portions offered to children by reducing the size of dishware (e.g. cups, bowls, plates) used to serve children and used by children to eat, reducing portion sizes of amorphous (e.g. pasta) and unit foods (e.g. juice box) served to children, and encourage feeding practices that provide structure and autonomy support. The primary outcome, measured at baseline and at the end of the 12 week intervention, children's energy intake of discretionary calories from SoFAS.

Formative qualitative research was used to guide the development of FFF in a manner consistent with low-income mothers' parenting goals and responsive to their socioeconomic constraints. The FFF intervention was tested the "proof of concept" (i.e. efficacy) by evaluating an intensive version of the intervention in a randomized clinical trial (RCT). The findings were used to translate FFF for delivery by Supplemental Nutrition Assistance Program Education (SNAP-Ed) educators in urban communities of VA (VA), with the potential of being disseminated nationwide through the SNAP-Ed program.

Specific objectives were:

  1. Phase I: Qualitatively understand the contextual factors (i.e. psychosocial, economic, structural) that will support mothers' acceptance and implementation of environmental and behavioral portion size strategies to decrease SFAS portions among low-income, at-risk preschoolers.
  2. Phase II: To develop and evaluate the efficacy of the FFF obesity prevention nutrition education program for low-income mothers of preschoolers emphasizing behavioral and environmental parenting strategies around portion size in a clinic-based setting.

    • FFF will result in lower child SoFAS intakes compared to a no-treatment control group at the end of the 12 week intervention (primary outcome), adjusted for baseline values

  3. Phase III: To translate the FFF program for delivery in SNAP-ED to mothers of preschool aged children.

Study Type

Interventional

Enrollment (Actual)

131

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University- Center for Obesity Research and Education

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • has a child that is 3-5 y at enrollment (up to 66 mo)
  • Supplemental Nutrition Assistance Program (SNAP) eligible
  • 18 y or older
  • self-reported comfort with spoken and written English

Exclusion Criteria:

  • child has a restrictive diet
  • child has a severe food allergies
  • child has a chronic illness or medication that influences intake/growth
  • sever psychosocial impairment
  • non-English speakers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FFF
FFF teaches authoritative parenting skills for reducing children's exposure to and intakes of SoFAS, including changes to the family food environment, mothers' own eating behaviors, and food parenting practices.
FFF teaches authoritative parenting skills for reducing children's exposure to and intakes of SoFAS, including changes to the family eating environment, mothers' own eating behaviors, and food parenting practices.
No Intervention: Control Group
Data are collected at baseline and post intervention session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Children's combined energy intake from solid fat and added sugars
Time Frame: At end of the FFF intervention (12 weeks), controlling for baseline values
Daily intake (kcal/d); mean of 3, 24-hour dietary recalls. Recalls were administered using Nutrition Data System for Research Software by trained and certified staff at the Nutrition Coordinating Center (NCC), University of Minnesota, Minneapolis, MN who were blind to condition assignment.
At end of the FFF intervention (12 weeks), controlling for baseline values

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Children's total daily energy intake
Time Frame: At end of the FFF intervention (12 weeks), controlling for baseline values
Daily intake (kcal/d); mean of 3, 24-hour dietary recalls. Recalls were administered using Nutrition Data System for Research Software by trained and certified staff at the Nutrition Coordinating Center (NCC), University of Minnesota, Minneapolis, MN who were blind to condition assignment.
At end of the FFF intervention (12 weeks), controlling for baseline values
Children's total daily solid fat intake
Time Frame: At end of the FFF intervention (12 weeks), controlling for baseline values
Daily intake (kcal/d); mean of 3, 24-hour dietary recalls. Recalls were administered using Nutrition Data System for Research Software by trained and certified staff at the Nutrition Coordinating Center (NCC), University of Minnesota, Minneapolis, MN who were blind to condition assignment.
At end of the FFF intervention (12 weeks), controlling for baseline values
Children's total daily added sugar intake
Time Frame: At end of the FFF intervention (12 weeks), controlling for baseline values
Daily intake (kcal/d); mean of 3, 24-hour dietary recalls. Recalls were administered using Nutrition Data System for Research Software by trained and certified staff at the Nutrition Coordinating Center (NCC), University of Minnesota, Minneapolis, MN who were blind to condition assignment.
At end of the FFF intervention (12 weeks), controlling for baseline values
BMI status
Time Frame: At end of the FFF intervention (12 weeks), controlling for baseline values
Child height (cm) and weight (kg) will be measured in triplicate and converted to Body Mass Index z-scores specific to age and sex using Centers for Disease Control reference data.
At end of the FFF intervention (12 weeks), controlling for baseline values
Meal Observation
Time Frame: At the end of the FFF intervention (12 weeks)
Nine maternal FFF target behaviors were observed at a buffet-style meal where mothers ate with their children. Mothers were assigned a total score representing the sum of target behaviors observed (possible score 0-9)
At the end of the FFF intervention (12 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jennifer O Fisher, Ph.D, Temple University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

January 17, 2017

First Submitted That Met QC Criteria

August 22, 2018

First Posted (Actual)

August 24, 2018

Study Record Updates

Last Update Posted (Actual)

August 24, 2018

Last Update Submitted That Met QC Criteria

August 22, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • USDA-310138
  • USDA AFRI 2011-68001-30148 (Other Grant/Funding Number: USDA National Institute of Food and Agriculture, AFRI)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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