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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
131

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: FFF
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Temple University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Virginia Polytechnic Institute and State University
University of Minnesota

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 17, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 24, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 24, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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