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Feeding, Fun, and Families Study (FFF)

Primary Purpose

Childhood Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FFF
Sponsored by
Temple University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Childhood Obesity focused on measuring childhood, obesity, nutrition, intervention, portion size, behavioral, environmental, feeding practices

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Temple University- Center for Obesity Research and Education

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

FFF

Control Group

Arm Description

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.

Data are collected at baseline and post intervention session.

Outcomes

Primary Outcome Measures

Children's combined energy intake from solid fat and added sugars
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.

Secondary Outcome Measures

Children's total daily energy intake
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.
Children's total daily solid fat intake
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.
Children's total daily added sugar intake
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.
BMI status
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.
Meal Observation
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)

Full Information

First Posted
January 17, 2017
Last Updated
August 22, 2018
Sponsor
Temple University
Collaborators
Virginia Polytechnic Institute and State University, University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT03646201
Brief Title
Feeding, Fun, and Families Study
Acronym
FFF
Official Title
Reducing Solid Fat and Added Sugar Intakes in Low-income Preschoolers Through Environmental and Behavioral Portion Size Strategies
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Temple University
Collaborators
Virginia Polytechnic Institute and State University, University of Minnesota

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
childhood, obesity, nutrition, intervention, portion size, behavioral, environmental, feeding practices

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
131 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FFF
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Data are collected at baseline and post intervention session.
Intervention Type
Behavioral
Intervention Name(s)
FFF
Intervention Description
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.
Primary Outcome Measure Information:
Title
Children's combined energy intake from solid fat and added sugars
Description
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.
Time Frame
At end of the FFF intervention (12 weeks), controlling for baseline values
Secondary Outcome Measure Information:
Title
Children's total daily energy intake
Description
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.
Time Frame
At end of the FFF intervention (12 weeks), controlling for baseline values
Title
Children's total daily solid fat intake
Description
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.
Time Frame
At end of the FFF intervention (12 weeks), controlling for baseline values
Title
Children's total daily added sugar intake
Description
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.
Time Frame
At end of the FFF intervention (12 weeks), controlling for baseline values
Title
BMI status
Description
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.
Time Frame
At end of the FFF intervention (12 weeks), controlling for baseline values
Title
Meal Observation
Description
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)
Time Frame
At the end of the FFF intervention (12 weeks)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer O Fisher, Ph.D
Organizational Affiliation
Temple University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Temple University- Center for Obesity Research and Education
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23157723
Citation
Herman AN, Malhotra K, Wright G, Fisher JO, Whitaker RC. A qualitative study of the aspirations and challenges of low-income mothers in feeding their preschool-aged children. Int J Behav Nutr Phys Act. 2012 Nov 16;9:132. doi: 10.1186/1479-5868-9-132.
Results Reference
background
PubMed Identifier
24144074
Citation
Malhotra K, Herman AN, Wright G, Bruton Y, Fisher JO, Whitaker RC. Perceived benefits and challenges for low-income mothers of having family meals with preschool-aged children: childhood memories matter. J Acad Nutr Diet. 2013 Nov;113(11):1484-1493. doi: 10.1016/j.jand.2013.07.028.
Results Reference
background
PubMed Identifier
25240637
Citation
Fisher JO, Wright G, Herman AN, Malhotra K, Serrano EL, Foster GD, Whitaker RC. "Snacks are not food". Low-income, urban mothers' perceptions of feeding snacks to their preschool-aged children. Appetite. 2015 Jan;84:61-7. doi: 10.1016/j.appet.2014.09.007. Epub 2014 Sep 18.
Results Reference
background
PubMed Identifier
30654818
Citation
Fisher JO, Serrano EL, Foster GD, Hart CN, Davey A, Bruton YP, Kilby L, Harnack L, Ruth KJ, Kachurak A, Lawman HG, Martin A, Polonsky HM. Title: efficacy of a food parenting intervention for mothers with low income to reduce preschooler's solid fat and added sugar intakes: a randomized controlled trial. Int J Behav Nutr Phys Act. 2019 Jan 17;16(1):6. doi: 10.1186/s12966-018-0764-3.
Results Reference
derived

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Feeding, Fun, and Families Study

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