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Completed

NCT Number: NCT03646201

Feeding, Fun, and Families Study

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.

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Key information

Conditions

Childhood Obesity Behavior Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Temple University- Center for Obesity Research and Education

Philadelphia, Pennsylvania, 19140, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FFF

Behavioral

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 outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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)

Sponsors and collaborators

Lead sponsor

Temple University

Other

Collaborators

  • University of Minnesota
  • Virginia Polytechnic Institute and State University

Registry information

Official study title

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

Acronym: FFF

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Aug 24, 2018
Registry last updated
Aug 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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