NCT03646201

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
131

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2017

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

August 24, 2018

Completed
Last Updated

August 24, 2018

Status Verified

August 1, 2018

Enrollment Period

3.2 years

First QC Date

January 17, 2017

Last Update Submit

August 22, 2018

Conditions

Keywords

childhoodobesitynutritioninterventionportion sizebehavioralenvironmentalfeeding practices

Outcome Measures

Primary Outcomes (1)

  • 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.

    At end of the FFF intervention (12 weeks), controlling for baseline values

Secondary Outcomes (5)

  • Children's total daily energy intake

    At end of the FFF intervention (12 weeks), controlling for baseline values

  • Children's total daily solid fat intake

    At end of the FFF intervention (12 weeks), controlling for baseline values

  • Children's total daily added sugar intake

    At end of the FFF intervention (12 weeks), controlling for baseline values

  • BMI status

    At end of the FFF intervention (12 weeks), controlling for baseline values

  • Meal Observation

    At the end of the FFF intervention (12 weeks)

Study Arms (2)

FFF

EXPERIMENTAL

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

Control Group

NO INTERVENTION

Data are collected at baseline and post intervention session.

Interventions

FFFBEHAVIORAL

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.

FFF

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Temple University- Center for Obesity Research and Education

Philadelphia, Pennsylvania, 19140, United States

Location

Related Publications (4)

  • 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.

    PMID: 23157723BACKGROUND
  • 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.

    PMID: 24144074BACKGROUND
  • 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.

    PMID: 25240637BACKGROUND
  • 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.

MeSH Terms

Conditions

Pediatric ObesityObesityBehavior

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jennifer O Fisher, Ph.D

    Temple University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2017

First Posted

August 24, 2018

Study Start

July 1, 2012

Primary Completion

September 1, 2015

Study Completion

March 1, 2016

Last Updated

August 24, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations