Childhood Obesity Clinical Trial
Official title:
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05437406 -
Family, Responsibility, Education, Support, and Health for Latino Caregivers (FRESH-LC)
|
N/A | |
Completed |
NCT03297541 -
Healthy Kids I-PAL
|
N/A | |
Completed |
NCT05527938 -
Web-based Interventions on Nonalcoholic Fatty Liver Disease (NAFLD) in Obese Children
|
N/A | |
Completed |
NCT05501392 -
South Texas Early Prevention Studies PreK
|
N/A | |
Completed |
NCT03334266 -
Preventing Early Childhood Obesity, Part 2: Family Spirit Nurture, Prenatal - 18 Months
|
N/A | |
Active, not recruiting |
NCT03342092 -
Early Adiposity Rebound Amongst 4-y.o. Children and Overweight Risk Amongst 11-y.o Children : Third Phase of a Cohort Study in Franche-Comté
|
N/A | |
Completed |
NCT06239662 -
Therapeutic Education Groups for Childhood Obesity
|
N/A | |
Withdrawn |
NCT02767830 -
Cleveland Kids Run
|
N/A | |
Not yet recruiting |
NCT02889406 -
Motivation Approach for Childhood Obesity Treatment
|
N/A | |
Completed |
NCT03245164 -
The Effects of Group Exercise and Basketball on Obese Children
|
N/A | |
Completed |
NCT02484976 -
Brain Activation and Satiety in Children: Functional Magnetic Resonance Imaging
|
N/A | |
Completed |
NCT02559076 -
The Eat Right Emirates Healthy Lifestyle Study
|
N/A | |
Completed |
NCT02087774 -
Brief Physical Activity Program to Increase Physical Fitness in Elementary School Children
|
N/A | |
Completed |
NCT01977105 -
Healthy Growth Abbreviated Pilot Study
|
N/A | |
Completed |
NCT01821313 -
CASH- Children Active to Stay Healthy
|
N/A | |
Completed |
NCT01789671 -
Peer Counseling in Family-Based Treatment for Childhood Obesity
|
N/A | |
Completed |
NCT01849315 -
Effects of Physical Activity on Disease Risk Factors
|
N/A | |
Completed |
NCT02637752 -
Nutrition and Physical Activity Counselling
|
N/A | |
Completed |
NCT02799433 -
Evaluation of the Healthy Apple Program in San Francisco
|
N/A | |
Completed |
NCT01290848 -
A Health Promotion Campaign Targeting Caregivers of Young Children
|
Phase 2 |