Childhood ObesityFFFNCT03646201
Feeding, Fun, and Families Study
A study testing FFF in people with Childhood Obesity, run by Temple University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- FFF
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Temple University- Center for Obesity Research and Education
Philadelphia, Pennsylvania, 19140
About this study
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.
Read the 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.
- Conditions
- Childhood Obesity
- Being tested
- FFF
- Keywords
- childhood, obesity, nutrition, intervention, portion size, behavioral, environmental, feeding practices
- Medical subject headings
- Pediatric Obesity, Obesity, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FFFBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: FFF |
| Control Group | No intervention | Data are collected at baseline and post intervention session. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At end of the FFF intervention (12 weeks), controlling for baseline values
Secondary outcomes (5)
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.
Measured: At end of the FFF intervention (12 weeks), controlling for baseline values
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.
Measured: At end of the FFF intervention (12 weeks), controlling for baseline values
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.
Measured: At end of the FFF intervention (12 weeks), controlling for baseline values
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.
Measured: At end of the FFF intervention (12 weeks), controlling for baseline values
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)
Measured: At the end of the FFF intervention (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study startJul 2012
- Primary completionSep 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- Virginia Polytechnic Institute and State University, University of Minnesota
- Responsible party
- Sponsor
- Investigators
- Jennifer O Fisher, Ph.D, Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03646201
- Sponsor's protocol ID
- USDA-310138
- Other IDs
- USDA AFRI 2011-68001-30148
- Acronym
- FFF
- Status last verified
- Aug 2018
- First submitted
- 17 Jan 2017
- Last updated
- 24 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 23157723Malhotra 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.
PubMed 24144074Fisher 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.
PubMed 25240637Fisher 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.
PubMed 30654818
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Solid Fat and Added Sugar Intakes in Low-income Preschoolers Through Environmental and Behavioral Portion Size Strategies
- ClinicalTrials.gov ID
- NCT03646201
- Acronym / sponsor ID
- FFF / USDA-310138
- Conditions
- Childhood Obesity
- Keywords
- childhood, obesity, nutrition, intervention, portion size, behavioral, environmental, feeding practices
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- Virginia Polytechnic Institute and State University, University of Minnesota
- Study start
- Jul 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 24 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FFF | Experimental | Behavioral: FFFFFF 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. |
| Control Group | No intervention | –Data are collected at baseline and post intervention session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FFFFFF 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. | Behavioural | FFF |
Primary outcome
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.
5 secondary outcomes
Children's total daily energy intake
Time frame: 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
Children's total daily added sugar intake
Time frame: 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
Meal Observation
Time frame: At the end of the FFF intervention (12 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2018.
- Background: PubMed 23157723Herman 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.
- Background: PubMed 24144074Malhotra 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.
- Background: PubMed 25240637Fisher 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.
- Derived from this study: PubMed 30654818Fisher 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer O Fisher, Ph.D principal investigator
Temple University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FFF in people with Childhood Obesity, run by Temple University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03646201, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2018.