Obesity, ChildhoodNCT03394326
Eat Healthy for Families
A study testing family-based obesity prevention lifestyle intervention in people with Obesity, Childhood and Energy Density, run by University of Delaware at 1 site in United States.
Trial summary
This study investigates the effect of a low energy-density dietary prescription as compared to MyPlate recommendations in preschool children at risk for obesity. Read more about this study
- Who is it for?
- Ages 2 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Childhood, Energy Density, Diet Quality
- What is being tested?
- family-based obesity prevention lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2017to 31 Dec 2021
- 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 2 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- the parent is ≥18 years-old with a BMI ≥30 kg/m2 (indicating the child to be at risk for obesity);
- the child is 2-5 years-old with a BMI-for-age and sex <95th percentile;
- the parent and child live together ≥50% of the time;
- the parent and child are able to read, speak and understand English;
- the family has transportation to the University of Delaware; and
- the family is committed to the 6-month program.
Who cannot join
- the child is participating in a weight management program or seeing a Registered Dietitian for weight loss;
- the child is taking weight loss medication or medication that impacts appetite; or
- the child has a medical condition that impacts growth or has a medical condition that requires a specific eating plan.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementing a Dietary Energy Density Intervention in Preschool Children
This study investigates the effect of a low energy-density dietary prescription as compared to MyPlate recommendations in preschool children at risk for obesity.
- Conditions
- Obesity, Childhood, Energy Density, Diet Quality
- Being tested
- family-based obesity prevention lifestyle intervention
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
family-based obesity prevention lifestyle interventionBehavioural
A family-based obesity prevention lifestyle intervention is based on the combination of behavioral therapy strategies, a physical activity prescription and a dietary prescription. Both the parent and child will be working to achieve the same behavioral targets.
| Study group | Role | What they receive |
|---|---|---|
| LOW-ED | Experimental | In the LOW-ED condition each participant will consume at least 10 low-ED foods/day (ED ≤1.0 kcal/g) and no more than 2 high ED foods/day (ED ≥3.0 kcal/g). Foods with an ED >1.0 kcal/g and <3.0 kcal/g will be unlimited; however, lowering the overall ED of the diet will be encouraged. Receives: Behavioral: family-based obesity prevention lifestyle intervention |
| STANDARD | Active comparator | In the STANDARD condition participants will consume the recommendations for calories, fruits, vegetables and whole grains based on age and sex corresponding with MyPlate. The daily caloric recommendations from MyPlate are for weight maintenance. Receives: Behavioral: family-based obesity prevention lifestyle intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dietary Energy Density
Dietary intake will be analyzed using NDSR and energy density (kcal/g) will be calculated.
Measured: 6 months
Energy Intake
Dietary intake will be analyzed using NDSR and energy intake will be calculated.
Measured: 6 months
Dietary Quality
Dietary intake will be analyzed using NDSR and used to calculate a Healthy Eating Index score.
Measured: 6 months
Secondary outcomes (1)
zBMI
A standardized z-score for BMI will be calculated based on the child's weight, height, age, and sex.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2018
- Study start1 Jul 2017
- Primary completion9 Nov 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, ChildhoodStudies 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
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shannon Robson, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03394326
- Sponsor's protocol ID
- 1097650
- Status last verified
- May 2022
- First submitted
- 3 Jan 2018
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing a Dietary Energy Density Intervention in Preschool Children
- ClinicalTrials.gov ID
- NCT03394326
- Acronym / sponsor ID
- 1097650
- Conditions
- Obesity, Childhood, Energy Density, Diet Quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 9 Nov 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 9 Jan 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.
This study investigates the effect of a low energy-density dietary prescription as compared to MyPlate recommendations in preschool children at risk for obesity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LOW-ED | Experimental | Behavioral: family-based obesity prevention lifestyle interventionIn the LOW-ED condition each participant will consume at least 10 low-ED foods/day (ED ≤1.0 kcal/g) and no more than 2 high ED foods/day (ED ≥3.0 kcal/g). Foods with an ED >1.0 kcal/g and <3.0 kcal/g will be unlimited; however, lowering the overall ED of the diet will be encouraged. |
| STANDARD | Active comparator | Behavioral: family-based obesity prevention lifestyle interventionIn the STANDARD condition participants will consume the recommendations for calories, fruits, vegetables and whole grains based on age and sex corresponding with MyPlate. The daily caloric recommendations from MyPlate are for weight maintenance. |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- the parent is ≥18 years-old with a BMI ≥30 kg/m2 (indicating the child to be at risk for obesity);
- the child is 2-5 years-old with a BMI-for-age and sex <95th percentile;
- the parent and child live together ≥50% of the time;
- the parent and child are able to read, speak and understand English;
- the family has transportation to the University of Delaware; and
Key exclusion criteria (3 listed)
- the child is participating in a weight management program or seeing a Registered Dietitian for weight loss;
- the child is taking weight loss medication or medication that impacts appetite; or
- the child has a medical condition that impacts growth or has a medical condition that requires a specific eating plan.
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 |
|---|---|---|
| family-based obesity prevention lifestyle interventionA family-based obesity prevention lifestyle intervention is based on the combination of behavioral therapy strategies, a physical activity prescription and a dietary prescription. Both the parent and child will be working to achieve the same behavioral targets. | Behavioural | LOW-ED, STANDARD |
Primary outcome
Dietary Energy Density
Time frame: 6 months
Dietary intake will be analyzed using NDSR and energy density (kcal/g) will be calculated.
Energy Intake
Time frame: 6 months
Dietary intake will be analyzed using NDSR and energy intake will be calculated.
Dietary Quality
Time frame: 6 months
Dietary intake will be analyzed using NDSR and used to calculate a Healthy Eating Index score.
1 secondary outcome
zBMI
Time frame: 6 months
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 18 May 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing family-based obesity prevention lifestyle intervention in people with Obesity, Childhood and Energy Density, run by University of Delaware 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 6 inclusion and 3 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 18 May 2022. 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?
Dietary Energy Density (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 May 2022.