Childhood ObesityNCT02923050

Simple Suppers Scale-up (S3)

A study testing Simple Suppers in people with Childhood Obesity, run by Ohio State University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to determine effectiveness of a family meals intervention, Simple Suppers, aimed at eliciting positive changes in child dietary intake and weight status. Read more about this study

Who is it for?: Ages 4 to 10 yearsHealthy volunteers can take part
Conditions the study is for: Childhood Obesity
What is being tested?: Simple Suppers
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 223 participants
Where: No sites listed yet
Study dates: Jan 2015to Jul 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 4 to 10 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Caregivers: Primary food preparer in the home; responsible for at least one child 4-10 years of age; speak English as the primary language in the home; lived in the U.S. for at least one year.

Who cannot join

Family member: Following a restrictive or therapeutic diet.

About this study

Official title: Simple Suppers Scale-up (S3): an Expanded Pilot Study to Determine the Effectiveness of a Family Meals Intervention Aimed at Eliciting Positive Changes in Child Diet and Weight Status

The purpose of this study is to determine effectiveness of a family meals intervention, Simple Suppers, aimed at eliciting positive changes in child dietary intake and weight status.

Conditions: Childhood Obesity
Being tested: Simple Suppers
Medical subject headings: Pediatric Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Simple SuppersBehavioural
Theory-based 10-week family meals program

Study groups in NCT02923050
Study group	Role	What they receive
Waitlist control	No intervention	Not described
10-week family meals program	Experimental	Not described Receives: Behavioral: Simple Suppers

What is being measured

The primary outcome is the main question the study is designed to answer.

Child standardized body mass index (BMI)
Measured: Change from baseline child BMI at 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2015Jul 2016

First posted4 Oct 2016 (estimated)
Study startJan 2015
Primary completionJul 2016
Study completionJul 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Childhood ObesityStudies of the same condition, open and under way.
More trials run by Ohio State UniversityThe sponsor's other registered studies.
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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 223 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02923050
Sponsor's protocol ID: 2014B0494
Status last verified: Oct 2016
First submitted: 28 Sep 2016
Last updated: 4 Oct 2016
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

Gunther C, Rogers C, Holloman C, Hopkins LC, Anderson SE, Miller CK, Copeland KA, Dollahite JS, Pratt KJ, Webster A, Labyk AN, Penicka C. Child diet and health outcomes of the simple suppers program: a 10-week, 2-group quasi-experimental family meals trial. BMC Public Health. 2019 Dec 10;19(1):1657. doi: 10.1186/s12889-019-7930-7.
PubMed 31823753
Rogers C, Anderson SE, Dollahite JS, Hill TF, Holloman C, Miller CK, Pratt KJ, Gunther C. Methods and design of a 10-week multi-component family meals intervention: a two group quasi-experimental effectiveness trial. BMC Public Health. 2017 Jan 9;17(1):50. doi: 10.1186/s12889-016-3908-x.
PubMed 28069006

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity
Active, not recruiting
Growing Healthy Children and Families in Rural Arkansas
Pediatric Obesity, Health Behavior, Risky
Recruiting
Cities for Better Health Childhood Obesity Prevention Initiative in JAPAN
Quality of Life (QOL), Nutrition
Not yet recruiting
Weight Gain in Pediatric Leukemia Survivors
Leukemia, Pediatric Acute Lymphoblastic Leukemia

All Childhood Obesity trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Simple Suppers Scale-up (S3): an Expanded Pilot Study to Determine the Effectiveness of a Family Meals Intervention Aimed at Eliciting Positive Changes in Child Diet and Weight Status
ClinicalTrials.gov ID: NCT02923050
Acronym / sponsor ID: 2014B0494
Conditions: Childhood Obesity
Study type: Interventional
Recruitment status: Completed
Enrolment: 223 participants (actual)
Lead sponsor: Ohio State UniversityUniversity, hospital or other
Collaborators: Cardinal Health
Study start: Jan 2015
Primary completion: Jul 2016 (actual)
Study completion: Jul 2016 (actual)
First posted: 4 Oct 2016 (estimated)
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.

The purpose of this study is to determine effectiveness of a family meals intervention, Simple Suppers, aimed at eliciting positive changes in child dietary intake and weight status.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Waitlist control	No intervention	–
10-week family meals program	Experimental	Behavioral: Simple Suppers

Who may qualify

Ages: 4 to 10 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (1 listed)

Caregivers: Primary food preparer in the home; responsible for at least one child 4-10 years of age; speak English as the primary language in the home; lived in the U.S. for at least one year.

Key exclusion criteria (1 listed)

Family member: Following a restrictive or therapeutic diet.

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
Simple SuppersTheory-based 10-week family meals program	Behavioural	10-week family meals program

Primary outcome

Child standardized body mass index (BMI)
Time frame: Change from baseline child BMI at 10 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 4 Oct 2016.
Derived from this study: PubMed 31823753Gunther C, Rogers C, Holloman C, Hopkins LC, Anderson SE, Miller CK, Copeland KA, Dollahite JS, Pratt KJ, Webster A, Labyk AN, Penicka C. Child diet and health outcomes of the simple suppers program: a 10-week, 2-group quasi-experimental family meals trial. BMC Public Health. 2019 Dec 10;19(1):1657. doi: 10.1186/s12889-019-7930-7.
Derived from this study: PubMed 28069006Rogers C, Anderson SE, Dollahite JS, Hill TF, Holloman C, Miller CK, Pratt KJ, Gunther C. Methods and design of a 10-week multi-component family meals intervention: a two group quasi-experimental effectiveness trial. BMC Public Health. 2017 Jan 9;17(1):50. doi: 10.1186/s12889-016-3908-x.
Individual participant dataSharing planned: No

Related trials for Childhood Obesity

RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity
Active, not recruiting
Growing Healthy Children and Families in Rural Arkansas
Pediatric Obesity, Health Behavior, Risky
Recruiting
Cities for Better Health Childhood Obesity Prevention Initiative in JAPAN
Quality of Life (QOL), Nutrition
Not yet recruiting
Weight Gain in Pediatric Leukemia Survivors
Leukemia, Pediatric Acute Lymphoblastic Leukemia

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.

Questions about this trial

What is this clinical trial studying?

A study testing Simple Suppers in people with Childhood Obesity, run by Ohio State University.

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 1 inclusion and 1 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 4 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

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?

Child standardized body mass index (BMI) (time frame: Change from baseline child BMI at 10 weeks). 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 NCT02923050, which also lists 2 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 4 Oct 2016.