Childhood ObesityNCT03405246
KIDFIT: Keeping Ideal Cardiovascular Health Family Intervention Trial
A study testing KIDFIT HEALTHY and KIDFIT SAFE in people with Childhood Obesity and Weight Gain, run by Northwestern University at 1 site in United States.
Trial summary
Adverse influences starting in utero may predestine an individual's long- term risk for developing cardiometabolic diseases. The Keeping Ideal CVH (cardiovascular health) Family Intervention Trial (KIDFIT) will test whether preschool-age children, born to overweight/obese (OW/OB (mothers who did or did not experience… Read more about this study
- Who is it for?
- Ages 3 to 5 years
- Conditions the study is for
- Childhood Obesity, Weight Gain, Diet Modification
- What is being tested?
- KIDFIT HEALTHY and KIDFIT SAFE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2018to 31 Dec 2023
- 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 3 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- planning to move away within 18 months
- child has a medical condition (e.g. fed by gastric tube, wheelchair user) that limits ability or willingness to adhere to diet and activity recommendations (parents will be encouraged to discuss with their pediatrician if there is any question)
- child is already under the care of a nutritionist and mother and/or nutritionist unwilling to collaborate with KIDFIT Dietitian-Interventionist to optimize diet recommendations
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Univeristy: Department of Preventive Medicine
Chicago, Illinois, 60611
About this study
Official title: Keeping Ideal Cardiovascular Health Family Intervention Trial (KIDFIT)
Adverse influences starting in utero may predestine an individual's long- term risk for developing cardiometabolic diseases. The Keeping Ideal CVH (cardiovascular health) Family Intervention Trial (KIDFIT) will test whether preschool-age children, born to overweight/obese (OW/OB (mothers who did or did not experience a diet and lifestyle intervention to reduce GWG: 1) demonstrate more favorable adiposity (body fat %), body mass index percentiles (BMI%), diet quality (DASH diet score), physical activity, and other CVH metrics at baseline according to antenatal intervention status; and 2) respond to an early childhood intervention targeting diet and lifestyle behaviors with improvement in these same adiposity and CVH metrics.
We hypothesize children randomized to the KIDFIT diet and lifestyle intervention group at age 3-5 years, regardless of initial maternal antenatal group assignment, will demonstrate more favorable adiposity changes assessed by anthropometry (body fat %/sum of skinfolds) and a lower cumulative incidence of obesity after the 12-month intervention, as compared with the control group. Additionally, after 12 months of the KIDFIT Intervention, children will have more favorable blood pressure and blood lipids, better diet quality (as measured by the DASH-style diet score), increased physical activity levels, and more optimal sleep duration, without adverse effects on height, compared to the control group
Read the detailed description
A randomized controlled trial (RCT) is planned among 140 of the MOMFIT offspring, aged 3-5 years old. The KIDFIT Study follows final data collection in the MOMFIT RCT. Moms were randomized to either the MAMA DASH Diet and lifestyle intervention or the "Web-Watcher" enhanced usual care group that received periodic newsletters highlighting publicly available websites and reputable links related to healthy pregnancy. The first MOMFIT baby was born in September 2013 and the last was born in July 2016; the KIDFIT cohort will include children who are ages 3-5 years at the time of randomization. Post-partum, the MAMA DASH Intervention Group received ongoing encouragement for maternal adherence to the DASH Diet and breastfeeding of the child for as long as possible, preferably at least six months. General diet information regarding post-weaning was provided briefly to further encourage maternal adherence to the diet. KIDFIT will randomize children stratified by the original MOMFIT groups to either the DASH Diet and Lifestyle intervention (called KIDFIT-Healthy) or enhanced (websites/apps) Usual Care called KIDFIT-Safe. Children randomized to the intervention group will have a 12 month diet and lifestyle intervention that will implement the DASH kids diet, encourage physical activity, limit screen time, and encourage 10 to 13 hours of sleep. Mother-Child Dyads randomized to the usual care group will be sent monthly guides addressing environmentally safe home settings to raise children and given related resources for healthy family lifestyle habits for their family.
The KIDFIT clinical intervention will develop, implement and test a lifestyle intervention to determine whether (1) children ages 3-5 years, born to overweight/obese (OW/OB) mothers who adhered to an antenatal diet and lifestyle intervention, demonstrate improvements in weight gain trajectories, diet pattern quality, physical activity levels and other ideal cardiovascular health (iCVH) measures compared to children whose OW/OB mothers underwent usual care; (2) lifestyle intervention at ages 3-5 years is associated with improvements in those same measures independent of or additive to maternal intervention; and (3) epigenetic mechanisms and molecular pathways underlying these associations can be differentiated.KIDFIT results will help determine whether antenatal diet and lifestyle interventions and/or early life child-focused diet and lifestyle interventions offer the potential for prevention of obesity, thereby maintaining iCVH earlier and longer.
- Conditions
- Childhood Obesity, Weight Gain, Diet Modification
- Being tested
- KIDFIT HEALTHY, KIDFIT SAFE
- Keywords
- Childhood obesity, Weight gain in children, Diet intervention
- Medical subject headings
- Pediatric Obesity, Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KIDFIT HEALTHYBehavioural
Also called Intervention Group
KIDFIT Healthy intervention combines traditional in-person and electronic participant contacts.
KIDFIT SAFEBehavioural
Also called Control Group
KIDFIT Safe group will be referred to the KIDFIT Safe website for monthly Homestyles Safe Guides about safe home environments for raising children and related material emailed monthly to the moms.
| Study group | Role | What they receive |
|---|---|---|
| KIDFIT SAFE | Active comparator | The Control Group will be provided 12 web-based monthly Homestyles Safe Guides about safe home environments for raising children and related material emailed monthly to the moms. KIDFIT Safe web site targets environmentally safe childcare related topics such as use of sun screen, avoidance of choking hazards, pet safety, protection from electrical appliances, etc. KIDFIT Safe participants will attend both baseline and 12 month clinical visits. Receives: Behavioral: KIDFIT SAFE |
| KIDFIT HEALTHY | Experimental | The KIDFIT intervention group combines traditional in-person and electronic participant contacts, including two scheduled individual visits with a nutrition coach, coaching calls throughout the year, and monthly group videoconferencing-type sessions. KIDFIT Healthy participants will attend both baseline and 12 month clinical visits. Receives: Behavioral: KIDFIT HEALTHY |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body fat percent
The primary outcome is change from baseline body fat percent of the child at 12 or 18-month visit. Body fat percent is assessed by sum of the skin folds at 4 locations: triceps, thigh, subscapular, suprailiac.
Measured: Baseline, 12-months, 18-months
Secondary outcomes (1)
Body Mass Index (BMI) percentile
The secondary outcome is sex and age-specific BMI percentile of the child.
Measured: Baseline, 12-months, 18-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start13 Jun 2018
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- More trials run by Northwestern 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Linda Van Horn, Northwestern University
- Investigators
- Linda V Van Horn, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03405246
- Sponsor's protocol ID
- 17SFRN33700242
- Status last verified
- Aug 2021
- First submitted
- 12 Jan 2018
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Keeping Ideal Cardiovascular Health Family Intervention Trial (KIDFIT)
- ClinicalTrials.gov ID
- NCT03405246
- Acronym / sponsor ID
- 17SFRN33700242
- Conditions
- Childhood Obesity, Weight Gain, Diet Modification
- Keywords
- Childhood obesity, Weight gain in children, Diet intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 13 Jun 2018 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 23 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.
Adverse influences starting in utero may predestine an individual's long- term risk for developing cardiometabolic diseases. The Keeping Ideal CVH (cardiovascular health) Family Intervention Trial (KIDFIT) will test whether preschool-age children, born to overweight/obese (OW/OB (mothers who did or did not experience a diet and lifestyle intervention to reduce GWG: 1) demonstrate more favorable adiposity (body fat %), body mass index percentiles (BMI%), diet quality (DASH diet score), physical activity, and other CVH metrics at baseline according to antenatal intervention status; and 2) respond to an early childhood intervention targeting diet and lifestyle behaviors with improvement in these same adiposity and CVH metrics.
We hypothesize children randomized to the KIDFIT diet and lifestyle intervention group at age 3-5 years, regardless of initial maternal antenatal group assignment, will demonstrate more favorable adiposity changes assessed by anthropometry (body fat %/sum of skinfolds) and a lower cumulative incidence of obesity after the 12-month intervention, as compared with the control group. Additionally, after 12 months of the KIDFIT Intervention, children will have more favorable blood pressure and blood lipids, better diet quality (as measured by the DASH-style diet score), increased physical activity levels, and more optimal sleep duration, without adverse effects on height, compared to the control group
Detailed description
A randomized controlled trial (RCT) is planned among 140 of the MOMFIT offspring, aged 3-5 years old. The KIDFIT Study follows final data collection in the MOMFIT RCT. Moms were randomized to either the MAMA DASH Diet and lifestyle intervention or the "Web-Watcher" enhanced usual care group that received periodic newsletters highlighting publicly available websites and reputable links related to healthy pregnancy. The first MOMFIT baby was born in September 2013 and the last was born in July 2016; the KIDFIT cohort will include children who are ages 3-5 years at the time of randomization. Post-partum, the MAMA DASH Intervention Group received ongoing encouragement for maternal adherence to the DASH Diet and breastfeeding of the child for as long as possible, preferably at least six months. General diet information regarding post-weaning was provided briefly to further encourage maternal adherence to the diet. KIDFIT will randomize children stratified by the original MOMFIT groups to either the DASH Diet and Lifestyle intervention (called KIDFIT-Healthy) or enhanced (websites/apps) Usual Care called KIDFIT-Safe. Children randomized to the intervention group will have a 12 month diet and lifestyle intervention that will implement the DASH kids diet, encourage physical activity, limit screen time, and encourage 10 to 13 hours of sleep. Mother-Child Dyads randomized to the usual care group will be sent monthly guides addressing environmentally safe home settings to raise children and given related resources for healthy family lifestyle habits for their family.
The KIDFIT clinical intervention will develop, implement and test a lifestyle intervention to determine whether (1) children ages 3-5 years, born to overweight/obese (OW/OB) mothers who adhered to an antenatal diet and lifestyle intervention, demonstrate improvements in weight gain trajectories, diet pattern quality, physical activity levels and other ideal cardiovascular health (iCVH) measures compared to children whose OW/OB mothers underwent usual care; (2) lifestyle intervention at ages 3-5 years is associated with improvements in those same measures independent of or additive to maternal intervention; and (3) epigenetic mechanisms and molecular pathways underlying these associations can be differentiated.KIDFIT results will help determine whether antenatal diet and lifestyle interventions and/or early life child-focused diet and lifestyle interventions offer the potential for prevention of obesity, thereby maintaining iCVH earlier and longer.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KIDFIT SAFE | Active comparator | Behavioral: KIDFIT SAFEThe Control Group will be provided 12 web-based monthly Homestyles Safe Guides about safe home environments for raising children and related material emailed monthly to the moms. KIDFIT Safe web site targets environmentally safe childcare related topics such as use of sun screen, avoidance of choking hazards, pet safety, protection from electrical appliances, etc. KIDFIT Safe participants will attend both baseline and 12 month clinical visits. |
| KIDFIT HEALTHY | Experimental | Behavioral: KIDFIT HEALTHYThe KIDFIT intervention group combines traditional in-person and electronic participant contacts, including two scheduled individual visits with a nutrition coach, coaching calls throughout the year, and monthly group videoconferencing-type sessions. KIDFIT Healthy participants will attend both baseline and 12 month clinical visits. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- planning to move away within 18 months
- child has a medical condition (e.g. fed by gastric tube, wheelchair user) that limits ability or willingness to adhere to diet and activity recommendations (parents will be encouraged to discuss with their pediatrician if there is any question)
- child is already under the care of a nutritionist and mother and/or nutritionist unwilling to collaborate with KIDFIT Dietitian-Interventionist to optimize diet recommendations
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 |
|---|---|---|
| KIDFIT HEALTHYAlso: Intervention GroupKIDFIT Healthy intervention combines traditional in-person and electronic participant contacts. | Behavioural | KIDFIT HEALTHY |
| KIDFIT SAFEAlso: Control GroupKIDFIT Safe group will be referred to the KIDFIT Safe website for monthly Homestyles Safe Guides about safe home environments for raising children and related material emailed monthly to the moms. | Behavioural | KIDFIT SAFE |
Primary outcome
Body fat percent
Time frame: Baseline, 12-months, 18-months
The primary outcome is change from baseline body fat percent of the child at 12 or 18-month visit. Body fat percent is assessed by sum of the skin folds at 4 locations: triceps, thigh, subscapular, suprailiac.
1 secondary outcome
Body Mass Index (BMI) percentile
Time frame: Baseline, 12-months, 18-months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 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.
Linda V Van Horn, PhD principal investigator
Northwestern 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 KIDFIT HEALTHY and KIDFIT SAFE in people with Childhood Obesity and Weight Gain, run by Northwestern 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 0 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: status not confirmed, as of the sponsor's last update on 5 Apr 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?
Results are not available in the source record.
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?
Body fat percent (time frame: Baseline, 12-months, 18-months). 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 5 Apr 2022.