KIDFIT: Keeping Ideal Cardiovascular Health Family Intervention Trial
| Status: | Recruiting |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 3 - 5 |
| Updated: | 1/13/2019 |
| Start Date: | June 13, 2018 |
| End Date: | September 2020 |
| Contact: | Sarah Al-Sharif, MPH |
| Email: | sarah.al-sharif@northwestern.edu |
| Phone: | 312-503-4922 |
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
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
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.
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.
Inclusion Criteria: Because this cohort includes former participants of the MOMFIT study,
there are certain pre-existing criteria regarding the health, age, and antenatal BMI (25-40
kg/m2) among the mothers of the KIDFIT children. In addition, eligibility for this study
requires willingness of the mother/child dyad:
- to be randomized
- to attend study visits and participate in intervention sessions
- to monitor the child's diet, physical activity, and sleep
Exclusion Criteria:
- 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
We found this trial at
1
site
680 North Lake Shore Drive
Chicago, Illinois 60611
Chicago, Illinois 60611
Principal Investigator: Linda V Van Horn, PhD
Phone: 312-503-4922
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