KIDFIT: Keeping Ideal Cardiovascular Health Family Intervention Trial

NCT03405246 | Unknown DMC

• 1 other identifier: 17SFRN33700242
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief 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 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

Conditions

Childhood Obesity; Weight Gain; Diet Modification

Keywords

Childhood obesity; Weight gain in children; Diet intervention

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 12-months, 18-months

Secondary Outcomes (1)

• Body Mass Index (BMI) percentile

  Baseline, 12-months, 18-months

Study Arms (2)

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.

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.

Behavioral: KIDFIT HEALTHY

Interventions

KIDFIT HEALTHY BEHAVIORAL

KIDFIT Healthy intervention combines traditional in-person and electronic participant contacts.

Also known as: Intervention Group

KIDFIT HEALTHY

KIDFIT SAFE BEHAVIORAL

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.

Also known as: Control Group

KIDFIT SAFE

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• to be randomized
• to attend study visits and participate in intervention sessions
• to monitor the child's diet, physical activity, and sleep

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• American Heart Association: collaborator

Study Sites (1)

Northwestern Univeristy: Department of Preventive Medicine

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Pediatric Obesity; Weight Gain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Linda V Van Horn, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Northwestern University

Study Record Dates

• First Submitted: January 12, 2018
• First Posted: January 23, 2018
• Study Start: June 13, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: April 5, 2022

Record last verified: 2021-08

Locations

US (1)