HealthPartners Research Foundation
Bloomington, Minnesota, 55425, United States
NCT Number: NCT01080885
The goals of this study are to evaluate the feasibility, acceptability, and potential efficacy of an innovative obesity prevention intervention integrating pediatrician counseling and a home-based program to prevent unhealthy weight gain among 2-4 year old children at risk for obesity.
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Notify Me2 year–4 year
All sexes
Interventional
Not applicable
Bloomington, Minnesota, 55425, United States
The pediatric primary care setting is a relatively untapped resource for addressing obesity prevention. The goals of this developmental study are to develop and evaluate the feasibility and acceptability of a primary care-based, preschool obesity prevention intervention integrating pediatrician counseling and a home-based program for parents of 2-4 year old children at risk for obesity. We propose to recruit 60 parent-child dyads from families of 2-4 year old at risk children (e.g., BMI between the 85th and 95th percentile for age and gender or a BMI between the 50th and 85th percentile and at least one overweight parent) and randomize each dyad to one of the following groups: (a) Healthy Eating/Physical Activity Intervention including brief pediatrician counseling regarding the child's current BMI%ile status, recommendations for home environmental changes to achieve a healthy weight gain trajectory, and home safety and injury risk reduction recommendations paired with a 6 month home-based program delivered via phone by a health behavior specialist to promote implementation of the obesity prevention home environmental strategies, or (b) General Health/Safety/Injury Prevention Contact Control Intervention: Families will receive the same brief counseling from their pediatrician paired with a 6 month home-based program delivered via phone by a health behavior specialist to promote implementation of the general health, safety and injury prevention home environmental strategies.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This intervention will include brief counseling from the pediatrician paired with a 6 month home-based program delivered via phone by a masters-level health behavior specialist to promote implementation of the healthy eating and physical activity home environmental strategies.
This intervention will include the same brief counseling from the pediatrician paired with a 6 month home-based program delivered via phone by a masters-level health behavior specialist to promote implementation of the safety and injury prevention home environmental strategies.
Time frame: 6 months
Parents of at risk preschool children and pediatricians will show high participation rates in and report high levels of satisfaction with the interventions.
Time frame: 6 months
Healthy Eating/Physical Activity Home-based Intervention participants will show lower levels of sweetened beverage and higher levels of lower fat/calorie snack and meal consumption compared to Safety/Injury Prevention Home-based Contact Control Intervention participants. The Nutrition Data System for Research will be used to measure this change.
Time frame: 6 months
Healthy Eating/Physical Activity Home-based Intervention participants will show lower levels of TV watching compared to Safety/Injury Prevention Home-based Contact Control Intervention participants;
Time frame: 6 months
Healthy Eating/Physical Activity Home-based Intervention participants will show higher levels of physical activity compared to Safety/Injury Prevention Home-based Contact Control Intervention participants. Physical activity level will be measured by accelerometry.
Time frame: 6 months
Parents in the Healthy Eating/Physical Activity Home-based Intervention will report more favorable levels of hypothesized mediators of BMI change (e.g., family meal frequency, availability of lower fat/calorie foods and physical activity opportunities) compared to Safety/Injury Prevention Home-based Contact Control Intervention participants.
Time frame: 6 months
Participation in the Healthy Eating/Physical Activity Home-based Intervention will lead to reduced BMI percentile compared to Safety/Injury Prevention Home-based Contact Control Intervention participant.
HealthPartners Institute
Other
Linking Home Environments and Primary Care: Obesity Prevention for 2-5 Year Olds
Acronym: HHHK
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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