Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Childhood Obesity
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 5 years and 11 years
Gender
Both males and females

Description

This study will utilize a purposive (non-random) sampling strategy. Children belonging to a family headed by a parent/guardian will be identified local healthcare providers practicing in any rural Indiana counties. The sampling frame will be based on the list of pediatric patients who meet eligibili...

This study will utilize a purposive (non-random) sampling strategy. Children belonging to a family headed by a parent/guardian will be identified local healthcare providers practicing in any rural Indiana counties. The sampling frame will be based on the list of pediatric patients who meet eligibility criteria who currently receive services from the rural pediatric practices. Members of the research team will not have access to any medical records. Identification of the universe of eligible participants is at the sole discretion of the healthcare provider. This study has a set of primary and secondary objectives for children and their parents/guardians, and a separate set of hypotheses for the feasibility of intervention delivery. The short-term goal is to develop a prototype for a theory-driven, tailored, family-based, telehealth intervention that can sustainably reduce pediatric obesity rates in rural areas. The long-term goal is to sustainably reduce pediatric obesity and its consequences in rural areas, solely via behavioral change. The primary objectives for children are to improve children's behavioral indicators in terms of nutrition, physical activity, sleep, and sedentary behaviors, measured both objectively and subjectively and sustain them over time. In the end of phase-1 (at crossover point), improvement of behavioral indicators related to nutrition, physical activity, sleep, and sedentary behaviors among children who were in the intervention group will be superior to those in the control group, however, there will be no difference after phase-2 (end of study). The secondary objective for children is to improve children's body composition, measured with the age-sex based BMI percentile. In the end of phase 1, improvement in age-sex based BMI percentile among children who were in the intervention group will be superior to those who were in the control group; however, there will be no difference after phase 2. The primary objectives for parents/guardians are to improve caregivers' attitudes and skills, measured as constructs in the Theory of Planned Behavior (i.e., attitudes toward behavior, subjective norms, perceived behavioral control, and response efficacy), that are necessary to change their child's behaviors. In the end of phase 1, parents/guardians who were in the intervention group will show improved attitudes and skills that evidence suggests helps to change their child's behaviors, compared to those who were in the control group. The secondary objectives for parents/guardians is to improve perceived stress and quality of life among parents/guardians. In the end of phase 1, perceived stress and perceived quality of life among parents/guardians will be better in the intervention group than the control group; however, there will be no difference after phase 2. The tertiary objective is to assess the feasibility of the intervention at the end of the study for the intervention group only. Intervention will have the levels of attendance and participation (i.e., interaction) and technology feasibility (i.e., internet connectivity and digital literacy) required for it to be successful.

Tracking Information

NCT #
NCT04720703
Collaborators
Not Provided
Investigators
Principal Investigator: Wasantha P Jayawardene, MD, MS, PhD Indiana University School of Public Health-Bloomington Principal Investigator: Mary Lynn Davis-Ajami, PhD, MBA, MS Indiana University School of Nursing-Bloomington Study Director: Allisandra G Kummer Indiana University School of Public Health-Bloomington